IAMABLE: Implementation and Evaluation of an App for Evidence-Based Self-Management Rehabilitation Strategies
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age44-75
SponsorMcMaster University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
scores < 11/15 on the Montreal Cognitive Assessment (MoCA) 5-Minute Test (Version 2.1).
Trial design
Design model
Parallel
Treatments tested in this trial
IAMABLE web-based app
Other interventionThe 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.
General health information
Other interventionThe 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.
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: IAMABLE GroupExperimental treatment 1 intervention
Group B: Control GroupSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
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).
Time frame
Baseline2
Feasibility - Response outcome adherence
Response outcome adherence will be measured by completion of secondary outcomes (Criterion: ≥80%).
Time frame
Baseline3
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).
Time frame
Baseline4
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).
Time frame
4 monthsSecondary outcomes
1
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.
Time frame
Baseline2
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.
Time frame
Baseline3
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.
Time frame
Baseline4
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.
Time frame
BaselineOther outcomes
1
Reach
Reach will be measured by the number of participants who are given access to initiate use of the app.
Time frame
8 months2
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.
Time frame
8 months3
Adoption - Satisfaction
Satisfaction with the IAMABLE app will be measured using the 14-item mHealth Satisfaction Questionnaire.
Time frame
8 months4
Implementation
Study feasibility data on program adherence, treatment fidelity, and adverse events and harms will contribute to our understanding of implementation.
Time frame
8 monthsSponsors and contacts
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Source ClinicalTrials.gov