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DisabilitiesJCHSPNCT07346040

Health Support Project for Persons With Disabilities

A study testing Health Support Program in people with Disabilities, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 15 years and older
Conditions the study is for
Disabilities
What is being tested?
Health Support Program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
600 participants
Where
1 siteHong Kong
Study dates
28 Mar 2025to 28 Feb 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 15 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Hong Kong1 site
  • Sheltered Workshops & Integrated Vocational Rehabilitation Services Centers

    Hong Kong Island, Kowloon, New Territories

Other trials in Hong Kong

About this study

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.

Read the 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
Being tested
Health Support Program
Keywords
People with disabilities, Chronic diseases, Nutrition, Physical activity, Self-management
Medical subject headings
Chronic Disease, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Health Support ProgramBehavioural

    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.

Study groups in NCT07346040
Study groupRoleWhat they receive
Control groupNo interventionWe 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
Intervention groupExperimentalThe intervention will last for 24 weeks.
Receives: Behavioral: Health Support Program

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Comprehensive health literacy

    Comprehensive health literacy will be measured as general knowledge of nutrition, physical exercise, and self-management of chronic diseases using a self-designed, closed-ended questionnaire. Responses will be scored as follows: 1 point for the correct answer, and 0 points for the incorrect answer or for the "Not sure" response. The dichotomized scores for each item in each area will be summed, with results ranging from 0 to 30 for knowledge of nutrition, 0 to15 for knowledge of physical activity, and 0 to 27 for knowledge of self-management of chronic diseases. For participants with intellectual disabilities, the number of items will be reduced. The results will range from 0 to 21 for knowledge of nutrition, 0 to15 for knowledge of physical activity, and 0 to 27 for knowledge of self-management of chronic diseases. Higher scores indicate better health literacy regarding nutrition, physical exercise, and self-management of chronic diseases, separately.

    Measured: Baseline, 12-week mid-intervention, 24-week post-intervention, and 6-month follow-up

Secondary outcomes (11)
  1. Dietary intake

    Dietary intake will be captured via a self-designed, closed-ended questionnaire that asks individuals about the frequency of their consumption of 12 food items on a weekly basis. Participants will rate their weekly consumption of each food item on a 5-point Likert scale. On this scale, less healthy food items will be rated from daily consumption (0) to never consumption (4), while healthy food items will be rated in reverse, from daily consumption (4) to never consumption (0). In addition, there is 1 item, "Do you think your dietary habit is health", with responses is rating from "very unhealthy" (0) to "very health" (4). Total scores will range from 0 to 52, with higher scores indicating a healthier diet. For those with intellectual disabilities, the food items will be shorted to 8, with 6 less healthy food items and 2 healthy food items, resulting a total of score ranged from 0 to 32.

    Measured: Baseline, 12-week mid-intervention, 24-week post-intervention, and 6-month follow-up

  2. Achievement of physical activity goals

    Achievement of physical activity goals will be retrieved from each sheltered workshops and integrated vocational rehabilitation services centers if individuals meet the World Health Organization's recommendation of at least 150 minutes of moderate-intensity physical activity per week. The scoring system is dichotomous as: a "yes" response receives 1 point, and a "no" response receives 0 points.

    Measured: Baseline, 12-week mid-intervention, 24-week post-intervention, and 6-month follow-up

  3. Self-efficacy for physical activity

    Self-efficacy for physical activity will be assessed using the Chinese version of Self-Efficacy for Exercise (SEE) scale. The SEE evaluates individuals' perceived confidence in overcoming nine barriers to regular exercise: weather, boredom, pain, exercising alone, not pleasurable, too busy, feel tired, stress, depressed. For each situation, individuals rate their current confidence in exercising three times per week for 20 minutes each time using an 11-point Likert scale ranging from 0 (Not confident) to 10 (Very confident). The total score ranges from 0 to 90, with higher scores reflecting stronger levels of self-efficacy for exercise. This scale will not be used for participants with intellectual disabilities.

    Measured: Baseline, 12-week mid-intervention, 24-week post-intervention, and 6-month follow-up

  4. Body mass index (BMI)

    Body mass index (BMI) will be calculated as the weight in kilograms (kg; measured to the nearest 0.1 kg while wearing light clothing and stand erect, barefoot) divided by the squared height in meters (measured to the nearest 0.1 centimeters).

    Measured: Baseline, 12-week mid-intervention, 24-week post-intervention, and 6-month follow-up

  5. Blood pressure

    Blood pressure will be collected twice after a five-minute rest in a sitting position, with a five-minute rest in between. Readings will be taken on the right arm when possible; otherwise, readings will be taken on the left arm for those with conditions that preclude the use of the right arm, using electronic automated sphygmomanometers. The second reading will be used in all analyses, unless missing. According to the national guidelines, hypertension is defined as a systolic blood pressure of 140 mmHg or higher, a diastolic blood pressure of 90 mmHg or higher, or both.

    Measured: Baseline, 12-week mid-intervention, 24-week post-intervention, and 6-month follow-up

  6. Handgrip strength

    Handgrip strength will be measured three times in kilograms to the nearest 0.1 kg for each hand using a digital dynamometer, with a 60-second rest in between. Participants will be instructed to keep their elbow at a 90° angle flexion while either standing or sitting, with a neutral wrist position, and upper arm set vertically against the trunk. Participants will be required to squeeze the handle as hard as possible for three seconds. Handgrip strength will be considered as the maximum value of the three measurements for each hand.

    Measured: Baseline, 12-week mid-intervention, 24-week post-intervention, and 6-month follow-up

  7. Medication adherence

    Medication adherence will be measured with the Chinese version of the eight-item Morisky Medication Adherence Scale (MMAS-8). The scale includes seven dichotomous yes/no questions and one question answered on a five-point Likert scale. For Item 1 through 7, each "no" response is rated as 1, and each "yes" response is rated as 0, except for Item 5, where the "yes" response is rated as 1 and the "no" response is rated as 0. Item 8 contributes a score between 0 (All the time) and 1 (Never) in 0.25-point increments on a 5-point scale that assesses how often patients forget to take their medications. Item 8 will be adjusted for participants with intellectual disabilities as follows: "Do you have difficulty remembering to take all your medication(s)?" In the adjusted Item 8, the response of "difficulty" or "not sure" will be coded as 0, while "without difficulty" will be coded as 1. The total score is the sum of all MMAS-8 items and ranges between 0 and 8.

    Measured: Baseline, 12-week mid-intervention, 24-week post-intervention, and 6-month follow-up

  8. Mental well-being

    Mental well-being will be assessed using the Chinese version of the World Health Organization-Five Well-Being Index (WHO-5). The WHO-5 consists of five items, each of which is scored on a 6-point Likert scale with response options ranging from 0 (At no time) to 5 (All of the time). The WHO-5 raw score ranges from 0 to 25 and is conventionally multiplied by 4 to give a percentage score from 0, representing the worst imaginable well-being, to 100, corresponding to the best imaginable state of subjective well-being. For participants with intellectual disabilities, responses will be scored on a 3-point Likert scale: 0 (At no time), 1 (Sometimes), and 2 (All of the time) The total score is obtained by summing the scores of the five items and multiplying the raw score by 10, resulting in a percentage score ranging from 0 (worst well-being) to 100 (best well-being).

    Measured: Baseline, 12-week mid-intervention, 24-week post-intervention, and 6-month follow-up

  9. Health-related QoL

    Health-related quality of life will be evaluated via the Chinese version of the EuroQoL-5 Dimension-5 Level (EQ-5D-5L) instrument. The EQ-5D-5L descriptive system consists of the dimension of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, and each dimension includes five response categories of 1 (no problem), 2 (slight problems), 3 (moderate problems), 4 (severe problems), and 5 (extreme problems). A total of 3,125 (55) possible health states exists that are derived from the combination of each level of each dimension, with "11111" and "55555" representing the best and worst health states, respectively. The utility score of EQ-5D-5L will be derived using the established Hong Kong value set by weighting each respondent's self-report health status to a single preference-based health index (utility scores). A higher score in EQ-5D-5L will indicate better health-related quality of life.

    Measured: Baseline, 12-week mid-intervention, 24-week post-intervention, and 6-month follow-up

  10. Productivity levels

    Productivity levels improved after the launch of the Health Support Program. This improvement will be reflected in statistics from non-governmental organizations, particularly the total number of completed tasks by the people with disabilities in sheltered workshops and integrated vocational rehabilitation services centers.

    Measured: Baseline, 12-week mid-intervention, 24-week post-intervention, and 6-month follow-up

  11. Satisfaction levels

    The satisfaction levels of participants will be rated on a 5-point Likert scale, ranging from"lowest satisfaction" (1) to "highest satisfaction" (5) for each component of the HSP intervention.

    Measured: 12-week mid-intervention, 24-week post-intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jan 2026
  2. Study start28 Mar 2025
  3. Primary completion28 Feb 2027 (estimated)
  4. Study completion28 Feb 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
600 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07346040
Sponsor's protocol ID
P0045968
Other IDs
P0045968
Acronym
JCHSP
Status last verified
May 2026
First submitted
20 Dec 2025
Last updated
26 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Only IPD used in the results publication

Questions about this trial

What is this clinical trial studying?

A study testing Health Support Program in people with Disabilities, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 26 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Comprehensive health literacy (time frame: Baseline, 12-week mid-intervention, 24-week post-intervention, and 6-month follow-up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2026.

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