IAMABLE App for Musculoskeletal Disorders

(IAMABLE Trial)

Overseen By Lori Letts, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: McMaster University

Disqualifiers: Cognitive impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

50 Participants Needed

Trial Summary

Do I need to stop my current medications for the IAMABLE trial?

The trial protocol does not specify whether you need to stop taking your current medications. It seems likely that you can continue them, as the study focuses on using an app for rehabilitation.

What data supports the effectiveness of the IAMABLE treatment for musculoskeletal disorders?

Research shows that digital physical therapy delivered through a mobile app can help reduce pain and improve function for people with musculoskeletal conditions. Additionally, mobile messaging for individuals with musculoskeletal pain has shown positive effects on pain and disability. ^{1 2 3 4 5}

How does the IAMABLE treatment differ from other treatments for musculoskeletal disorders?

The IAMABLE treatment is unique because it involves the use of a mobile app, which may incorporate wearable sensors and mobile messaging to manage musculoskeletal disorders. This approach is different from traditional treatments as it leverages technology to potentially improve pain management and rehabilitation through personalized digital interactions. ^{5 6 7 8 9}

What is the purpose of 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.

Research Team

Lori Letts, PhD

Principal Investigator

McMaster University

Julie Richardson, PhD

Principal Investigator

McMaster University

Eligibility Criteria

The IAMABLE trial is for individuals aged 45 to 75 with at least one chronic condition such as muscle and joint pain, neurological disorders, sleep apnea, aviator's disease, cardiovascular or musculoskeletal disorders. Participants will be recruited from five communities and must not have any conditions that exclude them from the study.

Inclusion Criteria

Responds 'somewhat easily' or 'very easily' to questions on the Modified Computer Proficiency Questionnaire (MCPQ-12)

Community-dwelling individual with access to a computer or mobile device, an email address, and ability to follow directions in English

I have a chronic condition like heart disease, arthritis, or a neurological issue.

Exclusion Criteria

Scores less than 11 out of 15 on the Montreal Cognitive Assessment (MoCA) 5-Minute Test (Version 2.1)

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants in the IAMABLE group use the app for self-management, while the control group receives general health information

4 months

Virtual interactions with the app

Follow-up

Participants are monitored for outcomes such as function, quality of life, and app usage

4 months

Data collection at 4 and 8 months

Treatment Details

Interventions

• IAMABLE

Trial Overview This pilot randomized controlled trial tests the IAMABLE web-based app designed to provide evidence-based rehabilitation strategies versus general health information. Participants will use the app for four months to see if it improves their function and quality of life among other outcomes.

Participant Groups

Group I: IAMABLE Group Experimental Treatment 1 Intervention

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

Group II: Control Group Placebo Group 1 Intervention

The Control Group will receive general health information.

Who Is Running the Clinical Trial?

McMaster University

Lead Sponsor

Trials

936

Recruited

2,630,000+

Findings from Research

The musculoskeletal Digital Assessment Routing Tool (DART) was successfully developed and tested with 22 adult participants, resolving all serious usability issues and achieving a high mean satisfaction score of 84.3, indicating it is user-friendly and effective for self-assessment in musculoskeletal disorders.

The study demonstrated that DART can provide immediate care recommendations without errors, paving the way for future randomized controlled trials to evaluate its safety and effectiveness compared to traditional care methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Usability Testing of a Digital Assessment Routing Tool for Musculoskeletal Disorders: Iterative, Convergent Mixed Methods Study. Lowe, C., Browne, M., Marsh, W., et al.[2022]

The study aims to rigorously test the usability of the Digital Assessment Routing Tool (DART) for musculoskeletal conditions, involving 20-30 participants over 4 months to ensure it meets usability standards before clinical trials.

By optimizing DART's user experience, the goal is to create a safe and effective mobile health solution that improves patient access to care and reduces the burden on healthcare services, setting a precedent for future mobile health innovations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Usability Testing of a Digital Assessment Routing Tool: Protocol for an Iterative Convergent Mixed Methods Study. Lowe, C., Hanuman Sing, H., Browne, M., et al.[2021]

This study aims to systematically review and map the existing literature on mobile messaging interventions for adults with musculoskeletal pain, focusing on their efficacy, effectiveness, and economic impact, based on both experimental and observational studies.

The review will help identify optimal configurations for mobile messaging systems, including content presentation and patient preferences, to enhance support for individuals suffering from acute or chronic musculoskeletal pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and use of mobile messaging for individuals with musculoskeletal pain conditions: a scoping review protocol. Scotti Requena, S., Sterling, M., Elphinston, RA., et al.[2021]

References

1. Canada pubmed.ncbi.nlm.nih.gov

Usability Testing of a Digital Assessment Routing Tool for Musculoskeletal Disorders: Iterative, Convergent Mixed Methods Study. [2022]

2. Canada pubmed.ncbi.nlm.nih.gov

Usability Testing of a Digital Assessment Routing Tool: Protocol for an Iterative Convergent Mixed Methods Study. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Can Physical Therapy Deliver Clinically Meaningful Improvements in Pain and Function Through a Mobile App? An Observational Retrospective Study. [2022]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Relationship between physical performance and self-reported function in healthy individuals across the lifespan. [2018]

5. England pubmed.ncbi.nlm.nih.gov

Development and use of mobile messaging for individuals with musculoskeletal pain conditions: a scoping review protocol. [2021]

6. England pubmed.ncbi.nlm.nih.gov

The usability of a modified Astrand bicycle test to assess the aerobic capacity in patients with musculoskeletal pain and healthy controls. [2009]

7. United States pubmed.ncbi.nlm.nih.gov

Methods to discriminate between mechanism-based categories of pain experienced in the musculoskeletal system: a systematic review. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Applications of wearable sensors in upper extremity MSK conditions: a scoping review. [2023]

9. Pakistan pubmed.ncbi.nlm.nih.gov

Musculoskeletal pain and its associated risk factors among medical students of a public sector University in Karachi, Pakistan. [2019]