Adopting a Health-social Partnership Program to Promote Health and Self-care Management Among Older Adults in the Community

Healthy Aging Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05621720
• Other study ID #: HSEARS20210401002
• Status: Recruiting
• Phase: N/A
• Start date: June 6, 2022
• Est. completion date: January 1, 2025

Study information

• Verified date: November 2022
• Source: The Hong Kong Polytechnic University
• Contact: Wilson Yeung-Yuk Kwok
• Phone: +852 2766 4112
• Email: wilson-yy.kwok[@]polyu.edu.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 788
• Est. completion date: January 1, 2025
• Est. primary completion date: January 5, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years and older

Eligibility

Inclusion Criteria:

• (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

Exclusion Criteria:

• (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

Related Conditions & MeSH terms

• Healthy Aging

Intervention

Other:
• Case management
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 are
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.

Locations

Country	Name	City	State
Hong Kong	The Hong Kong Polytechnic University	Kowloon

Sponsors (1)

Lead Sponsor	Collaborator
The Hong Kong Polytechnic University

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Self-efficacy	The General Self-efficacy scale was developed based on social cognitive theory with 20 items originally. It was later shortened to 10 items and translated to Chinese.The items are rated on a 4-point Likert scale, which the higher the score, the greater self-efficacy the respondents possess.	Baseline pre-intervention (T1), at three-month when the interventions are completed (T2), and three-month post-intervention (T3)
Primary	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.	Baseline pre-intervention (T1), at three-month when the interventions are completed (T2), and three-month post-intervention (T3)
Secondary	Change in quality of life	Quality of life will be measured by the 12-item Short Form Health Survey version 2 Chinese (HK) version (SF-12). The questionnaire includes the scales of physical functioning, role limitation due to physical problems, role limitation due to emotional problems, mental health, bodily pain, general health, vitality, and social functioning. Higher score means better quality of life.	Baseline pre-intervention (T1), at three-month when the interventions are completed (T2), and three-month post-intervention (T3)
Secondary	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.	Baseline pre-intervention (T1), at three-month when the interventions are completed (T2), and three-month post-intervention (T3)
Secondary	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	Baseline pre-intervention (T1), at three-month when the interventions are completed (T2), and three-month post-intervention (T3)
Secondary	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.	Baseline pre-intervention (T1), at three-month when the interventions are completed (T2), and three-month post-intervention (T3)
Secondary	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.	Baseline pre-intervention (T1), at three-month when the interventions are completed (T2), and three-month post-intervention (T3)
Secondary	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.	Baseline pre-intervention (T1), at three-month when the interventions are completed (T2), and three-month post-intervention (T3)
Secondary	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.	Baseline pre-intervention (T1), at three-month when the interventions are completed (T2), and three-month post-intervention (T3)
Secondary	Change in fall incidence	Asking the fall incidence in the past three months. A fall diary is suggested to completed.	Baseline pre-intervention (T1), at three-month when the interventions are completed (T2), and three-month post-intervention (T3)
Secondary	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.	Baseline pre-intervention (T1), at three-month when the interventions are completed (T2), and three-month post-intervention (T3)
Secondary	Change in capillary blood glucose	Capillary blood glucose level will be measured by a standard capillary glucose meter.	Baseline pre-intervention (T1), at three-month when the interventions are completed (T2), and three-month post-intervention (T3)