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

NCT04521608 | Completed Results

• 2 other identifiers: 18-002453R61HL142933
• Study Type: interventional
• Target: 296
• Locations: 1 country
• Sites: 2

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.

Conditions

COPD Exacerbation

Outcome Measures

Primary Outcomes (3)

• Adherence to Pulmonary Rehabilitation (PR)

  The number of subjects who completed PR through 3 months

  baseline; 3 months

• Change in Health Related Quality of Life as Measured by the Chronic Respiratory Questionnaire (CRQ).

  The Chronic Respiratory Questionnaire (CRQ) is a validated tool that is completed by participants at baseline and 3 months, measuring health-related quality of life. This questionnaire measures both physical and emotional aspects of chronic respiratory disease. We reported the difference between baseline and 3 months on the CRQ emotional summary scores (comprised of the summation of the mastery and emotional domains of CRQ divided by 2) and the physical summary score (comprised of the summation of the dyspnea and fatigue domains of the CRQ divided by 2). Summary scores as well as the original domains , all have a range of 1 to 7 points, with a higher number being a better health-related quality of life. 0.5 points is the minimal clinically important difference for this tool. Then, for the interpretation of CRQ results: a difference\>0.5 is considered clinically meaningful

  baseline; 3 months

• Change in EuroQol (EQ-5D) Score

  The EuroQol (EQ-5D) is a 5-item questionnaire that assesses health-related quality of life over five different dimensions of health: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. It also includes a Visual Analogue Scale (VAS) for self-related heath. Each dimension uses a 5-level Likert scale (1 = no problems, 5 = extreme problems), ensuring nuanced data collection. The VAS ranges from 0 (worst imaginable health) to 100 (best imaginable health). Scores are calculated for each dimension with total scores ranging from 1 (no problems) to 5 (extreme problems), with higher scores indicating a worse outcome. The score from the VAS portion of the questionnaire ranges from 0 (worst imaginable health) to 100 (best imaginable health), with higher scores indicating a better outcome.

  baseline; 3 months

Secondary Outcomes (6)

• Number of Subjects Who Visited the Emergency Department

  baseline to 3 months

• Number of Subjects Who Had a Hospitalization

  baseline; 3 months

• Change in Self-Management Ability Scale

  baseline; 3 months

• Change in Daily Step Count

  baseline; 3 months

• Change in Daily Total Physical Activity and Sedentary Time

  Baseline; 3 months

Study Arms (2)

Intervention- Home Pulmonary Rehabilitation

EXPERIMENTAL

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

Behavioral: Intervention- Home-based Pulmonary Rehabilitation

Control- Choice

NO INTERVENTION

This arm was the choice of Pulmonary Rehabilitation at a facility or Home-based pulmonary rehabilitation program with health coaching.

Interventions

Intervention- Home-based Pulmonary Rehabilitation BEHAVIORAL

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).

Intervention- Home Pulmonary Rehabilitation

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Mayo Clinic: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (2)

Health Partners Institute

Bloomington, Minnesota, 55425, United States

Location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Publications (1)

• 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.

  PMID: 33511633 DERIVED

Related Links

• Mayo Clinic Clinical Trials

Results Point of Contact

• Title: Roberto Benzo, M.D.
• Organization: Mayo Clinic

benzo.roberto@mayo.edu

480-301-8244

Study Officials

• Roberto P Benzo, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 17, 2020
• First Posted: August 20, 2020
• Study Start: November 30, 2020
• Primary Completion: September 19, 2024
• Study Completion: September 19, 2024
• Last Updated: November 21, 2025
• Results First Posted: November 21, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)