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Home Pulmonary Rehabilitation for COPD

Primary Purpose

COPD, Emphysema

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Home Based Pulmonary Rehabilitation
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for COPD focused on measuring Pulmonary Rehabilitation

Eligibility Criteria

40 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria

  • Clinical diagnosis of COPD,
  • Age ≥40 years
  • Current or previous smoker (≥10 packs per year)
  • Confidence in using the proposed PR system
  • English or Spanish language fluency

Exclusion Criteria

  • Unable or unwilling to do Rehabilitation due to physical conditions

Sites / Locations

  • Mayo Clinic in Florida
  • Health Partners
  • Mayo Clinic in Rochester

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention

Control

Arm Description

Patients randomized in this arm will start with the home based pulmonary rehabilitation program.

Patients randomized in this arm will start the intervention after 12 weeks of usual care.

Outcomes

Primary Outcome Measures

Participants on home-based PR will have higher quality of life at month three after randomization than participants in the waitlist control group.
Participants will complete quality of life questionnaires at enrollment and at 3 months. The Chronic Respiratory Questionnaire (CRQ) will be utilized to measure quality of life. The intervention participants will have a change in quality of life.

Secondary Outcome Measures

Daily Physical Activity will be measured and compared between baseline and three months
Actigraph GT3X is the validated tool to measure physical activity. The Actigraph will be worn for one week to measures sedentary time, daily step, and time in sedentary mode, and mild-moderate and vigorous physical activity.
Self-Management
Self-Management Ability Scale-30 item questionnaire measuring ability and function. A higher score indicates higher function and ability.The SMAS consists of 30 items on four- and five-point Likert scales. 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.
Depression
Patient Health Questionnaire-9 item questionnaire screening for depression. A higher score indicates that depression may be present. Scores range from 0-27.
Social Support
The MSPSS is a 12-item scale designed to measure perceived social support from three sources: Family, Friends, and a Significant Other.- 12 item questionnaire with a range of 12-84. A higher score indicates a greater amount of social support.
Meaning in Life
Meaning in Life Questionnaire- 10 item questionnaire measuring the purpose, meaning and presence in life. A higher score indicates a perception of higher meaning and purpose. Scores range from 10-70, a higher score indicates a high perceived meaning and purpose in the respondents life.
Sleep Quality
Sleep Quality Assessment - 9 item questionnaire measuring the quality and patterns of sleep. Scores range from 0 to 21. A lower score suggests a better quality of sleep.
Anxiety
General Anxiety Disorder-2 item Questionnaire screening for anxiety. Score ranges from 0-6, a higher score suggests that anxiety is present.

Full Information

First Posted
February 26, 2018
Last Updated
October 11, 2022
Sponsor
Mayo Clinic
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
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1. Study Identification

Unique Protocol Identification Number
NCT03480386
Brief Title
Home Pulmonary Rehabilitation for COPD
Official Title
Home Pulmonary Rehabilitation for COPD
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
September 23, 2022 (Actual)
Study Completion Date
September 23, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
While pulmonary rehabilitation provides benefits to people with COPD, only 25% have access to pulmonary rehabilitation each year. The main barriers are related to travel and transportation. This protocol will evaluate the effect of a home-based rehabilitation system on quality of life and steps. The system allows for monitoring by a health care system. A health coach will review the data and provide coaching to facilitate behavioral change and self-efficacy.
Detailed Description
This study will test the effectiveness of a home-base pulmonary rehabilitation program, that includes off-the-shelf technology (Android computer tablet, Nonin pulse oximeter and Garmin Fitness Tracker), health coaching and an online platform that allows a health coach to review patient monitoring and progress. The comparison will be a wait-list control group.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COPD, Emphysema
Keywords
Pulmonary Rehabilitation

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomization will be stratified by whether the participant has poor lung function (forced expiratory volume [FEV1] <50% predicted) and whether the participant has severe dyspnea (recorded modified Medical Research Council Dyspnea Scale [mMRC] score, 3-4; scale, 0-4); critical factors that can make the study arms unbalanced regarding risk factors.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Patients randomized in this arm will start with the home based pulmonary rehabilitation program.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Patients randomized in this arm will start the intervention after 12 weeks of usual care.
Intervention Type
Behavioral
Intervention Name(s)
Home Based Pulmonary Rehabilitation
Intervention Description
The intervention consists of doing 12 weeks of exercises at home, with a weekly call from a health coach.
Primary Outcome Measure Information:
Title
Participants on home-based PR will have higher quality of life at month three after randomization than participants in the waitlist control group.
Description
Participants will complete quality of life questionnaires at enrollment and at 3 months. The Chronic Respiratory Questionnaire (CRQ) will be utilized to measure quality of life. The intervention participants will have a change in quality of life.
Time Frame
baseline, 3 months.
Secondary Outcome Measure Information:
Title
Daily Physical Activity will be measured and compared between baseline and three months
Description
Actigraph GT3X is the validated tool to measure physical activity. The Actigraph will be worn for one week to measures sedentary time, daily step, and time in sedentary mode, and mild-moderate and vigorous physical activity.
Time Frame
baseline and 3 months
Title
Self-Management
Description
Self-Management Ability Scale-30 item questionnaire measuring ability and function. A higher score indicates higher function and ability.The SMAS consists of 30 items on four- and five-point Likert scales. 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.
Time Frame
baseline and 3 months
Title
Depression
Description
Patient Health Questionnaire-9 item questionnaire screening for depression. A higher score indicates that depression may be present. Scores range from 0-27.
Time Frame
baseline and 3 months
Title
Social Support
Description
The MSPSS is a 12-item scale designed to measure perceived social support from three sources: Family, Friends, and a Significant Other.- 12 item questionnaire with a range of 12-84. A higher score indicates a greater amount of social support.
Time Frame
baseline and 3 months
Title
Meaning in Life
Description
Meaning in Life Questionnaire- 10 item questionnaire measuring the purpose, meaning and presence in life. A higher score indicates a perception of higher meaning and purpose. Scores range from 10-70, a higher score indicates a high perceived meaning and purpose in the respondents life.
Time Frame
baseline and 3 month
Title
Sleep Quality
Description
Sleep Quality Assessment - 9 item questionnaire measuring the quality and patterns of sleep. Scores range from 0 to 21. A lower score suggests a better quality of sleep.
Time Frame
baseline and 3 month
Title
Anxiety
Description
General Anxiety Disorder-2 item Questionnaire screening for anxiety. Score ranges from 0-6, a higher score suggests that anxiety is present.
Time Frame
baseline and 3 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria Clinical diagnosis of COPD, Age ≥40 years Current or previous smoker (≥10 packs per year) Confidence in using the proposed PR system English or Spanish language fluency Exclusion Criteria Unable or unwilling to do Rehabilitation due to physical conditions
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roberto P Benzo
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Florida
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
Health Partners
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55122
Country
United States
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
35914215
Citation
Benzo R, Hoult J, McEvoy C, Clark M, Benzo M, Johnson M, Novotny P. Promoting Chronic Obstructive Pulmonary Disease Wellness through Remote Monitoring and Health Coaching: A Clinical Trial. Ann Am Thorac Soc. 2022 Nov;19(11):1808-1817. doi: 10.1513/AnnalsATS.202203-214OC.
Results Reference
derived
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials

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Home Pulmonary Rehabilitation for COPD

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