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A Home-based Module to Promote Mindful Breathing Awareness for COPD Patients

Primary Purpose

COPD

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Home-based pulmonary rehabilitation program
Mindful breathing module
Health coaching
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for COPD

Eligibility Criteria

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

Inclusion Criteria:

  • Adults, age ≥ 40 years old.
  • Clinical diagnosis of Chronic Obstructive Pulmonary Disease (COPD).
  • At least 10 pack years of smoking.

Exclusion Criteria:

  • Unable to do mild exercise (orthopedic-neurologic problems or confined to a bed).
  • Unable to follow commands (cognitive impairment).
  • Have a high likelihood of being lost to follow-up (active alcohol or drug abuse).
  • Live in an area that does not have cellular service (Verizon).

Sites / Locations

  • Minnesota HealthSolutions Corporporation
  • Mayo Clinic in RochesterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Home-base pulmonary rehabilitation with mindful breathing modu

Home-base pulmonary rehabilitation

Arm Description

Subjects will complete in a home-based pulmonary rehabilitation program and in addition will complete a mindful breathing practice using a module on a computer tablet.

Subjects will complete 12 week home-based pulmonary rehabilitation with health coaching

Outcomes

Primary Outcome Measures

Change in Chronic Respiratory Disease Questionnaire (CRQ)- Dyspnea Summary
The CRQ is a 20-question inventory assessing the areas of health related quality of life in dyspnea (shortness of breath), fatigue, emotion, and feelings of mastery of chronic respiratory disease. The Dyspnea Summary score includes dyspnea (symptom #1 in COPD) and fatigue (symptom #2 in COPD) domains. The questions in each domain are added together and then divided by the number of questions. The possible range is 1-7, where 1 is the worst and 7 the best.
Change in Chronic Respiratory Disease Questionnaire (CRQ)- Emotions Summary
The CRQ Emotion Summary score includes the emotion (independent factor for admissions and poor quality of life) and mastery (self-management) domains of the CRQ. The scores for each domain are calculated by simply added together the answers and then dividing by the number of questions, the range is 1-7 where 1 is the worst and 7 the best.

Secondary Outcome Measures

Change in daily Physical Activity- daily steps
An Actigraph activity monitor will be used to measure daily steps and activity counts. The activity monitor is wrist worn for 7 days.

Full Information

First Posted
July 17, 2020
Last Updated
May 22, 2023
Sponsor
Mayo Clinic
Collaborators
National Center for Complementary and Integrative Health (NCCIH), Minnesota HealthSolutions Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT04517500
Brief Title
A Home-based Module to Promote Mindful Breathing Awareness for COPD Patients
Official Title
A Home-based Intervention to Promote Mindful Breathing Awareness Through Pursed-lip Breathing Training for COPD Patients
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 6, 2021 (Actual)
Primary Completion Date
April 2024 (Anticipated)
Study Completion Date
April 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
Collaborators
National Center for Complementary and Integrative Health (NCCIH), Minnesota HealthSolutions Corporation

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
The purpose of this study is to develop a mindful breathing module to an already effective and developed home based rehabilitation program for guiding COPD patients in a mindful breathing practice and further palliate breathlessness and anxiety.
Detailed Description
A breathing technique called Pursed Lipped Breathing (PLB) has been proven to be beneficial for patients with COPD. PLB can ease shortness of breath and reduce stress and anxiety. This study will develop a mindful PLB module to compliment an already developed home based pulmonary rehabilitation program. In this study, patients will be randomized to either a group that does the home based pulmonary rehabilitation with the mindful breathing module and health coaching or a group that does the home based pulmonary rehabilitation with health coaching without the mindful breathing module. Both groups will do the home based pulmonary rehabilitation for 12 weeks. In addition there are questionnaires and the wearing of an activity monitor when you sign up and at 3 and 6 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COPD

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Home-base pulmonary rehabilitation with mindful breathing modu
Arm Type
Experimental
Arm Description
Subjects will complete in a home-based pulmonary rehabilitation program and in addition will complete a mindful breathing practice using a module on a computer tablet.
Arm Title
Home-base pulmonary rehabilitation
Arm Type
Active Comparator
Arm Description
Subjects will complete 12 week home-based pulmonary rehabilitation with health coaching
Intervention Type
Behavioral
Intervention Name(s)
Home-based pulmonary rehabilitation program
Intervention Description
Subjects will wear an activity monitor while doing at home exercises using a computer tablet
Intervention Type
Behavioral
Intervention Name(s)
Mindful breathing module
Intervention Description
Additional module on the computer tablet that involves inhaling and exhaling while following an animated ball on the computer screen.
Intervention Type
Behavioral
Intervention Name(s)
Health coaching
Intervention Description
Weekly coaching calls to discuss rehabilitation and health process using motivational interviewing
Primary Outcome Measure Information:
Title
Change in Chronic Respiratory Disease Questionnaire (CRQ)- Dyspnea Summary
Description
The CRQ is a 20-question inventory assessing the areas of health related quality of life in dyspnea (shortness of breath), fatigue, emotion, and feelings of mastery of chronic respiratory disease. The Dyspnea Summary score includes dyspnea (symptom #1 in COPD) and fatigue (symptom #2 in COPD) domains. The questions in each domain are added together and then divided by the number of questions. The possible range is 1-7, where 1 is the worst and 7 the best.
Time Frame
The change from baseline of the CRQ will be assessed at 3 and 6 month.
Title
Change in Chronic Respiratory Disease Questionnaire (CRQ)- Emotions Summary
Description
The CRQ Emotion Summary score includes the emotion (independent factor for admissions and poor quality of life) and mastery (self-management) domains of the CRQ. The scores for each domain are calculated by simply added together the answers and then dividing by the number of questions, the range is 1-7 where 1 is the worst and 7 the best.
Time Frame
The change from baseline of the CRQ will be assessed at 3 and 6 month.
Secondary Outcome Measure Information:
Title
Change in daily Physical Activity- daily steps
Description
An Actigraph activity monitor will be used to measure daily steps and activity counts. The activity monitor is wrist worn for 7 days.
Time Frame
The change from baseline on daily Physical activity will be assessed at 3 and 6 month.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adults, age ≥ 40 years old. Clinical diagnosis of Chronic Obstructive Pulmonary Disease (COPD). At least 10 pack years of smoking. Exclusion Criteria: Unable to do mild exercise (orthopedic-neurologic problems or confined to a bed). Unable to follow commands (cognitive impairment). Have a high likelihood of being lost to follow-up (active alcohol or drug abuse). Live in an area that does not have cellular service (Verizon).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Johanna Hoult
Phone
507-293-1989
Email
hoult.johanna@mayo.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roberto P Benzo
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kevin Kramer, PhD
Organizational Affiliation
Minnesota HealthSolutions Corporation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Minnesota HealthSolutions Corporporation
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55414
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kevin Kramer, PhD
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials

Learn more about this trial

A Home-based Module to Promote Mindful Breathing Awareness for COPD Patients

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