<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/NCT04442867</url>
  </required_header>
  <id_info>
    <org_study_id>HEIPS</org_study_id>
    <nct_id>NCT04442867</nct_id>
  </id_info>
  <brief_title>A Health-social Partnership Programme for Improving Health Self-management of Community-dwelling Older Adults</brief_title>
  <official_title>A Health-social Partnership Programme for Improving Health Self-management of Community-dwelling Older Adults: a Hybrid Effectiveness-implementation Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Hong Kong Polytechnic University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The Hong Kong Polytechnic 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>
      Health-social partnership has been governed by regulations in many developed countries for&#xD;
      some years. For instance, the government of United Kingdom has implemented a policy&#xD;
      specifically designed to facilitate the discharge of older adults by collaborating health and&#xD;
      social care workers in hospitals. The United States also formulated a policy to support the&#xD;
      development of collaborative and multi-agency care services in community setting for helping&#xD;
      those who are vulnerable and underserved including ethnic minorities, homeless people, and&#xD;
      those without health insurance. While these services were shown to reduce the delays in&#xD;
      hospital discharge and improve access to services, they were found to be health-dominated and&#xD;
      the involvement of service users in strategic design and planning was lacking. As a result,&#xD;
      the actual process in practice was reported to be poor and a true model of health and social&#xD;
      care partnership was not attained. Currently in Hong Kong, health-social partnership has not&#xD;
      yet been driven and guided by policy. It is still unknown for researchers and practitioners&#xD;
      as how to effectively build a seamless working partnership among two different disciplines&#xD;
      and sustain in the community to support the independent living of older adults.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Introduction: There is a growing body of literature supporting the involvement of a&#xD;
      health-social approach using complex interventions in enhancing self-care management among&#xD;
      community-dwelling older adults. However, there is a paucity of research on how this&#xD;
      intervention strategy implements and disseminates in a real community setting. Bridging the&#xD;
      gap between research-based evidence and primary health policy and practice is a considerable&#xD;
      challenge to researchers, service providers and policymakers. The present pilot study aims to&#xD;
      test the feasibility and acceptability of an evidence-based health-management intervention&#xD;
      programme to be incorporated into the existing community services provided in the elderly&#xD;
      centers. Results of this pilot study will provide important information if the health-social&#xD;
      partnership program rooted in the community is acceptable and feasible and factors that may&#xD;
      facilitate or hinder implementation when reaching the target group of older adults dwelling&#xD;
      in the community. The preliminary outcomes of enhancing self-management and older adults in&#xD;
      maximizing their independence in their home environment will also be examined.&#xD;
&#xD;
      Method: The present pilot study adopts an effectiveness-implementation hybrid design and&#xD;
      intends to 1) evaluate the effectiveness of a community-based Health-Social Partnership&#xD;
      Programme (HSPP) and 2) explore the reach, adoption, implementation, and maintenance of&#xD;
      adopting HSPP in the community. The potential subjects will be recruited from the member list&#xD;
      of a community centre of the Hong Kong Lutheran social services if they are (1) aged 60 or&#xD;
      above, and (2) cognitively competent. Subjects will receive nurse-led case management&#xD;
      supported by a social service team. Factors that hinder or facilitate the program delivery&#xD;
      will also be examined to determine the implementation and sustained effects of the programme.&#xD;
      The measures include the components of RE-AIM (Reach, Effectiveness, Adoption,&#xD;
      Implementation, and Maintenance) framework. Data will be collected at pre-intervention (T1),&#xD;
      post-intervention (T2), and 3 months after intervention (T3).&#xD;
&#xD;
      Discussion: There are conventional randomized controlled trials testing the effects of&#xD;
      community-based programs but these trial designs tend to control the contextual factors&#xD;
      rather than incorporating the program in the real environment. Positive outcomes may have&#xD;
      been produced in these trials but it is uncertain whether the tested intervention program can&#xD;
      be rooted in the real life context and sustain in practice. This pilot study chooses to use&#xD;
      the hybrid model to not only test the effectiveness but also examine the measures relating to&#xD;
      implementation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 30, 2020</start_date>
  <completion_date type="Actual">July 10, 2022</completion_date>
  <primary_completion_date type="Actual">June 30, 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>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in self-efficacy</measure>
    <time_frame>baseline pre-intervention (T1), at three-month when the interventions are completed (T2), and three-month post-intervention (T3)</time_frame>
    <description>The change of self-efficacy in three time-points. Self-efficacy will be measured by using the Chinese version of the General Self-efficacy Scale. The scale was validated in Chinese population and had a reliability alpha coefficient of 0.89. The scale consists of ten questions, scores ranging from 10 to 40, with higher scores representing better self-efficacy.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in quality of life</measure>
    <time_frame>baseline pre-intervention (T1), at three-month when the interventions are completed (T2), and three-month post-intervention (T3)</time_frame>
    <description>Quality of life will be measured by 12-item Short Form Health Survey version 2-Chinese (HK) version. The scale has been used in numerous studies with reliability confirmed when used locally. The rating of the items ranged from 0 to 100, with 50 indicating the standardized norm score.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change in health service utilisation</measure>
    <time_frame>baseline pre-intervention (T1), at three-month when the interventions are completed (T2), and three-month post-intervention (T3)</time_frame>
    <description>The outcomes of health services utilisation include the total numbers of unscheduled general out-patient department, general practitioners, emergency room, and hospital admissions and the total number of health service attendance. The information will be collected by the subjective report of participants and confirmed with the medical and attendance certificates, with good reliability</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">92</enrollment>
  <condition>Healthy Aging</condition>
  <arm_group>
    <arm_group_label>Intervention group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will receive nurse-led case management supported by a social service team.The nurse, functioning as a case manager, is involved in the initial assessment of the participant using the Omaha system. After the initial assessment, the NCM will equip participants with the skills required to perform self-care in health maintenance, including self-monitoring of vital signs, medication adherence, and sources of help if needed.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Participants in the control group will receive a monthly social control call from a trained research assistant</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Case management</intervention_name>
    <description>Based on the clients' problems, individualized and specific health education such as recognition of the early signs and symptoms of an exacerbation or deterioration of disease condition, the frequency, dosage, duration of each health-promoting activity that was of therapeutic value, and the techniques required to perform these activities will be provided by the Nurse Case Manager.</description>
    <arm_group_label>Intervention group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Social call</intervention_name>
    <description>Provide social call to participants, such as ask the participants what TV program do you like most, and how are you recently.</description>
    <arm_group_label>Control group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  aged 60 or above&#xD;
&#xD;
          -  cognitively competent with the Hong Kong version of Montreal Cognitive Assessment&#xD;
             (HK-MoCA) with score ≥ 22&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  not communicable&#xD;
&#xD;
          -  not reachable by phone&#xD;
&#xD;
          -  not living at home&#xD;
&#xD;
          -  bedbound&#xD;
&#xD;
          -  with known psychiatric problems with recent hospitalization within last 6 months&#xD;
&#xD;
          -  already engaged in structured health or social programmes&#xD;
&#xD;
          -  will not stay in Hong Kong for the current three months&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Frances KY Wong</last_name>
    <role>Study Chair</role>
    <affiliation>The Hong Kong Polytechnic University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hong Kong Lutheran Social Services</name>
      <address>
        <city>Hong Kong</city>
        <country>Hong Kong</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Hong Kong</country>
  </location_countries>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>June 19, 2020</study_first_submitted>
  <study_first_submitted_qc>June 19, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 23, 2020</study_first_posted>
  <last_update_submitted>August 1, 2022</last_update_submitted>
  <last_update_submitted_qc>August 1, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 3, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The Hong Kong Polytechnic University</investigator_affiliation>
    <investigator_full_name>Arkers, Wong</investigator_full_name>
    <investigator_title>Clinical associate</investigator_title>
  </responsible_party>
  <keyword>hybrid effectiveness-implementation design</keyword>
  <keyword>health-social partnership</keyword>
  <keyword>community</keyword>
  <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/NCT04442867
org study id: HEIPS
nct id: NCT04442867
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Health-social partnership has been governed by regulations in many developed countries for
      some years. For instance, the government of United Kingdom has implemented a policy
      specifically designed to facilitate the discharge of older adults by collaborating health and
      social care workers in hospitals. The United States also formulated a policy to support the
      development of collaborative and multi-agency care services in community setting for helping
      those who are vulnerable and underserved including ethnic minorities, homeless people, and
      those without health insurance. While these services were shown to reduce the delays in
      hospital discharge and improve access to services, they were found to be health-dominated and
      the involvement of service users in strategic design and planning was lacking. As a result,
      the actual process in practice was reported to be poor and a true model of health and social
      care partnership was not attained. Currently in Hong Kong, health-social partnership has not
      yet been driven and guided by policy. It is still unknown for researchers and practitioners
      as how to effectively build a seamless working partnership among two different disciplines
      and sustain in the community to support the independent living of older adults.
Introduction: There is a growing body of literature supporting the involvement of a
      health-social approach using complex interventions in enhancing self-care management among
      community-dwelling older adults. However, there is a paucity of research on how this
      intervention strategy implements and disseminates in a real community setting. Bridging the
      gap between research-based evidence and primary health policy and practice is a considerable
      challenge to researchers, service providers and policymakers. The present pilot study aims to
      test the feasibility and acceptability of an evidence-based health-management intervention
      programme to be incorporated into the existing community services provided in the elderly
      centers. Results of this pilot study will provide important information if the health-social
      partnership program rooted in the community is acceptable and feasible and factors that may
      facilitate or hinder implementation when reaching the target group of older adults dwelling
      in the community. The preliminary outcomes of enhancing self-management and older adults in
      maximizing their independence in their home environment will also be examined.

      Method: The present pilot study adopts an effectiveness-implementation hybrid design and
      intends to 1) evaluate the effectiveness of a community-based Health-Social Partnership
      Programme (HSPP) and 2) explore the reach, adoption, implementation, and maintenance of
      adopting HSPP in the community. The potential subjects will be recruited from the member list
      of a community centre of the Hong Kong Lutheran social services if they are (1) aged 60 or
      above, and (2) cognitively competent. Subjects will receive nurse-led case management
      supported by a social service team. Factors that hinder or facilitate the program delivery
      will also be examined to determine the implementation and sustained effects of the programme.
      The measures include the components of RE-AIM (Reach, Effectiveness, Adoption,
      Implementation, and Maintenance) framework. Data will be collected at pre-intervention (T1),
      post-intervention (T2), and 3 months after intervention (T3).

      Discussion: There are conventional randomized controlled trials testing the effects of
      community-based programs but these trial designs tend to control the contextual factors
      rather than incorporating the program in the real environment. Positive outcomes may have
      been produced in these trials but it is uncertain whether the tested intervention program can
      be rooted in the real life context and sustain in practice. This pilot study chooses to use
      the hybrid model to not only test the effectiveness but also examine the measures relating to
      implementation.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Outcomes Assessor)
measure: Change in self-efficacy
time frame: baseline pre-intervention (T1), at three-month when the interventions are completed (T2), and three-month post-intervention (T3)
description: The change of self-efficacy in three time-points. Self-efficacy will be measured by using the Chinese version of the General Self-efficacy Scale. The scale was validated in Chinese population and had a reliability alpha coefficient of 0.89. The scale consists of ten questions, scores ranging from 10 to 40, with higher scores representing better self-efficacy.
measure: Change in quality of life
time frame: baseline pre-intervention (T1), at three-month when the interventions are completed (T2), and three-month post-intervention (T3)
description: Quality of life will be measured by 12-item Short Form Health Survey version 2-Chinese (HK) version. The scale has been used in numerous studies with reliability confirmed when used locally. The rating of the items ranged from 0 to 100, with 50 indicating the standardized norm score.
measure: change in health service utilisation
time frame: baseline pre-intervention (T1), at three-month when the interventions are completed (T2), and three-month post-intervention (T3)
description: The outcomes of health services utilisation include the total numbers of unscheduled general out-patient department, general practitioners, emergency room, and hospital admissions and the total number of health service attendance. The information will be collected by the subjective report of participants and confirmed with the medical and attendance certificates, with good reliability
arm group label: Intervention group
arm group type: Experimental
description: Subjects will receive nurse-led case management supported by a social service team.The nurse, functioning as a case manager, is involved in the initial assessment of the participant using the Omaha system. After the initial assessment, the NCM will equip participants with the skills required to perform self-care in health maintenance, including self-monitoring of vital signs, medication adherence, and sources of help if needed.
arm group label: Control group
arm group type: Other
description: Participants in the control group will receive a monthly social control call from a trained research assistant
intervention type: Other
intervention name: Case management
description: Based on the clients' problems, individualized and specific health education such as recognition of the early signs and symptoms of an exacerbation or deterioration of disease condition, the frequency, dosage, duration of each health-promoting activity that was of therapeutic value, and the techniques required to perform these activities will be provided by the Nurse Case Manager.
arm group label: Intervention group
intervention type: Other
intervention name: Social call
description: Provide social call to participants, such as ask the participants what TV program do you like most, and how are you recently.
arm group label: Control group
criteria: 
gender: All
minimum age: 60 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Frances KY Wong
role: Study Chair
affiliation: The Hong Kong Polytechnic University
facility: 
country: Hong Kong
responsible party type: Principal Investigator
investigator affiliation: The Hong Kong Polytechnic University
investigator full name: Arkers, Wong
investigator title: Clinical associate
sharing ipd: No