<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04437238</url>
  </required_header>
  <id_info>
    <org_study_id>KeepWell RCT</org_study_id>
    <nct_id>NCT04437238</nct_id>
  </id_info>
  <brief_title>Pilot Evaluation of &quot;KeepWell&quot; Using a Hybrid Effectiveness-Implementation Pragmatic Randomized Controlled Trial</brief_title>
  <official_title>Effectiveness of an eHealth Tool for Older Adults With Multimorbidity (&quot;KeepWell&quot;): Protocol for a Hybrid Effectiveness-implementation, Pragmatic Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>North York General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Unity Health Toronto</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Sunnybrook Health Sciences Centre</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>North York General Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The burden of chronic disease is a global phenomenon, particularly amongst seniors. Aging is&#xD;
      an expensive process. In Canada, 10% of seniors who have the most complex health needs&#xD;
      account for 60% of the total annual health care spending in many provinces. Given these&#xD;
      projections, we need to adapt our current models of care. In response, different chronic&#xD;
      disease management tools have been created with a central aim to facilitate ongoing,&#xD;
      proactive and preventive support for optimal chronic disease management. In particular,&#xD;
      self-management tools have been acknowledged as an effective way to optimize disease&#xD;
      management and are easily scalable and can reach a broader population of older people with&#xD;
      chronic diseases. In fact, online self-management tools are particularly relevant for&#xD;
      supporting seniors with complex care needs in their homes; and they are interested in using&#xD;
      the Internet and social media. However, interventions and tools seldom consider all aspects&#xD;
      of disease management, are not usually developed specifically for seniors or created for&#xD;
      sustained use and are primarily focused on a single disease. As such, the projected health&#xD;
      outcomes of seniors continue to remain poor, and the quality and efficiency of care remain&#xD;
      sub-optimal. To respond to these challenges, we created an eHealth self-management&#xD;
      application called &quot;KeepWell&quot; that supports seniors with complex care needs in their homes.&#xD;
      It is a patient-centered, multi-chronic disease management tool that incorporates the care&#xD;
      for two or more chronic conditions from among the top high-burden chronic diseases. KeepWell&#xD;
      was built on a strong evidentiary base including several knowledge syntheses, a co-design&#xD;
      process with our integrated knowledge translation team involving patients, researchers,&#xD;
      clinicians and developers; and a usability and pilot evaluation. The objectives of our study&#xD;
      will be to evaluate the effectiveness, economic impact and uptake of KeepWell in a 6-month,&#xD;
      pragmatic, hybrid effectiveness-implementation randomized controlled trial (RCT).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Methods&#xD;
&#xD;
      Design We will evaluate the effectiveness and uptake of the KeepWell solution in a 6-month,&#xD;
      pragmatic, hybrid effectiveness-implementation RCT for optimizing and sustaining the&#xD;
      self-management of older adults with multimorbidity. We will use the type 2 design, which&#xD;
      facilitates the simultaneously investigation of the effectiveness of an intervention while&#xD;
      rigorously testing the implementation strategy. The implementation evaluation will be guided&#xD;
      by the Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM) framework.&#xD;
&#xD;
      Theoretical basis of our work We used the Knowledge-to-Action (KTA) model to guide our&#xD;
      methods. Our team has experience applying the KTA framework in creating technology-based&#xD;
      interventions [refs]. We have also adapted an integrated KT (IKT) strategy whereby all our&#xD;
      stakeholder team members who helped us to create KeepWell and prepare this protocol are going&#xD;
      to continue to steer the execution of our study. This team helped to develop the objectives,&#xD;
      project plan and timelines; discussed potential barriers and mitigating strategies, and&#xD;
      monitored progress.&#xD;
&#xD;
      Population and recruitment Older adults will be identified with support from: (i) the&#xD;
      University of Toronto Primary Care Research Network (UTOPIAN); (ii) the Retired Teachers of&#xD;
      Ontario (RTO); and (iii) our clinician (geriatricians and family physicians) partnering&#xD;
      sites: North York General Hospital, St. Michael's hospital of Unity Health, Sunnybrook&#xD;
      healthcentre, and St. Peter's hospital. All these recruitment sources have a roster of older&#xD;
      adults with multiple chronic conditions via their affiliated primary care and geriatric&#xD;
      clinics. We have created a recruitment poster that will be administered at each site&#xD;
      according to a procedure most feasible and practical for their practice flow and resources.&#xD;
      For example, the poster may be administered directly to older adults by family physicians and&#xD;
      geriatricians during a visit or through their clinic staff upon registering for a visit or&#xD;
      posted on walls. In addition, the poster will be distributed via an email listserv from our&#xD;
      patient partner organization, the RTO with a membership of more than 70,000 older adults.&#xD;
      Study eligibility criteria are: (i) age 65 years; (ii) have one or more of the following&#xD;
      chronic conditions: diabetes, heart failure, cardiovascular disease, dementia, chronic kidney&#xD;
      disease, osteoporosis, osteoarthritis, rheumatoid arthritis, Chronic Obstructive Pulmonary&#xD;
      Disease (COPD), depression, urinary incontinence, stroke; (iii) English speaking; (iv) access&#xD;
      to a computer or tablet device; (v) have an email address; and (vi) able to consent.&#xD;
      Consent-giving capacity will be assessed using the validated &quot;MacCAT-CR&quot; tool.&#xD;
&#xD;
      The recruitment poster includes a phone number and email address dedicated to this research&#xD;
      project. Potential participants will self-refer after reviewing the poster, by contacting the&#xD;
      research coordinator using one of two strategies: (1) if their mode of reply is by phone, the&#xD;
      research coordinator will review the study information sheet and consent process document&#xD;
      with potential participants and answer any questions. Study eligibility will also be&#xD;
      assessed. Participants will have the option to consent over the phone or via an online survey&#xD;
      (SurveyMonkey). Non-consenting respondents will be asked to provide a reason for their&#xD;
      decision; (2) if the mode of reply is email, an automated, email response system will be&#xD;
      initiated. The email will include the same study and consent process information as described&#xD;
      for the phone option and a link to a survey (via SurveyMonkey) that will include questions to&#xD;
      assess their eligibility and to obtain conent. Regardless of participants' mode of reply,&#xD;
      they will be enrolled and assigned a unique identification number and randomization sequence&#xD;
      as soon as the research coordinator receives confirmation of eligibility and consent. Once&#xD;
      they do, participants will receive an email with a link to KeepWell and their unique login&#xD;
      details (intervention condition) or to a link to an online survey to complete a risk&#xD;
      assessment questionnaire (usual care control condition).&#xD;
&#xD;
      Randomization and blinding Consenting participants will be randomly allocated to the&#xD;
      intervention (KeepWell) or control (usual care) using a random number generator. Consenting&#xD;
      participants will be assigned a login and password by the research coordinator, which they&#xD;
      can use to access the KepWell tool. Each individual login and password will be randomly&#xD;
      allocated into intervention or control using a 1:1 ratio; participants will be the unit of&#xD;
      randomization. The research coordinator will have the master list of logins and allocation.&#xD;
      Allocation will thus be concealed because this list will not be shared with the research&#xD;
      team. To protect against sources of bias, investigators, outcome assessors and data analysts&#xD;
      will be blinded to the randomization sequence. Blinding of older adults will not be possible&#xD;
      given that the intervention is a standalone, web-based tool and the control condition is&#xD;
      usual care.&#xD;
&#xD;
      Intervention and Control KeepWell is a fully functional, standalone eHealth application aimed&#xD;
      at supporting the self-management of older adults with multimorbidity. KeepWell can be used&#xD;
      on any electronic device and has innovative features that most other chronic disease&#xD;
      solutions don't have: (i) a multi-disease focus (it can generate lifestyle advice for any&#xD;
      combination of the top 10 chronic conditions affecting older adults); (ii) an avatar health&#xD;
      coach that walks users through a health prioritization and goal setting exercise; (iii) a&#xD;
      health risk questionnaire (HRQ) covering three risk dimensions: health (chronic diseases),&#xD;
      lifestyle (physical activity, diet, smoking, alcohol, caffeine, bladder health), and social&#xD;
      and emotional well-being (social frailty, isolation, loneliness); (iv) an evidence-based&#xD;
      Action plan with lifestyle advice customized to user's risks; and (v) other eHealth&#xD;
      self-management tactics that have been shown to improve outcomes (interactive lifestyle&#xD;
      tracker, journaling. A health coach avatar leads users through a health priority and goal&#xD;
      setting exercise that allows them to create a customized action plan based on guideline&#xD;
      recommendations for lifestyle changes. Users can then put their plan into action through a&#xD;
      lifestyle tracking feature that allows them to track their progress in their identified&#xD;
      lifestyle areas. KeepWell also has an extensive resource library, which has links to&#xD;
      additional high-quality health and lifestyle information across topics of interest to older&#xD;
      adults. Participants allocated to the control condition will receive care as usual but will&#xD;
      be asked to complete the health risk questionnaire at baseline, 3- and 6-month follow-up via&#xD;
      an online survey to collect outcomes data. The control group will receive full access to&#xD;
      KeepWell at the conclusion of the study.&#xD;
&#xD;
      Outcomes Primary outcome: perceived self-efficacy for managing identified chronic diseases or&#xD;
      risks measured at 6-months follow-up using a validated 6-item, self-efficacy scale, which is&#xD;
      embedded within the health risk questionnaire of the KeepWell platform. We selected this&#xD;
      outcome because increasing self-efficacy is a prerequisite for behaviour change which,&#xD;
      through improved self-management may influence health and healthcare use. All participants&#xD;
      will complete this outcome assessment via the health risk questionnaire of KeepWell at&#xD;
      baseline, 3- and 6-month follow-up.&#xD;
&#xD;
      Secondary outcomes: (i) self-efficacy at 3-months follow-up; (ii) cost description analysis&#xD;
      to assess the total cost of implementing the KeepWell overall and by stage (e.g., one-time&#xD;
      costs vs. ongoing costs); (iii) implementation outcomes according to Proctor et al: reach&#xD;
      (access), adoption (uptake, utilization); fidelity; maintenance; acceptability&#xD;
      (satisfaction), appropriateness (relevance), feasibility; (iv) patient reported outcomes&#xD;
      (self-reported disease management, perceived health and functional status, emotional&#xD;
      well-being, QOL); (v) patient-reported experiences (self-reported patient activation,&#xD;
      empowerment, patient-practitioner communication, shared decision-making). Outcomes will be&#xD;
      measured using the health risk questionnaire embedded within KeepWell and an online survey at&#xD;
      final follow-up.&#xD;
&#xD;
      Sample size calculation An increase in self efficacy of 40% is considered significant and has&#xD;
      been achieved in other studies of self-management interventions including one of the highest&#xD;
      quality studies of a chronic disease self-management program. In their Cochrane review of&#xD;
      lay-led self-management interventions, Foster et al found 10 studies that looked at self&#xD;
      efficacy and these interventions showed a small, statistically-significant improvement&#xD;
      (standardized mean difference -0.30, 95% confidence interval (CI) -0.41 to -0.19). Using&#xD;
      these estimates to calculate our sample size, targeting a power of 0.8 and assuming a dropout&#xD;
      rate of 25%, we estimate that 220 older adults are needed per group for a total of 440&#xD;
      participants. In a previous interrupted time series study, an Osteoporosis self-management&#xD;
      tool housed in a touch-screen laptop computer was implemented across 3 primary care practices&#xD;
      for 12 months, with a total of 350 patients who completed the risk assessment questionnaire,&#xD;
      so our proposed sample size of 440 patients is feasible, given our hospital and primary care&#xD;
      partnerships.&#xD;
&#xD;
      Analysis We will perform descriptive statistics (binary outcomes) and means and standard&#xD;
      deviations (continuous outcomes). For the primary outcome, a general linear model will be fit&#xD;
      to investigate differences between groups in self-efficacy at 6 months. We will adjust for&#xD;
      potential confounders (including baseline self-efficacy) and perform subgroup analyses&#xD;
      (patient chronic conditions, risk factors, mode of KeepWell use [Tablet/Laptop], age group&#xD;
      [65-74, 75-84, 85+], sex and gender). We will use the chi-squared and Fisher's exact test to&#xD;
      compare binary outcomes and independent two sample t-tests for continuous outcomes. We will&#xD;
      adjust for potential confounders in the final analysis (e.g., receipt of education about&#xD;
      chronic diseases and risks or specialist referrals); and perform subgroup analyses (e.g.,&#xD;
      setting, gender, and age: 65-74 and 75+). We will perform visual investigation (through&#xD;
      scatter plot displays) and analytical outcomes along with logistic regression analyses to&#xD;
      determine whether unique patient characteristics predict thresholds of use for different&#xD;
      KeepWell components. To examine the change in self-efficacy over time between groups&#xD;
      (incorporating self-efficacy scores at baseline, 3- and 6- months), we will use a linear&#xD;
      mixed-effects model. For the cost description analysis, we will estimate the cost to&#xD;
      delivering KeepWell from the public healthcare payer perspective, including out-of-pocket&#xD;
      costs for patients, technical costs for the clinic, efficiencies gained, estimated health&#xD;
      care utilization increases / reductions; and exploration resource costs required (e.g.,&#xD;
      online data collection / analysis, web system testing / hosting). The KeepWell platform&#xD;
      collects user data for these measures, so we will be able to track them longitudinally to&#xD;
      observe how the solution impacts on outcomes. The findings from the economic analysis will&#xD;
      represent the potential preliminary economic impact of KeepWell to the healthcare system. All&#xD;
      outcomes will be measured at baseline, 3- and 6-months follow-up and assessed according to&#xD;
      intention to treat. All statistical analyses will be carried out using the R statistical&#xD;
      software.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 1, 2020</start_date>
  <completion_date type="Actual">April 12, 2022</completion_date>
  <primary_completion_date type="Actual">March 31, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
    <masking_description>Consenting participants will be randomly allocated to the intervention (KeepWell) or control (usual care) using a random number generator; allocation will be concealed. Consenting participants will be assigned a login and password by the research coordinator, which they can use to access the KepWell tool. Each individual login and password will be randomly allocated into intervention or control using a 1:1 ratio; participants will be the unit of randomization. The research coordinator will have the master list of logins and allocation. Allocation will thus be concealed because this list will not be shared with the research team. To protect against sources of bias, investigators, outcome assessors and data analysts will be blinded to the randomization sequence. Blinding of older adults will not be possible given that the intervention is a standalone, web-based tool and the control condition is usual care.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Self-efficacy</measure>
    <time_frame>Measured at baseline and 6 months of follow-up</time_frame>
    <description>Self-efficacy for managing chronic disease (6-item scale)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Implementation</measure>
    <time_frame>Measured at 3 and 6 months of follow-up</time_frame>
    <description>Measurement of change between 3 and 6 months follow-up in implementation outcomes (reach, adoption, fidelity, maintenance, acceptability, appropriateness, feasibility)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient reported outcomes</measure>
    <time_frame>Measured at 3 and 6 months of follow-up</time_frame>
    <description>Change between 3 and 6 months of follow-up in self-reported disease management, perceived health and functional status, emotional well-being, quality of life</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change between 3 and 6 months of follow-up in patient reported experiences</measure>
    <time_frame>Measured at 3 and 6-months of followup</time_frame>
    <description>Self-reported patient activation, empowerment, patient-practitioner communication, shared decision-making.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Self-efficacy</measure>
    <time_frame>Measured at 3 months of follow-up</time_frame>
    <description>Self-efficacy for managing chronic disease (6-item scale)</description>
  </other_outcome>
  <other_outcome>
    <measure>The total cost of implementing KeepWell</measure>
    <time_frame>Cumulative, reported at 6 months of follow-up</time_frame>
    <description>Cost description analysis to assess the total cost of implementing KeepWell</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">456</enrollment>
  <condition>Chronic Disease</condition>
  <arm_group>
    <arm_group_label>Intervention - KeepWell tool</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>KeepWell is standalone eHealth application aimed at supporting the self-management of older adults with multimorbidity, and it has the following features: (i) lifestyle advice for any combination of the top 10 chronic conditions affecting older adults); (ii) an avatar health coach that walks users through a health prioritization and goal setting exercise; (iii) a health risk questionnaire (HRQ) covering health (chronic diseases), lifestyle (physical activity, diet, smoking, alcohol, caffeine, bladder health), and social and emotional well-being (social frailty, isolation, loneliness) dimensions; (iv) an evidence-based, customized Action plan; (v) an interactive lifestyle tracker; (vi) journaling; (vii) and a health resources library. A health coach avatar leads users through a health priority and goal setting exercise that allows them to create a customized action plan based on guideline recommendations for lifestyle changes.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants allocated to the control condition will receive care as usual but will be asked to complete the health risk questionnaire at baseline, 3- and 6-month follow-up via an online survey to collect outcomes data. The control group will receive full access to KeepWell at the conclusion of the study.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>KeepWell tool</intervention_name>
    <description>KeepWell is standalone eHealth application aimed at supporting the self-management of older adults with multimorbidity, and it has the following features: (i) lifestyle advice for any combination of the top 10 chronic conditions affecting older adults); (ii) an avatar health coach that walks users through a health prioritization and goal setting exercise; (iii) a health risk questionnaire (HRQ) covering health (chronic diseases), lifestyle (physical activity, diet, smoking, alcohol, caffeine, bladder health), and social and emotional well-being (social frailty, isolation, loneliness) dimensions; (iv) an evidence-based, customized Action plan; (v) an interactive lifestyle tracker; (vi) journaling; (vii) and a health resources library. A health coach avatar leads users through a health priority and goal setting exercise that allows them to create a customized action plan based on guideline recommendations for lifestyle changes.</description>
    <arm_group_label>Intervention - KeepWell tool</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Control - Usual care</intervention_name>
    <description>Participants allocated to the control condition will receive care as usual.</description>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
        (i) age 65 years; (ii) have one or more of the following chronic conditions: diabetes,&#xD;
        heart failure, cardiovascular disease, dementia, chronic kidney disease, osteoporosis,&#xD;
        osteoarthritis, rheumatoid arthritis, COPD, depression, urinary incontinence, stroke; (iii)&#xD;
        English speaking; (iv) access to a computer or tablet device; (v) have an email address;&#xD;
        and (vi) able to consent.&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
        (i) Non-English speaking; (ii) no access to a computer or tablet device; (ii) no email&#xD;
        address; and (iii) unable to consent (as assessed by the MacCAT-CR tool)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Monika Kastner, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>North York General Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>North York General Hospital</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M2K 1E1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>March 12, 2020</study_first_submitted>
  <study_first_submitted_qc>June 16, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 18, 2020</study_first_posted>
  <last_update_submitted>April 12, 2022</last_update_submitted>
  <last_update_submitted_qc>April 12, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 13, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>North York General Hospital</investigator_affiliation>
    <investigator_full_name>Monika Kastner</investigator_full_name>
    <investigator_title>Research Chair</investigator_title>
  </responsible_party>
  <keyword>Older adults</keyword>
  <keyword>Multimorbidity</keyword>
  <keyword>Web-based intervention</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Chronic Disease</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>We will share de-identified participant level data with our bio-statistician. We will share this information through encrypted, secured hospital email. We will also share all IPD that underlie results in a publication.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
    <ipd_time_frame>We will share supporting information at the beginning of the study for the purposes of sharing the plan with the research team and providing them with the opportunity to provide feedback on supporting information (2-4 weeks), and IPD at the conclusion of our study for the purposes of data interpretation and analysis (2-4 weeks).</ipd_time_frame>
    <ipd_access_criteria>The biostatistician and health economist will have access to PID to perform the analysis of primary and secondary outcomes including the cost analysis. They will have access to the data via an encrypted file via secured hospital email for 2-4 weeks or longer if needed (no more than 8 weeks).&#xD;
The biostatistician will perform descriptive statistics (binary outcomes) and means and standard deviations (continuous outcomes). For the primary outcome, a general linear model will be fit to investigate differences between groups in self-efficacy at 6 months. We will adjust for potential confounders and perform subgroup analyses. For the cost description analysis, the health economist will estimate the cost to delivering KeepWell, including out-of-pocket costs for patients, technical costs for the clinic, efficiencies gained, estimated health care utilization increases / reductions; and exploration resource costs required. All outcomes will be assessed according to intention to treat.</ipd_access_criteria>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04437238
org study id: KeepWell RCT
nct id: NCT04437238
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The burden of chronic disease is a global phenomenon, particularly amongst seniors. Aging is
      an expensive process. In Canada, 10% of seniors who have the most complex health needs
      account for 60% of the total annual health care spending in many provinces. Given these
      projections, we need to adapt our current models of care. In response, different chronic
      disease management tools have been created with a central aim to facilitate ongoing,
      proactive and preventive support for optimal chronic disease management. In particular,
      self-management tools have been acknowledged as an effective way to optimize disease
      management and are easily scalable and can reach a broader population of older people with
      chronic diseases. In fact, online self-management tools are particularly relevant for
      supporting seniors with complex care needs in their homes; and they are interested in using
      the Internet and social media. However, interventions and tools seldom consider all aspects
      of disease management, are not usually developed specifically for seniors or created for
      sustained use and are primarily focused on a single disease. As such, the projected health
      outcomes of seniors continue to remain poor, and the quality and efficiency of care remain
      sub-optimal. To respond to these challenges, we created an eHealth self-management
      application called "KeepWell" that supports seniors with complex care needs in their homes.
      It is a patient-centered, multi-chronic disease management tool that incorporates the care
      for two or more chronic conditions from among the top high-burden chronic diseases. KeepWell
      was built on a strong evidentiary base including several knowledge syntheses, a co-design
      process with our integrated knowledge translation team involving patients, researchers,
      clinicians and developers; and a usability and pilot evaluation. The objectives of our study
      will be to evaluate the effectiveness, economic impact and uptake of KeepWell in a 6-month,
      pragmatic, hybrid effectiveness-implementation randomized controlled trial (RCT).
Methods

      Design We will evaluate the effectiveness and uptake of the KeepWell solution in a 6-month,
      pragmatic, hybrid effectiveness-implementation RCT for optimizing and sustaining the
      self-management of older adults with multimorbidity. We will use the type 2 design, which
      facilitates the simultaneously investigation of the effectiveness of an intervention while
      rigorously testing the implementation strategy. The implementation evaluation will be guided
      by the Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM) framework.

      Theoretical basis of our work We used the Knowledge-to-Action (KTA) model to guide our
      methods. Our team has experience applying the KTA framework in creating technology-based
      interventions [refs]. We have also adapted an integrated KT (IKT) strategy whereby all our
      stakeholder team members who helped us to create KeepWell and prepare this protocol are going
      to continue to steer the execution of our study. This team helped to develop the objectives,
      project plan and timelines; discussed potential barriers and mitigating strategies, and
      monitored progress.

      Population and recruitment Older adults will be identified with support from: (i) the
      University of Toronto Primary Care Research Network (UTOPIAN); (ii) the Retired Teachers of
      Ontario (RTO); and (iii) our clinician (geriatricians and family physicians) partnering
      sites: North York General Hospital, St. Michael's hospital of Unity Health, Sunnybrook
      healthcentre, and St. Peter's hospital. All these recruitment sources have a roster of older
      adults with multiple chronic conditions via their affiliated primary care and geriatric
      clinics. We have created a recruitment poster that will be administered at each site
      according to a procedure most feasible and practical for their practice flow and resources.
      For example, the poster may be administered directly to older adults by family physicians and
      geriatricians during a visit or through their clinic staff upon registering for a visit or
      posted on walls. In addition, the poster will be distributed via an email listserv from our
      patient partner organization, the RTO with a membership of more than 70,000 older adults.
      Study eligibility criteria are: (i) age 65 years; (ii) have one or more of the following
      chronic conditions: diabetes, heart failure, cardiovascular disease, dementia, chronic kidney
      disease, osteoporosis, osteoarthritis, rheumatoid arthritis, Chronic Obstructive Pulmonary
      Disease (COPD), depression, urinary incontinence, stroke; (iii) English speaking; (iv) access
      to a computer or tablet device; (v) have an email address; and (vi) able to consent.
      Consent-giving capacity will be assessed using the validated "MacCAT-CR" tool.

      The recruitment poster includes a phone number and email address dedicated to this research
      project. Potential participants will self-refer after reviewing the poster, by contacting the
      research coordinator using one of two strategies: (1) if their mode of reply is by phone, the
      research coordinator will review the study information sheet and consent process document
      with potential participants and answer any questions. Study eligibility will also be
      assessed. Participants will have the option to consent over the phone or via an online survey
      (SurveyMonkey). Non-consenting respondents will be asked to provide a reason for their
      decision; (2) if the mode of reply is email, an automated, email response system will be
      initiated. The email will include the same study and consent process information as described
      for the phone option and a link to a survey (via SurveyMonkey) that will include questions to
      assess their eligibility and to obtain conent. Regardless of participants' mode of reply,
      they will be enrolled and assigned a unique identification number and randomization sequence
      as soon as the research coordinator receives confirmation of eligibility and consent. Once
      they do, participants will receive an email with a link to KeepWell and their unique login
      details (intervention condition) or to a link to an online survey to complete a risk
      assessment questionnaire (usual care control condition).

      Randomization and blinding Consenting participants will be randomly allocated to the
      intervention (KeepWell) or control (usual care) using a random number generator. Consenting
      participants will be assigned a login and password by the research coordinator, which they
      can use to access the KepWell tool. Each individual login and password will be randomly
      allocated into intervention or control using a 1:1 ratio; participants will be the unit of
      randomization. The research coordinator will have the master list of logins and allocation.
      Allocation will thus be concealed because this list will not be shared with the research
      team. To protect against sources of bias, investigators, outcome assessors and data analysts
      will be blinded to the randomization sequence. Blinding of older adults will not be possible
      given that the intervention is a standalone, web-based tool and the control condition is
      usual care.

      Intervention and Control KeepWell is a fully functional, standalone eHealth application aimed
      at supporting the self-management of older adults with multimorbidity. KeepWell can be used
      on any electronic device and has innovative features that most other chronic disease
      solutions don't have: (i) a multi-disease focus (it can generate lifestyle advice for any
      combination of the top 10 chronic conditions affecting older adults); (ii) an avatar health
      coach that walks users through a health prioritization and goal setting exercise; (iii) a
      health risk questionnaire (HRQ) covering three risk dimensions: health (chronic diseases),
      lifestyle (physical activity, diet, smoking, alcohol, caffeine, bladder health), and social
      and emotional well-being (social frailty, isolation, loneliness); (iv) an evidence-based
      Action plan with lifestyle advice customized to user's risks; and (v) other eHealth
      self-management tactics that have been shown to improve outcomes (interactive lifestyle
      tracker, journaling. A health coach avatar leads users through a health priority and goal
      setting exercise that allows them to create a customized action plan based on guideline
      recommendations for lifestyle changes. Users can then put their plan into action through a
      lifestyle tracking feature that allows them to track their progress in their identified
      lifestyle areas. KeepWell also has an extensive resource library, which has links to
      additional high-quality health and lifestyle information across topics of interest to older
      adults. Participants allocated to the control condition will receive care as usual but will
      be asked to complete the health risk questionnaire at baseline, 3- and 6-month follow-up via
      an online survey to collect outcomes data. The control group will receive full access to
      KeepWell at the conclusion of the study.

      Outcomes Primary outcome: perceived self-efficacy for managing identified chronic diseases or
      risks measured at 6-months follow-up using a validated 6-item, self-efficacy scale, which is
      embedded within the health risk questionnaire of the KeepWell platform. We selected this
      outcome because increasing self-efficacy is a prerequisite for behaviour change which,
      through improved self-management may influence health and healthcare use. All participants
      will complete this outcome assessment via the health risk questionnaire of KeepWell at
      baseline, 3- and 6-month follow-up.

      Secondary outcomes: (i) self-efficacy at 3-months follow-up; (ii) cost description analysis
      to assess the total cost of implementing the KeepWell overall and by stage (e.g., one-time
      costs vs. ongoing costs); (iii) implementation outcomes according to Proctor et al: reach
      (access), adoption (uptake, utilization); fidelity; maintenance; acceptability
      (satisfaction), appropriateness (relevance), feasibility; (iv) patient reported outcomes
      (self-reported disease management, perceived health and functional status, emotional
      well-being, QOL); (v) patient-reported experiences (self-reported patient activation,
      empowerment, patient-practitioner communication, shared decision-making). Outcomes will be
      measured using the health risk questionnaire embedded within KeepWell and an online survey at
      final follow-up.

      Sample size calculation An increase in self efficacy of 40% is considered significant and has
      been achieved in other studies of self-management interventions including one of the highest
      quality studies of a chronic disease self-management program. In their Cochrane review of
      lay-led self-management interventions, Foster et al found 10 studies that looked at self
      efficacy and these interventions showed a small, statistically-significant improvement
      (standardized mean difference -0.30, 95% confidence interval (CI) -0.41 to -0.19). Using
      these estimates to calculate our sample size, targeting a power of 0.8 and assuming a dropout
      rate of 25%, we estimate that 220 older adults are needed per group for a total of 440
      participants. In a previous interrupted time series study, an Osteoporosis self-management
      tool housed in a touch-screen laptop computer was implemented across 3 primary care practices
      for 12 months, with a total of 350 patients who completed the risk assessment questionnaire,
      so our proposed sample size of 440 patients is feasible, given our hospital and primary care
      partnerships.

      Analysis We will perform descriptive statistics (binary outcomes) and means and standard
      deviations (continuous outcomes). For the primary outcome, a general linear model will be fit
      to investigate differences between groups in self-efficacy at 6 months. We will adjust for
      potential confounders (including baseline self-efficacy) and perform subgroup analyses
      (patient chronic conditions, risk factors, mode of KeepWell use [Tablet/Laptop], age group
      [65-74, 75-84, 85+], sex and gender). We will use the chi-squared and Fisher's exact test to
      compare binary outcomes and independent two sample t-tests for continuous outcomes. We will
      adjust for potential confounders in the final analysis (e.g., receipt of education about
      chronic diseases and risks or specialist referrals); and perform subgroup analyses (e.g.,
      setting, gender, and age: 65-74 and 75+). We will perform visual investigation (through
      scatter plot displays) and analytical outcomes along with logistic regression analyses to
      determine whether unique patient characteristics predict thresholds of use for different
      KeepWell components. To examine the change in self-efficacy over time between groups
      (incorporating self-efficacy scores at baseline, 3- and 6- months), we will use a linear
      mixed-effects model. For the cost description analysis, we will estimate the cost to
      delivering KeepWell from the public healthcare payer perspective, including out-of-pocket
      costs for patients, technical costs for the clinic, efficiencies gained, estimated health
      care utilization increases / reductions; and exploration resource costs required (e.g.,
      online data collection / analysis, web system testing / hosting). The KeepWell platform
      collects user data for these measures, so we will be able to track them longitudinally to
      observe how the solution impacts on outcomes. The findings from the economic analysis will
      represent the potential preliminary economic impact of KeepWell to the healthcare system. All
      outcomes will be measured at baseline, 3- and 6-months follow-up and assessed according to
      intention to treat. All statistical analyses will be carried out using the R statistical
      software.
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Health Services Research
masking: Double (Investigator, Outcomes Assessor)
masking description: Consenting participants will be randomly allocated to the intervention (KeepWell) or control (usual care) using a random number generator; allocation will be concealed. Consenting participants will be assigned a login and password by the research coordinator, which they can use to access the KepWell tool. Each individual login and password will be randomly allocated into intervention or control using a 1:1 ratio; participants will be the unit of randomization. The research coordinator will have the master list of logins and allocation. Allocation will thus be concealed because this list will not be shared with the research team. To protect against sources of bias, investigators, outcome assessors and data analysts will be blinded to the randomization sequence. Blinding of older adults will not be possible given that the intervention is a standalone, web-based tool and the control condition is usual care.
measure: Self-efficacy
time frame: Measured at baseline and 6 months of follow-up
description: Self-efficacy for managing chronic disease (6-item scale)
measure: Implementation
time frame: Measured at 3 and 6 months of follow-up
description: Measurement of change between 3 and 6 months follow-up in implementation outcomes (reach, adoption, fidelity, maintenance, acceptability, appropriateness, feasibility)
measure: Patient reported outcomes
time frame: Measured at 3 and 6 months of follow-up
description: Change between 3 and 6 months of follow-up in self-reported disease management, perceived health and functional status, emotional well-being, quality of life
measure: Change between 3 and 6 months of follow-up in patient reported experiences
time frame: Measured at 3 and 6-months of followup
description: Self-reported patient activation, empowerment, patient-practitioner communication, shared decision-making.
measure: Self-efficacy
time frame: Measured at 3 months of follow-up
description: Self-efficacy for managing chronic disease (6-item scale)
measure: The total cost of implementing KeepWell
time frame: Cumulative, reported at 6 months of follow-up
description: Cost description analysis to assess the total cost of implementing KeepWell
arm group label: Intervention - KeepWell tool
arm group type: Experimental
description: KeepWell is standalone eHealth application aimed at supporting the self-management of older adults with multimorbidity, and it has the following features: (i) lifestyle advice for any combination of the top 10 chronic conditions affecting older adults); (ii) an avatar health coach that walks users through a health prioritization and goal setting exercise; (iii) a health risk questionnaire (HRQ) covering health (chronic diseases), lifestyle (physical activity, diet, smoking, alcohol, caffeine, bladder health), and social and emotional well-being (social frailty, isolation, loneliness) dimensions; (iv) an evidence-based, customized Action plan; (v) an interactive lifestyle tracker; (vi) journaling; (vii) and a health resources library. A health coach avatar leads users through a health priority and goal setting exercise that allows them to create a customized action plan based on guideline recommendations for lifestyle changes.
arm group label: Control
arm group type: Placebo Comparator
description: Participants allocated to the control condition will receive care as usual but will be asked to complete the health risk questionnaire at baseline, 3- and 6-month follow-up via an online survey to collect outcomes data. The control group will receive full access to KeepWell at the conclusion of the study.
intervention type: Other
intervention name: KeepWell tool
description: KeepWell is standalone eHealth application aimed at supporting the self-management of older adults with multimorbidity, and it has the following features: (i) lifestyle advice for any combination of the top 10 chronic conditions affecting older adults); (ii) an avatar health coach that walks users through a health prioritization and goal setting exercise; (iii) a health risk questionnaire (HRQ) covering health (chronic diseases), lifestyle (physical activity, diet, smoking, alcohol, caffeine, bladder health), and social and emotional well-being (social frailty, isolation, loneliness) dimensions; (iv) an evidence-based, customized Action plan; (v) an interactive lifestyle tracker; (vi) journaling; (vii) and a health resources library. A health coach avatar leads users through a health priority and goal setting exercise that allows them to create a customized action plan based on guideline recommendations for lifestyle changes.
arm group label: Intervention - KeepWell tool
intervention type: Other
intervention name: Control - Usual care
description: Participants allocated to the control condition will receive care as usual.
arm group label: Control
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: No
last name: Monika Kastner, PhD
role: Principal Investigator
affiliation: North York General Hospital
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: North York General Hospital
investigator full name: Monika Kastner
investigator title: Research Chair
mesh term: Chronic Disease
sharing ipd: Yes
ipd description: We will share de-identified participant level data with our bio-statistician. We will share this information through encrypted, secured hospital email. We will also share all IPD that underlie results in a publication.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Clinical Study Report (CSR)
ipd info type: Analytic Code
ipd time frame: We will share supporting information at the beginning of the study for the purposes of sharing the plan with the research team and providing them with the opportunity to provide feedback on supporting information (2-4 weeks), and IPD at the conclusion of our study for the purposes of data interpretation and analysis (2-4 weeks).
ipd access criteria: The biostatistician and health economist will have access to PID to perform the analysis of primary and secondary outcomes including the cost analysis. They will have access to the data via an encrypted file via secured hospital email for 2-4 weeks or longer if needed (no more than 8 weeks).
The biostatistician will perform descriptive statistics (binary outcomes) and means and standard deviations (continuous outcomes). For the primary outcome, a general linear model will be fit to investigate differences between groups in self-efficacy at 6 months. We will adjust for potential confounders and perform subgroup analyses. For the cost description analysis, the health economist will estimate the cost to delivering KeepWell, including out-of-pocket costs for patients, technical costs for the clinic, efficiencies gained, estimated health care utilization increases / reductions; and exploration resource costs required. All outcomes will be assessed according to intention to treat.