Pulmonary Arterial HypertensionNCT05521113
Home-based Pulmonary Rehabilitation With Remote Monitoring in Pulmonary Arterial Hypertension
An observational study of Pulmonary Arterial Hypertension, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this study is to test new technology and health coaching aimed to help people with PAH become more physically active in their daily lives. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Arterial Hypertension
- What is being tested?
- Home Rehabilitation Monitoring System and Health coaching calls
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Sep 2022to 30 Jun 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 identified with the medical diagnoses of Pulmonary Arterial Hypertension (PAH) from the Mayo Clinic in Rochester, MN PH clinic.
Who may be able to join
- Diagnosis of PAH, confirmed by right heart catheterization (mean pulmonary artery pressure of 20 mmHg or greater, pulmonary vascular resistance of 3.0 Woods units or greater, Pulmonary capillary wedge pressure of 15 mmHg or lower).
- On PAH-specific therapy which is at stable dosing (i.e., not currently titrating therapy).
- NYHA class II-III symptoms.
- Able to complete a six-minute walk test.
Who cannot join
- Patients experiencing syncope or exertional syncope.
- Patients not experiencing exertional dyspnea.
- Inability to walk.
- Patients currently in pulmonary rehab or having completed pulmonary rehab within three months (unlikely to improve).
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Feasibility of Home-based Pulmonary Rehabilitation With Remote Monitoring in Pulmonary Arterial Hypertension
The purpose of this study is to test new technology and health coaching aimed to help people with PAH become more physically active in their daily lives.
- Conditions
- Pulmonary Arterial Hypertension
- Being tested
- Home Rehabilitation Monitoring System, Health coaching calls
- Medical subject headings
- Pulmonary Arterial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home Rehabilitation Monitoring SystemBehavioural
The system consists of a small activity monitor worn on the wrist and a pulse oximeter worn on the finger while exercising. Simple exercises will be completed daily and the monitors will send information to a rehabilitation coach during a 12-week period.
Health coaching callsBehavioural
12 telephone-based health coaching calls over a 12-week period
| Study group | Role | What they receive |
|---|---|---|
| Home Rehabilitation Monitoring System | Subjects will complete a home pulmonary rehabilitation program while using a home rehabilitation monitoring system and completing health coaching calls. 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.
Adverse Events
Number of adverse events attributed to home-based pulmonary rehabilitation
Measured: 12 weeks
Secondary outcomes (5)
Change in EmPHasis-10 Quality of Life Survey
Measured using the EmPHasis-10 to determine how pulmonary hypertension affect subject's life. 10-item self-reported questionnaire, total score 0-50 with higher scores indicating worse outcomes or quality of life.
Measured: Baseline, 3 months
Change in PAH-SYMPACT domain scores Quality of Life
Measured using the Pulmonary Arterial Hypertension-Symptoms and Impact (PAH-SYMPACT) Questionnaire to assess pulmonary arterial hypertension symptoms over the past 24 hours and 7 days. 23-item self-reported questionnaire, total score 0-89 with higher scores indicating worse outcomes or quality of life.
Measured: Baseline, 3 months
Change in self-management abilities
Measured by the Self-Management Ability Scale (SMAS-30) to determine self-management abilities. 30-item self-reported questionnaire, average overall scores 5-30 with higher scores indicating higher self-management abilities.
Measured: Baseline, 3 months
Change in daily physical activity
Number of daily steps captured by the Home Rehabilitation Monitoring System
Measured: Baseline, 3 months
Change in exercise capacity
Measured by 6-minute walk exercise captured by the Home Rehabilitation Monitoring System
Measured: Baseline, 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2022
- Study start6 Sep 2022
- Primary completion30 Jun 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Arterial HypertensionStudies 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
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hilary M. DuBrock, MD, Mayo Clinic
- Investigators
- Hilary DuBrock, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05521113
- Sponsor's protocol ID
- 22-000414
- Status last verified
- Apr 2024
- First submitted
- 26 Aug 2022
- Last updated
- 22 Apr 2024
- 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 22 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Home-based Pulmonary Rehabilitation With Remote Monitoring in Pulmonary Arterial Hypertension
- ClinicalTrials.gov ID
- NCT05521113
- Acronym / sponsor ID
- 22-000414
- Conditions
- Pulmonary Arterial Hypertension
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 6 Sep 2022 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 30 Aug 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 test new technology and health coaching aimed to help people with PAH become more physically active in their daily lives.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Home Rehabilitation Monitoring System | – | Behavioral: Home Rehabilitation Monitoring System, Behavioral: Health coaching callsSubjects will complete a home pulmonary rehabilitation program while using a home rehabilitation monitoring system and completing health coaching calls. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects identified with the medical diagnoses of Pulmonary Arterial Hypertension (PAH) from the Mayo Clinic in Rochester, MN PH clinic.
Key inclusion criteria (4 listed)
- Diagnosis of PAH, confirmed by right heart catheterization (mean pulmonary artery pressure of 20 mmHg or greater, pulmonary vascular resistance of 3.0 Woods units or greater, Pulmonary capillary wedge pressure of 15 mmHg or lower).
- On PAH-specific therapy which is at stable dosing (i.e., not currently titrating therapy).
- NYHA class II-III symptoms.
- Able to complete a six-minute walk test.
Key exclusion criteria (4 listed)
- Patients experiencing syncope or exertional syncope.
- Patients not experiencing exertional dyspnea.
- Inability to walk.
- Patients currently in pulmonary rehab or having completed pulmonary rehab within three months (unlikely to improve).
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 SystemThe system consists of a small activity monitor worn on the wrist and a pulse oximeter worn on the finger while exercising. Simple exercises will be completed daily and the monitors will send information to a rehabilitation coach during a 12-week period. | Behavioural | Home Rehabilitation Monitoring System |
| Health coaching calls12 telephone-based health coaching calls over a 12-week period | Behavioural | Home Rehabilitation Monitoring System |
Primary outcome
Adverse Events
Time frame: 12 weeks
Number of adverse events attributed to home-based pulmonary rehabilitation
5 secondary outcomes
Change in EmPHasis-10 Quality of Life Survey
Time frame: Baseline, 3 months
Change in PAH-SYMPACT domain scores Quality of Life
Time frame: Baseline, 3 months
Change in self-management abilities
Time frame: Baseline, 3 months
Change in daily physical activity
Time frame: Baseline, 3 months
Change in exercise capacity
Time frame: Baseline, 3 months
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 22 Apr 2024.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Hilary DuBrock, 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 Pulmonary Arterial Hypertension, 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 4 inclusion and 4 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 22 Apr 2024. 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?
Adverse Events (time frame: 12 weeks). 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 22 Apr 2024.