<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/NCT04416815</url>
  </required_header>
  <id_info>
    <org_study_id>GoteborgU-GPCC-IHOPe</org_study_id>
    <nct_id>NCT04416815</nct_id>
  </id_info>
  <brief_title>Integrating Health Promotion With and for Older People - eHealth</brief_title>
  <acronym>IHOPe</acronym>
  <official_title>Integrating Health Promotion With and for Older People - eHealth: a Randomised Controlled Trial, in the Context of Good Quality Local Health Care</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Göteborg University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Göteborg University</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 Integrating Health promotion with and for Older People eHealth (IHOPe) project is&#xD;
      expected to contribute vital knowledge on how older peoples capabilities and societal&#xD;
      resources can be used in a more efficient way to promote health, self-management and enhance&#xD;
      teamwork in partnership.The aim is to describe and evaluate this person-centered e-support&#xD;
      intervention that promotes a sustainable partnership between community-dwelling frail older&#xD;
      people and health and social care professionals. A digital platform, co-created with users&#xD;
      and designed to create inclusion of individuals who today are living in a digital alienation,&#xD;
      will be used in the health planning. In IHOPe frail older people will be able to identify&#xD;
      their potential health issues but also their resources together with team partners from&#xD;
      health- and social care, family or societal representatives. The intervention consists of&#xD;
      person-centered phone calls with a health care professional as well as access to a digital&#xD;
      platform that is accessible to the old person and invited team-partners. The project includes&#xD;
      a randomized controlled trial, a process evaluation and a health economic evaluation. People&#xD;
      75 years or older screened as frail will be included. Also, in the process evaluation&#xD;
      team-partners using the digital platform will be included. Specifically, this project is&#xD;
      expected to reduce hospitalizations, result in improved or retained self-efficacy whilst&#xD;
      being cost effective. Additionally, the project is expected to enhance frail older peoples&#xD;
      opportunities to participate as an equal partner in their contacts with health and social&#xD;
      services.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background:&#xD;
&#xD;
      Healthcare systems worldwide are not equipped to accommodate for the growing population of&#xD;
      older people. In Sweden alone the proportion of people aged 65 years and older is estimated&#xD;
      to increase to 23% by 2030. Furthermore, the number of people aged over 80 years in 2017&#xD;
      exceeded 500 000 and is expected to increase by around 50% by 2027. People in this age group&#xD;
      often have an increased risk for developing frailty, multi-morbidity and functional&#xD;
      impairments. Thus, there is an urgent call for innovative approaches to both promote health&#xD;
      and to design a sustainable healthcare system that is accessible, resource effective and&#xD;
      enables health in frail older people. Person-centered care (PCC) and digital health services&#xD;
      are considered keystones in such a healthcare system redesign, and may enable efficient and&#xD;
      resource effective teamwork that strengthens a preventive approach and promotes older&#xD;
      people's self-efficacy. Previous and ongoing studies show that PCC can be delivered at a&#xD;
      distance, but needs to be further developed from a teamwork aspect. Therefore, the IHOPe&#xD;
      project focuses on integrating health promotion with and for frail older people by working as&#xD;
      a team via a digital platform. To the best of our knowledge, no previous research has&#xD;
      investigated the effectiveness of initiating health planning with and for frail older people&#xD;
      through a PCC telephone support and eHealth intervention where patients are able to create a&#xD;
      personal team by inviting informal and formal carers from both health and social care&#xD;
      services into their health team if needed.&#xD;
&#xD;
      The overall aim is to describe and evaluate a person-centered eHealth intervention that&#xD;
      promotes a sustainable partnership between community-dwelling frail older people and health&#xD;
      and social care professionals.&#xD;
&#xD;
      Design:&#xD;
&#xD;
      The IHOPe trial is designed as a randomized, controlled, trial with two parallel groups and a&#xD;
      primary endpoint 6 month after inclusion. Randomization will be performed through computer&#xD;
      generated lists with a 1:1 allocation. In addition, the IHOPe project includes a pilot and&#xD;
      feasibility study, a health economic evaluation and a process evaluation. The project is a&#xD;
      complex intervention and as such features a multitude of influencing factors. The study&#xD;
      design was guided by the revised Medical Research Council's (MRC) framework for complex&#xD;
      interventions. The IHOPe project consists of two phases:&#xD;
&#xD;
      Phase 1: Develop and test feasibility of a person-centered eHealth intervention and pilot the&#xD;
      RCT design.&#xD;
&#xD;
      Phase 2: Evaluate the effects, describe the process and perform a health economic evaluation&#xD;
      of the person-centered eHealth intervention.&#xD;
&#xD;
      Studysetting/Context:&#xD;
&#xD;
      The IHOPe project is conducted in a middle sized city in Sweden and targets community&#xD;
      dwelling older people, their family and friends and professionals working in local social and&#xD;
      health care services. The intervention is delivered in an eHealth context and is coordinated&#xD;
      by designated research nurses.&#xD;
&#xD;
      In Sweden there is an ongoing redesign of health care services towards good quality local&#xD;
      health care [nära vård], which aims to strengthen primary care services and self-care. Health&#xD;
      care costs in medical care are mainly financed through taxes and municipalities are&#xD;
      responsible for services for older persons according to assessed needs. There are a number of&#xD;
      actors representing different organizations involved in health and social care targeting&#xD;
      older people. In addition, to such municipal services there are also private health and&#xD;
      social care providers. It is also common that older people are receiving support or help from&#xD;
      significant others.&#xD;
&#xD;
      Participants and recruitment procedure:&#xD;
&#xD;
      Participants will be recruited from either an emergency department or a primary care center&#xD;
      in the western region of Sweden. Potential participants will be screened against inclusion&#xD;
      and exclusion criteria for eligibility. Frailty screening will be performed by research&#xD;
      assistants employed in the project at the emergency department or a primary care center if&#xD;
      possible or otherwise by phone. The FRESH screening tool will be used which includes four&#xD;
      short questions. If the answer is yes on two or more of these four questions patients is&#xD;
      applicable for inclusion in the study. A Study Information letter and invitation to&#xD;
      participate will be sent to eligible patients. After informed consent participants will be&#xD;
      randomized to the intervention- or the control group.&#xD;
&#xD;
      Study population:&#xD;
&#xD;
      The RCT, targets frail older people aged 75 years or older living in ordinary housing. The&#xD;
      feasibility study and process evaluation also include significant others and carers that are&#xD;
      invited to the IHOPe platform.&#xD;
&#xD;
      Control group/usual care:&#xD;
&#xD;
      The participants allocated to the control group received no intervention. However, they&#xD;
      could, on their own initiative, approach the usual range of community or health services&#xD;
      (e.g., home help services, rehabilitation, or medical care).&#xD;
&#xD;
      Intervention/The eHealth support:&#xD;
&#xD;
      The IHOPe intervention is provided in addition to usual care for six months. It comprises an&#xD;
      agreed upon number of person-centered phone calls (stimulating narration) and co-creation of&#xD;
      care through a digital platform. The intervention aims to initiate partnership-building and&#xD;
      to promote older people to identify and use their own capabilities and resources such as&#xD;
      strong will, social relations, etc. During the intervention goals will be formulated and set&#xD;
      in partnership to promote self-efficacy and the ability to cope with frailty in daily life.&#xD;
      The older person (at times in collaboration with significant others) will together with a&#xD;
      dedicated health care professional (HCP) formulate a person-centered health plan, which is&#xD;
      then uploaded to the IHOPe platform. The health plan will focus on the older persons' goals,&#xD;
      resources and needs, and experienced need of support from health and/or social care as well&#xD;
      as family and friends to reach the goals. Depending on agreements during the phone-call&#xD;
      family and friends and additional health or social care professionals may be invited to&#xD;
      teamwork on the IHOPe platform. The health plan will be the point of departure for the&#xD;
      forthcoming dialogue. IHOPe is provided in an eHealth context by designated HCPs trained in&#xD;
      delivering PCC at a distance. Throughout the study, the HCP and patient (and team) will&#xD;
      communicate to regularly evaluate the health plan and any need to reformulate the goals. The&#xD;
      intervention is provided at a distance. If needed one home visit to install the digital&#xD;
      platform (via the participant's smart tablet, smartphone or computer) will be conducted. A&#xD;
      health professional will introduce how to use the digital platform and create a personal&#xD;
      account.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 25, 2021</start_date>
  <completion_date type="Anticipated">January 30, 2025</completion_date>
  <primary_completion_date type="Anticipated">June 30, 2024</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>Parallel Assignment</intervention_model>
    <intervention_model_description>RCT: All older people who give consent for participation and who fulfill the inclusion criteria will be randomised. Randomisation will be conducted by research nurses. Participants will be randomly assigned to either control or intervention group with a 1:1 allocation as per a computer generated randomisation. The control group will receive usual care. The intervention group will receive person-centred care intervention during 6 month on top of usual care.</intervention_model_description>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>The nature of the intervention means that neither participants nor the health care professionals (HCP) in the IHOPe intervention can be blinded to allocation in the RCT.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>A composite of changes in general self-efficacy and need for hospital care</measure>
    <time_frame>Baseline, 3</time_frame>
    <description>The primary outcome is a composite of changes in general self-efficacy and need for hospital care for unscheduled reasons. Each participant will be classified as improved, deteriorated or unchanged if at 3 months:&#xD;
Deteriorated: the participant's self-efficacy has decreased by ≥ 5 units (the minimal change of clinical significance), or the participant has been admitted to hospital for unscheduled reasons two times or more.&#xD;
Improved: general self-efficacy has increased by ≥ 5 units and the participant has been admitted to hospital no more than once.&#xD;
Unchanged: Neither deteriorated nor improved. (Questionnaire and medical record)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Health-related quality of life by EuroQol 5 dimensions health state questionnaire (EQ5D)</measure>
    <time_frame>Baseline, 3, 6, 12 months</time_frame>
    <description>EQ5D is a generic measure of health status consisting of five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), each with responses indicating three levels of severity (no problems/some or moderate problems/extreme problems), the EQ Visual Analogue scale (EQ-VAS); a standard vertical 20 cm visual analogue scale for recording an individual's rating of their current health-related quality of life state raging from 'the best health you can imagine' to 'the worst health you can imagine'. (Questionnaire)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>General Self Efficacy</measure>
    <time_frame>Baseline, 3, 6, 12 months</time_frame>
    <description>General Self-Efficacy Scale (GSE scale) is a 10-item self-assessment questionnaire designed to measure a broad and stable sense of personal competence to deal effectively with a variety of stressful situations. Ratings are made on a 4-point scale (1 = not at all true, 2 = hardly true, 3 = moderately true, 4 = exactly true) and are summed to a total score ranging from 10 to 40, where higher scores indicate greater self-efficacy. (Questionnaire)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospitalization</measure>
    <time_frame>Baseline, 3, 6, 12 months</time_frame>
    <description>The number of un-planned hospitalization. (Questionnaire and medical record)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ICEpop CAPability measure for Older people (ICECAP-O)</measure>
    <time_frame>Baseline, 3, 6, 12 months</time_frame>
    <description>The ICECAP-O capability index estimate quality of life in a broader sense, including five attributes (attachment, role, enjoyment, security, and control), each with four levels of response. (Questionnaire)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>A composite of changes in general self-efficacy and need for hospital care for unscheduled reasons</measure>
    <time_frame>Baseline, 6, 12 months</time_frame>
    <description>A composite of changes in general self-efficacy and need for hospital care for unscheduled reasons at 6 and 12 moths.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in daily activities based on the ADL-staircase</measure>
    <time_frame>Baseline, 3, 6, 12 months</time_frame>
    <description>Independence from, or dependence on, another person in daily activities will be assessed based the ADL-staircase. The ADL-staircase applies a cumulative scale of ten well-defined personal activities (P-ADLs: bathing, dressing, going to the toilet, transfer, continence and feeding) and instrumental activities (I-ADLs: cleaning, shopping, transportation and cooking). Dependence is defined as receiving personal or directive assistance from another person. Participants living with another person is assessed as &quot;independent&quot; if they are capable of performing the activity independently. (Questionnaire)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Societal costs</measure>
    <time_frame>Baseline, 3, 6, 12 months</time_frame>
    <description>Resource use included in the economic evaluation will include: healthcare use (Region Västra Götaland), drug use and social care (National Board of Health and Welfare), as well as costs for informal care and other costs to the individual and/or family and friends related to the treatment collected from patient questionnaires and diaries. Costs (both reimbursements and out of pocket costs) for prescribed medications will be obtained from the Swedish Prescribed Drug Register. Cost per patient for healthcare use will be obtained from the register, and in resource use not recorded costs will be derived using national statistics, as will costs for social care and other costs reported in questionnaires. Informal care costs will be viewed as directs costs, and thus valued at the average wage and social security contribution of employing a formal caregiver.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incremental cost-effectiveness Ratio (ICER)</measure>
    <time_frame>Baseline, 3, 6, 12 months</time_frame>
    <description>The ICER will be calculated as the difference in costs, between groups, divided by the corresponding difference in quality-adjusted life years (QALY). For the main analysis, QALYs will be derived from the EQ-5D index using the Swedish experience-based value set and using an area-under-the-curve calculation. Sensitivity analyses will be conducted using a society-based value set and the economic evaluation will also be conducted using a corresponding method with ICECAP-O as the health outcome.(Questionnaire)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in number of fall</measure>
    <time_frame>Baseline, 3, 6, 12 months</time_frame>
    <description>Self-reported number of fall during the last three months (Questionnaire)</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Change in burden of medicines use in everyday life based on The Living with medicines questionnaire version 3 (LMQ-3)</measure>
    <time_frame>Baseline, 3, 6, 12 months</time_frame>
    <description>Participants self-rate the following domains (relationships with health professionals, practical difficulties, interference with daily life, lack of effectiveness, side effects, general concerns, cost, and lack of autonomy) on a 5-point Likert scale (strongly agree to strongly disagree).</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in the participants' self-rated overall level of medicines burden</measure>
    <time_frame>Baseline, 3, 6, 12 months</time_frame>
    <description>Participants assess the overall level of medicines burden on a 10 cm visual analogue scale from 0 (no burden at all) to 10 (extremely burdensome).</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">220</enrollment>
  <condition>Frailty</condition>
  <condition>Old Age</condition>
  <arm_group>
    <arm_group_label>Usual care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The participants allocated to the control group received no intervention. However, they could, on their own initiative, approach the usual range of community or health services (e.g., home help services, rehabilitation, or medical care).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>eHealth</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The intervention will be delivered for 6 months on top of usual care.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Integrating Health promotion with and for Older People - eHealth</intervention_name>
    <description>The intervention will be delivered for 6 months on top of usual care. It will be provided by HCPs. If needed one home visit to install the digital platform will be conducted. A HCP will introduce how to use the digital platform and create a personal account. The intervention starts with a person-centred phone-call where a health plan is co-created and potential team members to support this are identified and invited. The health plan includes the older persons' goals, internal and external resources, and need of support from health and/or social-services. This plan will be the point of departure for the forthcoming dialogue. A digital platform will open up for extended and safe communication and visualize the health planning between the older person and team-members in different settings. The older person and the HCP and involved team members on the digital platform will regularly evaluate the health plan and commonly agreed goals.</description>
    <arm_group_label>eHealth</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  National registration within the Västra Götalands region (VGR), community dwelling&#xD;
             people (men and women) aged 75 and older living in ordinary housing, and screened as&#xD;
             frail at a primary care center or the emergency department but not hospitalized.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  In need of palliative care in the final stages of life, no registered address,&#xD;
             participating in any other conflicting randomised study, or cognitive dysfunctional&#xD;
             (not oriented to time, place and person).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>75 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Inger Ekman</last_name>
    <role>Study Chair</role>
    <affiliation>University of Gothenburg, Institute of health and caring scineces</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Inger Ekman, Senior Prof.</last_name>
    <phone>+46739815765</phone>
    <email>inger.ekman@gu.se</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Emmelie Barenfeld, phD</last_name>
    <email>emmelie.barenfeld@gu.se</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Arvid Wallgrensbacke 7</name>
      <address>
        <city>Gothenburg</city>
        <zip>40530</zip>
        <country>Sweden</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Inger Ekman, Professor</last_name>
      <phone>+46739815765</phone>
      <email>inger.ekman@gu.se</email>
    </contact>
    <contact_backup>
      <last_name>Emmelie Barenfeld, pHD</last_name>
      <phone>+46701586948</phone>
      <email>emmelie.barenfeld@gu.se</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
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  <verification_date>June 2021</verification_date>
  <study_first_submitted>April 2, 2020</study_first_submitted>
  <study_first_submitted_qc>June 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>June 7, 2021</last_update_submitted>
  <last_update_submitted_qc>June 7, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">June 10, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Person-centredness</keyword>
  <keyword>Telemedicine</keyword>
  <keyword>RCT</keyword>
  <keyword>e-health</keyword>
  <keyword>Process Evaluation</keyword>
  <keyword>Health Economic Evaluation</keyword>
  <keyword>Health Plan</keyword>
  <keyword>Partnership</keyword>
  <keyword>Frailty</keyword>
  <keyword>Elderly</keyword>
  <keyword>Person-centred care</keyword>
  <keyword>Patient-centred care</keyword>
  <keyword>Person-centered care</keyword>
  <keyword>Patient-centered care</keyword>
  <keyword>Integrated care</keyword>
  <keyword>Health promotion</keyword>
  <keyword>eHealth</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Frailty</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT04416815
org study id: GoteborgU-GPCC-IHOPe
nct id: NCT04416815
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The Integrating Health promotion with and for Older People eHealth (IHOPe) project is
      expected to contribute vital knowledge on how older peoples capabilities and societal
      resources can be used in a more efficient way to promote health, self-management and enhance
      teamwork in partnership.The aim is to describe and evaluate this person-centered e-support
      intervention that promotes a sustainable partnership between community-dwelling frail older
      people and health and social care professionals. A digital platform, co-created with users
      and designed to create inclusion of individuals who today are living in a digital alienation,
      will be used in the health planning. In IHOPe frail older people will be able to identify
      their potential health issues but also their resources together with team partners from
      health- and social care, family or societal representatives. The intervention consists of
      person-centered phone calls with a health care professional as well as access to a digital
      platform that is accessible to the old person and invited team-partners. The project includes
      a randomized controlled trial, a process evaluation and a health economic evaluation. People
      75 years or older screened as frail will be included. Also, in the process evaluation
      team-partners using the digital platform will be included. Specifically, this project is
      expected to reduce hospitalizations, result in improved or retained self-efficacy whilst
      being cost effective. Additionally, the project is expected to enhance frail older peoples
      opportunities to participate as an equal partner in their contacts with health and social
      services.
Background:

      Healthcare systems worldwide are not equipped to accommodate for the growing population of
      older people. In Sweden alone the proportion of people aged 65 years and older is estimated
      to increase to 23% by 2030. Furthermore, the number of people aged over 80 years in 2017
      exceeded 500 000 and is expected to increase by around 50% by 2027. People in this age group
      often have an increased risk for developing frailty, multi-morbidity and functional
      impairments. Thus, there is an urgent call for innovative approaches to both promote health
      and to design a sustainable healthcare system that is accessible, resource effective and
      enables health in frail older people. Person-centered care (PCC) and digital health services
      are considered keystones in such a healthcare system redesign, and may enable efficient and
      resource effective teamwork that strengthens a preventive approach and promotes older
      people's self-efficacy. Previous and ongoing studies show that PCC can be delivered at a
      distance, but needs to be further developed from a teamwork aspect. Therefore, the IHOPe
      project focuses on integrating health promotion with and for frail older people by working as
      a team via a digital platform. To the best of our knowledge, no previous research has
      investigated the effectiveness of initiating health planning with and for frail older people
      through a PCC telephone support and eHealth intervention where patients are able to create a
      personal team by inviting informal and formal carers from both health and social care
      services into their health team if needed.

      The overall aim is to describe and evaluate a person-centered eHealth intervention that
      promotes a sustainable partnership between community-dwelling frail older people and health
      and social care professionals.

      Design:

      The IHOPe trial is designed as a randomized, controlled, trial with two parallel groups and a
      primary endpoint 6 month after inclusion. Randomization will be performed through computer
      generated lists with a 1:1 allocation. In addition, the IHOPe project includes a pilot and
      feasibility study, a health economic evaluation and a process evaluation. The project is a
      complex intervention and as such features a multitude of influencing factors. The study
      design was guided by the revised Medical Research Council's (MRC) framework for complex
      interventions. The IHOPe project consists of two phases:

      Phase 1: Develop and test feasibility of a person-centered eHealth intervention and pilot the
      RCT design.

      Phase 2: Evaluate the effects, describe the process and perform a health economic evaluation
      of the person-centered eHealth intervention.

      Studysetting/Context:

      The IHOPe project is conducted in a middle sized city in Sweden and targets community
      dwelling older people, their family and friends and professionals working in local social and
      health care services. The intervention is delivered in an eHealth context and is coordinated
      by designated research nurses.

      In Sweden there is an ongoing redesign of health care services towards good quality local
      health care [nära vård], which aims to strengthen primary care services and self-care. Health
      care costs in medical care are mainly financed through taxes and municipalities are
      responsible for services for older persons according to assessed needs. There are a number of
      actors representing different organizations involved in health and social care targeting
      older people. In addition, to such municipal services there are also private health and
      social care providers. It is also common that older people are receiving support or help from
      significant others.

      Participants and recruitment procedure:

      Participants will be recruited from either an emergency department or a primary care center
      in the western region of Sweden. Potential participants will be screened against inclusion
      and exclusion criteria for eligibility. Frailty screening will be performed by research
      assistants employed in the project at the emergency department or a primary care center if
      possible or otherwise by phone. The FRESH screening tool will be used which includes four
      short questions. If the answer is yes on two or more of these four questions patients is
      applicable for inclusion in the study. A Study Information letter and invitation to
      participate will be sent to eligible patients. After informed consent participants will be
      randomized to the intervention- or the control group.

      Study population:

      The RCT, targets frail older people aged 75 years or older living in ordinary housing. The
      feasibility study and process evaluation also include significant others and carers that are
      invited to the IHOPe platform.

      Control group/usual care:

      The participants allocated to the control group received no intervention. However, they
      could, on their own initiative, approach the usual range of community or health services
      (e.g., home help services, rehabilitation, or medical care).

      Intervention/The eHealth support:

      The IHOPe intervention is provided in addition to usual care for six months. It comprises an
      agreed upon number of person-centered phone calls (stimulating narration) and co-creation of
      care through a digital platform. The intervention aims to initiate partnership-building and
      to promote older people to identify and use their own capabilities and resources such as
      strong will, social relations, etc. During the intervention goals will be formulated and set
      in partnership to promote self-efficacy and the ability to cope with frailty in daily life.
      The older person (at times in collaboration with significant others) will together with a
      dedicated health care professional (HCP) formulate a person-centered health plan, which is
      then uploaded to the IHOPe platform. The health plan will focus on the older persons' goals,
      resources and needs, and experienced need of support from health and/or social care as well
      as family and friends to reach the goals. Depending on agreements during the phone-call
      family and friends and additional health or social care professionals may be invited to
      teamwork on the IHOPe platform. The health plan will be the point of departure for the
      forthcoming dialogue. IHOPe is provided in an eHealth context by designated HCPs trained in
      delivering PCC at a distance. Throughout the study, the HCP and patient (and team) will
      communicate to regularly evaluate the health plan and any need to reformulate the goals. The
      intervention is provided at a distance. If needed one home visit to install the digital
      platform (via the participant's smart tablet, smartphone or computer) will be conducted. A
      health professional will introduce how to use the digital platform and create a personal
      account.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: RCT: All older people who give consent for participation and who fulfill the inclusion criteria will be randomised. Randomisation will be conducted by research nurses. Participants will be randomly assigned to either control or intervention group with a 1:1 allocation as per a computer generated randomisation. The control group will receive usual care. The intervention group will receive person-centred care intervention during 6 month on top of usual care.
primary purpose: Health Services Research
masking: None (Open Label)
masking description: The nature of the intervention means that neither participants nor the health care professionals (HCP) in the IHOPe intervention can be blinded to allocation in the RCT.
measure: A composite of changes in general self-efficacy and need for hospital care
time frame: Baseline, 3
description: The primary outcome is a composite of changes in general self-efficacy and need for hospital care for unscheduled reasons. Each participant will be classified as improved, deteriorated or unchanged if at 3 months:
Deteriorated: the participant's self-efficacy has decreased by ≥ 5 units (the minimal change of clinical significance), or the participant has been admitted to hospital for unscheduled reasons two times or more.
Improved: general self-efficacy has increased by ≥ 5 units and the participant has been admitted to hospital no more than once.
Unchanged: Neither deteriorated nor improved. (Questionnaire and medical record)
measure: Health-related quality of life by EuroQol 5 dimensions health state questionnaire (EQ5D)
time frame: Baseline, 3, 6, 12 months
description: EQ5D is a generic measure of health status consisting of five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), each with responses indicating three levels of severity (no problems/some or moderate problems/extreme problems), the EQ Visual Analogue scale (EQ-VAS); a standard vertical 20 cm visual analogue scale for recording an individual's rating of their current health-related quality of life state raging from 'the best health you can imagine' to 'the worst health you can imagine'. (Questionnaire)
measure: General Self Efficacy
time frame: Baseline, 3, 6, 12 months
description: General Self-Efficacy Scale (GSE scale) is a 10-item self-assessment questionnaire designed to measure a broad and stable sense of personal competence to deal effectively with a variety of stressful situations. Ratings are made on a 4-point scale (1 = not at all true, 2 = hardly true, 3 = moderately true, 4 = exactly true) and are summed to a total score ranging from 10 to 40, where higher scores indicate greater self-efficacy. (Questionnaire)
measure: Hospitalization
time frame: Baseline, 3, 6, 12 months
description: The number of un-planned hospitalization. (Questionnaire and medical record)
measure: ICEpop CAPability measure for Older people (ICECAP-O)
time frame: Baseline, 3, 6, 12 months
description: The ICECAP-O capability index estimate quality of life in a broader sense, including five attributes (attachment, role, enjoyment, security, and control), each with four levels of response. (Questionnaire)
measure: A composite of changes in general self-efficacy and need for hospital care for unscheduled reasons
time frame: Baseline, 6, 12 months
description: A composite of changes in general self-efficacy and need for hospital care for unscheduled reasons at 6 and 12 moths.
measure: Change in daily activities based on the ADL-staircase
time frame: Baseline, 3, 6, 12 months
description: Independence from, or dependence on, another person in daily activities will be assessed based the ADL-staircase. The ADL-staircase applies a cumulative scale of ten well-defined personal activities (P-ADLs: bathing, dressing, going to the toilet, transfer, continence and feeding) and instrumental activities (I-ADLs: cleaning, shopping, transportation and cooking). Dependence is defined as receiving personal or directive assistance from another person. Participants living with another person is assessed as "independent" if they are capable of performing the activity independently. (Questionnaire)
measure: Societal costs
time frame: Baseline, 3, 6, 12 months
description: Resource use included in the economic evaluation will include: healthcare use (Region Västra Götaland), drug use and social care (National Board of Health and Welfare), as well as costs for informal care and other costs to the individual and/or family and friends related to the treatment collected from patient questionnaires and diaries. Costs (both reimbursements and out of pocket costs) for prescribed medications will be obtained from the Swedish Prescribed Drug Register. Cost per patient for healthcare use will be obtained from the register, and in resource use not recorded costs will be derived using national statistics, as will costs for social care and other costs reported in questionnaires. Informal care costs will be viewed as directs costs, and thus valued at the average wage and social security contribution of employing a formal caregiver.
measure: Incremental cost-effectiveness Ratio (ICER)
time frame: Baseline, 3, 6, 12 months
description: The ICER will be calculated as the difference in costs, between groups, divided by the corresponding difference in quality-adjusted life years (QALY). For the main analysis, QALYs will be derived from the EQ-5D index using the Swedish experience-based value set and using an area-under-the-curve calculation. Sensitivity analyses will be conducted using a society-based value set and the economic evaluation will also be conducted using a corresponding method with ICECAP-O as the health outcome.(Questionnaire)
measure: Change in number of fall
time frame: Baseline, 3, 6, 12 months
description: Self-reported number of fall during the last three months (Questionnaire)
measure: Change in burden of medicines use in everyday life based on The Living with medicines questionnaire version 3 (LMQ-3)
time frame: Baseline, 3, 6, 12 months
description: Participants self-rate the following domains (relationships with health professionals, practical difficulties, interference with daily life, lack of effectiveness, side effects, general concerns, cost, and lack of autonomy) on a 5-point Likert scale (strongly agree to strongly disagree).
measure: Change in the participants' self-rated overall level of medicines burden
time frame: Baseline, 3, 6, 12 months
description: Participants assess the overall level of medicines burden on a 10 cm visual analogue scale from 0 (no burden at all) to 10 (extremely burdensome).
arm group label: Usual care
arm group type: No Intervention
description: The participants allocated to the control group received no intervention. However, they could, on their own initiative, approach the usual range of community or health services (e.g., home help services, rehabilitation, or medical care).
arm group label: eHealth
arm group type: Experimental
description: The intervention will be delivered for 6 months on top of usual care.
intervention type: Other
intervention name: Integrating Health promotion with and for Older People - eHealth
description: The intervention will be delivered for 6 months on top of usual care. It will be provided by HCPs. If needed one home visit to install the digital platform will be conducted. A HCP will introduce how to use the digital platform and create a personal account. The intervention starts with a person-centred phone-call where a health plan is co-created and potential team members to support this are identified and invited. The health plan includes the older persons' goals, internal and external resources, and need of support from health and/or social-services. This plan will be the point of departure for the forthcoming dialogue. A digital platform will open up for extended and safe communication and visualize the health planning between the older person and team-members in different settings. The older person and the HCP and involved team members on the digital platform will regularly evaluate the health plan and commonly agreed goals.
arm group label: eHealth
criteria: 
gender: All
minimum age: 75 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Inger Ekman
role: Study Chair
affiliation: University of Gothenburg, Institute of health and caring scineces
last name: Inger Ekman, Senior Prof.
phone: +46739815765
email: inger.ekman@gu.se
last name: Emmelie Barenfeld, phD
email: emmelie.barenfeld@gu.se
facility: 
status: Recruiting
contact: 
contact backup: 
country: Sweden
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PMID: 15031310
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PMID: 12801252
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PMID: 25149667
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PMID: 21764386
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PMID: 17650326
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responsible party type: Sponsor
mesh term: Frailty
sharing ipd: No