Health Support Project for Persons With Disabilities

NCT ID: NCT07346040

Last Updated: 2026-01-16

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 600 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-15
• Study Completion Date: 2027-02-28

Brief Summary

The goal of this clinical trial is to evaluate the health status of people with disabilities, to improve their health outcomes by providing support on nutrition, physical activity, and self-management of chronic conditions, and to strengthen sectors' capacity to deliver health management services and support for people with disabilities through a train-the-trainer program.

Detailed Description

In sheltered workshops (SWs) and integrated vocational rehabilitation services centers (IVRSCs) across Hong Kong, people with disabilities (PWDs) are provided with one-stop, integrated, and seamless vocational rehabilitation services in a specially designed environment. The aim is to help PWDs develop their social and economic potential to the fullest extent. Comorbid disorders - often overlooked when relevant sectors (e.g., non-government organizations) or healthcare professionals fail to look beyond disabilities - are likely to impose additional burdens on existing workload, resulting in adverse effect on their performance in areas such as productivity, health outcomes, personal well-being, and quality of life. Poor management of comorbid disorders may even lead to increased morbidity and mortality rates.

The Health Support Program (HSP) is a structured, multi-component intervention developed in close collaboration with a multidisciplinary research team of occupational therapists, physiotherapists, dietitians, and nurses from the Department of Rehabilitation Sciences and the Department of Food Science and Nutrition at The Hong Kong Polytechnic University. The program consists of three components: (1) nutrition, (2) physical activity, and (3) self-management of chronic conditions. The intervention is rooted in the Health Belief Model, and each component is developed based on international guidelines and current research findings. The HSP is tailored for PWDs with or without intellectual disabilities to improve health outcomes and is delivered with the assistance of the Digital Health Profile (DHP) System for the PWDs in the SWs and IVRSCs.

The DHP is a centralized database designed to record the health conditions of PWDs and optimize workflow management. Supported by an interactive dashboard and e-resources on health management, the core function of the DHP is to create health profiles for each PWDs, so that trained personnel from the SWs and IVRSCs can monitor and manage the health status of each PWDs more effectively and accurately. The DHP in all SWs and IVRSCs can together produce a comprehensive overview of the health conditions of PWDs in the community, which could facilitate and provide useful information for policy making.

Eligible PWDs in the SWs and IVRSCs who have at least one of the following physician-diagnosed chronic conditions: diabetes, hypertension, hyperlipidemia, cardiovascular disease, or obesity, will be recruited in a pragmatic, open-label, parallel-group, cluster-randomized clinical trial. The implementation of the HSP will be evaluated using the Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM) Framework.

Conditions

Disabilities

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Control group

We will use a waiting-list control group. People with disabilities in the control group will receive care as usual at study sites, be free to seek any health services during the study period, and be invited to join the HSP program for 24 weeks after the study ends

Group Type: NO_INTERVENTION

No interventions assigned to this group

Intervention group

The intervention will last for 24 weeks.

Group Type: EXPERIMENTAL

Health Support Program

Intervention Type: BEHAVIORAL

The Health Support Program (HSP) is a structured, multi-component intervention. The nutrition component will consist of one 45-minute \[for those without intellectual disability (ID)\] or 30-minute \[for ID participants\] group-based healthy eating education session per week, led by registered dietitians. The physical activity component will consist of three 30-minute sessions per week led by registered physiotherapists, together with the encouragement of community exercise and walk every day. Self-management of chronic conditions component will be implemented weekly in a 45-minute \[for non-ID participants\] or 30-minute \[for ID participants\] education session in a group format, which will be led by occupational therapists and nurses. To accommodate cognitive deficits in participants with ID and maximize their learning outcomes, additional support will be provided in terms of the structure (e.g., interactive format) of the intervention.

Interventions

Health Support Program

The Health Support Program (HSP) is a structured, multi-component intervention. The nutrition component will consist of one 45-minute \[for those without intellectual disability (ID)\] or 30-minute \[for ID participants\] group-based healthy eating education session per week, led by registered dietitians. The physical activity component will consist of three 30-minute sessions per week led by registered physiotherapists, together with the encouragement of community exercise and walk every day. Self-management of chronic conditions component will be implemented weekly in a 45-minute \[for non-ID participants\] or 30-minute \[for ID participants\] education session in a group format, which will be led by occupational therapists and nurses. To accommodate cognitive deficits in participants with ID and maximize their learning outcomes, additional support will be provided in terms of the structure (e.g., interactive format) of the intervention.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• People with disabilities in sheltered workshops and integrated vocational rehabilitation services centers who had at least one of the following physician-diagnosed chronic conditions: diabetes, hypertension, hyperlipidaemia, cardiovascular disease, or obesity

Exclusion Criteria

• Those with severe intellectual disabilities (IQ below 35) or at imminent risk of suicide

• Minimum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Hong Kong Polytechnic University

OTHER

Sponsor Role: lead

Responsible Party

TSANG Hector Wing-Hong

Chair Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Jiali Dr. He, PhD

Role: CONTACT

stacy.he@polyu.edu.hk

+852 95218090

Other Identifiers

P0045968

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

P0045968

Identifier Type: -

Identifier Source: org_study_id