A Study of Home-based Pulmonary Rehabilitation and Health Coaching to Treat Bronchiectasis
Home-based Pulmonary Rehabilitation and Health Coaching in Bronchiectasis
2 other identifiers
observational
35
1 country
1
Brief Summary
The purpose of this study is to gather information on the effectiveness on a home-based pulmonary rehabilitation in patients with bronchiectasis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Aug 2022
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 25, 2022
CompletedFirst Submitted
Initial submission to the registry
September 21, 2022
CompletedFirst Posted
Study publicly available on registry
September 23, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
July 30, 2023
CompletedSeptember 7, 2023
September 1, 2023
11 months
September 21, 2022
September 6, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Change in patient-reported quality of life
As defined by the COPD Assessment Test (CAT). The CAT is a validated tool for measuring health status in patients with bronchiectasis and is divided into eight domains of cough, mucous production, chest tightness, shortness of breath with activity, activity limitation at home, confidence leaving home, sleep quality, and energy. A lower score suggests no health-related quality of life (HRQL) impairment, while the maximum score of 40 represents significant impact.
Baseline, after completion of the 12-week intervention.
Secondary Outcomes (1)
Physical activity
12 weeks
Study Arms (1)
Home-based Pulmonary Rehabilitation and Health Coaching
Subjects with symptomatic bronchiectasis (CAT score ≥10) will receive a 12-week intervention with home-based pulmonary rehab (PR).
Interventions
Established home-based pulmonary rehab system consists of three commercial devices (Garmin Vívofit™ activity monitor, Nonin 3150 WristOx2® Pulse Oximeter, Android tablet) and two software applications for telemonitored home pulmonary rehabilitation.
Coaching calls based on motivational interviewing principles will occur weekly for twelve weeks following a standard protocol, lasting no more than 5-10 minutes.
Eligibility Criteria
Subjects with a medical diagnosis of bronchiectasis being see in the Mayo Clinic Bronchiectasis Clinic in Rochester, MN.
You may qualify if:
- Ability to communicate in English.
You may not qualify if:
- Inability to walk (orthopedic/neurologic/cardiac limitation causing immobility).
- Cognitive impairment or inability to understand and follow instructions.
- Traditional PR completed within 3 months of study recruitment.
- Hospice or end-of-life care at the time of screening.
- Acute exacerbation at the time of screening.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
- National Heart, Lung, and Blood Institute (NHLBI)collaborator
Study Sites (1)
Mayo Clinic in Rochester
Rochester, Minnesota, 55905, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Roberto Benzo, MD
Mayo Clinic
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
September 21, 2022
First Posted
September 23, 2022
Study Start
August 25, 2022
Primary Completion
July 30, 2023
Study Completion
July 30, 2023
Last Updated
September 7, 2023
Record last verified: 2023-09
Data Sharing
- IPD Sharing
- Will not share