BronchiectasisNCT05553119
A Study of Home-based Pulmonary Rehabilitation and Health Coaching to Treat Bronchiectasis
An observational study of Bronchiectasis, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this study is to gather information on the effectiveness on a home-based pulmonary rehabilitation in patients with bronchiectasis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bronchiectasis
- What is being tested?
- Home Rehabilitation Monitoring System and Health coaching calls
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Aug 2022to 30 Jul 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects with a medical diagnosis of bronchiectasis being see in the Mayo Clinic Bronchiectasis Clinic in Rochester, MN.
Who may be able to join
- Having a diagnosis of non-cystic fibrosis bronchiectasis (primary inclusion criteria) ,confirmed by records, that are symptomatic.
- Ability to communicate in English.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Home-based Pulmonary Rehabilitation and Health Coaching in Bronchiectasis
The purpose of this study is to gather information on the effectiveness on a home-based pulmonary rehabilitation in patients with bronchiectasis.
Read the detailed description
The purpose of this study is to gather information on the effectiveness on a home-based pulmonary rehabilitation in patients with bronchiectasis. We hope that by participating in home-rehab that patients with bronchiectasis will become more physically active in their daily lives.
Pulmonary Rehabilitation in a medical center has proven to have a positive impact on physical activity and shortness of breath in patients with chronic lung disease. However, travel and access can make going to a center difficult.
Study participation involves completing gentle flexibility exercises and walking practice using a provided computer tablet, pulse oximeter and an activity tracker for 12 weeks. During that time, you will talk to a health coach once a week on the phone. At the end of the 12 weeks, someone will call you and ask you questions about your experience with the home-based rehab. Health Coaching calls will be recorded so that it can later be transcribed. All identifying information will be removed and the answers will be lumped together.
- Conditions
- Bronchiectasis
- Being tested
- Home Rehabilitation Monitoring System, Health coaching calls
- Medical subject headings
- Bronchiectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home Rehabilitation Monitoring SystemBehavioural
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.
Health coaching callsBehavioural
Coaching calls based on motivational interviewing principles will occur weekly for twelve weeks following a standard protocol, lasting no more than 5-10 minutes.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Behavioral: Home Rehabilitation Monitoring System; Behavioral: Health coaching calls |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, after completion of the 12-week intervention.
Secondary outcomes (1)
Physical activity
As measured by number of steps per 24-hr period.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2022
- Study start25 Aug 2022
- Primary completion30 Jul 2023
- Study completion30 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BronchiectasisStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Roberto P. Benzo, Mayo Clinic
- Investigators
- Roberto Benzo, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05553119
- Sponsor's protocol ID
- 22-004626
- Other IDs
- 5K24HL138150-05
- Status last verified
- Sep 2023
- First submitted
- 21 Sep 2022
- Last updated
- 7 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home-based Pulmonary Rehabilitation and Health Coaching in Bronchiectasis
- ClinicalTrials.gov ID
- NCT05553119
- Acronym / sponsor ID
- 22-004626
- Conditions
- Bronchiectasis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 25 Aug 2022 (actual)
- Primary completion
- 30 Jul 2023 (actual)
- Study completion
- 30 Jul 2023 (actual)
- First posted
- 23 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to gather information on the effectiveness on a home-based pulmonary rehabilitation in patients with bronchiectasis.
Detailed description
The purpose of this study is to gather information on the effectiveness on a home-based pulmonary rehabilitation in patients with bronchiectasis. We hope that by participating in home-rehab that patients with bronchiectasis will become more physically active in their daily lives.
Pulmonary Rehabilitation in a medical center has proven to have a positive impact on physical activity and shortness of breath in patients with chronic lung disease. However, travel and access can make going to a center difficult.
Study participation involves completing gentle flexibility exercises and walking practice using a provided computer tablet, pulse oximeter and an activity tracker for 12 weeks. During that time, you will talk to a health coach once a week on the phone. At the end of the 12 weeks, someone will call you and ask you questions about your experience with the home-based rehab. Health Coaching calls will be recorded so that it can later be transcribed. All identifying information will be removed and the answers will be lumped together.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Home-based Pulmonary Rehabilitation and Health Coaching | – | Behavioral: Home Rehabilitation Monitoring System, Behavioral: Health coaching callsSubjects with symptomatic bronchiectasis (CAT score ≥10) will receive a 12-week intervention with home-based pulmonary rehab (PR). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with a medical diagnosis of bronchiectasis being see in the Mayo Clinic Bronchiectasis Clinic in Rochester, MN.
Key inclusion criteria (2 listed)
- Having a diagnosis of non-cystic fibrosis bronchiectasis (primary inclusion criteria) ,confirmed by records, that are symptomatic.
- Ability to communicate in English.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Home Rehabilitation Monitoring SystemEstablished 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. | Behavioural | Home-based Pulmonary Rehabilitation and Health Coaching |
| Health coaching callsCoaching calls based on motivational interviewing principles will occur weekly for twelve weeks following a standard protocol, lasting no more than 5-10 minutes. | Behavioural | Home-based Pulmonary Rehabilitation and Health Coaching |
Primary outcome
Change in patient-reported quality of life
Time frame: Baseline, after completion of the 12-week intervention.
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.
1 secondary outcome
Physical activity
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2023.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Bronchiectasis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roberto Benzo, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bronchiectasis, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in patient-reported quality of life (time frame: Baseline, after completion of the 12-week intervention.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2023.