COPDCHIEF-PRNCT03981783
Informatics Framework for Pulmonary Rehabilitation
A study testing Best available care (BAC) and Telerehabilitation (TH) in people with COPD, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial summary
Previous studies clearly established clinical benefits of pulmonary rehabilitation in patients with chronic obstructive pulmonary disease however uptake and completion rate of pulmonary rehabilitation programs by these patients is limited by multiple barriers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COPD
- What is being tested?
- Best available care (BAC) and Telerehabilitation (TH)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jun 2020to 31 Aug 2023
- Phase
- Interventional
- 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
Who may be able to join
- Age 40 years and older at the time of randomization;
- Have a physician diagnosis of COPD
- Have moderate to severe COPD according to GOLD classification (Stages II - III)
- Understand spoken English or Spanish
- Urgent care event due to COPD within 4 weeks of enrollment
- Have no other member of the household enrolled in the study
Who cannot join
- Evidence that the patient may move from the study area before the completion of the study
- Impaired cognitive status as indicated by MMSE<24
- Presence of any health condition, that would preclude participation (e.g., psychiatric diagnosis, unstable cardiovascular condition or physical disability)
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Mount Sinai Hospital
New York, New York, 10029
Joseph Finkelstein, MD, 212-659-9596, Joseph.Finkelstein@mssm.edu
Venus Velez, MBA, 212-659-9686, Venus.Velez@mssm.edu
About this study
Official title: Comprehensive Health Informatics Engagement Framework for Pulmonary Rehab
Previous studies clearly established clinical benefits of pulmonary rehabilitation in patients with chronic obstructive pulmonary disease however uptake and completion rate of pulmonary rehabilitation programs by these patients is limited by multiple barriers. The goal of this project to systematically evaluate impact of Comprehensive Health Informatics Engagement Framework for Pulmonary Rehabilitation (CHIEF-PR) in a randomized controlled trial. The main hypothesis is that CHIEF-PR will result in significantly higher rates of completion of a comprehensive pulmonary rehabilitation program.
Read the detailed description
Previous studies clearly established clinical benefits of pulmonary rehabilitation in patients with chronic obstructive pulmonary disease (COPD) however uptake and completion rate of pulmonary rehabilitation (PR) programs by these patients is limited by multiple barriers. The study team developed a Comprehensive Health Informatics Engagement Framework for Pulmonary Rehabilitation which facilitates patient referral and promotes adherence with pulmonary rehabilitation program using innovative multi-pronged approach. It includes computer-mediated patient counseling to increase patient motivation in joining PR program followed by ongoing home-based support of PR by a telerehabilitation system that monitors patients' progress and allows remote oversight by clinical PR team. The goal of this project is to systematically evaluate impact of Comprehensive Health Informatics Engagement Framework for Pulmonary Rehabilitation (CHIEF-PR) in a randomized controlled trial. The study team's main hypothesis is that CHIEF-PR will result in significantly higher rates of completion of a comprehensive pulmonary rehabilitation program. The study team will enroll 120 COPD patients within 4 weeks of acute exacerbation of COPD into a randomized controlled trial and follow them for 12 months. Patients will be randomly assigned to intervention (CHIEF-PR) and control (best available standard of care) groups. Primary outcome will be completion rate of a comprehensive 3-month PR program. Secondary outcomes will include relevant clinical and patient-reported parameters.
- Conditions
- COPD
- Being tested
- Best available care (BAC), Telerehabilitation (TH)
- Keywords
- COPD, Pulmonary Rehabilitation, Telerehabilitation, Clinical Decision Support, Adherence
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Best available care (BAC)Behavioural
Eligible patients are assigned to a standard pulmonary rehabilitation program
Telerehabilitation (TH)Behavioural
Eligible patients are assigned to a pulmonary telerehabilitation program
| Study group | Role | What they receive |
|---|---|---|
| Best available care (BAC) | Active comparator | Not described Receives: Behavioral: Best available care (BAC) |
| Telerehabilitation (TH) | Experimental | Not described Receives: Behavioral: Telerehabilitation (TH) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients who completed the program
Percent of eligible COPD patients who completed a comprehensive 3-month PR program to assess adherence with pulmonary rehabilitation
Measured: 3 months
Secondary outcomes (5)
6 minute walking distance
The distance covered over a time of 6 minutes
Measured: 12 months
Chronic Respiratory Disease Questionnaire (CRDQ)
Disease-specific quality of life scaled on a 7-point modified Likert Scale from 1 to 7. The total scale ranges from 20 to 140 with higher scores indicate better health-related quality of life.
Measured: 12 months
Short Form-36 (SF-36)
General quality of life - consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability
Measured: 12 months
COPD self-efficacy Scale (CSES)
COPD Self-efficacy Scale is a 34 item scale, each item is scored on a 5-point likert scale from 1 to 5. Total scale range from 34 to 170, with higher score indicating lower confidence in managing and controlling dyspnea
Measured: 12 months
Shortness of Breath Questionnaire
Respiratory symptoms assessed by the shortness of breath questionnaire. 21 items scored on a 6 point scale from 0 to 5, with total scale from 0 to 120. Higher score indicates more symptoms.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2019
- Study start11 Jun 2020
- Primary completion28 Feb 2023 (estimated)
- Study completion31 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for COPDStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Comprehensive Health Informatics Engagement Framework for Pulmonary Rehabilitation (CHIEF-PR) will facilitate PR referrals, initial assessments, completion rates, and PR maintenance using multi-pronged approach at the healthcare, provider and patient levels that addresses current barriers for PR uptake and completion.
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Joseph Finkelstein, Icahn School of Medicine at Mount Sinai
- Investigators
- Joseph Finkelstein, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03981783
- Sponsor's protocol ID
- GCO 18-1637
- Other IDs
- R61HL143317-01
- Acronym
- CHIEF-PR
- Status last verified
- Oct 2022
- First submitted
- 7 Jun 2019
- Last updated
- 31 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Publications
Bedra M, McNabney M, Stiassny D, Nicholas J, Finkelstein J. Defining patient-centered characteristics of a telerehabilitation system for patients with COPD. Stud Health Technol Inform. 2013;190:24-6.
PubMed 23823363Gibbons MC, Wilson RF, Samal L, Lehman CU, Dickersin K, Lehmann HP, Aboumatar H, Finkelstein J, Shelton E, Sharma R, Bass EB. Impact of consumer health informatics applications. Evid Rep Technol Assess (Full Rep). 2009 Oct;(188):1-546.
PubMed 20629477Jeong IC, Finkelstein J. Remotely controlled biking is associated with improved adherence to prescribed cycling speed. Technol Health Care. 2015;23 Suppl 2:S543-9. doi: 10.3233/THC-150992.
PubMed 26410522Finkelstein J, Knight A, Marinopoulos S, Gibbons MC, Berger Z, Aboumatar H, Wilson RF, Lau BD, Sharma R, Bass EB. Enabling patient-centered care through health information technology. Evid Rep Technol Assess (Full Rep). 2012 Jun;(206):1-1531.
PubMed 24422882Finkelstein J, Cha E, Scharf SM. Chronic obstructive pulmonary disease as an independent risk factor for cardiovascular morbidity. Int J Chron Obstruct Pulmon Dis. 2009;4:337-49. doi: 10.2147/copd.s6400. Epub 2009 Sep 24.
PubMed 19802349Gibbons MC, Wilson RF, Samal L, Lehmann CU, Dickersin K, Lehmann HP, Aboumatar H, Finkelstein J, Shelton E, Sharma R, Bass EB. Consumer health informatics: results of a systematic evidence review and evidence based recommendations. Transl Behav Med. 2011 Mar;1(1):72-82. doi: 10.1007/s13142-011-0016-4.
PubMed 24073033Cox 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 31 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comprehensive Health Informatics Engagement Framework for Pulmonary Rehab
- ClinicalTrials.gov ID
- NCT03981783
- Acronym / sponsor ID
- CHIEF-PR / GCO 18-1637
- Conditions
- COPD
- Keywords
- COPD, Pulmonary Rehabilitation, Telerehabilitation, Clinical Decision Support, Adherence
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 11 Jun 2020 (actual)
- Primary completion
- 28 Feb 2023 (estimated)
- Study completion
- 31 Aug 2023 (estimated)
- First posted
- 11 Jun 2019 (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.
Previous studies clearly established clinical benefits of pulmonary rehabilitation in patients with chronic obstructive pulmonary disease however uptake and completion rate of pulmonary rehabilitation programs by these patients is limited by multiple barriers. The goal of this project to systematically evaluate impact of Comprehensive Health Informatics Engagement Framework for Pulmonary Rehabilitation (CHIEF-PR) in a randomized controlled trial. The main hypothesis is that CHIEF-PR will result in significantly higher rates of completion of a comprehensive pulmonary rehabilitation program.
Detailed description
Previous studies clearly established clinical benefits of pulmonary rehabilitation in patients with chronic obstructive pulmonary disease (COPD) however uptake and completion rate of pulmonary rehabilitation (PR) programs by these patients is limited by multiple barriers. The study team developed a Comprehensive Health Informatics Engagement Framework for Pulmonary Rehabilitation which facilitates patient referral and promotes adherence with pulmonary rehabilitation program using innovative multi-pronged approach. It includes computer-mediated patient counseling to increase patient motivation in joining PR program followed by ongoing home-based support of PR by a telerehabilitation system that monitors patients' progress and allows remote oversight by clinical PR team. The goal of this project is to systematically evaluate impact of Comprehensive Health Informatics Engagement Framework for Pulmonary Rehabilitation (CHIEF-PR) in a randomized controlled trial. The study team's main hypothesis is that CHIEF-PR will result in significantly higher rates of completion of a comprehensive pulmonary rehabilitation program. The study team will enroll 120 COPD patients within 4 weeks of acute exacerbation of COPD into a randomized controlled trial and follow them for 12 months. Patients will be randomly assigned to intervention (CHIEF-PR) and control (best available standard of care) groups. Primary outcome will be completion rate of a comprehensive 3-month PR program. Secondary outcomes will include relevant clinical and patient-reported parameters.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Comprehensive Health Informatics Engagement Framework for Pulmonary Rehabilitation (CHIEF-PR) will facilitate PR referrals, initial assessments, completion rates, and PR maintenance using multi-pronged approach at the healthcare, provider and patient levels that addresses current barriers for PR uptake and completion.
| Arm | Type | Receives |
|---|---|---|
| Best available care (BAC) | Active comparator | Behavioral: Best available care (BAC) |
| Telerehabilitation (TH) | Experimental | Behavioral: Telerehabilitation (TH) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 40 years and older at the time of randomization;
- Have a physician diagnosis of COPD
- Have moderate to severe COPD according to GOLD classification (Stages II - III)
- Understand spoken English or Spanish
- Urgent care event due to COPD within 4 weeks of enrollment
Key exclusion criteria (3 listed)
- Evidence that the patient may move from the study area before the completion of the study
- Impaired cognitive status as indicated by MMSE<24
- Presence of any health condition, that would preclude participation (e.g., psychiatric diagnosis, unstable cardiovascular condition or physical disability)
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 |
|---|---|---|
| Best available care (BAC)Eligible patients are assigned to a standard pulmonary rehabilitation program | Behavioural | Best available care (BAC) |
| Telerehabilitation (TH)Eligible patients are assigned to a pulmonary telerehabilitation program | Behavioural | Telerehabilitation (TH) |
Primary outcome
Percentage of patients who completed the program
Time frame: 3 months
Percent of eligible COPD patients who completed a comprehensive 3-month PR program to assess adherence with pulmonary rehabilitation
5 secondary outcomes
6 minute walking distance
Time frame: 12 months
Chronic Respiratory Disease Questionnaire (CRDQ)
Time frame: 12 months
Short Form-36 (SF-36)
Time frame: 12 months
COPD self-efficacy Scale (CSES)
Time frame: 12 months
Shortness of Breath Questionnaire
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2022.
- Background: PubMed 23823363Bedra M, McNabney M, Stiassny D, Nicholas J, Finkelstein J. Defining patient-centered characteristics of a telerehabilitation system for patients with COPD. Stud Health Technol Inform. 2013;190:24-6.
- Background: PubMed 20629477Gibbons MC, Wilson RF, Samal L, Lehman CU, Dickersin K, Lehmann HP, Aboumatar H, Finkelstein J, Shelton E, Sharma R, Bass EB. Impact of consumer health informatics applications. Evid Rep Technol Assess (Full Rep). 2009 Oct;(188):1-546.
- Background: PubMed 26410522Jeong IC, Finkelstein J. Remotely controlled biking is associated with improved adherence to prescribed cycling speed. Technol Health Care. 2015;23 Suppl 2:S543-9. doi: 10.3233/THC-150992.
- Background: PubMed 24422882Finkelstein J, Knight A, Marinopoulos S, Gibbons MC, Berger Z, Aboumatar H, Wilson RF, Lau BD, Sharma R, Bass EB. Enabling patient-centered care through health information technology. Evid Rep Technol Assess (Full Rep). 2012 Jun;(206):1-1531.
- Background: PubMed 19802349Finkelstein J, Cha E, Scharf SM. Chronic obstructive pulmonary disease as an independent risk factor for cardiovascular morbidity. Int J Chron Obstruct Pulmon Dis. 2009;4:337-49. doi: 10.2147/copd.s6400. Epub 2009 Sep 24.
- Background: PubMed 24073033Gibbons MC, Wilson RF, Samal L, Lehmann CU, Dickersin K, Lehmann HP, Aboumatar H, Finkelstein J, Shelton E, Sharma R, Bass EB. Consumer health informatics: results of a systematic evidence review and evidence based recommendations. Transl Behav Med. 2011 Mar;1(1):72-82. doi: 10.1007/s13142-011-0016-4.
- 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.
- Individual participant dataSharing planned: No. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
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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.
Joseph Finkelstein, MD principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Best available care (BAC) and Telerehabilitation (TH) in people with COPD, run by Icahn School of Medicine at Mount Sinai 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 6 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 31 Oct 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Joseph Finkelstein, MD (212-659-9596, Joseph.Finkelstein@mssm.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients who completed the program (time frame: 3 months). 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 NCT03981783, which also lists 7 linked publications.
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 31 Oct 2022.