A Home-based Intervention to Promote Mindful Breathing Aw... | NCT03814980

Studies
A Home-based Intervention to Promote Mindful Breathing Awareness Through Pursed-lip Breathing Training for COPD Patients

NCT03814980

Sponsor

Mayo Clinic

Status

Completed

Last Update Posted

Jan 6, 2020Actual

Enrollment

6Actual

Phase

Not Applicable

Conditions

COPD
Emphysema

Interventions

mindful breathing application
application on a computer tablet

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 1, 2018Actual

Primary Completion Date

Aug 30, 2019Actual

Completion Date

Aug 30, 2019Actual

First Submitted Date

Jan 21, 2019

First Submission Date that Met QC Criteria

Jan 23, 2019

First Posted Date

Jan 24, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 3, 2020

Last Update Posted Date

Jan 6, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

In this study, a system will be developed to guide patients with chronic obstructive pulmonary disease (COPD) to complete a mindful breathing practice at home. COPD is the third leading cause of death in the United States and no cure exists. Shortness of breath is the most common disabling symptom. Pursed lips breathing is a type of breathing practice that has demonstrated effectiveness for patients with COPD. It requires practice to maintain and there is currently no home system to provide the needed feedback and support to maintain PLB. Additionally, syncing breathing and heart rate variation offers patients additional benefits. The proposed project explores the use of biofeedback to guide COPD patients in a breathing practice and to provide data for health coaching to monitor and support the practice.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

6Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Pilot Study	Experimental	Participants will be shown how to use a mindful breathing software application. The software will be used for 1 week. At the end of the week, participants will evaluate the software.	Behavioral: mindful breathing application Device: application on a computer tablet

Interventions

Name	Type	Description	Arm Group Labels	Other Names
mindful breathing application	Behavioral	Participants will use a mindful breathing application on a computer tablet.	Pilot Study

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Test the feasibility of a mindful breathing application for COPD patients	Mindful Breathing Application on a computer tablet for COPD patients	About 1 week

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Patients eligible for Pulmonary Rehabilitation will be recruited for this study.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

99 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Roberto P Benzo	Mayo Clinic	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mayo Clinic in Rochester		Rochester	Minnesota	55905	United States

Label	URL
Mayo Clinic Clinical Trials	View source

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D029424	Pulmonary Disease, Chronic Obstructive
D004646	Emphysema

Ancestor Terms

ID	Term
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D002908	Chronic Disease

Browse Leaves

Not provided

Browse Branches

Not provided