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

Increasing Adherence to Pulmonary Rehabilitation After COPD Related Hospitalizations

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.

Study Overview

• Status: Active, not recruiting
• Conditions: COPD Exacerbation
• Intervention / Treatment: Behavioral: Intervention- Home-based Pulmonary Rehabilitation

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 Type: Interventional
• Enrollment (Actual): 296
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Johanna Hoult, MA; Phone Number: (507) 293-1989; Email: hoult.johanna@mayo.edu

Study Locations

• United States
  • Minnesota
    • Bloomington, Minnesota, United States, 55425
      • Health Partners Institute
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic in Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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)

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention- Home Pulmonary Rehabilitation; Participants enrolled in the intervention arm will be offered a Home-based pulmonary rehabilitation program with health coaching.	Behavioral: Intervention- Home-based Pulmonary Rehabilitation; Home-based Pulmonary Rehabilitation (PR) with health coaching using a remote system that will allow patients to complete PR at home. The program involves upper and lower extremity exercises, self-report of symptoms (fatigue, breathlessness, physical activity and overall well-being).
No Intervention: Control- Choice; This arm receives the standard of care which includes the choice of PR at a facility or through telehealth. Center based PR involves attending a medical center gym where they can do exercises and receive disease specific education. Telehealth PR is delivered virtually through the computer or telephone.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adherence to Pulmonary Rehabilitation	Percentage of Patients completing PR	baseline to 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health Related Quality of Life as measured by the Chronic Respiratory Questionnaire (CRQ).	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 )	baseline to 3 months
Self Management	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.	baseline to 3 months
Daily Physical Activity	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.	baseline to 3 months
Health Care Utilization	Number of ER and Hospital visits/days	baseline to 3 months
Duke-UNC Functional Social Support Questionnaire (FSSQ)	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.	baseline to 3 months
Qualitative interviews	Investigate barriers and facilitators to PR adherence	After intervention (3 months)

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
• Investigators: Principal Investigator: Roberto P Benzo, MD, Mayo Clinic

Publications and helpful links

General Publications

• Cox NS, Dal Corso S, Hansen H, McDonald CF, Hill CJ, Zanaboni P, Alison JA, O'Halloran P, Macdonald H, Holland AE. Telerehabilitation for chronic respiratory disease. Cochrane Database Syst Rev. 2021 Jan 29;1(1):CD013040. doi: 10.1002/14651858.CD013040.pub2.

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): November 30, 2020
• Primary Completion (Estimated): November 1, 2024
• Study Completion (Estimated): November 1, 2024

Study Registration Dates

• First Submitted: August 17, 2020
• First Submitted That Met QC Criteria: August 17, 2020
• First Posted (Actual): August 20, 2020

Study Record Updates

• Last Update Posted (Actual): April 9, 2024
• Last Update Submitted That Met QC Criteria: April 8, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 18-002453; R61HL142933-02 (U.S. NIH Grant/Contract); Study 2/R33 (Other Identifier: Mayo Clinic)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No