Increasing Adherence to Pulmonary Rehabilitation After COPD Related Hospitalizations (Study 2)

Not Applicable

Completed

• Conditions: COPD Exacerbation
• Interventions: Behavioral: Intervention- Home-based Pulmonary Rehabilitation

• Registration Number: NCT04521608
• Lead Sponsor: Mayo Clinic

Brief Summary

This study is being done to test the comparative effectiveness of participating in a Pulmonary Rehabilitation Program at home using new technology and health coaching following dismissal from the hospital compared to the referral to a center based pulmonary rehabilitation that may include the choice of center based or telehealth.

Detailed Description

Despite proven benefits, the proportion of people with COPD who receive Pulmonary Rehabilitation (PR) is very small. The current model of a center-based PR program fails to address the needs of many patients with COPD. After the COVID epidemic, telehealth is an option for individuals referred to patients referred to center based rehabilitation.

The direct referral to home-based, unsupervised PR has been proposed as an alternative model to hospital-based programs and has been found to be safe and effective. The refined home-based PR program from the pilot portion of the study supported by a separate grant mechanism (R61HL142933/NCT03865329) will be tested in this second part randomized control study.

Subjects with a COPD-related hospitalization (exacerbation or pneumonia) will be randomized after hospital discharge to either home-based PR or Choice (referral to conventional center-based PR or telehealth-based PR).

Study Timeline

• Study First Submitted: 2020-08-17
• Study First Submitted QC: 2020-08-17
• Study First Posted: 2020-08-20
• Study Start: 2020-11-30
• Primary Completion: 2024-09-19
• Study Completion: 2024-09-19
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-17
• Last Update Posted: 2024-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 296

Inclusion Criteria

• COPD related hospitalization and eligible for PR
• Age 40+
• Confidence (score > 5 in a self-efficacy question (1-10 scale): how confident you feel to use this system on a daily basis)

Read More

Exclusion Criteria

• Inability to walk (orthopedic-neurologic problems or confined to bed)

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention- Home Pulmonary Rehabilitation	Intervention- Home-based Pulmonary Rehabilitation	Participants enrolled in the intervention arm will be offered a Home-based pulmonary rehabilitation program with health coaching.

Primary Outcome Measures

Name	Time	Method
Adherence to Pulmonary Rehabilitation	baseline to 3 months	Percentage of Patients completing PR

Secondary Outcome Measures

Name	Time	Method
Health Related Quality of Life as measured by the Chronic Respiratory Questionnaire (CRQ).	baseline to 3 months	The CRQ will be completed by participants several times during the study. The questionnaire measures health related quality of life and is a validated tool. This questionnaire measures both physical and emotional aspects of chronic respiratory disease. Higher scores indicate better health related quality of life. (numerical, 1-7 point Likert Scale, emotional and physical summary scores will be reported )
Self Management	baseline to 3 months	The Self-Management Ability Scale (30) item questionnaire that measures ability and function. A higher score indicates more ability and function in everyday life. Scores on the subscales and the total score are transformed into scores ranging from 0 to 100 (higher number is best). Each question has a range from 1-5.
Daily Physical Activity	baseline to 3 months	Actigraph Activity Monitor will be worn for one week to measure daily steps, and time in sedentary mode, mild to moderate and vigorous physical activity.
Health Care Utilization	baseline to 3 months	Number of ER and Hospital visits/days
Duke-UNC Functional Social Support Questionnaire (FSSQ)	baseline to 3 months	8 item questionnaire that measures the amount of social support and availability of help from family and friends. The answers range from 1 "Much less than I would like" to 5 " As much as I would like". The scores from all 8 questions are summed (maximum 40) and then divided by 8 to get an average score. The higher the average score, the greater the perceived social support.
Qualitative interviews	After intervention (3 months)	Investigate barriers and facilitators to PR adherence

Trial Locations

Locations (2)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States

Health Partners Institute; 🇺🇸 Bloomington, Minnesota, United States