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

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.

Study Overview

• Status: Recruiting
• Conditions: Cardiovascular Diseases; Musculoskeletal Diseases or Conditions; Neurological Conditions
• Intervention / Treatment: Other: IAMABLE web-based app; Other: General health information

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.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lori Letts, PhD; Phone Number: 19055259140; Email: lettsl@mcmaster.ca
• Study Contact Backup: Name: Susanne Sinclair, BHSc(PT); Phone Number: 19055259140; Email: ssincla@mcmaster.ca

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada, L8S 1C7
      • Recruiting
      • McMaster University
      • Sub-Investigator: Ruth Barclay, PhD
      • Sub-Investigator: Lehana Thabane, PhD
      • Sub-Investigator: Joy MacDermid, PhD
      • Principal Investigator: Lori Letts, PhD
      • Principal Investigator: Julie Richardson, PhD
      • Sub-Investigator: Heather Colquhoun, PhD
      • Sub-Investigator: Denise Connelly, PhD
      • Sub-Investigator: Catherine Donnelly, PhD
      • Sub-Investigator: Carri Hand, PhD
      • Sub-Investigator: Ayse Kuspinar, PhD
      • Sub-Investigator: Caitlin McArthur, PhD
      • Sub-Investigator: Jordan Miller, PhD
      • Sub-Investigator: Tanya Packer, PhD
      • Sub-Investigator: Jacquie Ripat, PhD
      • Sub-Investigator: Jenna Smith, PhD
      • Sub-Investigator: Edward Sykes, PhD
      • Sub-Investigator: Feng Xie, PhD
      • Contact: Susanne Sinclair; Phone Number: 1-905-525-9140; Email: ssincla@mcmaster.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: IAMABLE Group; The IAMABLE Group will use the IAMABLE app to engage in self-management.	Other: 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.
Sham Comparator: Control Group; The Control Group will receive general health information.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effectiveness - Self-reported physical function	Self-reported physical function will be measured using the Patient Specific Functional Scale (PSFS), an outcome measure used in patients with varying levels of independence.	Baseline
Effectiveness - Patterns of mobility	Patterns of mobility will be evaluated using the Life-Space Assessment (LSA) Questionnaire, which assesses five space levels visited by the participant in the four weeks prior to the assessment.	Baseline
Effectiveness - Participation	Participation will be assessed using the Computer Adaptive Testing (CAT) version of the Late Life Disability Instrument (LLDI-CAT). The LLDI measures limitations in perceived ability to perform social and instrumental roles.	Baseline
Effectiveness - Knowledge, skill and confidence for SM	Knowledge, skill and confidence for SM will be measured using the Self-Efficacy for Managing Chronic Disease 6-item Scale (SES-6C), a measure of how confident patients with chronic disease are in managing fatigue, physical discomfort/pain, emotional distress, and activities needed to manage health conditions.	Baseline
Effectiveness - Pain-related functional impairment	Pain-related functional impairment will be measured using the Brief Pain Inventory (BPI) Interference Scale. The BPI contains 7 domains, including general activity, mood, and walking ability.	Baseline
Effectiveness - Fatigue	Fatigue will be assessed using the Checklist of Individual Strength (CIS), which assesses four dimensions of fatigue, fatigue severity, concentration problems, reduced motivation and activity.	Baseline
Effectiveness - Quality of life	Quality of life will be measured using the SF-12, a widely used health profile in clinical trials with high test-retest reliability and responsiveness. Preference-based scores can be obtained from the SF-12, which can be used to calculate quality-adjusted life years (QALYs) for cost-utility analysis.	Baseline
Effectiveness - Change in self-reported physical function	Self-reported physical function will be measured using the Patient Specific Functional Scale (PSFS), an outcome measure used in patients with varying levels of independence.	4 months
Effectiveness - Change in patterns of mobility	Patterns of mobility will be evaluated using the Life-Space Assessment (LSA) Questionnaire, which assesses five space levels visited by the participant in the four weeks prior to the assessment.	4 months
Effectiveness - Change in participation	Participation will be assessed using the Computer Adaptive Testing (CAT) version of the Late Life Disability Instrument (LLDI-CAT). The LLDI measures limitations in perceived ability to perform social and instrumental roles.	4 months
Effectiveness - Change in knowledge, skill and confidence for SM	Knowledge, skill and confidence for SM will be measured using the Self-Efficacy for Managing Chronic Disease 6-item Scale (SES-6C), a measure of how confident patients with chronic disease are in managing fatigue, physical discomfort/pain, emotional distress, and activities needed to manage health conditions.	4 months
Effectiveness - Change in pain-related functional impairment	Pain-related functional impairment will be measured using the Brief Pain Inventory (BPI) Interference Scale. The BPI contains 7 domains, including general activity, mood, and walking ability.	4 months
Effectiveness - Change in fatigue	Fatigue will be assessed using the Checklist of Individual Strength (CIS), which assesses four dimensions of fatigue, fatigue severity, concentration problems, reduced motivation and activity.	4 months
Effectiveness - Change in quality of life	Quality of life will be measured using the SF-12, a widely used health profile in clinical trials with high test-retest reliability and responsiveness. Preference-based scores can be obtained from the SF-12, which can be used to calculate quality-adjusted life years (QALYs) for cost-utility analysis.	4 months
Effectiveness - Healthcare utilization	Healthcare utilization data will be collected using a survey we have used in other clinical trials; this will contribute to planned cost-effectiveness.	4 months
Effectiveness - Change in self-reported physical function	Self-reported physical function will be measured using the Patient Specific Functional Scale (PSFS), an outcome measure used in patients with varying levels of independence.	8 months
Effectiveness - Change in patterns of mobility	Patterns of mobility will be evaluated using the Life-Space Assessment (LSA) Questionnaire, which assesses five space levels visited by the participant in the four weeks prior to the assessment.	8 months
Effectiveness - Change in participation	Participation will be assessed using the Computer Adaptive Testing (CAT) version of the Late Life Disability Instrument (LLDI-CAT). The LLDI measures limitations in perceived ability to perform social and instrumental roles.	8 months
Effectiveness - Change in knowledge, skill and confidence for SM	Knowledge, skill and confidence for SM will be measured using the Self-Efficacy for Managing Chronic Disease 6-item Scale (SES-6C), a measure of how confident patients with chronic disease are in managing fatigue, physical discomfort/pain, emotional distress, and activities needed to manage health conditions.	8 months
Effectiveness - Change in pain-related functional impairment	Pain-related functional impairment will be measured using the Brief Pain Inventory (BPI) Interference Scale. The BPI contains 7 domains, including general activity, mood, and walking ability.	8 months
Effectiveness - Change in fatigue	Fatigue will be assessed using the Checklist of Individual Strength (CIS), which assesses four dimensions of fatigue, fatigue severity, concentration problems, reduced motivation and activity.	8 months
Effectiveness - Change in quality of life	Quality of life will be measured using the SF-12, a widely used health profile in clinical trials with high test-retest reliability and responsiveness. Preference-based scores can be obtained from the SF-12, which can be used to calculate quality-adjusted life years (QALYs) for cost-utility analysis.	8 months
Effectiveness - Healthcare utilization	Healthcare utilization data will be collected using a survey we have used in other clinical trials; this will contribute to planned cost-effectiveness.	8 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reach	Reach will be measured by the number of participants who are given access to initiate use of the app.	8 months
Adoption - Acceptability	Acceptability will be measured using the Service User Technology Acceptability Questionnaire. It has 22 items and 6 domains: perceived benefit, privacy and discomfort, care personnel concerns, app as a substitution, and satisfaction.	8 months
Adoption - Satisfaction	Satisfaction with the IAMABLE app will be measured using the 14-item mHealth Satisfaction Questionnaire.	8 months
Implementation	Study feasibility data on program adherence, treatment fidelity, and adverse events and harms will contribute to our understanding of implementation.	8 months
Sustainability	Individual interviews will be conducted at the end of 8 months to explore participants' experience of using the app over the intervention period. Data compiled re: adherence, acceptability, satisfaction and implementation will be compiled to support development of a sustainability plan for the IAMABLE app.	8 months

Collaborators and Investigators

• Sponsor: McMaster University
• Investigators: Principal Investigator: Julie Richardson, PhD, McMaster University; Principal Investigator: Lori Letts, PhD, McMaster University

Study record dates

Study Major Dates

• Study Start (Actual): September 25, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): March 31, 2027

Study Registration Dates

• First Submitted: January 6, 2025
• First Submitted That Met QC Criteria: January 8, 2025
• First Posted (Actual): January 14, 2025

Study Record Updates

• Last Update Posted (Actual): February 6, 2026
• Last Update Submitted That Met QC Criteria: February 5, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: rehabilitation; self-management; technology; web-based application; chronic conditions
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Pathological Conditions, Signs and Symptoms; Cardiovascular Diseases; Musculoskeletal Diseases; Chronic Disease
• Other Study ID Numbers: PJT-195979 (Other Grant/Funding Number: Canadian Institutes for Health Research)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All IPD related to publication results
• IPD Sharing Time Frame: IPD will be available at the time of publication and for 24 months.
• IPD Sharing Access Criteria: Qualified researchers engaging in independent scientific research.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No