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

NCT04517500 | Completed Phase 3 Results

• 2 other identifiers: 19-0127722R44AT009665-02
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 2

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.

Conditions

COPD

Outcome Measures

Primary Outcomes (2)

• Change in Chronic Respiratory Disease Questionnaire (CRQ)- Dyspnea Score

  The CRQ-Dyspnea is a 5-item questionnaire that assesses dyspnea on a Likert scale from 1 (Extremely short of breath) to 7 (Not at all short of breath). Total scores range from 5 - 35. Lower scores indicated higher severity of dyspnea. Higher scores indicate less severity of dyspnea.

  Baseline, 3 months, 6 months

• Change in Chronic Respiratory Disease Questionnaire (CRQ)- Emotions Score

  The CRQ-Emotions is a 7-item questionnaire that assesses emotions on a Likert scale from 1 (All of the time) to 7 (None of the time). Total scores range from 7-49. Lower scores indicate more severity of emotions. Higher scores indicate less severity of emotions.

  baseline, 3 months, 6 months

Secondary Outcomes (1)

• Change in Daily Physical Activity

  baseline, 3 months, 6 months

Study Arms (2)

Home-base pulmonary rehabilitation with mindful breathing modu

EXPERIMENTAL

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.

Behavioral: Home-based pulmonary rehabilitation program; Behavioral: Mindful breathing module; Behavioral: Health coaching

Home-base pulmonary rehabilitation

ACTIVE COMPARATOR

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

Behavioral: Home-based pulmonary rehabilitation program; Behavioral: Health coaching

Interventions

Home-based pulmonary rehabilitation program BEHAVIORAL

Subjects will wear an activity monitor while doing at home exercises using a computer tablet

Home-base pulmonary rehabilitation; Home-base pulmonary rehabilitation with mindful breathing modu

Mindful breathing module BEHAVIORAL

Additional module on the computer tablet that involves inhaling and exhaling while following an animated ball on the computer screen.

Home-base pulmonary rehabilitation with mindful breathing modu

Health coaching BEHAVIORAL

Weekly coaching calls to discuss rehabilitation and health process using motivational interviewing

Home-base pulmonary rehabilitation; Home-base pulmonary rehabilitation with mindful breathing modu

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Mayo Clinic: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator
• Minnesota HealthSolutions: collaborator

Study Sites (2)

Minnesota HealthSolutions Corporporation

Minneapolis, Minnesota, 55414, United States

Location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

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

Benzo.Roberto@mayo.edu

507-284-0561

Study Officials

• Roberto P Benzo

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

• Kevin Kramer, PhD

  Minnesota HealthSolutions

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Since the patients will know if they have the Pursed Lipped Breathing Application and Spire tags, the outcome assessor will be blinded to which arm received the Application and tags.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Half of the participants will be randomized to receive the home-based PR with the mindful breathing module which consists of the Pursed Lipped Breathing Application and the Spire Health Tags (intervention) and half will receive the home-based PR (control).

Study Record Dates

• First Submitted: July 17, 2020
• First Posted: August 18, 2020
• Study Start: August 6, 2021
• Primary Completion: May 7, 2024
• Study Completion: May 7, 2024
• Last Updated: November 8, 2024
• Results First Posted: November 8, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)