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

NCT ID: NCT06773169

Last Updated: 2025-03-30

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-01
• Study Completion Date: 2026-03-31

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.

Detailed Description

Background: The global rise in chronic conditions and aging is associated with increased disability. Rehabilitation self-management (SM) strategies assist people with chronic conditions adjust to and manage their daily function. Technological interventions have the potential to increase the accessibility, availability and affordability of rehabilitation SM supports. IAMABLE is an evidence- and web-based app developed and tested by rehabilitation researchers. This app needs to be tested within a community context with consideration of implementation factors. Goals: The primary aim of this study is to assess the feasibility of conducting a fully powered RCT to assess the reach and effectiveness of the IAMABLE app in community-dwelling persons (45-76 years) with at least one musculoskeletal, cardiovascular or neurological chronic condition. The secondary aim is to assess adoption, implementation, and maintenance of the app in a population-based context.

Methods: We will conduct a hybrid (type 1) pilot effectiveness-implementation design guided by the REAIM framework. Assessments will be completed at baseline, 4- and 8-months. Participants (N=50) will be recruited in London, Hamilton, Kingston, Halifax and Winnipeg. Participants will be randomly allocated to receive the IAMABLE intervention (including access to modules, goal setting, self-assessments, tailored recommendations, and the "Ask a Therapist" feature) or a comparison group (with access to web-based general health information). For the effectiveness pilot, we will assess feasibility of conducting a fully-powered RCT. We will examine whether participants accessing the IAMABLE app for 4 months with a 4-month follow-up show greater improvement in self-reported function compared to persons in the comparison group. Secondary outcomes include quality of life, self-reported mobility, participation, efficacy with self-management, pain, fatigue, falls and health service use. To identify implementation, we will use integrated knowledge translation (quantitative and qualitative data from participants, therapists and app experts) engaged in expert panels using deliberative dialogue methods to evaluate adoption, use, and sustainability, and to formulate recommendations to improve implementation.

Research Team: Letts (NPA) and Richardson (PA) have collaborated for over 20 years in chronic disease SM research, incorporating technological innovations such as electronic self-monitoring, and web-based apps. Letts has expertise in community engagement and knowledge mobilization. Richardson has run numerous randomized trials. Co-applicants MacDermid and Colquhoun have expertise in implementation research. Co-applicants at each site will support participant recruitment and intervention delivery. All are rehabilitation researchers with expertise in chronic disease management; the team includes trainees, early career researchers and senior mentors. Patient partners will support recruitment and implementation research components. The team includes an expert in mobile app development and a statistician with expertise in pilot studies and trial methodology. Expected Outcomes: This research will demonstrate feasibility to determine if IAMABLE improves function and well-being of people with chronic conditions. Recommendations emerging from the study will support optimization of implementation of the app. Results will inform a fully powered trial embedded within a hybrid type 2 effectiveness implementation trial.

Conditions

Neurological Conditions; Musculoskeletal Diseases or Conditions; Cardiovascular Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

IAMABLE Group

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

Group Type: EXPERIMENTAL

IAMABLE web-based app

Intervention Type: 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.

Control Group

The Control Group will receive general health information.

Group Type: SHAM_COMPARATOR

General health information

Intervention Type: 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.

Interventions

IAMABLE web-based app

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.

Intervention Type: OTHER

General health information

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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).

Exclusion Criteria

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

• Minimum Eligible Age: 44 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

McMaster University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lori Letts, PhD

Role: PRINCIPAL_INVESTIGATOR

McMaster University

Julie Richardson, PhD

Role: PRINCIPAL_INVESTIGATOR

McMaster University

Locations

McMaster University

Hamilton, Ontario, Canada

Countries

Canada

Central Contacts

Lori Letts, PhD

Role: CONTACT

lettsl@mcmaster.ca

289-426-0757

Susanne Sinclair, BHSc(PT)

Role: CONTACT

ssincla@mcmaster.ca

289-426-5748

Facility Contacts

Susanne Sinclair

Role: primary

ssincla@mcmaster.ca

289-426-5748

Other Identifiers

PJT-195979

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

PJT-195979

Identifier Type: -

Identifier Source: org_study_id