Evaluating ICF-Based Case Management in Adults With Intellectual Disabilities

November 5, 2026 updated by: Po Leung Kuk

Effectiveness of ICF-based Case Management in Promoting Independence and Vocational Participation Among Adults With Intellectual Disabilities: A Randomized Controlled Trial

The goal of this clinical trial is to evaluate whether an ICF-based interdisciplinary case management model can improve adaptive functioning, functioning and participation, and vocational functioning among adults aged 18 to 60 years with mild to moderate intellectual disabilities receiving residential care or vocational rehabilitation services in Hong Kong. The main questions it aims to answer are:

  • Does ICF-based interdisciplinary case management lead to greater improvements in adaptive functioning, as measured by the Vineland Adaptive Behavior Scales, Third Edition (Vineland-3), compared with conventional multidisciplinary rehabilitation care?
  • Does ICF-based interdisciplinary case management improve functioning and participation outcomes across relevant ICF domains compared with conventional multidisciplinary rehabilitation care?
  • Among participants receiving vocational rehabilitation services, does the intervention improve vocational functioning and work-related behaviours compared with conventional multidisciplinary rehabilitation care?

Researchers will compare participants receiving ICF-based interdisciplinary case management with those receiving conventional multidisciplinary rehabilitation care to determine whether the ICF-based approach produces better outcomes in adaptive functioning, functioning and participation, and vocational functioning.

Participants will:

  • Complete baseline and post-intervention assessments over a 6-month study period.
  • Be randomly assigned to either the ICF-based case management group or the conventional care group.
  • Receive rehabilitation services from multidisciplinary professionals.
  • If assigned to the intervention group, undergo ICF-based assessment, interdisciplinary goal setting, case conferences, and coordinated rehabilitation planning guided by the ICF Rehab-Cycle®.
  • Complete outcome evaluations using the Vineland-3, WHO ICF Checklist v2.1a, and, where applicable, the Chinese Work Personality Profile (CWPP).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Adults with intellectual disabilities often experience complex and interrelated challenges in adaptive functioning, participation, and community integration that require coordinated interdisciplinary rehabilitation. The World Health Organization's International Classification of Functioning, Disability and Health (ICF) provides a biopsychosocial framework for understanding functioning and disability and facilitates communication, goal setting, and collaborative care planning among rehabilitation professionals.

This randomized controlled trial aims to evaluate the effectiveness of an ICF-based interdisciplinary case management model for adults with intellectual disabilities receiving residential care or vocational rehabilitation services. Participants will be randomly allocated to either an ICF-based interdisciplinary case management group or a conventional multidisciplinary rehabilitation care group and followed for six months.

The intervention is guided by the ICF Rehab-Cycle®, which comprises four key processes: assessment, assignment, intervention, and evaluation. Using the ICF framework, interdisciplinary team members will conduct a comprehensive assessment of participants' body functions, activities, participation, environmental factors, and personal factors. Assessment findings will be used to develop a shared understanding of each participant's functioning profile and to formulate individualized rehabilitation goals through interdisciplinary case conferences. These goals will guide coordinated intervention planning and service delivery. Participants' progress and goal attainment will be reviewed regularly, and intervention strategies will be adjusted according to changes in functioning and participation throughout the rehabilitation process.

Participants in the control group will receive routine multidisciplinary rehabilitation services according to existing service practices without the use of a structured ICF-based case management framework.

The findings will provide evidence regarding the clinical effectiveness and feasibility of implementing an ICF-based interdisciplinary case management approach in intellectual disability rehabilitation services and may inform future service development, interdisciplinary practice, and the application of the ICF framework in rehabilitation settings.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
84

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong, 999077
        • Po Leung Kuk Lau Chan Siu Po Integrated Rehabilitation Centre
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

To be eligible for participation, individuals must:

  1. be aged between 18 and 60 years;
  2. have a formal medical diagnosis of mild or moderate intellectual disability;
  3. be currently receiving residential care or vocational rehabilitation services;
  4. be medically stable and able to participate in routine rehabilitation programmes; and
  5. provide informed consent directly or via a legally authorized representative.

Individuals will be excluded if they:

  1. experience an acute or unstable medical condition requiring intensive treatment;
  2. present with acute psychiatric episodes that may substantially interfere with participation;
  3. are currently participating in ICF-Based Interdisciplinary Case Management Programme; or
  4. lack an available consent pathway through either personal consent or legal representation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: ICF-Based Interdisciplinary Case Management

Participants will receive rehabilitation services coordinated using the International Classification of Functioning, Disability and Health (ICF) framework. The intervention includes standardized ICF-based assessment, interdisciplinary case conferences, collaborative goal setting, individualized rehabilitation planning, and coordinated intervention delivery by multidisciplinary team members over a 6-month period. Outcomes are monitored and reviewed according to participants' functioning, participation, environmental, and personal factors.
Behavioral: ICF-Based Interdisciplinary Case Management

A structured case management model utilizing the ICF framework to guide assessment, goal setting, intervention planning, and interdisciplinary collaboration for adults with intellectual disabilities receiving rehabilitation services.
Active Comparator: Conventional Multidisciplinary Rehabilitation Care

Participants will receive usual rehabilitation services provided by multidisciplinary professionals according to existing service practices. Assessment, goal setting, and intervention planning will be conducted in accordance with routine procedures without the use of a structured ICF-based case management framework.
Other: Conventional Multidisciplinary Rehabilitation Care

Standard rehabilitation services delivered by multidisciplinary professionals, including discipline-specific assessment, rehabilitation planning, and intervention based on existing service protocols.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Adaptive Functioning
Time Frame: Baseline and 6 months (post-intervention)

Adaptive functioning measured by the Vineland Adaptive Behavior Scales, Third Edition (Vineland-3). The Vineland-3 assesses participants' adaptive behavior across domains including communication, daily living skills, and socialization. Change in scores from baseline to 6 months will be compared between the intervention and control groups.
Baseline and 6 months (post-intervention)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Functioning and Participation
Time Frame: Baseline and 6 months post-intervention.

Functioning and participation measured using the WHO ICF Checklist Version 2.1a. The assessment evaluates functioning across body functions, activities and participation, environmental factors, and personal factors. Changes from baseline to 6 months will be compared between groups.
Baseline and 6 months post-intervention.
Vocational Functioning
Time Frame: Baseline and 6 months post-intervention.

Vocational functioning measured using the Chinese Work Personality Profile (CWPP). The assessment evaluates work-related behaviors and vocational performance among participants receiving vocational rehabilitation services. Changes from baseline to 6 months will be compared between groups.
Baseline and 6 months post-intervention.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Po Leung Kuk

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 26, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 30, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 5, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 5, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 12, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 12, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 5, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PLK/REC/2026/01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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