Clinical trial NCT06773169: IAMABLE: Implementation and Evaluation of an App for Evidence-Based Self-Management Rehabilitation Strategies
Official title: IAMABLE: Implementation and Evaluation of an App for Evidence-Based Self-Management Rehabilitation Strategies
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Neurological Conditions
Musculoskeletal Diseases or Conditions
Cardiovascular Diseases
Keywords: rehabilitation
chronic conditions
self-management
technology
web-based application
Lead sponsor: McMaster University
Sponsor class: OTHER
First posted: 2025-01-14
Enrollment: 50
Sex: ALL
Minimum age (years): 44
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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).

Primary outcomes:
measure: Feasibility - Recruitment
timeFrame: Baseline
measure: Feasibility - Response outcome adherence
timeFrame: Baseline
measure: Feasibility - Attrition
timeFrame: Baseline
measure: Feasibility - Program adherence
timeFrame: 4 months
measure: Feasibility - Treatment fidelity
timeFrame: 4 months
measure: Feasibility - Adverse events
timeFrame: 4 months
measure: Feasibility - Response outcome adherence
timeFrame: 4 months
measure: Feasibility - Attrition
timeFrame: 4 months
measure: Feasibility - Response outcome adherence
timeFrame: 8 months
measure: Feasibility - Attrition
timeFrame: 8 months
Secondary outcomes:
measure: Effectiveness - Self-reported physical function
timeFrame: Baseline
measure: Effectiveness - Patterns of mobility
timeFrame: Baseline
measure: Effectiveness - Participation
timeFrame: Baseline
measure: Effectiveness - Knowledge, skill and confidence for SM
timeFrame: Baseline
measure: Effectiveness - Pain-related functional impairment
timeFrame: Baseline
measure: Effectiveness - Fatigue
timeFrame: Baseline
measure: Effectiveness - Quality of life
timeFrame: Baseline
measure: Effectiveness - Change in self-reported physical function
timeFrame: 4 months
measure: Effectiveness - Change in patterns of mobility
timeFrame: 4 months
measure: Effectiveness - Change in participation
timeFrame: 4 months
measure: Effectiveness - Change in knowledge, skill and confidence for SM
timeFrame: 4 months
measure: Effectiveness - Change in pain-related functional impairment
timeFrame: 4 months
measure: Effectiveness - Change in fatigue
timeFrame: 4 months
measure: Effectiveness - Change in quality of life
timeFrame: 4 months
measure: Effectiveness - Healthcare utilization
timeFrame: 4 months
measure: Effectiveness - Change in self-reported physical function
timeFrame: 8 months
measure: Effectiveness - Change in patterns of mobility
timeFrame: 8 months
measure: Effectiveness - Change in participation
timeFrame: 8 months
measure: Effectiveness - Change in knowledge, skill and confidence for SM
timeFrame: 8 months
measure: Effectiveness - Change in pain-related functional impairment
timeFrame: 8 months
measure: Effectiveness - Change in fatigue
timeFrame: 8 months
measure: Effectiveness - Change in quality of life
timeFrame: 8 months
measure: Effectiveness - Healthcare utilization
timeFrame: 8 months
Other outcomes:
measure: Reach
timeFrame: 8 months
measure: Adoption - Acceptability
timeFrame: 8 months
measure: Adoption - Satisfaction
timeFrame: 8 months
measure: Implementation
timeFrame: 8 months
measure: Sustainability
timeFrame: 8 months
Locations:
city: Hamilton
country: Canada
facility: McMaster University
state: Ontario
Study officials:
affiliation: McMaster University
name: Lori Letts, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: McMaster University
name: Julie Richardson, PhD
role: PRINCIPAL_INVESTIGATOR
References: