<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/NCT03293303</url>
  </required_header>
  <id_info>
    <org_study_id>ZonMw no. 50-53120-98-014</org_study_id>
    <nct_id>NCT03293303</nct_id>
  </id_info>
  <brief_title>The Feasibility, Effects and Costs of the 'Stay Active at Home Programme'</brief_title>
  <official_title>The Feasibility, Effects and Costs of the 'Stay Active at Home Programme': Evaluation of a Preventive Integral Approach in Primary Care That Stimulates Physical Activity Among Community-dwelling Older Adults</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Maastricht University Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Maastricht University Medical Center</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>
      BACKGROUND: Older adults spend approximately 80% of their awake time in sedentary activities&#xD;
      which represents 8 to 12 hours per day. In the past, numerous stand-alone exercise programs&#xD;
      have been developed. However, it is challenging to persuade older adults to become and&#xD;
      maintain physically active. Consequently, physical activity should be embedded in the daily&#xD;
      life of older adults to reduce their sedentary time, prevent negative health consequences and&#xD;
      facilitate ageing in place.&#xD;
&#xD;
      INTERVENTION: 'Stay Active at Home' is not an additional, (classical) exercise programme;&#xD;
      physical activity is integrated in usual home care. Healthcare professionals learn to engage&#xD;
      older adults in daily life in order to improve their physical activity and reduce their&#xD;
      sedentary time. For example, washing the upper body and face independently; changing the&#xD;
      pillowcase, while professional changes bedcover; and motivating clients to join a dancing&#xD;
      class at the community centre.&#xD;
&#xD;
      AIM and DESIGN: The aim of this cluster randomised controlled trial is to provide evidence&#xD;
      about the (cost-) effectiveness of 'Stay Active at Home' prior to dissemination and&#xD;
      implementation of the programme. Alongside the trial an extensive process evaluation will be&#xD;
      conducted.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Many community-dwelling older adults have a highly sedentary lifestyle, especially those&#xD;
      receiving homecare services. In the Netherlands 20% of older adults makes use of homecare.&#xD;
      The prevalence in frail older adults is even twice as high (40%). However, once in care often&#xD;
      a downward spiral sets in, as professionals tend to meet their clients' needs by task&#xD;
      completion rather than by stimulating self-management and active engagement in tasks to&#xD;
      contribute to active ageing. Thereby they deprive older adults of their opportunities to&#xD;
      engage in a routine range of movements necessary for maintaining underlying capability&#xD;
      resulting in further deconditioning and functional decline.&#xD;
&#xD;
      To prevent these negative consequences the behaviour of healthcare professionals has to&#xD;
      change from 'doing things for older adults' to 'engaging older adults' in daily life in order&#xD;
      to improve physical activity among older adults by reducing their sedentary time. This&#xD;
      innovative care philosophy is also known as Function Focused Care (FFC), restorative care or&#xD;
      reablement. These terms can be used interchangeably, but we will refer to it as FFC&#xD;
      throughout this project proposal. In the US the research group of Resnick and colleagues&#xD;
      conducted various studies in inpatient and residential care facilities. They have shown that&#xD;
      FFC succeeds in increasing physical activity. Furthermore, FFC has shown to result in&#xD;
      physical (e.g. daily functioning, muscle strength, balance) and psychological benefits (e.g.&#xD;
      mood, behavioural symptoms) and reduces the risk for adverse outcomes (e.g. falls, delirium).&#xD;
      Resnick et al. have little experience in homecare settings, but there is an emerging body of&#xD;
      evidence, especially in Norway, New Zealand and Australia, that FFC has also potential for&#xD;
      community-based care showing beneficial effects with regard to daily functioning,&#xD;
      self-perceived activity performance and satisfaction, health-related quality of life,&#xD;
      healthcare utilisation/costs, and even mortality. Experiences and results of FFC in Dutch&#xD;
      community-dwelling older adults are lacking.&#xD;
&#xD;
      Promising programmes in one particular care setting are not automatically replicable in other&#xD;
      settings due to cultural or organisational differences. Consequently, available programmes&#xD;
      need to be adapted to the local circumstances before they can be successfully implemented in&#xD;
      another setting. However, making changes requires careful planning and execution to prevent a&#xD;
      loss of effectiveness by affecting the original programme's theory or removing core&#xD;
      components of the programme. Therefore, the investigators have followed so far the first two&#xD;
      phases of the framework of the Medical Research Council in preparing the use of FFC in Dutch&#xD;
      community-dwelling older adults receiving homecare services:&#xD;
&#xD;
        -  Phase I (2013- first half of 2016): The investigators systematically adapted in&#xD;
           co-creation with international FFC experts and a Dutch panel of relevant stakeholders&#xD;
           the initial FFC philosophy and conducted a pilot study. Throughout the adaptation&#xD;
           process healthcare professionals, policy makers, managers and scientists were involved&#xD;
           at various times to ensure that all interests are considered and respected. Although not&#xD;
           the primary target population (i.e. homecare professionals), the project idea was also&#xD;
           intensively discussed with a panel of older adults. The final result of this adaptation&#xD;
           process was the 'Stay Active at Home' programme (in Dutch: 'Blijf Actief Thuis'). During&#xD;
           the pilot, data about its feasibility was collected from healthcare professionals and&#xD;
           older adults.&#xD;
&#xD;
        -  Phase II (second half of 2016 - first half of 2017): The investigators conducted a&#xD;
           second pilot study, a so-called 'early trial' prior to the currently proposed trial, as&#xD;
           part of the ZonMw project BASIC CARE REVISITED (ZonMw #520002003). This early trial&#xD;
           provided relevant information regarding: a) the implementation of specific intervention&#xD;
           components; b) key components of the chosen methodology (e.g. outcome measures); c)&#xD;
           rates of recruitment and retention; and d) the expected effect size. This information is&#xD;
           highly relevant with regard to finalising the intervention and designing a subsequent&#xD;
           main trial.&#xD;
&#xD;
      In conclusion, 'Stay Active at Home' is systematically developed for the Dutch homecare&#xD;
      setting based on international evidence in close collaboration with Dutch stakeholders (i.e.&#xD;
      older adults, healthcare professionals, policy makers and managers). The initial feasibility&#xD;
      of the programme and the proposed study design are evaluated in two pilot studies prior to&#xD;
      the grant period. In order to determine the (cost-) effectiveness of 'Stay Active at Home'&#xD;
      prior to dissemination and implementation of the programme in the Dutch homecare setting this&#xD;
      cluster randomised controlled trial has to be conducted. Alongside the trial an extensive&#xD;
      process evaluation will be conducted.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 6, 2017</start_date>
  <completion_date type="Actual">August 20, 2019</completion_date>
  <primary_completion_date type="Actual">July 5, 2019</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>A randomised controlled trial with 12 months follow-up will be conducted. In total, five homecare teams from MeanderGroep Zuid-Limburg and the local domestic support workers will be trained in 'Stay Active at Home' (intervention group). Another five homecare teams and domestic support workers will deliver usual care (control group). Both groups of professionals and their clients will be compared at baseline and after 6 and/or 12 months follow-up.</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Participant)</masking>
    <masking_description>Participants (i.e., older adults will be blinded); it's not possible to blind the healthcare professionals.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Sedentary behaviour measured by ActiGraph GT3X+ (older adults)</measure>
    <time_frame>12 months</time_frame>
    <description>An accelerometer that measures sedentary time and physical activity by assessing the magnitude of the body's acceleration in terms of 'counts' per unit time.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Disabilities in ADL and IADL by Groningen Activity Restriction Scale (older adults)</measure>
    <time_frame>baseline and after 12 months</time_frame>
    <description>The Groningen Activity Restriction Scale (GARS) is a non-disease-specific instrument to measure disability in activities of daily living (ADL) and instrumental activities of daily living (IADL). For each item, four hierarchical answer options are available ranging from 'Yes, I can do it fully independently without any difficulty' to 'No, I cannot do it fully independently. I can only do it with someone's help'. The scores for the total scale range from 18 to 72, with higher scores indicating more disability</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical activity by Short Physical Performance Battery (older adults)</measure>
    <time_frame>baseline and after 12 months</time_frame>
    <description>The Short Physical Performance Battery (SPPB) is a performance-based test of lower extremity function designed for elderly participants. It consists of three parts: the Balance Test, the Gait Speed Test, and the Chair Stand Test.Each test is scored 0 to 4 by previously determined criteria. Scores from the three tests will be summed into a composite score ranging from 0 to 12, with higher scores reflecting better physical functioning.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Major and minor depression by Patient Health Questionnaire-9 (older adults)</measure>
    <time_frame>baseline and after 12 months</time_frame>
    <description>The PHQ-9 is the first self-report questionnaire designed for use in primary care that reflects the Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV) diagnostic criteria for depression, and so (through examining the pattern and number of items endorsed) can be used as a diagnostic tool for major and minor depression. The PHQ-9 consists of nine items which measure the presence of depressive symptoms. Participants will score how often each of the symptoms was present during the last two weeks (0 = not at all; 1 = several days; 2 = more than half of the days; 3 = nearly every day). The summary score ranges from 0 to 27, with higher scores reflecting more severe symptoms of depression.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Falls, 1 item 'How often did you fall during the last 6 months?' (older adults)</measure>
    <time_frame>baseline and after 6, 12 months</time_frame>
    <description>One item about falls</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health-related quality of life by EQ-5D-5L (older adults)</measure>
    <time_frame>baseline and after 6, 12 months</time_frame>
    <description>EQ-5D is a standardized instrument developed by the EuroQol Group as a measure of health-related quality of life that can be used in a wide range of health conditions and treatments. The EQ-5D consists of a descriptive system and the EQ VAS. The EQ-5D-5L has 5 levels of severity for each of the 5 dimensions, ranging from 'no problems' to 'major problems'. The five dimensions can be summed into a health state, ranging from 0 to 100, with higher scores reflecting better health-related quality of life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Healthcare utilisation by iMTA Medical Consumption Questionnaire (older adults)</measure>
    <time_frame>baseline and after 6, 12 months</time_frame>
    <description>The iMTA questionnaire is a questionnaire that measures healthcare utilisation and is often used in economic evaluations.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">265</enrollment>
  <condition>Community-dwelling Older Adults</condition>
  <arm_group>
    <arm_group_label>Stay Active at Home</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>One group of homecare professionals receives a training programme. In this training they learn to motivate their clients to be more active in daily and physical activities.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Second group of homecare professionals will get no training and their clients will receive usual homecare.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Stay Active at Home</intervention_name>
    <description>Stay Active at Home' aims to change the behaviour of community nurses and domestic support workers by offering them an intensive training programme. Subsequently, professionals are expected to deliver goal-oriented, holistic and person-centred services focusing on supporting older adults to maintain, gain or restore their competences to engage in physical and daily activities so that they can manage their everyday life as independently as possible.</description>
    <arm_group_label>Stay Active at Home</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Receive home care services by the selected nursing teams&#xD;
&#xD;
          -  Age ≥65 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Terminal ill or bedbound&#xD;
&#xD;
          -  Serious cognitive or psychological problems&#xD;
&#xD;
          -  Not able to communicate in Dutch&#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>Gertrudis IJ Kempen, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Maastricht University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>MeanderGroep Zuid-Limburg</name>
      <address>
        <city>Landgraaf</city>
        <state>Limburg</state>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <reference>
    <citation>Metzelthin SF, Rooijackers TH, Zijlstra GAR, van Rossum E, Veenstra MY, Koster A, Evers SMAA, van Breukelen GJP, Kempen GIJM. Effects, costs and feasibility of the 'Stay Active at Home' Reablement training programme for home care professionals: study protocol of a cluster randomised controlled trial. BMC Geriatr. 2018 Nov 13;18(1):276. doi: 10.1186/s12877-018-0968-z.</citation>
    <PMID>30424738</PMID>
  </reference>
  <reference>
    <citation>Metzelthin SF, Zijlstra GA, van Rossum E, de Man-van Ginkel JM, Resnick B, Lewin G, Parsons M, Kempen GI. 'Doing with ...' rather than 'doing for ...' older adults: rationale and content of the 'Stay Active at Home' programme. Clin Rehabil. 2017 Nov;31(11):1419-1430. doi: 10.1177/0269215517698733. Epub 2017 Mar 14.</citation>
    <PMID>29050508</PMID>
  </reference>
  <verification_date>October 2020</verification_date>
  <study_first_submitted>September 20, 2017</study_first_submitted>
  <study_first_submitted_qc>September 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 26, 2017</study_first_posted>
  <last_update_submitted>October 15, 2020</last_update_submitted>
  <last_update_submitted_qc>October 15, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 19, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Prevention</keyword>
  <keyword>Physical activity</keyword>
  <keyword>Sedentary behaviour</keyword>
  <keyword>Daily activities</keyword>
  <keyword>Homecare</keyword>
  <keyword>Nursing</keyword>
  <keyword>Primary care</keyword>
  <keyword>Older adults</keyword>
  <keyword>Function Focused Care</keyword>
  <keyword>Reablement</keyword>
  <keyword>Restorative Care</keyword>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Individual participant data and data dictionaries that underlie the results reported in articles that are published within this project are available from the corresponding author on reasonable request after deidentification (text, tables, figures, and appendices).</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
    <ipd_time_frame>Data will be available beginning 9 months and ending 36 months following article publication.</ipd_time_frame>
    <ipd_access_criteria>Data will be available for researchers who provide a methodologically sound proposal to achieve aims in the approved proposal. Proposals should be directed to t.rooijackers@maastrichtuniversity.nl. To gain access, data requestors will need to sign a data access agreement.</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/NCT03293303
org study id: ZonMw no. 50-53120-98-014
nct id: NCT03293303
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
BACKGROUND: Older adults spend approximately 80% of their awake time in sedentary activities
      which represents 8 to 12 hours per day. In the past, numerous stand-alone exercise programs
      have been developed. However, it is challenging to persuade older adults to become and
      maintain physically active. Consequently, physical activity should be embedded in the daily
      life of older adults to reduce their sedentary time, prevent negative health consequences and
      facilitate ageing in place.

      INTERVENTION: 'Stay Active at Home' is not an additional, (classical) exercise programme;
      physical activity is integrated in usual home care. Healthcare professionals learn to engage
      older adults in daily life in order to improve their physical activity and reduce their
      sedentary time. For example, washing the upper body and face independently; changing the
      pillowcase, while professional changes bedcover; and motivating clients to join a dancing
      class at the community centre.

      AIM and DESIGN: The aim of this cluster randomised controlled trial is to provide evidence
      about the (cost-) effectiveness of 'Stay Active at Home' prior to dissemination and
      implementation of the programme. Alongside the trial an extensive process evaluation will be
      conducted.
Many community-dwelling older adults have a highly sedentary lifestyle, especially those
      receiving homecare services. In the Netherlands 20% of older adults makes use of homecare.
      The prevalence in frail older adults is even twice as high (40%). However, once in care often
      a downward spiral sets in, as professionals tend to meet their clients' needs by task
      completion rather than by stimulating self-management and active engagement in tasks to
      contribute to active ageing. Thereby they deprive older adults of their opportunities to
      engage in a routine range of movements necessary for maintaining underlying capability
      resulting in further deconditioning and functional decline.

      To prevent these negative consequences the behaviour of healthcare professionals has to
      change from 'doing things for older adults' to 'engaging older adults' in daily life in order
      to improve physical activity among older adults by reducing their sedentary time. This
      innovative care philosophy is also known as Function Focused Care (FFC), restorative care or
      reablement. These terms can be used interchangeably, but we will refer to it as FFC
      throughout this project proposal. In the US the research group of Resnick and colleagues
      conducted various studies in inpatient and residential care facilities. They have shown that
      FFC succeeds in increasing physical activity. Furthermore, FFC has shown to result in
      physical (e.g. daily functioning, muscle strength, balance) and psychological benefits (e.g.
      mood, behavioural symptoms) and reduces the risk for adverse outcomes (e.g. falls, delirium).
      Resnick et al. have little experience in homecare settings, but there is an emerging body of
      evidence, especially in Norway, New Zealand and Australia, that FFC has also potential for
      community-based care showing beneficial effects with regard to daily functioning,
      self-perceived activity performance and satisfaction, health-related quality of life,
      healthcare utilisation/costs, and even mortality. Experiences and results of FFC in Dutch
      community-dwelling older adults are lacking.

      Promising programmes in one particular care setting are not automatically replicable in other
      settings due to cultural or organisational differences. Consequently, available programmes
      need to be adapted to the local circumstances before they can be successfully implemented in
      another setting. However, making changes requires careful planning and execution to prevent a
      loss of effectiveness by affecting the original programme's theory or removing core
      components of the programme. Therefore, the investigators have followed so far the first two
      phases of the framework of the Medical Research Council in preparing the use of FFC in Dutch
      community-dwelling older adults receiving homecare services:

        -  Phase I (2013- first half of 2016): The investigators systematically adapted in
           co-creation with international FFC experts and a Dutch panel of relevant stakeholders
           the initial FFC philosophy and conducted a pilot study. Throughout the adaptation
           process healthcare professionals, policy makers, managers and scientists were involved
           at various times to ensure that all interests are considered and respected. Although not
           the primary target population (i.e. homecare professionals), the project idea was also
           intensively discussed with a panel of older adults. The final result of this adaptation
           process was the 'Stay Active at Home' programme (in Dutch: 'Blijf Actief Thuis'). During
           the pilot, data about its feasibility was collected from healthcare professionals and
           older adults.

        -  Phase II (second half of 2016 - first half of 2017): The investigators conducted a
           second pilot study, a so-called 'early trial' prior to the currently proposed trial, as
           part of the ZonMw project BASIC CARE REVISITED (ZonMw #520002003). This early trial
           provided relevant information regarding: a) the implementation of specific intervention
           components; b) key components of the chosen methodology (e.g. outcome measures); c)
           rates of recruitment and retention; and d) the expected effect size. This information is
           highly relevant with regard to finalising the intervention and designing a subsequent
           main trial.

      In conclusion, 'Stay Active at Home' is systematically developed for the Dutch homecare
      setting based on international evidence in close collaboration with Dutch stakeholders (i.e.
      older adults, healthcare professionals, policy makers and managers). The initial feasibility
      of the programme and the proposed study design are evaluated in two pilot studies prior to
      the grant period. In order to determine the (cost-) effectiveness of 'Stay Active at Home'
      prior to dissemination and implementation of the programme in the Dutch homecare setting this
      cluster randomised controlled trial has to be conducted. Alongside the trial an extensive
      process evaluation will be conducted.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: A randomised controlled trial with 12 months follow-up will be conducted. In total, five homecare teams from MeanderGroep Zuid-Limburg and the local domestic support workers will be trained in 'Stay Active at Home' (intervention group). Another five homecare teams and domestic support workers will deliver usual care (control group). Both groups of professionals and their clients will be compared at baseline and after 6 and/or 12 months follow-up.
primary purpose: Prevention
masking: Single (Participant)
masking description: Participants (i.e., older adults will be blinded); it's not possible to blind the healthcare professionals.
measure: Sedentary behaviour measured by ActiGraph GT3X+ (older adults)
time frame: 12 months
description: An accelerometer that measures sedentary time and physical activity by assessing the magnitude of the body's acceleration in terms of 'counts' per unit time.
measure: Disabilities in ADL and IADL by Groningen Activity Restriction Scale (older adults)
time frame: baseline and after 12 months
description: The Groningen Activity Restriction Scale (GARS) is a non-disease-specific instrument to measure disability in activities of daily living (ADL) and instrumental activities of daily living (IADL). For each item, four hierarchical answer options are available ranging from 'Yes, I can do it fully independently without any difficulty' to 'No, I cannot do it fully independently. I can only do it with someone's help'. The scores for the total scale range from 18 to 72, with higher scores indicating more disability
measure: Physical activity by Short Physical Performance Battery (older adults)
time frame: baseline and after 12 months
description: The Short Physical Performance Battery (SPPB) is a performance-based test of lower extremity function designed for elderly participants. It consists of three parts: the Balance Test, the Gait Speed Test, and the Chair Stand Test.Each test is scored 0 to 4 by previously determined criteria. Scores from the three tests will be summed into a composite score ranging from 0 to 12, with higher scores reflecting better physical functioning.
measure: Major and minor depression by Patient Health Questionnaire-9 (older adults)
time frame: baseline and after 12 months
description: The PHQ-9 is the first self-report questionnaire designed for use in primary care that reflects the Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV) diagnostic criteria for depression, and so (through examining the pattern and number of items endorsed) can be used as a diagnostic tool for major and minor depression. The PHQ-9 consists of nine items which measure the presence of depressive symptoms. Participants will score how often each of the symptoms was present during the last two weeks (0 = not at all; 1 = several days; 2 = more than half of the days; 3 = nearly every day). The summary score ranges from 0 to 27, with higher scores reflecting more severe symptoms of depression.
measure: Falls, 1 item 'How often did you fall during the last 6 months?' (older adults)
time frame: baseline and after 6, 12 months
description: One item about falls
measure: Health-related quality of life by EQ-5D-5L (older adults)
time frame: baseline and after 6, 12 months
description: EQ-5D is a standardized instrument developed by the EuroQol Group as a measure of health-related quality of life that can be used in a wide range of health conditions and treatments. The EQ-5D consists of a descriptive system and the EQ VAS. The EQ-5D-5L has 5 levels of severity for each of the 5 dimensions, ranging from 'no problems' to 'major problems'. The five dimensions can be summed into a health state, ranging from 0 to 100, with higher scores reflecting better health-related quality of life.
measure: Healthcare utilisation by iMTA Medical Consumption Questionnaire (older adults)
time frame: baseline and after 6, 12 months
description: The iMTA questionnaire is a questionnaire that measures healthcare utilisation and is often used in economic evaluations.
arm group label: Stay Active at Home
arm group type: Experimental
description: One group of homecare professionals receives a training programme. In this training they learn to motivate their clients to be more active in daily and physical activities.
arm group label: Usual care
arm group type: No Intervention
description: Second group of homecare professionals will get no training and their clients will receive usual homecare.
intervention type: Behavioral
intervention name: Stay Active at Home
description: Stay Active at Home' aims to change the behaviour of community nurses and domestic support workers by offering them an intensive training programme. Subsequently, professionals are expected to deliver goal-oriented, holistic and person-centred services focusing on supporting older adults to maintain, gain or restore their competences to engage in physical and daily activities so that they can manage their everyday life as independently as possible.
arm group label: Stay Active at Home
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: No
last name: Gertrudis IJ Kempen, PhD
role: Study Chair
affiliation: Maastricht University
facility: 
country: Netherlands
citation: Metzelthin SF, Rooijackers TH, Zijlstra GAR, van Rossum E, Veenstra MY, Koster A, Evers SMAA, van Breukelen GJP, Kempen GIJM. Effects, costs and feasibility of the 'Stay Active at Home' Reablement training programme for home care professionals: study protocol of a cluster randomised controlled trial. BMC Geriatr. 2018 Nov 13;18(1):276. doi: 10.1186/s12877-018-0968-z.
PMID: 30424738
citation: Metzelthin SF, Zijlstra GA, van Rossum E, de Man-van Ginkel JM, Resnick B, Lewin G, Parsons M, Kempen GI. 'Doing with ...' rather than 'doing for ...' older adults: rationale and content of the 'Stay Active at Home' programme. Clin Rehabil. 2017 Nov;31(11):1419-1430. doi: 10.1177/0269215517698733. Epub 2017 Mar 14.
PMID: 29050508
responsible party type: Sponsor
sharing ipd: Yes
ipd description: Individual participant data and data dictionaries that underlie the results reported in articles that are published within this project are available from the corresponding author on reasonable request after deidentification (text, tables, figures, and appendices).
ipd info type: Study Protocol
ipd info type: Informed Consent Form (ICF)
ipd info type: Analytic Code
ipd time frame: Data will be available beginning 9 months and ending 36 months following article publication.
ipd access criteria: Data will be available for researchers who provide a methodologically sound proposal to achieve aims in the approved proposal. Proposals should be directed to t.rooijackers@maastrichtuniversity.nl. To gain access, data requestors will need to sign a data access agreement.