Informatics Framework for Pulmonary Rehabilitation

NCT ID: NCT03981783

Last Updated: 2022-10-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-11

Study Completion Date

2023-08-31

Brief Summary

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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

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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

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COPD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Best available care (BAC)

Group Type ACTIVE_COMPARATOR

Best available care (BAC)

Intervention Type BEHAVIORAL

Eligible patients are assigned to a standard pulmonary rehabilitation program

Telerehabilitation (TH)

Group Type EXPERIMENTAL

Telerehabilitation (TH)

Intervention Type BEHAVIORAL

Eligible patients are assigned to a pulmonary telerehabilitation program

Interventions

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Best available care (BAC)

Eligible patients are assigned to a standard pulmonary rehabilitation program

Intervention Type BEHAVIORAL

Telerehabilitation (TH)

Eligible patients are assigned to a pulmonary telerehabilitation program

Intervention Type BEHAVIORAL

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role lead

Responsible Party

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Joseph Finkelstein

Chief Research Informatics Officer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Joseph Finkelstein, MD

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Locations

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Mount Sinai Hospital

New York, New York, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Joseph Finkelstein, MD

Role: CONTACT

212-659-9596

Facility Contacts

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Joseph Finkelstein, MD

Role: primary

212-659-9596

Venus Velez, MBA

Role: backup

212-659-9686

References

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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.

Reference Type BACKGROUND
PMID: 23823363 (View on PubMed)

Gibbons 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.

Reference Type BACKGROUND
PMID: 20629477 (View on PubMed)

Jeong 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.

Reference Type BACKGROUND
PMID: 26410522 (View on PubMed)

Finkelstein 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.

Reference Type BACKGROUND
PMID: 24422882 (View on PubMed)

Finkelstein 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.

Reference Type BACKGROUND
PMID: 19802349 (View on PubMed)

Gibbons 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.

Reference Type BACKGROUND
PMID: 24073033 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33511633 (View on PubMed)

Other Identifiers

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R61HL143317-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

GCO 18-1637

Identifier Type: -

Identifier Source: org_study_id

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