COPD ExacerbationNCT04521608
Increasing Adherence to Pulmonary Rehabilitation After COPD Related Hospitalizations (Study 2)
A study testing Intervention- Home-based Pulmonary Rehabilitation in people with COPD Exacerbation, run by Mayo Clinic at 2 sites in United States.
Trial summary
This study is being done to test the comparative effectiveness of participating in a Pulmonary Rehabilitation Program at home using new technology and health coaching following dismissal from the hospital compared to the referral to a center based pulmonary rehabilitation that may include the choice of center based or… 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
- 296 participants
- Where
- 2 sitesUnited States
- Study dates
- 30 Nov 2020to 19 Sep 2024
- 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
2 sites in 1 country.
United States2 sites
Health Partners Institute
Bloomington, Minnesota, 55425
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Increasing Adherence to Pulmonary Rehabilitation After COPD Related Hospitalizations
This study is being done to test the comparative effectiveness of participating in a Pulmonary Rehabilitation Program at home using new technology and health coaching following dismissal from the hospital compared to the referral to a center based pulmonary rehabilitation that may include the choice of center based or telehealth.
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. After the COVID epidemic, telehealth is an option for individuals referred to patients referred to center based rehabilitation.
The direct referral to home-based, unsupervised PR has been proposed as an alternative model to hospital-based programs and has been found to be safe and effective. The refined home-based PR program from the pilot portion of the study supported by a separate grant mechanism (R61HL142933/NCT03865329) will be tested in this second part randomized control study.
Subjects with a COPD-related hospitalization (exacerbation or pneumonia) will be randomized after hospital discharge to either home-based PR or Choice (referral to conventional center-based PR or home-based PR.
- 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 enrolled in the intervention arm will be offered a Home-based pulmonary rehabilitation program with health coaching. Receives: Behavioral: Intervention- Home-based Pulmonary Rehabilitation |
| Control- Choice | No intervention | This arm was the choice of Pulmonary Rehabilitation at a facility or Home-based pulmonary rehabilitation program with health coaching. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to Pulmonary Rehabilitation (PR)
The number of subjects who completed PR through 3 months
Measured: baseline; 3 months
Change in Health Related Quality of Life as Measured by the Chronic Respiratory Questionnaire (CRQ).
The Chronic Respiratory Questionnaire (CRQ) is a validated tool that is completed by participants at baseline and 3 months, measuring health-related quality of life. This questionnaire measures both physical and emotional aspects of chronic respiratory disease. We reported the difference between baseline and 3 months on the CRQ emotional summary scores (comprised of the summation of the mastery and emotional domains of CRQ divided by 2) and the physical summary score (comprised of the summation of the dyspnea and fatigue domains of the CRQ divided by 2). Summary scores as well as the original domains , all have a range of 1 to 7 points, with a higher number being a better health-related quality of life. 0.5 points is the minimal clinically important difference for this tool. Then, for the interpretation of CRQ results: a difference>0.5 is considered clinically meaningful
Measured: baseline; 3 months
Change in EuroQol (EQ-5D) Score
The EuroQol (EQ-5D) is a 5-item questionnaire that assesses health-related quality of life over five different dimensions of health: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. It also includes a Visual Analogue Scale (VAS) for self-related heath. Each dimension uses a 5-level Likert scale (1 = no problems, 5 = extreme problems), ensuring nuanced data collection. The VAS ranges from 0 (worst imaginable health) to 100 (best imaginable health). Scores are calculated for each dimension with total scores ranging from 1 (no problems) to 5 (extreme problems), with higher scores indicating a worse outcome. The score from the VAS portion of the questionnaire ranges from 0 (worst imaginable health) to 100 (best imaginable health), with higher scores indicating a better outcome.
Measured: baseline; 3 months
Secondary outcomes (6)
Number of Subjects Who Visited the Emergency Department
The number of subjects who had at least one Emergency Department visit from baseline to 3 months.
Measured: baseline to 3 months
Number of Subjects Who Had a Hospitalization
The number of subjects who had at least one hospitalization from baseline to 3 months.
Measured: baseline; 3 months
Change in Self-Management Ability Scale
Measured using the Self-Management Ability Scale-30 item questionnaire to assess ability and function. The SMAS consists of 30 items on four- and five-point Likert scales. Total score ranging from 0 to 100 with higher score indicating a higher function and ability, better outcome.
Measured: baseline; 3 months
Change in Daily Step Count
Participants wore an Actigraph Activity Monitor for one week to measure daily steps.
Measured: baseline; 3 months
Change in Daily Total Physical Activity and Sedentary Time
Participants wore an Actigraph Activity Monitor for one week to measure daily time spent doing sedentary (low energy expenditure) and non-sedentary (high energy expenditure) activities.
Measured: Baseline; 3 months
Change in Duke-UNC Functional Social Support Questionnaire (FSSQ) Score
The Duke-UNC Functional Social Support Questionnaire is an 8-item questionnaire that measures the amount of social support and availability of help from family and friends. The answers range from 1 "Much less than I would like" to 5 " As much as I would like". The scores from all 8 questions are summed (maximum 40) and then divided by 8 to get an average score. The higher the average score, the greater the perceived social support.
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 posted20 Aug 2020
- Study start30 Nov 2020
- Primary completion19 Sep 2024
- Study completion19 Sep 2024
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.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 296 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
- NCT04521608
- Sponsor's protocol ID
- 18-002453
- Other IDs
- R61HL142933
- Status last verified
- Nov 2025
- First submitted
- 17 Aug 2020
- Last updated
- 21 Nov 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cox NS, Dal Corso S, Hansen H, McDonald CF, Hill CJ, Zanaboni P, Alison JA, O'Halloran P, Macdonald H, Holland AE. Telerehabilitation for chronic respiratory disease. Cochrane Database Syst Rev. 2021 Jan 29;1(1):CD013040. doi: 10.1002/14651858.CD013040.pub2.
PubMed 33511633
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2025. 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
- NCT04521608
- Acronym / sponsor ID
- 18-002453
- Conditions
- COPD Exacerbation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 296 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 30 Nov 2020 (actual)
- Primary completion
- 19 Sep 2024 (actual)
- Study completion
- 19 Sep 2024 (actual)
- First posted
- 20 Aug 2020 (actual)
- Results
- Posted 21 Nov 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is being done to test the comparative effectiveness of participating in a Pulmonary Rehabilitation Program at home using new technology and health coaching following dismissal from the hospital compared to the referral to a center based pulmonary rehabilitation that may include the choice of center based or telehealth.
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. After the COVID epidemic, telehealth is an option for individuals referred to patients referred to center based rehabilitation.
The direct referral to home-based, unsupervised PR has been proposed as an alternative model to hospital-based programs and has been found to be safe and effective. The refined home-based PR program from the pilot portion of the study supported by a separate grant mechanism (R61HL142933/NCT03865329) will be tested in this second part randomized control study.
Subjects with a COPD-related hospitalization (exacerbation or pneumonia) will be randomized after hospital discharge to either home-based PR or Choice (referral to conventional center-based PR or home-based PR.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention- Home Pulmonary Rehabilitation | Experimental | Behavioral: Intervention- Home-based Pulmonary RehabilitationParticipants enrolled in the intervention arm will be offered a Home-based pulmonary rehabilitation program with health coaching. |
| Control- Choice | No intervention | –This arm was the choice of Pulmonary Rehabilitation at a facility or 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 Pulmonary Rehabilitation (PR)
Time frame: baseline; 3 months
The number of subjects who completed PR through 3 months
Change in Health Related Quality of Life as Measured by the Chronic Respiratory Questionnaire (CRQ).
Time frame: baseline; 3 months
The Chronic Respiratory Questionnaire (CRQ) is a validated tool that is completed by participants at baseline and 3 months, measuring health-related quality of life. This questionnaire measures both physical and emotional aspects of chronic respiratory disease. We reported the difference between baseline and 3 months on the CRQ emotional summary scores (comprised of the summation of the mastery and emotional domains of CRQ divided by 2) and the physical summary score (comprised of the summation of the dyspnea and fatigue domains of the CRQ divided by 2). Summary scores as well as the original domains , all have a range of 1 to 7 points, with a higher number being a better health-related quality of life. 0.5 points is the minimal clinically important difference for this tool. Then, for the interpretation of CRQ results: a difference>0.5 is considered clinically meaningful
Change in EuroQol (EQ-5D) Score
Time frame: baseline; 3 months
The EuroQol (EQ-5D) is a 5-item questionnaire that assesses health-related quality of life over five different dimensions of health: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. It also includes a Visual Analogue Scale (VAS) for self-related heath. Each dimension uses a 5-level Likert scale (1 = no problems, 5 = extreme problems), ensuring nuanced data collection. The VAS ranges from 0 (worst imaginable health) to 100 (best imaginable health). Scores are calculated for each dimension with total scores ranging from 1 (no problems) to 5 (extreme problems), with higher scores indicating a worse outcome. The score from the VAS portion of the questionnaire ranges from 0 (worst imaginable health) to 100 (best imaginable health), with higher scores indicating a better outcome.
6 secondary outcomes
Number of Subjects Who Visited the Emergency Department
Time frame: baseline to 3 months
Number of Subjects Who Had a Hospitalization
Time frame: baseline; 3 months
Change in Self-Management Ability Scale
Time frame: baseline; 3 months
Change in Daily Step Count
Time frame: baseline; 3 months
Change in Daily Total Physical Activity and Sedentary Time
Time frame: Baseline; 3 months
Change in Duke-UNC Functional Social Support Questionnaire (FSSQ) Score
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 21 Nov 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33511633Cox NS, Dal Corso S, Hansen H, McDonald CF, Hill CJ, Zanaboni P, Alison JA, O'Halloran P, Macdonald H, Holland AE. Telerehabilitation for chronic respiratory disease. Cochrane Database Syst Rev. 2021 Jan 29;1(1):CD013040. doi: 10.1002/14651858.CD013040.pub2.
- 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.
Roberto P Benzo, MD principal investigator
Mayo Clinic
2 sites 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 2 sites 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 21 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 21 Nov 2025). 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 Pulmonary Rehabilitation (PR) (time frame: baseline; 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04521608, which also lists 1 linked publication.
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 21 Nov 2025.