Informatics Framework for Pulmonary Rehabilitation

Study Overview
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Brief Summary
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Previous studies clearly established clinical benefits of pulmonary rehabilitation in patients with chronic obstructive pulmonary disease however uptake and completion rate of pulmonary rehabilitation programs by these patients is limited by multiple barriers. The goal of this project to systematically evaluate impact of Comprehensive Health Informatics Engagement Framework for Pulmonary Rehabilitation (CHIEF-PR) in a randomized controlled trial. The main hypothesis is that CHIEF-PR will result in significantly higher rates of completion of a comprehensive pulmonary rehabilitation program.

Detailed Description
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Previous studies clearly established clinical benefits of pulmonary rehabilitation in patients with chronic obstructive pulmonary disease (COPD) however uptake and completion rate of pulmonary rehabilitation (PR) programs by these patients is limited by multiple barriers. The study team developed a Comprehensive Health Informatics Engagement Framework for Pulmonary Rehabilitation which facilitates patient referral and promotes adherence with pulmonary rehabilitation program using innovative multi-pronged approach. It includes computer-mediated patient counseling to increase patient motivation in joining PR program followed by ongoing home-based support of PR by a telerehabilitation system that monitors patients' progress and allows remote oversight by clinical PR team. The goal of this project is to systematically evaluate impact of Comprehensive Health Informatics Engagement Framework for Pulmonary Rehabilitation (CHIEF-PR) in a randomized controlled trial. The study team's main hypothesis is that CHIEF-PR will result in significantly higher rates of completion of a comprehensive pulmonary rehabilitation program. The study team will enroll 120 COPD patients within 4 weeks of acute exacerbation of COPD into a randomized controlled trial and follow them for 12 months. Patients will be randomly assigned to intervention (CHIEF-PR) and control (best available standard of care) groups. Primary outcome will be completion rate of a comprehensive 3-month PR program. Secondary outcomes will include relevant clinical and patient-reported parameters.

Official Title
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Comprehensive Health Informatics Engagement Framework for Pulmonary Rehab

Conditions
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COPD

Intervention / Treatment
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* Behavioral: Best available care (BAC)
* Behavioral: Telerehabilitation (TH)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 40 years and older at the time of randomization; Have a physician diagnosis of COPD Have moderate to severe COPD according to GOLD classification (Stages II - III) Understand spoken English or Spanish Urgent care event due to COPD within 4 weeks of enrollment Have no other member of the household enrolled in the study Exclusion Criteria: Evidence that the patient may move from the study area before the completion of the study Impaired cognitive status as indicated by MMSE<24 Presence of any health condition, that would preclude participation (e.g., psychiatric diagnosis, unstable cardiovascular condition or physical disability)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Comprehensive Health Informatics Engagement Framework for Pulmonary Rehabilitation (CHIEF-PR) will facilitate PR referrals, initial assessments, completion rates, and PR maintenance using multi-pronged approach at the healthcare, provider and patient levels that addresses current barriers for PR uptake and completion.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Best available care (BAC)<br> | Behavioral: Best available care (BAC)<br>* Eligible patients are assigned to a standard pulmonary rehabilitation program<br>|
| Experimental: Telerehabilitation (TH)<br> | Behavioral: Telerehabilitation (TH)<br>* Eligible patients are assigned to a pulmonary telerehabilitation program<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients who completed the program | Percent of eligible COPD patients who completed a comprehensive 3-month PR program to assess adherence with pulmonary rehabilitation | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 6 minute walking distance | The distance covered over a time of 6 minutes | 12 months | 
| Chronic Respiratory Disease Questionnaire (CRDQ) | Disease-specific quality of life scaled on a 7-point modified Likert Scale from 1 to 7. The total scale ranges from 20 to 140 with higher scores indicate better health-related quality of life. | 12 months | 
| Short Form-36 (SF-36) | General quality of life - consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability | 12 months | 
| COPD self-efficacy Scale (CSES) | COPD Self-efficacy Scale is a 34 item scale, each item is scored on a 5-point likert scale from 1 to 5. Total scale range from 34 to 170, with higher score indicating lower confidence in managing and controlling dyspnea | 12 months | 
| Shortness of Breath Questionnaire | Respiratory symptoms assessed by the shortness of breath questionnaire. 21 items scored on a 6 point scale from 0 to 5, with total scale from 0 to 120. Higher score indicates more symptoms. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COPD, Pulmonary Rehabilitation, Telerehabilitation, Clinical Decision Support, Adherence