Informatics Framework for Pulmonary Rehabilitation

Not Applicable

Recruiting

• Conditions: COPD
• Interventions: Behavioral: Best available care (BAC); Behavioral: Telerehabilitation (TH)

• Registration Number: NCT03981783
• Lead Sponsor: Icahn School of Medicine at Mount Sinai

Brief Summary

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-06-07
• Study First Submitted QC: 2019-06-07
• Study First Posted: 2019-06-11
• Study Start: 2020-06-11
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-28
• Last Update Posted: 2022-10-31
• Primary Completion: 2023-02-28
• Study Completion: 2023-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Best available care (BAC)	Best available care (BAC)	-
Telerehabilitation (TH)	Telerehabilitation (TH)	-

Primary Outcome Measures

Name	Time	Method
Percentage of patients who completed the program	3 months	Percent of eligible COPD patients who completed a comprehensive 3-month PR program to assess adherence with pulmonary rehabilitation

Secondary Outcome Measures

Name	Time	Method
6 minute walking distance	12 months	The distance covered over a time of 6 minutes
Short Form-36 (SF-36)	12 months	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
Shortness of Breath Questionnaire	12 months	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.
Chronic Respiratory Disease Questionnaire (CRDQ)	12 months	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.
COPD self-efficacy Scale (CSES)	12 months	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

Trial Locations

Locations (1)

Mount Sinai Hospital; 🇺🇸 New York, New York, United States