Informatics Framework for Pulmonary Rehabilitation

NCT03981783 | Unknown

• 2 other identifiers: GCO 18-1637R61HL143317-01
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

COPD

Keywords

COPD; Pulmonary Rehabilitation; Telerehabilitation; Clinical Decision Support; Adherence

Outcome Measures

Primary Outcomes (1)

• 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

  3 months

Secondary Outcomes (5)

• 6 minute walking distance

  12 months

• Chronic Respiratory Disease Questionnaire (CRDQ)

  12 months

• Short Form-36 (SF-36)

  12 months

• COPD self-efficacy Scale (CSES)

  12 months

• Shortness of Breath Questionnaire

  12 months

Study Arms (2)

Best available care (BAC)

ACTIVE COMPARATOR

Behavioral: Best available care (BAC)

Telerehabilitation (TH)

EXPERIMENTAL

Behavioral: Telerehabilitation (TH)

Interventions

Best available care (BAC) BEHAVIORAL

Eligible patients are assigned to a standard pulmonary rehabilitation program

Best available care (BAC)

Telerehabilitation (TH) BEHAVIORAL

Eligible patients are assigned to a pulmonary telerehabilitation program

Telerehabilitation (TH)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Mount Sinai Hospital

New York, New York, 10029, United States

RECRUITING

Related Publications (7)

• 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.

  PMID: 23823363 BACKGROUND

• 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.

  PMID: 20629477 BACKGROUND

• 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.

  PMID: 26410522 BACKGROUND

• 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.

  PMID: 24422882 BACKGROUND

• 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.

  PMID: 19802349 BACKGROUND

• 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.

  PMID: 24073033 BACKGROUND

• 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.

  PMID: 33511633 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Telerehabilitation

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Telemedicine; Delivery of Health Care; Patient Care Management; Health Services Administration

Study Officials

• Joseph Finkelstein, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joseph Finkelstein, MD

CONTACT

212-659-9596; Joseph.Finkelstein@mssm.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Research Informatics Officer

Model Details: 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.

Study Record Dates

• First Submitted: June 7, 2019
• First Posted: June 11, 2019
• Study Start: June 11, 2020
• Primary Completion: February 28, 2023
• Study Completion: August 31, 2023
• Last Updated: October 31, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)