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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04863300
Other study ID # EA2003001
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 1, 2020
Est. completion date June 30, 2024

Study information

Verified date November 2022
Source The University of Hong Kong
Contact Bridget Liu, PhD
Phone 39170081
Email tianyin@hku.hk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The Jockey Club Holistic Support Project for Elderly Mental Wellness (JC JoyAge) has developed and implemented a collaborative stepped care model for older persons at-risk of or with depression in four districts in Hong Kong since 2015 (Clinical Trials Identifier: NCT03593889). Results from JC JoyAge show that the collaborative stepped-care model is effective in improving older persons' mental wellness, and the specialised training and engagement of Peer Supporters are effective in building capacity in the community. The proposed impact extension programme lasts for four years (from 2020 to 2023), and the overall goal is to expand the JC JoyAge model to all 18 districts in Hong Kong, to provide integrated and evidence-based mental health services to older adults with subclinical depressive symptoms, with the hope of model adoption in regular service upon project completion.


Description:

This four-year extension project includes three main elements: 1) Trainings, including different programmes for social services staff, Mental Wellness Ambassadors, and Peer Supporters; 2) Implementation of JoyAge service model: standardized collaborative stepped-care and Peer Support programmes for prevention and early intervention of depression in older adults; and 3) Public awareness campaign: coordinated programmes to increase mental health literacy and raise public awareness. Specific goals of the programmes through the above three elements include: 1. To implement JC JoyAge clinical protocol and guidelines to coordinate care among community mental health and aged care services centres for elderly mental wellness in 18 districts; 2. To engage vulnerable and at-risk older adults in the community through productive ageing activities and mental wellbeing self-management training; 3. To enhance the capacity of social service staff in handling elderly depression through specialized and infusion training and knowledge exchange; 4. To raise public awareness and elderly mental health literacy among family members, neighbours, community stakeholders, and the general public to encourage early detection/help-seeking on depressive risk of older adults; and 5. To establish evidence of the effectiveness and cost-effectiveness of JC JoyAge Phase II model.


Recruitment information / eligibility

Status Recruiting
Enrollment 3000
Est. completion date June 30, 2024
Est. primary completion date December 31, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 60 Years and older
Eligibility Inclusion Criteria: - age 60 years or above; and - have depressive symptoms of mild level or above; and - able to give informed consent to participate Exclusion Criteria: - known history of autism, intellectual disability, schizophrenia-spectrum disorder, bipolar disorder, Parkinson's disease, or dementia; and - (temporary exclusion criteria) imminent suicidal risk; and - difficulty in communication

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Collaborative stepped care and peer support
Case identification will be done through open referral and outreach activities such as street booth, talks, and home visits. For older adults with mild depressive symptoms (PHQ-9 score 5-9), 6-8 weeks of indicated prevention with psychoeducation or low-intensity psychotherapy would be provided by the project social workers in DECC. For participants with moderate depressive symptoms (PHQ-9 score 10-14), 6-8 weeks high-intensity clinical intervention, mainly group cognitive behavioral therapy (CBT), would be provided by project social workers from DECC and ICCMW. For those with moderately severe depressive symptoms (PHQ-9 score 15-19), 8-10 weeks individual CBT or group CBT at higher frequency would be provided by the project social workers from ICCMW. In the progress review when a client is assessed to meet the discharge criteria, a 2-month exit plan involving a Peer Supporter follow-up is invoked.

Locations

Country Name City State
Hong Kong Aberdeen Kaifong Welfare Association Services Centre Hong Kong
Hong Kong Baptist Oi Kwan Social Service Hong Kong
Hong Kong Baptist Oi Kwan Social Service Integrated Community Centre for Mental Wellness (Kwai Tsing) Hong Kong
Hong Kong Caritas Cheng Shing Fung District Elderly Centre (Sham Shui Po) Hong Kong
Hong Kong Caritas District Elderly Centre - Yuen Long(Tin Chak Centre) Hong Kong
Hong Kong Caritas Wellness Link - North District Hong Kong
Hong Kong Caritas Wellness Link Tsuen Wan Hong Kong
Hong Kong Chan Tseng Hsi Kwai Chung District Elderly Community Centre Hong Kong
Hong Kong Christian Family Service Centre (Kwun Tong) Hong Kong
Hong Kong Christian Family Service Centre Wellness Zone - Integrated Community Centre for Mental Wellness Hong Kong
Hong Kong Chuk Yuen Canon Martin District Elderly Community Centre_Wai Yuen House Hong Kong
Hong Kong Ellen Li District Elderly Community Centre - Yung Shing Shopping Centre Hong Kong
Hong Kong Fong Shu Chuen District Elderly Community Centre Hong Kong
Hong Kong H.K.S.K.H. Lady MacLehose Centre Dr. Lam Chik Suen District Elderly Community Centre Hong Kong
Hong Kong H.K.S.K.H. Lok Man Alice Kwok Integrated Service Centre Hong Kong
Hong Kong H.K.S.K.H. Western District Elderly Community Centre - Integrated Home Care Services Team Hong Kong
Hong Kong Haven of Hope Christian Service Hong Kong
Hong Kong Hong Kong Christian Service Bliss District Elderly Community Centre Hong Kong
Hong Kong Jockey Club Wong Chi Keung District Elderly Community Centre - Aberdeen Hong Kong
Hong Kong Neighbourhood Advice-action Council (Shan King) Community Nursing Services (CNS) Centre Hong Kong
Hong Kong New Life Psychiatric Rehabilitation Association (Sha Tin) Hong Kong
Hong Kong New Life Psychiatric Rehabilitation Association (Tuen Mun) Hong Kong
Hong Kong New Life Psychiatric Rehabilitation Association (Yau Tsim Mong) Hong Kong
Hong Kong New Life Psychiatric Rehabilitation Association Islands District Hong Kong
Hong Kong New Life Psychiatric Rehabilitation Association The Wellness Centre (Tin Shui Wai) Hong Kong
Hong Kong S.K.H. Holy Carpenter Church District Elderly Community Centre (Kowloon) Hong Kong
Hong Kong Sage Eastern District Elderly Community Centre Hong Kong
Hong Kong Sage Tsuen Wan District Elderly Community Centre Hong Kong
Hong Kong Shun On District Elderly Community Centre Hong Kong
Hong Kong St. James' Settlement Central & Western District Elderly Community Centre Hong Kong
Hong Kong St. James' Settlement Wan Chai District Elderly Community Centre Hong Kong
Hong Kong The Mental Health Association of Hong Kong Amity Place Hong Kong
Hong Kong The Mental Health Association of Hong Kong Tai Po District Hong Kong
Hong Kong The Neighbourhood Advice-Action Council Hong Kong
Hong Kong The Neighbourhood Advice-Action Counil Tung Chung Intergrated Service Centre Hong Kong
Hong Kong The Salvation Army Tai Po Multi-service Centre for Senior Citizens Hong Kong
Hong Kong The Society of Rehabilitation and Crime Prevention, Hong Kong Hong Kong
Hong Kong The Wellness Centre, New Life Psychiatric Rehabilitation Association (Kwai Chung) Hong Kong
Hong Kong Tseung Kwan O Aged Care Complex, Jockey Club District Elderly Community Centre cum Day Care Unit Hong Kong
Hong Kong Tung Wah Group of Hospitals Wilson T.S. Wang District Elderly Community Centre Hong Kong
Hong Kong TWGHs Lok Hong Integrated Community Centre for Mental Wellness Hong Kong
Hong Kong Wong Cho Tong District Elderly Community Centre Hong Kong
Hong Kong YWCA Ming Yue District Elderly Community Centre Hong Kong

Sponsors (15)

Lead Sponsor Collaborator
The University of Hong Kong Aberdeen Kai-fong Welfare Association Social Service, Caritas Medical Centre, Hong Kong, Christian Family Service Centre, Haven of Hope Hospital, Hong Kong Christian Service, Hong Kong Sheng Kung Hui Lady MacLehose Centre, Hong Kong Sheng Kung Hui Welfare Council Limited, Hong Kong Young Women's Christian Association (YWCA), New Life Psychiatric Rehabilitation Association, St James' Settlement (Hong Kong), The Hong Kong Society for the Aged, The Mental Health Association of Hong Kong, The Neighbourhood Advice-Action Council, Tung Wah Group of Hospitals

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change from Baseline Depression at 12 months Depression will be measured by the Patient Health Questionnaire (PHQ-9), a 9-item instrument that incorporates depression diagnostic criteria with other leading major depressive symptoms, and rates the frequency of the symptoms that factor into the scoring severity index. PHQ-9 total score ranges from 0 to 27, higher scores indicate higher levels of depression. Change scores of depression will be calculated by subtract the baseline PHQ-9 score from the follow-up PHQ-9 score, and negative results indicates reduction in depression. Baseline and 12-month follow-up
Primary Change from Baseline Anxiety at 12 months Anxiety will be measured by the Generalized Anxiety Disorder scale (GAD-7), a 7-item scale in which responses to each item are rated on a 4-point Likert scale ranging from 0 to 3. The total score will be used, ranging from 0 to 21. Higher scores indicate higher levels of anxiety symptoms. Change scores of anxiety will be calculated by subtract the baseline GAD-7 score from the follow-up GAD-7 score, and negative results indicates reduction in anxiety. Baseline and 12-month follow-up
Primary Change from Baseline Loneliness at 12 months Loneliness will be measured by the UCLA loneliness scale (UCLA-3), a 3-item self-report scale with each item evaluated with scores ranging from 0 (never) to 3 (often). The total score will be used, ranging from 0 to 9. Higher scores indicate greater loneliness. Change scores of loneliness will be calculated by subtract the baseline UCLA-3 score from the follow-up UCLA-3 score, and negative results indicates reduction in loneliness. Baseline and 12-month follow-up
Primary Change from Baseline Self-harm Risk at 12 months Self-harm risk will be assessed using eight items adapted from the Self-Harm Inventory, providing an overall assessment based on total score and clinical judgement. Social service staff assess participants' risk of self-harm (yes or no answers to 10 items) and harm to others (yes or no answers to 4 items). An overall evaluation of suicidal risk score ranges from 0 (No) to 3 (High). The overall evaluation score will be used. Change scores of self-harm risk will be calculated by subtract the baseline overall risk score from the follow-up risk score, and negative results indicates reduction in self-harm risk. Baseline and 12-month follow-up
Primary Change from Baseline Service Usage at 12 months Client Service Receipt Inventory (CSRI) will be used to collect the current types and level of social services which comprise the care package of each participant, and a locally adapted short version would be developed for this purpose. Participants report frequency of usage of different services in the past month when filling the questionnaire, higher frequency indicates more usage of that particular service. Baseline and 12-month follow-up
Secondary Change from Baseline Daily Activities at 12 months A semi-structured interview asking clients about their typical day activities in three domains: physical, social, and mental. A combination of being active in at least two domains would be used as one of the exit criteria. The changes of total numbers of activities reported will be calculated. Baseline and 12-month follow-up
Secondary Change from Baseline Cognition at 12 months Cognition will be measured by the Hong Kong Montreal Cognitive Assessment 5-Minute Protocol (HK-MoCA 5-Min). It is a validated and reliable cognitive screen for stroke and transient ischemic attack, brief and highly feasible for telephone administration. It includes four items examining attention, verbal learning and memory, executive functions/language, and orientation extracted from the MoCA. Total scores range between 0 and 30, with higher scores indicating better cognition. Change scores of cognition will be calculated by subtract the baseline HK-MoCA 5-Min score from the follow-up score, and positive results indicates improvements in cognition. Baseline and 12-month follow-up
Secondary Change from Baseline Social Network at 12 months Social support network is measured by a self-developed questionnaire asking participants to list out names of people who they would turn to (a) when they feel down, and (b) when they need help for trivial things. Participants can report up to 5 people to each condition. More people they can turn to indicates a wider social support network. Change in social support network will be calculated by subtract the baseline number of persons who they can turn to help from the follow-up number, positive results indicates increase in social support network. Baseline and 12-month follow-up
Secondary Change from Baseline Health-related Quality of Life at 12 months Health-related quality of life will be measured by the EuroQoL 5 Dimensions 5 Levels (EQ-5D-5L). The EQ-5D-5L is a generic preference-based measure of health on five dimensions (5D): mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, each with five levels (5L) of problems. The traditional Chinese version for Hong Kong developed by EuroQol Group will be used. Results will be presented by the EQ-5D-5L index value. Baseline and 12-month follow-up
Secondary Change from Baseline Self-rated Health at 12 months A visual analogue scale (EQ VAS) will be used for participants to rate their general health from 0 to 100. Change scores of overall self-rated health will be calculated by subtract the baseline EQ VAS from the follow-up EQ VAS score, and positive results indicates improvement in self-rated health. Baseline and 12-month follow-up
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