跳至主要内容
临床试验/NCT05621720
NCT05621720招募中不适用

Adopting a Health-social Partnership Program to Promote Health and Self-care Management Among Older Adults in the Community: an Effectiveness-implementation Hybrid Design

The Hong Kong Polytechnic University1 个研究点 分布在 1 个国家目标入组 788 人开始时间: 2022年6月6日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
788
试验地点
1
主要终点
Change in Self-efficacy

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

盲法说明

The individual who evaluates the outcome(s) of interest would be blinded from having knowledge of the intervention and control group assignment.

入排标准

年龄范围
60 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • (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

排除标准

  • (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

结局指标

主要结局

Change in Self-efficacy

时间窗: 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)

时间窗: 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.

次要结局

  • Change in capillary blood glucose(Baseline pre-intervention (T1), at three-month when the interventions are completed (T2), and three-month post-intervention (T3))
  • Change in quality of life(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(Baseline pre-intervention (T1), at three-month when the interventions are completed (T2), and three-month post-intervention (T3))
  • Change in depression(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(Baseline pre-intervention (T1), at three-month when the interventions are completed (T2), and three-month post-intervention (T3))
  • Change in health service utilization(Baseline pre-intervention (T1), at three-month when the interventions are completed (T2), and three-month post-intervention (T3))
  • Change in blood pressure(Baseline pre-intervention (T1), at three-month when the interventions are completed (T2), and three-month post-intervention (T3))
  • Change in body mass index(Baseline pre-intervention (T1), at three-month when the interventions are completed (T2), and three-month post-intervention (T3))
  • Change in fall incidence(Baseline pre-intervention (T1), at three-month when the interventions are completed (T2), and three-month post-intervention (T3))
  • Change in medication adherence(Baseline pre-intervention (T1), at three-month when the interventions are completed (T2), and three-month post-intervention (T3))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Frances Kam Yuet WONG

Professor

The Hong Kong Polytechnic University

研究点 (1)

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