Healthy AgingNCT05621720
Adopting a Health-social Partnership Program to Promote Health and Self-care Management Among Older Adults in the Community
A study testing Case management in people with Healthy Aging, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial summary
Hong Kong has notably the longest life expectancy in the world. Ever-increasing demand and challenges are posing to the healthcare, social welfare, and elderly care service system. 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
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 788 participants
- Where
- 1 siteHong Kong
- Study dates
- 6 Jun 2022to 30 Apr 2025
- 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
- (i) People aged 60 or above
- (ii) Living within the service areas of respective community centers
- (iii) Cognitively competent with Hong Kong version of Montreal Cognitive Assessment (HK-MoCA) with score ≥22
Who cannot join
- (i) Not communicable
- (ii) Not reachable by phone
- (iii) Not living at home
- (iv) Bed bound
- (v) With serious mental illness requiring hospitalization in recent 6 months
- (vi) Already engaged in similar structured health or social programs
- (vii) Will not stay in Hong Kong for the current three months
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site, 1 recruiting
- Recruiting
The Hong Kong Polytechnic University
Kowloon
Yeung Yuk Kwok, +852 2766 4112, wilson-yy.kwok@polyu.edu.hk
Frances Kam-Yuet Wong
About this study
Official title: Adopting a Health-social Partnership Program to Promote Health and Self-care Management Among Older Adults in the Community: an Effectiveness-implementation Hybrid Design
Hong Kong has notably the longest life expectancy in the world. Ever-increasing demand and challenges are posing to the healthcare, social welfare, and elderly care service system. As a global public health strategy to address the increasing burdens, there is a strong urge for an effective approach to enhance the health and self-care ability among the older adults dwelling in the community. Literature suggested that the effectiveness of community-based self-care management programs is inconclusive. In addition, though the concept of the health-social partnership has been widely promoted to improve primary care, literature addressed that the multiple barriers existed throughout the collaboration. More evidence should be sought in the local context to evaluate the effectiveness of self-care complex interventions program among older adults.
Read the detailed description
This randomized type 2 effectiveness-implementation hybrid trial study aims to examine the effectiveness of a community-based health-social partnership program in promoting health and self-care management among older adults dwelling in the community and to explore the reach, adoption, implementation, maintenance aspects of the implementation process of the program in a real-life setting.
This study has two parts. The first part involves a cluster randomized controlled trial with a two-arm, matched-pairs, equivalent allocation ratio, and parallel design to examine the effectiveness of this study. Based on socio-economic status, community centers will be matched into three comparable pair sets, and further randomized into three intervention and control groups. A total of 788 subjects (394 in each arm) aged 60 or above, dwelling in the community, and cognitively competent will be recruited. Three-time interval outcome measures will be collected. The second part of this study is an implementation research design concerning the implementation process of the program in a real-life setting. Focus group interviews with different stakeholders will be conducted and meeting minutes, and archives of documents will be studied. Summative data will be analyzed in the RE-AIM framework.
The findings of this study are anticipated to shed some light on the effectiveness and implementation of integrated health-social service in Hong Kong context. It will make important contributions, not only to the individuals, but also to the policymakers and service providers advocating the concept of ageing in place and health-social partnership approach care. The informed the health-social partnership collaboration practice in real-world setting can facilitate the translation of research evidence into practice to tackle the health burdens and challenges.
- Conditions
- Healthy Aging
- Being tested
- Case management, Social control call and usual are
- Keywords
- Community-dwelling older adults, Self-care, Health and social partnership
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Case managementOther
On enrolment, the nurse case manager will perform the initial comprehensive assessment based on the Omaha domains of environment, psychosocial, physiological and health-related behavior. The nurse case manager will execute the intervention scheme of teaching, guidance \& counseling, treatments \& procedure, case management, and/or surveillance, with the mutual goal set with clients to promote health and self-efficacy. Home visits and telephone calls will be employed. The referral network to health and social service will be activated as appropriate.
Social control call and usual areOther
Subjects in the control group will receive usual community service. in addition, a monthly social control call from trained community workers will be given to rule out the possible social effects of the intervention. These social calls will not be related the participants' health condition nor delivery of any health information.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Subjects in the intervention group will receive a 3-moth community-based health-social partnership program (C-HSPP) led by a nurse case manager, and supported by social workers and community workers. Receives: Other: Case management |
| Control group | Other | Subjects in the control group will receive usual community services and a monthly social control call from trained community workers. Receives: Other: Social control call and usual are |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Self-efficacy
The General Self-Efficacy Scale (GSE), developed based on social cognitive theory, initially consisted of 20 items and was later refined to a 10-item version that has been translated into Chinese. The scale items are rated on a 4-point Likert scale, ranging from 1 (not at all true) to 4 (exactly true). The total score ranges from 10 to 40, with higher scores indicating greater self-efficacy, meaning a stronger belief in one's ability to handle various situations effectively.
Measured: Baseline pre-intervention (T1), at three-month when the interventions are completed (T2), and three-month post-intervention (T3)
Change in Instrumental Activities of Daily Living (IADL)
The instrumental activities of daily living is measured by Lawton Instrumental Activities of Daily Living (IADL) Scale-Chinese version, a four-point scale with 9-items of activities which include use of telephone, transportation, shopping, meal preparation, housework, handyman work, laundry, medication management, and money management. Each item rate trichotomously (1 = unable, 2 = needs assistance, 3 = independent) and sum the night responses. Higher score means a worse IADL.
Measured: Baseline pre-intervention (T1), at three-month when the interventions are completed (T2), and three-month post-intervention (T3)
Secondary outcomes (10)
Change in quality of life
Quality of Life will be assessed using the 12-item Short Form Health Survey, version 2, Chinese (HK) version (SF-12v2). This survey includes subscales for physical functioning, role limitations due to physical and emotional problems, mental health, bodily pain, general health, vitality, and social functioning. Scores are weighted according to standard scoring algorithms and benchmarked against general population norms, yielding two summary scores: the Physical Component Summary (PCS) and the Mental Component Summary (MCS), each on a scale from 0 to 100. Higher scores indicate better quality of life, with higher PCS and MCS scores reflecting better physical and mental health, respectively.
Measured: Baseline pre-intervention (T1), at three-month when the interventions are completed (T2), and three-month post-intervention (T3)
Change in self-report of pain
Using numeric (0-10) pain rating scale to assess the pain level. 0-10 where 0 is no pain and 10 is the worst pain imaginable.
Measured: Baseline pre-intervention (T1), at three-month when the interventions are completed (T2), and three-month post-intervention (T3)
Change in depression
Using the 15-item Chinese version of the Geriatric Depression Scale (GDS) to assess depression level. The maximum score is 15 (higher score, more severe) with a cut-off point of 8 with high sensitivity and specificity for detection of depression
Measured: Baseline pre-intervention (T1), at three-month when the interventions are completed (T2), and three-month post-intervention (T3)
Change in activity of daily living
Use of Modified Barthel Index-Chinese version to measure 10 basic activities of daily living function (feeding, dressing, grooming, bathing, toileting, bed-chair transfer, bladder and bowel control, ambulation and stair climbing).It is measured using a 5-point Likert scale from 1= totally dependent to 5= fully independent. Higher score means better in performing activity of daily living.
Measured: Baseline pre-intervention (T1), at three-month when the interventions are completed (T2), and three-month post-intervention (T3)
Change in health service utilization
Measuring the number of attendance to government out-patient clinics (GOPC), and number of unscheduled visits to the emergency department and hospital admission.
Measured: Baseline pre-intervention (T1), at three-month when the interventions are completed (T2), and three-month post-intervention (T3)
Change in blood pressure
Blood pressure measurement will be performed after 10 minutes of sitting rest. A standard electronic sphygmomanometer will be used to measure supine blood pressure on the right arm of each candidate (unless contraindicated). Both systolic and diastolic blood pressure will be measured. Individuals with an average BP 135/85mmHg based on readings in the morning and evening based on 6 consecutive days are considered to be hypertensive based on the Hong Kong Reference Framework for Hypertension Care for Adults in Primary Care Settings.
Measured: Baseline pre-intervention (T1), at three-month when the interventions are completed (T2), and three-month post-intervention (T3)
Change in body mass index
BMI will be measured by the calculation of weight/(height*height) based on a regularly calibrated weight scale and stadiometer when the subjects wear light clothing without shoes. Normal readings are within 18.5-23.
Measured: Baseline pre-intervention (T1), at three-month when the interventions are completed (T2), and three-month post-intervention (T3)
Change in fall incidence
Asking the fall incidence in the past three months. A fall diary is suggested to completed.
Measured: Baseline pre-intervention (T1), at three-month when the interventions are completed (T2), and three-month post-intervention (T3)
Change in medication adherence
Using 12-item Adherence to Refills and Medications Scale to the respondent's ability to take and refill all prescribed medications under different circumstances.The options vary from "none of the time" to "all of the time", with total scores ranging from 12-48 . Higher score means worse in adherence to refills and medication.
Measured: Baseline pre-intervention (T1), at three-month when the interventions are completed (T2), and three-month post-intervention (T3)
Change in capillary blood glucose
Capillary blood glucose level will be measured by a standard capillary glucose meter.
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 posted18 Nov 2022
- Study start6 Jun 2022
- Primary completion31 Jan 2025 (estimated)
- Study completion30 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- 788 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Frances Kam Yuet WONG, The Hong Kong Polytechnic University
- Investigators
- Frances Kam-Yuet Wong, Principal investigator, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05621720
- Sponsor's protocol ID
- HSEARS20210401002
- Status last verified
- Oct 2024
- First submitted
- 13 Jun 2022
- Last updated
- 17 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kwok WYY, Wong FKY, Wong AKC, Bayuo J. Community-Based Health-Social Partnership Programme (C-HSPP) for enhancing self-care management among older adults: protocol for a hybrid effectiveness-implementation trial. BMC Public Health. 2025 May 7;25(1):1678. doi: 10.1186/s12889-025-22846-6.
PubMed 40335958
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adopting a Health-social Partnership Program to Promote Health and Self-care Management Among Older Adults in the Community: an Effectiveness-implementation Hybrid Design
- ClinicalTrials.gov ID
- NCT05621720
- Acronym / sponsor ID
- HSEARS20210401002
- Conditions
- Healthy Aging
- Keywords
- Community-dwelling older adults, Self-care, Health and social partnership
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 788 participants (estimated)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 6 Jun 2022 (actual)
- Primary completion
- 31 Jan 2025 (estimated)
- Study completion
- 30 Apr 2025 (estimated)
- First posted
- 18 Nov 2022 (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.
Hong Kong has notably the longest life expectancy in the world. Ever-increasing demand and challenges are posing to the healthcare, social welfare, and elderly care service system. As a global public health strategy to address the increasing burdens, there is a strong urge for an effective approach to enhance the health and self-care ability among the older adults dwelling in the community. Literature suggested that the effectiveness of community-based self-care management programs is inconclusive. In addition, though the concept of the health-social partnership has been widely promoted to improve primary care, literature addressed that the multiple barriers existed throughout the collaboration. More evidence should be sought in the local context to evaluate the effectiveness of self-care complex interventions program among older adults.
Detailed description
This randomized type 2 effectiveness-implementation hybrid trial study aims to examine the effectiveness of a community-based health-social partnership program in promoting health and self-care management among older adults dwelling in the community and to explore the reach, adoption, implementation, maintenance aspects of the implementation process of the program in a real-life setting.
This study has two parts. The first part involves a cluster randomized controlled trial with a two-arm, matched-pairs, equivalent allocation ratio, and parallel design to examine the effectiveness of this study. Based on socio-economic status, community centers will be matched into three comparable pair sets, and further randomized into three intervention and control groups. A total of 788 subjects (394 in each arm) aged 60 or above, dwelling in the community, and cognitively competent will be recruited. Three-time interval outcome measures will be collected. The second part of this study is an implementation research design concerning the implementation process of the program in a real-life setting. Focus group interviews with different stakeholders will be conducted and meeting minutes, and archives of documents will be studied. Summative data will be analyzed in the RE-AIM framework.
The findings of this study are anticipated to shed some light on the effectiveness and implementation of integrated health-social service in Hong Kong context. It will make important contributions, not only to the individuals, but also to the policymakers and service providers advocating the concept of ageing in place and health-social partnership approach care. The informed the health-social partnership collaboration practice in real-world setting can facilitate the translation of research evidence into practice to tackle the health burdens and challenges.
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 in the intervention group will receive a 3-moth community-based health-social partnership program (C-HSPP) led by a nurse case manager, and supported by social workers and community workers. |
| Control group | Other | Other: Social control call and usual areSubjects in the control group will receive usual community services and a monthly social control call from trained community workers. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- (i) People aged 60 or above
- (ii) Living within the service areas of respective community centers
- (iii) Cognitively competent with Hong Kong version of Montreal Cognitive Assessment (HK-MoCA) with score ≥22
Key exclusion criteria (7 listed)
- (i) Not communicable
- (ii) Not reachable by phone
- (iii) Not living at home
- (iv) Bed bound
- (v) With serious mental illness requiring hospitalization in recent 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 managementOn enrolment, the nurse case manager will perform the initial comprehensive assessment based on the Omaha domains of environment, psychosocial, physiological and health-related behavior. The nurse case manager will execute the intervention scheme of teaching, guidance \& counseling, treatments \& procedure, case management, and/or surveillance, with the mutual goal set with clients to promote health and self-efficacy. Home visits and telephone calls will be employed. The referral network to health and social service will be activated as appropriate. | Other | Intervention group |
| Social control call and usual areSubjects in the control group will receive usual community service. in addition, a monthly social control call from trained community workers will be given to rule out the possible social effects of the intervention. These social calls will not be related the participants' health condition nor delivery of any health information. | 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 General Self-Efficacy Scale (GSE), developed based on social cognitive theory, initially consisted of 20 items and was later refined to a 10-item version that has been translated into Chinese. The scale items are rated on a 4-point Likert scale, ranging from 1 (not at all true) to 4 (exactly true). The total score ranges from 10 to 40, with higher scores indicating greater self-efficacy, meaning a stronger belief in one's ability to handle various situations effectively.
Change in Instrumental Activities of Daily Living (IADL)
Time frame: Baseline pre-intervention (T1), at three-month when the interventions are completed (T2), and three-month post-intervention (T3)
The instrumental activities of daily living is measured by Lawton Instrumental Activities of Daily Living (IADL) Scale-Chinese version, a four-point scale with 9-items of activities which include use of telephone, transportation, shopping, meal preparation, housework, handyman work, laundry, medication management, and money management. Each item rate trichotomously (1 = unable, 2 = needs assistance, 3 = independent) and sum the night responses. Higher score means a worse IADL.
10 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 self-report of pain
Time frame: Baseline pre-intervention (T1), at three-month when the interventions are completed (T2), and three-month post-intervention (T3)
Change in depression
Time frame: Baseline pre-intervention (T1), at three-month when the interventions are completed (T2), and three-month post-intervention (T3)
Change in activity of daily living
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 utilization
Time frame: Baseline pre-intervention (T1), at three-month when the interventions are completed (T2), and three-month post-intervention (T3)
Change in blood pressure
Time frame: Baseline pre-intervention (T1), at three-month when the interventions are completed (T2), and three-month post-intervention (T3)
Change in body mass index
Time frame: Baseline pre-intervention (T1), at three-month when the interventions are completed (T2), and three-month post-intervention (T3)
Change in fall incidence
Time frame: Baseline pre-intervention (T1), at three-month when the interventions are completed (T2), and three-month post-intervention (T3)
Change in medication adherence
Time frame: Baseline pre-intervention (T1), at three-month when the interventions are completed (T2), and three-month post-intervention (T3)
Change in capillary blood glucose
Time frame: Baseline pre-intervention (T1), at three-month when the interventions are completed (T2), and three-month post-intervention (T3)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2024.
- Derived from this study: PubMed 40335958Kwok WYY, Wong FKY, Wong AKC, Bayuo J. Community-Based Health-Social Partnership Programme (C-HSPP) for enhancing self-care management among older adults: protocol for a hybrid effectiveness-implementation trial. BMC Public Health. 2025 May 7;25(1):1678. doi: 10.1186/s12889-025-22846-6.
- 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 Kam-Yuet Wong principal investigator
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 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 3 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: status not confirmed, as of the sponsor's last update on 17 Oct 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wilson Yeung-Yuk Kwok (+852 2766 4112, wilson-yy.kwok@polyu.edu.hk), or a site near the patient. 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)). The study lists 2 primary outcomes in all. 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 NCT05621720, which also lists 1 linked publication.
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 17 Oct 2024.