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临床试验/NCT05553730
NCT05553730已完成不适用

The Effects of Digital Buddy Programme on Older Adults' Mental Well-being: Study Protocol for a Multi-centre, Cluster Randomized Controlled Trial

Sally CHAN2 个研究点 分布在 1 个国家目标入组 292 人开始时间: 2022年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
292
试验地点
2
主要终点
Change from Baseline 12-item Short Form survey version 2 (SF-12v2) at 6 months

研究概览

简要总结

Digital exclusion is prominent in the older adult population in Hong Kong. Symptoms of depression and anxiety are shown to be linked with increased barriers to participate in society. It is essential for older adults to be digitally included, get prepared for the future challenges, make use of the online services offered by the Government and social organisations, and stay connected with families, friends and the wider world. The purposes of this study are to:

  1. evaluate the effectiveness of a Digital Buddy program (digital literacy and psychoeducation training and interact with a young buddy for six-month period) on older adults' mental wellbeing, depressive symptoms, quality of life, self-efficacy and perceived social support; and
  2. explore the perceptions of older adults and young buddie' perception of the Digital Buddy programme.

With one-to-one support from the young buddies, the older adults will be regularly using their digital device to communicate with family and friends, access to services available online, access to mental health and other healthcare information, more adherence to medication intake and easier to manage their health through health management/monitoring apps, and attend online activities organised by social organisations. It is hoped that by participating in this study, their mental well-being, self-efficacy and quality of life will be further improved. A long-term relationship is expected to build up among the young buddies and the older adults so that there would be ongoing social support for the older adults. Upon completion of this study, the toolkit will be made available to the public which can benefit the wider community.

详细描述

Study design:

This study will employ a multi-centre, cluster-randomized, two-parallel-group, controlled trial design with a 1:1 allocation ratio and no stratification. A total of 292 older adult participants and 30 young buddies will be recruited. Eligible older adults will be randomly assigned to intervention and control group. Intervention group will receive six months (a minimum of 23 hours) of digital literacy and psychoeducation training with a young buddy for six-month period. Under the guidance of a young buddy, older adult participants will learn and practice skills demonstrated in the video training courses and become familiarize with online health resources.

Intervention:

The Digital Buddy Program partners youth students from higher education institutions with older adults over the course of a six-month training program to help participants develop basic ICT skill and mental health knowledge. A new e-learning program will be developed which consists of video training courses, daily mood assessments and online health resources related to mental health and age-related conditions. The Program is expected to help older adults build confidence with navigating the internet and become familiarize with e-government resources and common social media platform, overcoming the barriers that prevent them from fully participating in society.

Study setting:

研究设计

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

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

  • aged 60 years or above,
  • able to speak Cantonese and read Chinese,
  • mentally capacitated is defined as having no diagnosed mental diseases leading to being mentally disabled and certified by a psychiatrist

排除标准

  • unable to communicate in Cantonese.

结局指标

主要结局

Change from Baseline 12-item Short Form survey version 2 (SF-12v2) at 6 months

时间窗: Collected at T0 (baseline) and T1 (i.e., the week six months after the completion of the intervention

The version 2 of the 12-item Short Form Health Survey (SF-12v2) will be used to measure health-related quality of life over the past four weeks. SF-12v2 comprises 12 items rated by scales with varying points measuring eight domains of health, including physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. The scores of eight domains are aggregated into two scores: 1) physical component summary score and 2) mental component summary score. The scores will be calculated by a standard algorithm. A higher component summary scores indicates a better health-related quality of life. The Chinese version of SF-12v2 showed good test-retest reliability (r=0.67-0.82), good construct validity with \>80% of total variance explained by the two-factor model.

Change from Baseline 10-item General Self-Efficacy Scale (GSES-10) at 6 months

时间窗: Collected at T0 (baseline) and T1 (i.e., the week six months after the completion of the intervention

The 10-item General Self-efficacy scale (GSES-10) will be used to measure self-efficacy. GSES-10 comprises 10 items and each item is rated by a 4-point Likert scale from 1 (not at all true) to 4 (exactly true). The total score ranges from 10 to 40. A higher score indicates better self-efficacy. The Chinese version GSES-10 showed good internal consistency (α=0.91), good criterion validity with wellbeing (r=0.56-0.63, p\<0.001), self-esteem (r=0.40-0.49, p\<0.001), and mental health (0.39-0.41, p\<0.001).

Change from Baseline Five Well Being Index (WHO-5) at 6 months

时间窗: Collected at T0 (baseline) and T1 (i.e., the week six months after the completion of the intervention

The World Health Organization Five Well-being Index (WHO-5) will be used to measure mental well-being over the past two weeks. WHO-5 comprises five items and each item is rated by a 6-point Likert scale from 0 (at no time) to 5 (all of the time). The total score ranges from 0 to 25. A higher score indicates an increased sense of psychological well-being. The Cantonese version of WHO-5 showed good internal consistency (α=0.86) and good concurrent validity with quality of life (r=0.41-0.51).

Change from Baseline 9-item Patient Health Questionnaire - 9 (PHQ-9) at 6months

时间窗: Collected at T0 (baseline) and T1 (i.e., the week six months after the completion of the intervention

The 9-item Patient Health Questionnaire (PHQ-9) will be used to measure depressive symptoms over the past two weeks. PHQ-9 comprises nine items and each item is rated by a 4-point Likert scale from 0 (not at all) to 3 (nearly every day). The total score ranges from 0 to 27. A higher score indicates greater severity of depressive symptoms. The Cantonese version of PHQ-9 showed good internal consistency (α=0.82), test-retest reliability (r=0.76), and satisfactory concurrent validity with the mental component of quality of life (r=-0.60).

Change from Baseline Multidimensional Scale of Perceived Social Support (MSPSSC) at 6 months

时间窗: Collected at T0 (baseline) and T1 (i.e., the week six months after the completion of the intervention

The 12-item Multidimensional Scale of Perceived Social Support (MSPSS) will be used to measure perceived social support. MSPS comprises 12 items which are factored in three subscales by sources of support (i.e., family, friends, significant others). Each subscale comprises four items. Each item is rated on a 7-point Likert scale from 1 (strongly disagree) to 7 (strongly agree). The total score ranges from 12 to 84. A higher score indicates better social support. The Chinese version of MSPSS showed good internal consistency (Cronbach's α=0.95), good test-retest reliability (ICC=0.91), and satisfactory concurrent validity with perceived stress (r=-0.221) and caregiving rewarding feelings (r=-0.327).

次要结局

未报告次要终点

研究者

发起方
Sally CHAN
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Sally CHAN

President

Tung Wah College

研究点 (2)

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