Healthy AgingNCT04442867
A Health-social Partnership Programme for Improving Health Self-management of Community-dwelling Older Adults
A study testing Case management and Social call in people with Healthy Aging, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Aging
- What is being tested?
- Case management and Social call
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteHong Kong
- Study dates
- 30 Dec 2020to 10 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- aged 60 or above
- cognitively competent with the Hong Kong version of Montreal Cognitive Assessment (HK-MoCA) with score ≥ 22
Who cannot join
- not communicable
- not reachable by phone
- not living at home
- bedbound
- with known psychiatric problems with recent hospitalization within last 6 months
- already engaged in structured health or social programmes
- will not stay in Hong Kong for the current three months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Health-social Partnership Programme for Improving Health Self-management of Community-dwelling Older Adults: a Hybrid Effectiveness-implementation Pilot Study
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.
Read the detailed description
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.
- Conditions
- Healthy Aging
- Being tested
- Case management, Social call
- Keywords
- hybrid effectiveness-implementation design, health-social partnership, community
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Case managementOther
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.
Social callOther
Provide social call to participants, such as ask the participants what TV program do you like most, and how are you recently.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | 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. Receives: Other: Case management |
| Control group | Other | Participants in the control group will receive a monthly social control call from a trained research assistant Receives: Other: Social call |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in self-efficacy
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.
Measured: baseline pre-intervention (T1), at three-month when the interventions are completed (T2), and three-month post-intervention (T3)
Secondary outcomes (2)
Change in quality of life
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.
Measured: baseline pre-intervention (T1), at three-month when the interventions are completed (T2), and three-month post-intervention (T3)
change in health service utilisation
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
Measured: baseline pre-intervention (T1), at three-month when the interventions are completed (T2), and three-month post-intervention (T3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2020
- Study start30 Dec 2020
- Primary completion30 Jun 2022
- Study completion10 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Healthy AgingStudies of the same condition, open and under way.
- More trials run by The Hong Kong Polytechnic UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arkers, Wong, The Hong Kong Polytechnic University
- Investigators
- Frances KY Wong, Study chair, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04442867
- Sponsor's protocol ID
- HEIPS
- Status last verified
- Aug 2022
- First submitted
- 19 Jun 2020
- Last updated
- 3 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wong AKC, Wong FKY, Chow KKS, Kwan DKS, Lau DYS, Lau ACK. A health-social service partnership programme for improving the health self-management of community-dwelling older adults: a hybrid effectiveness-implementation pilot study protocol. Pilot Feasibility Stud. 2023 Nov 8;9(1):184. doi: 10.1186/s40814-023-01412-0.
PubMed 37941087Wong AKC, Wong FKY, Wong MCS, Chow KKS, Kwan DKS, Lau DYS. A community-based health-social partnership program for community-dwelling older adults: a hybrid effectiveness-implementation pilot study. BMC Geriatr. 2022 Oct 7;22(1):789. doi: 10.1186/s12877-022-03463-z.
PubMed 36207685
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Health-social Partnership Programme for Improving Health Self-management of Community-dwelling Older Adults: a Hybrid Effectiveness-implementation Pilot Study
- ClinicalTrials.gov ID
- NCT04442867
- Acronym / sponsor ID
- HEIPS
- Conditions
- Healthy Aging
- Keywords
- hybrid effectiveness-implementation design, health-social partnership, community
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 30 Dec 2020 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 10 Jul 2022 (actual)
- First posted
- 23 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Case managementSubjects 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. |
| Control group | Other | Other: Social callParticipants in the control group will receive a monthly social control call from a trained research assistant |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- aged 60 or above
- cognitively competent with the Hong Kong version of Montreal Cognitive Assessment (HK-MoCA) with score ≥ 22
Key exclusion criteria (7 listed)
- not communicable
- not reachable by phone
- not living at home
- bedbound
- with known psychiatric problems with recent hospitalization within last 6 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Case managementBased 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. | Other | Intervention group |
| Social callProvide social call to participants, such as ask the participants what TV program do you like most, and how are you recently. | Other | Control group |
Primary outcome
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)
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.
2 secondary outcomes
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)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2022.
- Derived from this study: PubMed 37941087Wong AKC, Wong FKY, Chow KKS, Kwan DKS, Lau DYS, Lau ACK. A health-social service partnership programme for improving the health self-management of community-dwelling older adults: a hybrid effectiveness-implementation pilot study protocol. Pilot Feasibility Stud. 2023 Nov 8;9(1):184. doi: 10.1186/s40814-023-01412-0.
- Derived from this study: PubMed 36207685Wong AKC, Wong FKY, Wong MCS, Chow KKS, Kwan DKS, Lau DYS. A community-based health-social partnership program for community-dwelling older adults: a hybrid effectiveness-implementation pilot study. BMC Geriatr. 2022 Oct 7;22(1):789. doi: 10.1186/s12877-022-03463-z.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frances KY Wong study chair
The Hong Kong Polytechnic University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Case management and Social call in people with Healthy Aging, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04442867, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2022; AzTrials last refreshed its copy on 7 Nov 2026.