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Neurological ConditionsIAMABLENCT06773169

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

A study testing IAMABLE web-based app and General health information in people with Neurological Conditions and Musculoskeletal Diseases or Conditions, run by McMaster University at 1 site in Canada.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 44 to 75 years
What is being tested?
IAMABLE web-based app and General health information
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
50 participants
Where
1 siteCanada
Study dates
25 Sep 2025to 31 Mar 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 44 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Canada1 site
  • McMaster University

    Hamilton, Ontario, L8S 1C7

Other trials in Canada

About this study

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.

Read more

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.

Read the 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.

Being tested
IAMABLE web-based app, General health information
Keywords
rehabilitation, chronic conditions, self-management, technology, web-based application
Medical subject headings
Musculoskeletal Diseases, Cardiovascular Diseases, Chronic Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IAMABLE web-based appOther

    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.

  • General health informationOther

    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.

Study groups in NCT06773169
Study groupRoleWhat they receive
IAMABLE GroupExperimentalThe IAMABLE Group will use the IAMABLE app to engage in self-management.
Receives: Other: IAMABLE web-based app
Control GroupSham comparatorThe Control Group will receive general health information.
Receives: Other: General health information

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: Baseline

  2. Feasibility - Response outcome adherence

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

    Measured: Baseline

  3. 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).

    Measured: Baseline

  4. 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).

    Measured: 4 months

  5. 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).

    Measured: 4 months

  6. 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).

    Measured: 4 months

  7. Feasibility - Response outcome adherence

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

    Measured: 4 months

  8. 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).

    Measured: 4 months

  9. Feasibility - Response outcome adherence

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

    Measured: 8 months

  10. 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).

    Measured: 8 months

Secondary outcomes (23)
  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.

    Measured: Baseline

  2. 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.

    Measured: Baseline

  3. 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.

    Measured: Baseline

  4. 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.

    Measured: Baseline

  5. 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.

    Measured: Baseline

  6. 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.

    Measured: Baseline

  7. 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.

    Measured: Baseline

  8. 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.

    Measured: 4 months

  9. 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.

    Measured: 4 months

  10. 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.

    Measured: 4 months

  11. 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.

    Measured: 4 months

  12. 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.

    Measured: 4 months

  13. 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.

    Measured: 4 months

  14. 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.

    Measured: 4 months

  15. 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.

    Measured: 4 months

  16. 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.

    Measured: 8 months

  17. 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.

    Measured: 8 months

  18. 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.

    Measured: 8 months

  19. 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.

    Measured: 8 months

  20. 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.

    Measured: 8 months

  21. 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.

    Measured: 8 months

  22. 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.

    Measured: 8 months

  23. 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.

    Measured: 8 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jan 2025
  2. Study start25 Sep 2025
  3. Primary completion1 Dec 2026 (estimated)
  4. Study completion31 Mar 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06773169
Sponsor's protocol ID
PJT-195979
Other IDs
PJT-195979
Acronym
IAMABLE
Status last verified
Oct 2026
First submitted
6 Jan 2025
Last updated
7 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: All IPD related to publication results

Questions about this trial

What is this clinical trial studying?

A study testing IAMABLE web-based app and General health information in people with Neurological Conditions and Musculoskeletal Diseases or Conditions, run by McMaster University at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility - Recruitment (time frame: Baseline). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026; AzTrials last refreshed its copy on 30 Oct 2026.

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