COPD ExacerbationNCT03865329
Increasing Adherence to Pulmonary Rehabilitation After COPD Related Hospitalizations (Pilot Study)
A study testing Intervention- Home-based Pulmonary Rehabilitation in people with COPD Exacerbation, run by Mayo Clinic at 1 site in United States.
Trial summary
This pilot study will look at investigating barriers, facilitators, adherence and effectiveness of an interactive home-based pulmonary rehabilitation program and health coaching for patients who have recently been hospitalized for a COPD related cause. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- COPD Exacerbation
- What is being tested?
- Intervention- Home-based Pulmonary Rehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jan 2018to 2 Aug 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- COPD related hospitalization and eligible for PR
- Age 40+
- Confidence (score > 5 in a self-efficacy question (1-10 scale): how confident you feel to use this system on a daily basis)
Who cannot join
- Inability to walk (orthopedic-neurologic problems or confined to bed)
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Increasing Adherence to Pulmonary Rehabilitation After COPD Related Hospitalizations
This pilot study will look at investigating barriers, facilitators, adherence and effectiveness of an interactive home-based pulmonary rehabilitation program and health coaching for patients who have recently been hospitalized for a COPD related cause.
Read the detailed description
Despite proven benefits, the proportion of people with COPD who receive Pulmonary Rehabilitation (PR) is very small. The current model of a center-based PR program fails to address the needs of many patients with COPD. The most common patient barrier to attendance is travel to center-based programs, particularly for frail patients with more severe COPD who need transportation assistance. Home-based, unsupervised PR has been proposed as an alternative model to hospital-based programs and has been found to be safe and effective.
In this pilot study researchers will investigate barriers, facilitators and adherence to a home-based pulmonary rehabilitation program after hospitalization. The results of this pilot study will inform the second part of this study as a randomized control study under a different grant (Study 2/R33). Both quantitative and qualitative methods will be used for the evaluation.
10 patients will be enrolled in this pilot study and allocated to a home-based PR in order to polish the intervention before the randomized portion of the study. This pilot is supported by a grant mechanism (R61) explicitly oriented to adjust the intervention and identify barriers for the next randomized portion of this study (Study 2) supported by a separate grant mechanism (R33).
- Conditions
- COPD Exacerbation
- Being tested
- Intervention- Home-based Pulmonary Rehabilitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention- Home-based Pulmonary RehabilitationBehavioural
Home-based Pulmonary Rehabilitation (PR) with health coaching using a remote system that will allow patients to complete PR at home. The program involves upper and lower extremity exercises, self-report of symptoms (fatigue, breathlessness, physical activity and overall well-being).
| Study group | Role | What they receive |
|---|---|---|
| Intervention- Home Pulmonary Rehabilitation | Experimental | Participants will be offered a Home-based pulmonary rehabilitation program with health coaching. Receives: Behavioral: Intervention- Home-based Pulmonary Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to One Balance Practice Routine
Percentage of participants to adhere to one balance practice routine per day for 6 out of the 7 days for 12 weeks prescribed via the interactive home-based pulmonary rehabilitation program
Measured: Baseline to 3 months
Adherence to Two Balance Practice Routine
Percentage of participants to adhere to two balance practices routine per day for 6 out of the 7 days for 12 weeks prescribed via the interactive home-based pulmonary rehabilitation program
Measured: Baseline to 3 months
Adherence to Daily Flexible Practice Routine
Percentage of participants to adhere to the daily flexible practice routine for 6 out of the 7 days for 12 weeks prescribed via the interactive home-based pulmonary rehabilitation program
Measured: Baseline to 3 months
Completion of the Daily Self-assessment
Percentage of participants to complete the daily self-assessment for 6 out of the 7 days for 12 weeks via the interactive home-based pulmonary rehabilitation program
Measured: Baseline to 3 months
Secondary outcomes (5)
Change in Chronic Respiratory Questionnaire (CRQ) Physical Symptoms Summary
The CRQ is a 20-question inventory assessing the areas of health related quality of life in dyspnea (shortness of breath), fatigue, emotion, and feelings of mastery of chronic respiratory disease. The Physical Summary score includes dyspnea (symptom #1 in COPD) and fatigue (symptom #2 in COPD) domains. The questions in each domain are added together and then divided by the number of questions. The possible range is 1-7, where 1 is the worst and 7 the best.
Measured: Baseline, 3 months
Change in Chronic Respiratory Questionnaire (CRQ) Emotional Symptoms Summary
The CRQ Emotion Summary score includes the emotion (independent factor for admissions and poor quality of life) and mastery (self-management) domains of the CRQ. The scores for each domain are calculated by simply added together the answers and then dividing by the number of questions, the range is 1-7 where 1 is the worst and 7 the best.
Measured: Baseline, 3 months
Daily Physical Activity
Average number of steps per day recorded by ActiGraph activity monitor worn on the wrist for seven days at 3 months
Measured: 3 months
Change in the Self-Management Ability Scale (SMAS) Total Score
Measured using the total score from the self-reported SMAS 30 item questionnaire that measures ability and function. A higher score indicates more ability and function in everyday life. The SMAS30 has six areas, each with 5 questions. The minimum score is one and the max is 5. The mean is calculated for each section. A higher score indicates better self management.
Measured: Baseline, 3 months
Change in Patient Health Questionnaire (PHQ-2)
Measured using the self-reported PHQ-2 consisting of a 2 item questionnaire inquiring about the frequency of depressed mood over the past 2 weeks on a scale of 0 to 3, 0=Not at all, 1=several days, 2=more than half the days, 3=nearly everyday. The minimum score is zero and the highest score is 6. A score greater than 3 may indicate depression.
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 posted6 Mar 2019
- Study start20 Jan 2018
- Primary completion2 Aug 2019
- Study completion2 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for COPD ExacerbationStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 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 P Benzo, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03865329
- Sponsor's protocol ID
- 18-002453 (Pilot Study/R61)
- Other IDs
- R61HL142933
- Status last verified
- Jul 2020
- First submitted
- 21 Jan 2019
- Last updated
- 10 Aug 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increasing Adherence to Pulmonary Rehabilitation After COPD Related Hospitalizations
- ClinicalTrials.gov ID
- NCT03865329
- Acronym / sponsor ID
- 18-002453 (Pilot Study/R61)
- Conditions
- COPD Exacerbation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 20 Jan 2018 (actual)
- Primary completion
- 2 Aug 2019 (actual)
- Study completion
- 2 Aug 2019 (actual)
- First posted
- 6 Mar 2019 (actual)
- Results
- Posted 10 Aug 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This pilot study will look at investigating barriers, facilitators, adherence and effectiveness of an interactive home-based pulmonary rehabilitation program and health coaching for patients who have recently been hospitalized for a COPD related cause.
Detailed description
Despite proven benefits, the proportion of people with COPD who receive Pulmonary Rehabilitation (PR) is very small. The current model of a center-based PR program fails to address the needs of many patients with COPD. The most common patient barrier to attendance is travel to center-based programs, particularly for frail patients with more severe COPD who need transportation assistance. Home-based, unsupervised PR has been proposed as an alternative model to hospital-based programs and has been found to be safe and effective.
In this pilot study researchers will investigate barriers, facilitators and adherence to a home-based pulmonary rehabilitation program after hospitalization. The results of this pilot study will inform the second part of this study as a randomized control study under a different grant (Study 2/R33). Both quantitative and qualitative methods will be used for the evaluation.
10 patients will be enrolled in this pilot study and allocated to a home-based PR in order to polish the intervention before the randomized portion of the study. This pilot is supported by a grant mechanism (R61) explicitly oriented to adjust the intervention and identify barriers for the next randomized portion of this study (Study 2) supported by a separate grant mechanism (R33).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention- Home Pulmonary Rehabilitation | Experimental | Behavioral: Intervention- Home-based Pulmonary RehabilitationParticipants will be offered a Home-based pulmonary rehabilitation program with health coaching. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- COPD related hospitalization and eligible for PR
- Age 40+
- Confidence (score > 5 in a self-efficacy question (1-10 scale): how confident you feel to use this system on a daily basis)
Key exclusion criteria (1 listed)
- Inability to walk (orthopedic-neurologic problems or confined to bed)
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 |
|---|---|---|
| Intervention- Home-based Pulmonary RehabilitationHome-based Pulmonary Rehabilitation (PR) with health coaching using a remote system that will allow patients to complete PR at home. The program involves upper and lower extremity exercises, self-report of symptoms (fatigue, breathlessness, physical activity and overall well-being). | Behavioural | Intervention- Home Pulmonary Rehabilitation |
Primary outcome
Adherence to One Balance Practice Routine
Time frame: Baseline to 3 months
Percentage of participants to adhere to one balance practice routine per day for 6 out of the 7 days for 12 weeks prescribed via the interactive home-based pulmonary rehabilitation program
Adherence to Two Balance Practice Routine
Time frame: Baseline to 3 months
Percentage of participants to adhere to two balance practices routine per day for 6 out of the 7 days for 12 weeks prescribed via the interactive home-based pulmonary rehabilitation program
Adherence to Daily Flexible Practice Routine
Time frame: Baseline to 3 months
Percentage of participants to adhere to the daily flexible practice routine for 6 out of the 7 days for 12 weeks prescribed via the interactive home-based pulmonary rehabilitation program
Completion of the Daily Self-assessment
Time frame: Baseline to 3 months
Percentage of participants to complete the daily self-assessment for 6 out of the 7 days for 12 weeks via the interactive home-based pulmonary rehabilitation program
5 secondary outcomes
Change in Chronic Respiratory Questionnaire (CRQ) Physical Symptoms Summary
Time frame: Baseline, 3 months
Change in Chronic Respiratory Questionnaire (CRQ) Emotional Symptoms Summary
Time frame: Baseline, 3 months
Daily Physical Activity
Time frame: 3 months
Change in the Self-Management Ability Scale (SMAS) Total Score
Time frame: Baseline, 3 months
Change in Patient Health Questionnaire (PHQ-2)
Time frame: Baseline, 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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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.
Roberto P 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?
A study testing Intervention- Home-based Pulmonary Rehabilitation in people with COPD Exacerbation, 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 3 inclusion and 1 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 10 Aug 2020. 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?
Yes. Results are posted in the registry (first posted 10 Aug 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Adherence to One Balance Practice Routine (time frame: Baseline to 3 months). The study lists 4 primary outcomes in all. 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 10 Aug 2020.