IAMABLE: Implementation and Evaluation of an App for Evidence-Based Self-Management Rehabilitation Strategies

NCT06773169 | Recruiting

• 1 other identifier: PJT-195979
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Background: As the population gets older, a rise in chronic conditions has resulted in increased demand for rehabilitation. We developed a web-based app called IAMABLE (I am able), to share evidence-based rehabilitation strategies with people with chronic conditions. Our project will guide us to test this app's effectiveness and explore the ways that people use it. Goals, Methods, Approach: This pilot randomized controlled trial will offer people receiving the intervention access and use of the IAMABLE app for 4 months. People in the comparison group will have access to general web-based health information. We will recruit 50 people, 45 to 75 years, with at least one chronic condition; we will advertise in five communities (Hamilton, Kingston, London, Halifax, Winnipeg) to evaluate feasibility of the study design. Patients, therapists and app experts will be an expert group to study how the app encourages people to start and continue to use it. We will use patient-reported measures to determine if the people in the IAMABLE group experience better function; quality of life, mobility, participation, self management, pain, health service use, and falls are secondary outcomes. We will measure outcomes at baseline, 4 and 8 months. Research Team: Our team is led by researchers with experience in rehabilitation and chronic disease management, including testing technology innovations. Patient advisors will support the project, along with co-investigators with expertise in statistics, technology, and rehabilitation research. Expected Outcomes: This research has the potential to prove how a web-based app can deliver occupational therapy and physiotherapy to support health and well being for people with chronic conditions. After this study, we plan a larger trial that will focus on effectiveness and address sustained use. IAMABLE will become a resource for people with chronic illnesses to support their independent self-management with rehabilitation strategies.

Conditions

Neurological Conditions; Cardiovascular Diseases; Musculoskeletal Diseases or Conditions

Keywords

rehabilitation; chronic conditions; self-management; technology; web-based application

Outcome Measures

Primary Outcomes (10)

• Feasibility - Recruitment

  Recruitment will be assessed by documenting the number of individuals who 1) express interest in participating, 2) were deemed eligible during telephone screening, 3) declined participation (and reasons for doing so), 4) were eligible at the baseline evaluation, and 5) withdrew consent after baseline assessment (and reasons of doing so). (Criterion: ≥75% of eligible participants recruited).

  Baseline

• Feasibility - Response outcome adherence

  Response outcome adherence will be measured by completion of secondary outcomes (Criterion: ≥80%).

  Baseline

• Feasibility - Attrition

  Attrition will be quantified throughout the study period as the number of participants who complete the outcome measures at the 3 timepoints (Criterion: ≤ 20% of participants enrolled withdrawn).

  Baseline

• Feasibility - Program adherence

  Program adherence will be quantified throughout the intervention period by documenting participant adherence to the protocol (e.g., # interactions with the app and frequency) (Criteria: at least one goal set, one module reviewed, two action plans completed).

  4 months

• Feasibility - Treatment fidelity

  Treatment fidelity will be measured by monitoring therapists' responses when prompted by participants (Ask a Therapist feature) for timeliness of response being within 2 business days for any participant request (Criterion: ≥90% response within 2 days). We will audit 50% of the therapists' recommendations which will be de-identified (Criterion: ≥85% align with evidence-based modules and best evidence).

  4 months

• Feasibility - Adverse events

  Adverse events and harms, including but not limited to muscle stiffness, soreness, injuries, or falls, will be documented throughout the intervention period. (Criterion: 0 serious adverse events related to module activities).

  4 months

• Feasibility - Response outcome adherence

  Response outcome adherence will be measured by completion of secondary outcomes (Criterion: ≥80%).

  4 months

• Feasibility - Attrition

  Attrition will be quantified throughout the study period as the number of participants who complete the outcome measures at the 3 timepoints (Criterion: ≤ 20% of participants enrolled withdrawn).

  4 months

• Feasibility - Response outcome adherence

  Response outcome adherence will be measured by completion of secondary outcomes (Criterion: ≥80%).

  8 months

• Feasibility - Attrition

  Attrition will be quantified throughout the study period as the number of participants who complete the outcome measures at the 3 timepoints (Criterion: ≤ 20% of participants enrolled withdrawn).

  8 months

Secondary Outcomes (23)

• Effectiveness - Self-reported physical function

  Baseline

• Effectiveness - Patterns of mobility

  Baseline

• Effectiveness - Participation

  Baseline

• Effectiveness - Knowledge, skill and confidence for SM

  Baseline

• Effectiveness - Pain-related functional impairment

  Baseline

Other Outcomes (5)

• Reach

  8 months

• Adoption - Acceptability

  8 months

• Adoption - Satisfaction

  8 months

Study Arms (2)

IAMABLE Group

EXPERIMENTAL

The IAMABLE Group will use the IAMABLE app to engage in self-management.

Other: IAMABLE web-based app

Control Group

SHAM COMPARATOR

The Control Group will receive general health information.

Other: General health information

Interventions

IAMABLE web-based app OTHER

The Intervention Group will use the IAMABLE app for 4 months. IAMABLE users identify activities that they are having difficulty with because of their health problem and set goals they want to work toward. Self-management (SM) modules help them reach their goals, providing information and rehabilitation strategies about exercise, fall prevention, fatigue management, pain management, physical activity, and stress management. Users complete a self-assessment associated with each module, and receive tailored recommendations that guide them to access relevant module topics. Users create 7-day action plans using the strategies in the module to address their activity goals. Users receive automated notifications when it is time to evaluate action plans and activity goals, as well as weekly messages to remind them to engage with the app. Users have access to therapist support using the Ask a Therapist feature and receive individual consultations in response to queries about SM.

IAMABLE Group

General health information OTHER

The Control Group will receive a monthly email with general health information (not specific to rehabilitation or chronic diseases) for 4 months. Topics will include Nutrition, Vision Care, Foot Care, Hearing, Skin Care and Oral Care. Each email will include an introduction to the topic and links for additional information.

Control Group

Eligibility Criteria

• Age: 44 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• is community-dwelling, has access to a computer or mobile device, has an email address, is able to follow directions in English, self-reports at least one of three types of prevalent chronic conditions associated with disability that frequently require rehabilitation supports (i.e., musculoskeletal, cardiovascular, and neurological conditions), responds "somewhat easily" or "very easily" to questions on the Modified Computer Proficiency Questionnaire (MCPQ-12).

You may not qualify if:

• scores \< 11/15 on the Montreal Cognitive Assessment (MoCA) 5-Minute Test (Version 2.1).

Sponsors & Collaborators

• McMaster University: lead

Study Sites (1)

McMaster University

Hamilton, Ontario, L8S 1C7, Canada

RECRUITING

MeSH Terms

Conditions

Musculoskeletal Diseases; Cardiovascular Diseases; Chronic Disease

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Lori Letts, PhD

  McMaster University

  PRINCIPAL INVESTIGATOR

• Julie Richardson, PhD

  McMaster University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lori Letts, PhD

CONTACT

19055259140; lettsl@mcmaster.ca

Susanne Sinclair, BHSc(PT)

CONTACT

19055259140; ssincla@mcmaster.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2025
• First Posted: January 14, 2025
• Study Start: September 25, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): March 31, 2027
• Last Updated: February 6, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: IPD will be available at the time of publication and for 24 months.
• Access Criteria: Qualified researchers engaging in independent scientific research.

Locations

CA (1)