NCT07813806

Brief 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 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
9mo left

Started Oct 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress1%
Oct 2026Jun 2027

First Submitted

Initial submission to the registry

August 31, 2026

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 10, 2026

Completed
21 days until next milestone

Study Start

First participant enrolled

October 1, 2026

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 14, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 14, 2027

Last Updated

September 10, 2026

Status Verified

September 1, 2026

Enrollment Period

9 months

First QC Date

August 31, 2026

Last Update Submit

September 6, 2026

Conditions

Keywords

Intellectual DisabilityInternational Classification of Functioning, Disability and Health (ICF)Interdisciplinary Case ManagementCommunity-Based RehabilitationClient-centered Practice

Outcome Measures

Primary Outcomes (1)

  • 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).

    before and after the experimental and control interventions in a 6-month period

Secondary Outcomes (2)

  • Satisfaction with Life Scale (SWLS)

    before and after the experimental and control interventions in a 6-month period

  • Provider-Perceptions of Team Effectiveness (Provider-PTE)

    before and after the experimental and control interventions in a 6-month period

Study Arms (2)

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.

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.

Behavioral: Conventional Care Management

Interventions

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.

ICF-based care management group with interdisciplinary Rehab-Cycle® process

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.

Conventional care management group without interdisciplinary Rehab-Cycle® process

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Hong Kong Polytechnic University

Hong Kong, Hong Kong

RECRUITING

Related Publications (26)

  • International Classification of Functioning, Disability and Health (ICF), Geneva, CH: WHO.

    BACKGROUND
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  • Steiner 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.

    PMID: 12405874BACKGROUND
  • Stucki 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.

    PMID: 12523361BACKGROUND
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    PMID: 18484387BACKGROUND
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    PMID: 16040536BACKGROUND
  • Scherer 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.

    PMID: 17852261BACKGROUND
  • Reddihough 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.

    PMID: 33885172BACKGROUND
  • Reinhardt 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.

    PMID: 20450408BACKGROUND
  • Rauch 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.

    PMID: 18762742BACKGROUND
  • Leonard 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.

    PMID: 36090348BACKGROUND
  • Enemark Larsen A, Wehberg S, Christensen JR. Looking into the Content of the Canadian Occupational Performance Measure (COPM): A Danish Cross-Sectional Study. Occup Ther Int. 2020 May 14;2020:9573950. doi: 10.1155/2020/9573950. eCollection 2020.

    PMID: 32565758BACKGROUND
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    PMID: 31632051BACKGROUND
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    PMID: 40383005BACKGROUND
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    PMID: 16367493BACKGROUND
  • Chiu WT, Yen CF, Teng SW, Liao HF, Chang KH, Chi WC, Wang YH, Liou TH. Implementing disability evaluation and welfare services based on the framework of the International Classification of Functioning, Disability and Health: experiences in Taiwan. BMC Health Serv Res. 2013 Oct 14;13:416. doi: 10.1186/1472-6963-13-416.

    PMID: 24125482BACKGROUND
  • Bolte S, Lawson WB, Marschik PB, Girdler S. Reconciling the seemingly irreconcilable: The WHO's ICF system integrates biological and psychosocial environmental determinants of autism and ADHD: The International Classification of Functioning (ICF) allows to model opposed biomedical and neurodiverse views of autism and ADHD within one framework. Bioessays. 2021 Sep;43(9):e2000254. doi: 10.1002/bies.202000254. Epub 2021 Apr 1.

    PMID: 33797095BACKGROUND
  • Glasson EJ, Buckley N, Chen W, Leonard H, Epstein A, Skoss R, Jacoby P, Blackmore AM, Bourke J, Downs J. Systematic Review and Meta-analysis: Mental Health in Children With Neurogenetic Disorders Associated With Intellectual Disability. J Am Acad Child Adolesc Psychiatry. 2020 Sep;59(9):1036-1048. doi: 10.1016/j.jaac.2020.01.006. Epub 2020 Jan 13.

    PMID: 31945412BACKGROUND
  • Bickenbach JE, Chatterji S, Badley EM, Ustun TB. Models of disablement, universalism and the international classification of impairments, disabilities and handicaps. Soc Sci Med. 1999 May;48(9):1173-87. doi: 10.1016/s0277-9536(98)00441-9.

    PMID: 10220018BACKGROUND
  • Arnadottir SA, Gunnarsdottir ED, Stenlund H, Lundin-Olsson L. Participation frequency and perceived participation restrictions at older age: applying the International Classification of Functioning, Disability and Health (ICF) framework. Disabil Rehabil. 2011;33(23-24):2208-16. doi: 10.3109/09638288.2011.563818. Epub 2011 Mar 29.

    PMID: 21446857BACKGROUND
  • Alford VM, Ewen S, Webb GR, McGinley J, Brookes A, Remedios LJ. The use of the International Classification of Functioning, Disability and Health to understand the health and functioning experiences of people with chronic conditions from the person perspective: a systematic review. Disabil Rehabil. 2015;37(8):655-66. doi: 10.3109/09638288.2014.935875. Epub 2014 Jul 2.

    PMID: 24986707BACKGROUND
  • First MB. Diagnostic and statistical manual of mental disorders, 5th edition, and clinical utility. J Nerv Ment Dis. 2013 Sep;201(9):727-9. doi: 10.1097/NMD.0b013e3182a2168a. No abstract available.

    PMID: 23995026BACKGROUND

MeSH Terms

Conditions

Intellectual DisabilityDevelopmental Disabilities

Condition Hierarchy (Ancestors)

Neurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurodevelopmental DisordersMental Disorders

Study Officials

  • Sam Chi Chung Chan

    The Hong Kong Polytechnic University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sam Chi Chung Chan, PhD

CONTACT

Sam Chi Chung Chan

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

August 31, 2026

First Posted

September 10, 2026

Study Start

October 1, 2026

Primary Completion (Estimated)

June 14, 2027

Study Completion (Estimated)

June 14, 2027

Last Updated

September 10, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

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.

Locations