Intellectual Disability, Mild to ModerateICFNCT07813806
ICF-Based Interdisciplinary Case Management for Individuals With Disabilities
A study testing ICF-Based Interdisciplinary Case Management (Rehab-Cycle®) and Conventional Care Management in people with Intellectual Disability, Mild to Moderate and Developmental Disability, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial summary
This study evaluates whether an interdisciplinary case management approach based on the International Classification of Functioning, Disability and Health (ICF) and the Rehab-Cycle® framework can improve rehabilitation outcomes for adults with intellectual disabilities receiving community-based rehabilitation… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Intellectual Disability, Mild to Moderate, Developmental Disability
- What is being tested?
- ICF-Based Interdisciplinary Case Management (Rehab-Cycle®) and Conventional Care Management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Oct 2026to 14 Jun 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- between the age of 18 and 60 years old,
- intellectual disability with mild grade (IQ 50-69) or moderate grade (IQ 35-49) as confirmed by medical doctors,
- ability to communicate verbally in Cantonese or English.
Who cannot join
- acute and unstable medical conditions (such as seizures),
- Current or recent diagnosis of severe psychiatric disorders (e.g., active psychosis, major depressive episode within the past 12 months, or other conditions that significantly impair participation)
- Their caregivers will provide proxy consent if the participants with intellectual disability were unable to give the informed consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
The Hong Kong Polytechnic University
Hong Kong
Sam Chi Chung Chan, PhD, 27664310, samcc.chan@polyu.edu.hk
Sam Chi Chung Chan, PhD, samcc.chan@polyu.edu.hk
About this study
Official title: Application of the International Classification of Functioning, Disability, and Health (ICF) on Interdisciplinary Case Management for Healthcare Service Delivery for Individuals With Disabilities
This study evaluates whether an interdisciplinary case management approach based on the International Classification of Functioning, Disability and Health (ICF) and the Rehab-Cycle® framework can improve rehabilitation outcomes for adults with intellectual disabilities receiving community-based rehabilitation services.
A total of 120 adults with mild to moderate intellectual disabilities will be recruited from community rehabilitation services and randomly assigned to either an ICF-based interdisciplinary case management group or a conventional care management group. Participants in the ICF-based group will receive coordinated assessments, goal-setting, intervention planning, and outcome evaluation conducted by an interdisciplinary rehabilitation team. Participants in the control group will continue to receive standard services delivered through conventional care management practices.
The study will assess changes in functioning, activity participation, quality of life, life satisfaction, and rehabilitation team effectiveness. The findings will help determine whether ICF-based interdisciplinary case management can provide more personalized, coordinated, and effective community rehabilitation services for individuals with intellectual disabilities.
Read the detailed description
The International Classification of Functioning, Disability and Health (ICF), developed by the World Health Organization, provides a biopsychosocial framework for understanding functioning and disability by integrating body functions, activities, participation, environmental factors, and personal factors. Although the ICF framework has been increasingly promoted for rehabilitation and social service planning, its application in community-based disability services remains limited. This study aims to evaluate the effectiveness of implementing an ICF-based interdisciplinary case management model inspired by the Rehab-Cycle® framework in community rehabilitation services for individuals with intellectual disabilities.
The study will employ a randomized controlled trial with pre-intervention and post-intervention assessments. One hundred and twenty adults aged 18 to 60 years with medically confirmed mild or moderate intellectual disabilities will be recruited from community-based rehabilitation facilities operated by participating non-governmental organizations. Participants will be randomly allocated to either an ICF-based interdisciplinary case management group (n=60) or a conventional care management group (n=60). In addition, approximately fifteen rehabilitation professionals, including social workers, occupational therapists, physiotherapists, speech therapists, nurses, and clinical psychologists, will participate in the interdisciplinary service delivery process.
The intervention will be developed according to the Rehab-Cycle® process. First, a Neurodevelopment Core Set for Intellectual Condition will be established through an expert consensus process using relevant ICF core sets and the Delphi method. The selected ICF categories will guide interdisciplinary assessment and rehabilitation planning. Participants in the intervention group will undergo ICF-based assessment, development of individualized functioning profiles, interdisciplinary goal setting, coordinated intervention planning, and ongoing case review. Participants in the control group will receive conventional rehabilitation services, with assessments and interventions provided independently by different professionals without formal interdisciplinary ICF-based planning.
The primary purpose of the intervention is to improve functioning and participation through coordinated interdisciplinary rehabilitation management. By identifying participants' strengths, limitations, environmental barriers, and facilitators, the interdisciplinary team will establish mutually agreed rehabilitation goals and implement individualized interventions tailored to each participant's needs. Regular interdisciplinary meetings will be conducted to review progress and modify intervention plans as needed.
Outcome measures will evaluate functioning using selected ICF Core Set items covering body functions, activities and participation, and environmental factors. Additional outcomes will include life satisfaction as measured by the Satisfaction With Life Scale (SWLS), quality of life as measured by the World Health Organization Quality of Life-BREF (WHOQOL-BREF), and interdisciplinary team effectiveness as measured by the Provider-Perceptions of Team Effectiveness (Provider-PTE) scale. Outcomes will be assessed before and after the intervention period.
The study hypothesizes that participants receiving ICF-based interdisciplinary case management will demonstrate greater improvements in functioning, participation, life satisfaction, and quality of life than those receiving conventional care management. It is also expected that healthcare professionals implementing the ICF-based approach will report enhanced interdisciplinary team effectiveness. The results will contribute evidence regarding the feasibility and effectiveness of integrating the ICF and Rehab-Cycle® frameworks into community-based rehabilitation services and may inform future disability and rehabilitation service planning in Hong Kong and other settings.
- Being tested
- ICF-Based Interdisciplinary Case Management (Rehab-Cycle®), Conventional Care Management
- Keywords
- Intellectual Disability, International Classification of Functioning, Disability and Health (ICF), Interdisciplinary Case Management, Community-Based Rehabilitation, Client-centered Practice
- Medical subject headings
- Intellectual Disability, Developmental Disabilities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICF-Based Interdisciplinary Case Management (Rehab-Cycle®)Behavioural
Participants will receive interdisciplinary case management based on the International Classification of Functioning, Disability and Health (ICF) framework and the Rehab-Cycle® process. The intervention includes ICF-based assessment, development of individualized functioning profiles, collaborative goal setting involving participants and healthcare professionals, interdisciplinary care planning, coordinated rehabilitation interventions, and regular interdisciplinary review meetings. Interventions are designed to address body functions, activities, participation, and environmental factors according to each participant's needs within community-based rehabilitation services.
Conventional Care ManagementBehavioural
Participants will receive standard community rehabilitation services routinely provided by participating non-governmental organizations. Assessments, goal setting, intervention planning, and treatment implementation will be conducted independently by individual healthcare professionals according to usual practice. No ICF-based functioning profile, structured Rehab-Cycle® process, formal interdisciplinary case conference, or coordinated interdisciplinary intervention planning will be used.
| Study group | Role | What they receive |
|---|---|---|
| ICF-based care management group with interdisciplinary Rehab-Cycle® process | Experimental | Participants will receive an interdisciplinary case management program based on the International Classification of Functioning, Disability and Health (ICF) framework and the Rehab-Cycle® model. The intervention includes ICF-based assessment, development of individualized functioning profiles, client-centered goal setting, interdisciplinary care planning, coordinated rehabilitation interventions, and regular team reviews. Healthcare professionals collaboratively identify participant needs, establish rehabilitation goals, implement interventions, and monitor outcomes related to functioning, activity, participation, and environmental factors within routine community rehabilitation services. Receives: Behavioral: ICF-Based Interdisciplinary Case Management (Rehab-Cycle®) |
| Conventional care management group without interdisciplinary Rehab-Cycle® process | Active comparator | Participants will receive standard community rehabilitation services routinely provided by participating organizations. Assessments, goal setting, intervention planning, and service delivery will be conducted independently by individual healthcare professionals according to existing practice. No ICF-based functioning profile, structured interdisciplinary case conference, coordinated Rehab-Cycle® process, or formal interdisciplinary intervention planning will be implemented. Participants will continue to receive usual rehabilitation and support services throughout the study period. Receives: Behavioral: Conventional Care Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
ICF-based assessments of the core set items
The selected core set items will be used to assess (a) body functions (b117 intellectual function), (b) activity capacity and participation performance in daily living (e.g. basic interpersonal interactions) and (c) environmental and personal influence (e.g. e310 immediate family). The ICF 5-point qualifier will be used based on the converted results of the corresponding assessments with a scale from 0 (no problem) to 4 (complete problem).
Measured: before and after the experimental and control interventions in a 6-month period
Secondary outcomes (2)
Satisfaction with Life Scale (SWLS)
The SWLS a brief 5-item self-report measure assessing global cognitive judgments of life satisfaction (Diener et al., 1985). Each item is rated on a 7-point Likert scale from 1 ("strongly disagree") to 7 ("strongly agree"), producing a total score between 5 and 35, with higher scores reflecting greater satisfaction. The scale captures cognitive judgments rather than emotional states, making it suitable for diverse populations. Research consistently demonstrates strong psychometric properties, including high internal consistency, good test-retest reliability, and solid construct validity across cultures and age groups. With its robust measurement performance, the SWLS is a widely used tool in health, rehabilitation, and social science research
Measured: before and after the experimental and control interventions in a 6-month period
Provider-Perceptions of Team Effectiveness (Provider-PTE)
A brief self-report questionnaire that evaluates healthcare providers' perceptions of interdisciplinary team effectiveness in delivering coordinated care. The instrument assesses key domains including communication, role clarity, shared goals, collaboration, and overall team functioning using Likert-type response scales. Higher scores indicate more positive perceptions of team effectiveness. The Provider-PTE has demonstrated good reliability and validity and is sensitive to differences in interprofessional team performance across healthcare settings. The measure will be used to assess changes in interdisciplinary team functioning associated with implementation of the ICF-based case management approach
Measured: before and after the experimental and control interventions in a 6-month period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2026
- Study start1 Oct 2026 (estimated)
- Primary completion14 Jun 2027 (estimated)
- Study completion14 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (26)Papers the sponsor has linked to this study.
- Other trials for Intellectual Disability, Mild to ModerateStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Collaborators
- Evangelical Lutheran Church Social Service-Hong Kong, Salvation Army, St. James' Settlement, Yan Chai Hospital Social Services, Yang Memorial Methodist Social Services, University of Alberta, Sun Yat-sen University, Ludwig-Maximilians - University of Munich
- Responsible party
- Principal investigator, Prof. Sam Chan, The Hong Kong Polytechnic University
- Investigators
- Sam Chi Chung Chan, Principal investigator, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07813806
- Sponsor's protocol ID
- HSEARS20260103001
- Acronym
- ICF
- Status last verified
- Sep 2026
- First submitted
- 31 Aug 2026
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared to protect the privacy and confidentiality of participants who are services users of the collaborated NGOs. The informed consent and ethics approval for this study do not include permission for public sharing of individual participant-level data.
Publications
International Classification of Functioning, Disability and Health (ICF), Geneva, CH: WHO.
Verkerk G, van der Molen-Meulmeester L, van Hartingsveldt M, Alsem M. Instructions for Administering the Canadian Occupational Performance Measure with Children Themselves. Phys Occup Ther Pediatr. 2023;43(1):58-73. doi: 10.1080/01942638.2022.2079392. Epub 2022 Jun 8.
PubMed 35676806Van Naarden Braun K, Christensen D, Doernberg N, Schieve L, Rice C, Wiggins L, Schendel D, Yeargin-Allsopp M. Trends in the prevalence of autism spectrum disorder, cerebral palsy, hearing loss, intellectual disability, and vision impairment, metropolitan atlanta, 1991-2010. PLoS One. 2015 Apr 29;10(4):e0124120. doi: 10.1371/journal.pone.0124120. eCollection 2015.
PubMed 25923140Thyson S, Werminghaus M, Volpert S, Althaus L, Buscher L, Schatton D, van Treeck W, Klenzner T. Assessment of Cochlear Implant Rehabilitation Success by Speech-Language Therapists Using International Classification of Functioning, Disability and Health Criteria. J Speech Lang Hear Res. 2024 Oct 8;67(10):3826-3840. doi: 10.1044/2024_JSLHR-23-00534. Epub 2024 Oct 4.
PubMed 39366007Development of the World Health Organization WHOQOL-BREF quality of life assessment. The WHOQOL Group. Psychol Med. 1998 May;28(3):551-8. doi: 10.1017/s0033291798006667.
PubMed 9626712Schiariti V, Selb M, Cieza A, O'Donnell M. International Classification of Functioning, Disability and Health Core Sets for children and youth with cerebral palsy: a consensus meeting. Dev Med Child Neurol. 2015 Feb;57(2):149-58. doi: 10.1111/dmcn.12551. Epub 2014 Aug 6.
PubMed 25131642Steiner WA, Ryser L, Huber E, Uebelhart D, Aeschlimann A, Stucki G. Use of the ICF model as a clinical problem-solving tool in physical therapy and rehabilitation medicine. Phys Ther. 2002 Nov;82(11):1098-107.
PubMed 12405874Stucki G, Ewert T, Cieza A. Value and application of the ICF in rehabilitation medicine. Disabil Rehabil. 2002 Nov 20;24(17):932-8. doi: 10.1080/09638280210148594.
PubMed 12523361Schraner I, De Jonge D, Layton N, Bringolf J, Molenda A. Using the ICF in economic analyses of Assistive Technology systems: methodological implications of a user standpoint. Disabil Rehabil. 2008;30(12-13):916-26. doi: 10.1080/09638280701800293.
PubMed 18484387Stucki G, Stier-Jarmer M, Grill E, Melvin J. Rationale and principles of early rehabilitation care after an acute injury or illness. Disabil Rehabil. 2005 Apr 8-22;27(7-8):353-9. doi: 10.1080/09638280400014105.
PubMed 16040536Scherer MJ, DiCowden MA. Organizing future research and intervention efforts on the impact and effects of gender differences on disability and rehabilitation: the usefulness of the International Classification of functioning, Disability and Health (ICF). Disabil Rehabil. 2008;30(3):161-5. doi: 10.1080/09638280701532292.
PubMed 17852261Reddihough D, Leonard H, Jacoby P, Kim R, Epstein A, Murphy N, Reid S, Whitehouse A, Williams K, Downs J. Comorbidities and quality of life in children with intellectual disability. Child Care Health Dev. 2021 Sep;47(5):654-666. doi: 10.1111/cch.12873. Epub 2021 May 4.
PubMed 33885172Reinhardt JD, Fellinghauer BA, Strobl R, Stucki G. Dimension reduction in human functioning and disability outcomes research: graphical models versus principal components analysis. Disabil Rehabil. 2010;32(12):1000-10. doi: 10.3109/09638281003775410.
PubMed 20450408Rauch A, Cieza A, Stucki G. How to apply the International Classification of Functioning, Disability and Health (ICF) for rehabilitation management in clinical practice. Eur J Phys Rehabil Med. 2008 Sep;44(3):329-42.
PubMed 18762742Leonard H, Montgomery A, Wolff B, Strumpher E, Masi A, Woolfenden S, Williams K, Eapen V, Finlay-Jones A, Whitehouse A, Symons M, Licari M, Varcin K, Alvares G, Evans K, Downs J, Glasson E. A systematic review of the biological, social, and environmental determinants of intellectual disability in children and adolescents. Front Psychiatry. 2022 Aug 25;13:926681. doi: 10.3389/fpsyt.2022.926681. eCollection 2022.
PubMed 36090348
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of the International Classification of Functioning, Disability, and Health (ICF) on Interdisciplinary Case Management for Healthcare Service Delivery for Individuals With Disabilities
- ClinicalTrials.gov ID
- NCT07813806
- Acronym / sponsor ID
- ICF / HSEARS20260103001
- Keywords
- Intellectual Disability, International Classification of Functioning, Disability and Health (ICF), Interdisciplinary Case Management, Community-Based Rehabilitation, Client-centered Practice
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Collaborators
- Evangelical Lutheran Church Social Service-Hong Kong, Salvation Army, St. James' Settlement, Yan Chai Hospital Social Services, Yang Memorial Methodist Social Services, University of Alberta, Sun Yat-sen University, Ludwig-Maximilians - University of Munich
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 14 Jun 2027 (estimated)
- Study completion
- 14 Jun 2027 (estimated)
- First posted
- 10 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates whether an interdisciplinary case management approach based on the International Classification of Functioning, Disability and Health (ICF) and the Rehab-Cycle® framework can improve rehabilitation outcomes for adults with intellectual disabilities receiving community-based rehabilitation services.
A total of 120 adults with mild to moderate intellectual disabilities will be recruited from community rehabilitation services and randomly assigned to either an ICF-based interdisciplinary case management group or a conventional care management group. Participants in the ICF-based group will receive coordinated assessments, goal-setting, intervention planning, and outcome evaluation conducted by an interdisciplinary rehabilitation team. Participants in the control group will continue to receive standard services delivered through conventional care management practices.
The study will assess changes in functioning, activity participation, quality of life, life satisfaction, and rehabilitation team effectiveness. The findings will help determine whether ICF-based interdisciplinary case management can provide more personalized, coordinated, and effective community rehabilitation services for individuals with intellectual disabilities.
Detailed description
The International Classification of Functioning, Disability and Health (ICF), developed by the World Health Organization, provides a biopsychosocial framework for understanding functioning and disability by integrating body functions, activities, participation, environmental factors, and personal factors. Although the ICF framework has been increasingly promoted for rehabilitation and social service planning, its application in community-based disability services remains limited. This study aims to evaluate the effectiveness of implementing an ICF-based interdisciplinary case management model inspired by the Rehab-Cycle® framework in community rehabilitation services for individuals with intellectual disabilities.
The study will employ a randomized controlled trial with pre-intervention and post-intervention assessments. One hundred and twenty adults aged 18 to 60 years with medically confirmed mild or moderate intellectual disabilities will be recruited from community-based rehabilitation facilities operated by participating non-governmental organizations. Participants will be randomly allocated to either an ICF-based interdisciplinary case management group (n=60) or a conventional care management group (n=60). In addition, approximately fifteen rehabilitation professionals, including social workers, occupational therapists, physiotherapists, speech therapists, nurses, and clinical psychologists, will participate in the interdisciplinary service delivery process.
The intervention will be developed according to the Rehab-Cycle® process. First, a Neurodevelopment Core Set for Intellectual Condition will be established through an expert consensus process using relevant ICF core sets and the Delphi method. The selected ICF categories will guide interdisciplinary assessment and rehabilitation planning. Participants in the intervention group will undergo ICF-based assessment, development of individualized functioning profiles, interdisciplinary goal setting, coordinated intervention planning, and ongoing case review. Participants in the control group will receive conventional rehabilitation services, with assessments and interventions provided independently by different professionals without formal interdisciplinary ICF-based planning.
The primary purpose of the intervention is to improve functioning and participation through coordinated interdisciplinary rehabilitation management. By identifying participants' strengths, limitations, environmental barriers, and facilitators, the interdisciplinary team will establish mutually agreed rehabilitation goals and implement individualized interventions tailored to each participant's needs. Regular interdisciplinary meetings will be conducted to review progress and modify intervention plans as needed.
Outcome measures will evaluate functioning using selected ICF Core Set items covering body functions, activities and participation, and environmental factors. Additional outcomes will include life satisfaction as measured by the Satisfaction With Life Scale (SWLS), quality of life as measured by the World Health Organization Quality of Life-BREF (WHOQOL-BREF), and interdisciplinary team effectiveness as measured by the Provider-Perceptions of Team Effectiveness (Provider-PTE) scale. Outcomes will be assessed before and after the intervention period.
The study hypothesizes that participants receiving ICF-based interdisciplinary case management will demonstrate greater improvements in functioning, participation, life satisfaction, and quality of life than those receiving conventional care management. It is also expected that healthcare professionals implementing the ICF-based approach will report enhanced interdisciplinary team effectiveness. The results will contribute evidence regarding the feasibility and effectiveness of integrating the ICF and Rehab-Cycle® frameworks into community-based rehabilitation services and may inform future disability and rehabilitation service planning in Hong Kong and other settings.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ICF-based care management group with interdisciplinary Rehab-Cycle® process | Experimental | Behavioral: ICF-Based Interdisciplinary Case Management (Rehab-Cycle®)Participants will receive an interdisciplinary case management program based on the International Classification of Functioning, Disability and Health (ICF) framework and the Rehab-Cycle® model. The intervention includes ICF-based assessment, development of individualized functioning profiles, client-centered goal setting, interdisciplinary care planning, coordinated rehabilitation interventions, and regular team reviews. Healthcare professionals collaboratively identify participant needs, establish rehabilitation goals, implement interventions, and monitor outcomes related to functioning, activity, participation, and environmental factors within routine community rehabilitation services. |
| Conventional care management group without interdisciplinary Rehab-Cycle® process | Active comparator | Behavioral: Conventional Care ManagementParticipants will receive standard community rehabilitation services routinely provided by participating organizations. Assessments, goal setting, intervention planning, and service delivery will be conducted independently by individual healthcare professionals according to existing practice. No ICF-based functioning profile, structured interdisciplinary case conference, coordinated Rehab-Cycle® process, or formal interdisciplinary intervention planning will be implemented. Participants will continue to receive usual rehabilitation and support services throughout the study period. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- between the age of 18 and 60 years old,
- intellectual disability with mild grade (IQ 50-69) or moderate grade (IQ 35-49) as confirmed by medical doctors,
- ability to communicate verbally in Cantonese or English.
Key exclusion criteria (3 listed)
- acute and unstable medical conditions (such as seizures),
- Current or recent diagnosis of severe psychiatric disorders (e.g., active psychosis, major depressive episode within the past 12 months, or other conditions that significantly impair participation)
- Their caregivers will provide proxy consent if the participants with intellectual disability were unable to give the informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ICF-Based Interdisciplinary Case Management (Rehab-Cycle®)Participants will receive interdisciplinary case management based on the International Classification of Functioning, Disability and Health (ICF) framework and the Rehab-Cycle® process. The intervention includes ICF-based assessment, development of individualized functioning profiles, collaborative goal setting involving participants and healthcare professionals, interdisciplinary care planning, coordinated rehabilitation interventions, and regular interdisciplinary review meetings. Interventions are designed to address body functions, activities, participation, and environmental factors according to each participant's needs within community-based rehabilitation services. | Behavioural | ICF-based care management group with interdisciplinary Rehab-Cycle® process |
| Conventional Care ManagementParticipants will receive standard community rehabilitation services routinely provided by participating non-governmental organizations. Assessments, goal setting, intervention planning, and treatment implementation will be conducted independently by individual healthcare professionals according to usual practice. No ICF-based functioning profile, structured Rehab-Cycle® process, formal interdisciplinary case conference, or coordinated interdisciplinary intervention planning will be used. | Behavioural | Conventional care management group without interdisciplinary Rehab-Cycle® process |
Primary outcome
ICF-based assessments of the core set items
Time frame: before and after the experimental and control interventions in a 6-month period
The selected core set items will be used to assess (a) body functions (b117 intellectual function), (b) activity capacity and participation performance in daily living (e.g. basic interpersonal interactions) and (c) environmental and personal influence (e.g. e310 immediate family). The ICF 5-point qualifier will be used based on the converted results of the corresponding assessments with a scale from 0 (no problem) to 4 (complete problem).
2 secondary outcomes
Satisfaction with Life Scale (SWLS)
Time frame: before and after the experimental and control interventions in a 6-month period
Provider-Perceptions of Team Effectiveness (Provider-PTE)
Time frame: before and after the experimental and control interventions in a 6-month period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- BackgroundInternational Classification of Functioning, Disability and Health (ICF), Geneva, CH: WHO.
- Background: PubMed 35676806Verkerk G, van der Molen-Meulmeester L, van Hartingsveldt M, Alsem M. Instructions for Administering the Canadian Occupational Performance Measure with Children Themselves. Phys Occup Ther Pediatr. 2023;43(1):58-73. doi: 10.1080/01942638.2022.2079392. Epub 2022 Jun 8.
- Background: PubMed 25923140Van Naarden Braun K, Christensen D, Doernberg N, Schieve L, Rice C, Wiggins L, Schendel D, Yeargin-Allsopp M. Trends in the prevalence of autism spectrum disorder, cerebral palsy, hearing loss, intellectual disability, and vision impairment, metropolitan atlanta, 1991-2010. PLoS One. 2015 Apr 29;10(4):e0124120. doi: 10.1371/journal.pone.0124120. eCollection 2015.
- Background: PubMed 39366007Thyson S, Werminghaus M, Volpert S, Althaus L, Buscher L, Schatton D, van Treeck W, Klenzner T. Assessment of Cochlear Implant Rehabilitation Success by Speech-Language Therapists Using International Classification of Functioning, Disability and Health Criteria. J Speech Lang Hear Res. 2024 Oct 8;67(10):3826-3840. doi: 10.1044/2024_JSLHR-23-00534. Epub 2024 Oct 4.
- Background: PubMed 9626712Development of the World Health Organization WHOQOL-BREF quality of life assessment. The WHOQOL Group. Psychol Med. 1998 May;28(3):551-8. doi: 10.1017/s0033291798006667.
- Background: PubMed 25131642Schiariti V, Selb M, Cieza A, O'Donnell M. International Classification of Functioning, Disability and Health Core Sets for children and youth with cerebral palsy: a consensus meeting. Dev Med Child Neurol. 2015 Feb;57(2):149-58. doi: 10.1111/dmcn.12551. Epub 2014 Aug 6.
- Background: PubMed 12405874Steiner WA, Ryser L, Huber E, Uebelhart D, Aeschlimann A, Stucki G. Use of the ICF model as a clinical problem-solving tool in physical therapy and rehabilitation medicine. Phys Ther. 2002 Nov;82(11):1098-107.
- Background: PubMed 12523361Stucki G, Ewert T, Cieza A. Value and application of the ICF in rehabilitation medicine. Disabil Rehabil. 2002 Nov 20;24(17):932-8. doi: 10.1080/09638280210148594.
- Background: PubMed 18484387Schraner I, De Jonge D, Layton N, Bringolf J, Molenda A. Using the ICF in economic analyses of Assistive Technology systems: methodological implications of a user standpoint. Disabil Rehabil. 2008;30(12-13):916-26. doi: 10.1080/09638280701800293.
- Background: PubMed 16040536Stucki G, Stier-Jarmer M, Grill E, Melvin J. Rationale and principles of early rehabilitation care after an acute injury or illness. Disabil Rehabil. 2005 Apr 8-22;27(7-8):353-9. doi: 10.1080/09638280400014105.
- Background: PubMed 17852261Scherer MJ, DiCowden MA. Organizing future research and intervention efforts on the impact and effects of gender differences on disability and rehabilitation: the usefulness of the International Classification of functioning, Disability and Health (ICF). Disabil Rehabil. 2008;30(3):161-5. doi: 10.1080/09638280701532292.
- Background: PubMed 33885172Reddihough D, Leonard H, Jacoby P, Kim R, Epstein A, Murphy N, Reid S, Whitehouse A, Williams K, Downs J. Comorbidities and quality of life in children with intellectual disability. Child Care Health Dev. 2021 Sep;47(5):654-666. doi: 10.1111/cch.12873. Epub 2021 May 4.
- Individual participant dataSharing planned: No. IPD will not be shared to protect the privacy and confidentiality of participants who are services users of the collaborated NGOs. The informed consent and ethics approval for this study do not include permission for public sharing of individual participant-level data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sam Chi Chung Chan principal investigator
The Hong Kong Polytechnic University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ICF-Based Interdisciplinary Case Management (Rehab-Cycle®) and Conventional Care Management in people with Intellectual Disability, Mild to Moderate and Developmental Disability, 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 3 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 10 Sep 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?
Contact Sam Chi Chung Chan, PhD (27664310, samcc.chan@polyu.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ICF-based assessments of the core set items (time frame: before and after the experimental and control interventions in a 6-month period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07813806, which also lists 26 linked publications.
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 10 Sep 2026.