- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04442867
A Health-social Partnership Programme for Improving Health Self-management of Community-dwelling Older Adults
A Health-social Partnership Programme for Improving Health Self-management of Community-dwelling Older Adults: a Hybrid Effectiveness-implementation Pilot Study
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Hong Kong, Hong Kong
- Hong Kong Lutheran Social Services
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- aged 60 or above
- cognitively competent with the Hong Kong version of Montreal Cognitive Assessment (HK-MoCA) with score ≥ 22
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention group
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.
|
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.
|
Other: Control group
Participants in the control group will receive a monthly social control call from a trained research assistant
|
Provide social call to participants, such as ask the participants what TV program do you like most, and how are you recently.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
baseline pre-intervention (T1), at three-month when the interventions are completed (T2), and three-month post-intervention (T3)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
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.
|
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)
|
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
|
baseline pre-intervention (T1), at three-month when the interventions are completed (T2), and three-month post-intervention (T3)
|
Collaborators and Investigators
Investigators
- Study Chair: Frances KY Wong, The Hong Kong Polytechnic University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- HEIPS
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Healthy Aging
-
San Diego State UniversityCompleted
-
Lithuanian Sports UniversityCompletedAging | Healthy AgingLithuania
-
Beijing HospitalBGI-ShenzhenCompletedAging | Healthy Aging
-
Northumbria UniversityUniversity of East AngliaSuspendedSleep | Aging | Healthy AgingUnited Kingdom
-
Baskent UniversityCompleted
-
Hasselt UniversityRecruitingHealthy | Healthy AgingBelgium
-
University of PennsylvaniaActive, not recruitingHealthy | Healthy AgingUnited States
-
University of StirlingCompletedAging | Healthy Aging | Older Adults | AgedUnited Kingdom
-
King's College LondonUniversity of ReadingCompletedHealthy | Healthy AgingUnited Kingdom
-
Amazentis SAAtlantia Food Clinical TrialsCompletedHealthy | Healthy AgingUnited States
Clinical Trials on Case management
-
National Taiwan University HospitalCompleted
-
Minneapolis Veterans Affairs Medical CenterCompletedDiabetes MellitusUnited States
-
New York State Psychiatric InstituteEmory UniversityCompletedDepressive Disorder | Bipolar Disorder | Mental Disorders, Severe | Schizophrenia and Related Disorders
-
Johns Hopkins UniversityJohns Hopkins Community PhysiciansWithdrawnSubstance-related DisorderUnited States
-
Centre Hospitalier Universitaire de NīmesRecruiting
-
Kaiser PermanenteNot yet recruiting
-
Dalin Tzu Chi General HospitalCompletedArthritis, Rheumatoid | Case Management | Managed Care ProgramsTaiwan
-
Yong Seog OhUnknown
-
National Clinical Research Coordination Center,...CompletedMajor Depressive Disorders | Senile; DepressionKorea, Republic of