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Informatics Framework for Pulmonary Rehabilitation (CHIEF-PR)

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ClinicalTrials.gov Identifier: NCT03981783
Recruitment Status : Not yet recruiting
First Posted : June 11, 2019
Last Update Posted : June 11, 2019
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Joseph Finkelstein, Icahn School of Medicine at Mount Sinai

Brief 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. 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.

Condition or disease Intervention/treatment Phase
COPD Behavioral: Best available care (BAC) Behavioral: Telerehabilitation (TH) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Supportive Care
Official Title: Comprehensive Health Informatics Engagement Framework for Pulmonary Rehab
Estimated Study Start Date : March 1, 2020
Estimated Primary Completion Date : February 28, 2023
Estimated Study Completion Date : August 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arm Intervention/treatment
Active Comparator: Best available care (BAC) Behavioral: Best available care (BAC)
Eligible patients are assigned to a standard pulmonary rehabilitation program

Experimental: Telerehabilitation (TH) Behavioral: Telerehabilitation (TH)
Eligible patients are assigned to a pulmonary telerehabilitation program




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 6 minute walking distance [ Time Frame: 12 months ]
    The distance covered over a time of 6 minutes

  2. Chronic Respiratory Disease Questionnaire (CRDQ) [ Time Frame: 12 months ]
    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.

  3. Short Form-36 (SF-36) [ Time Frame: 12 months ]
    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

  4. COPD self-efficacy Scale (CSES) [ Time Frame: 12 months ]
    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

  5. Shortness of Breath Questionnaire [ Time Frame: 12 months ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03981783


Contacts
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Contact: Joseph Finkelstein, MD 212-659-9596 Joseph.Finkelstein@mssm.edu
Contact: Venus Velez, MBA 212-659-9686 Venus.Velez@mssm.edu

Locations
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United States, New York
Mount Sinai Hospital Not yet recruiting
New York, New York, United States, 10029
Contact: Joseph Finkelstein, MD    212-659-9596    Joseph.Finkelstein@mssm.edu   
Contact: Venus Velez, MBA    212-659-9686    Venus.Velez@mssm.edu   
Principal Investigator: Joseph Finkelstein, MD         
Sponsors and Collaborators
Icahn School of Medicine at Mount Sinai
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
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Principal Investigator: Joseph Finkelstein, MD Icahn School of Medicine at Mount Sinai

Publications:
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Responsible Party: Joseph Finkelstein, Chief Research Informatics Officer, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT03981783     History of Changes
Other Study ID Numbers: GCO 18-1637
R61HL143317-01 ( U.S. NIH Grant/Contract )
First Posted: June 11, 2019    Key Record Dates
Last Update Posted: June 11, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Joseph Finkelstein, Icahn School of Medicine at Mount Sinai:
COPD
Pulmonary Rehabilitation
Telerehabilitation
Clinical Decision Support
Adherence