Informatics Framework for Pulmonary Rehabilitation (CHIEF-PR)

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.

Study Overview

• Status: Recruiting
• Conditions: COPD
• Intervention / Treatment: Behavioral: Best available care (BAC); Behavioral: Telerehabilitation (TH)

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 Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Joseph Finkelstein, MD; Phone Number: 212-659-9596; Email: Joseph.Finkelstein@mssm.edu

Study Locations

• United States
  • New York
    • New York, New York, United States, 10029
      • Recruiting
      • Mount Sinai Hospital
      • Contact: Joseph Finkelstein, MD; Phone Number: 212-659-9596; Email: Joseph.Finkelstein@mssm.edu
      • Contact: Venus Velez, MBA; Phone Number: 212-659-9686; Email: Venus.Velez@mssm.edu
      • Principal Investigator: Joseph Finkelstein, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
6 minute walking distance	The distance covered over a time of 6 minutes	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.	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	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	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.	12 months

Collaborators and Investigators

• Sponsor: Icahn School of Medicine at Mount Sinai
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
• Investigators: Principal Investigator: Joseph Finkelstein, MD, Icahn School of Medicine at Mount Sinai

Publications and helpful links

General 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 11, 2020
• Primary Completion (ANTICIPATED): February 28, 2023
• Study Completion (ANTICIPATED): August 31, 2023

Study Registration Dates

• First Submitted: June 7, 2019
• First Submitted That Met QC Criteria: June 7, 2019
• First Posted (ACTUAL): June 11, 2019

Study Record Updates

• Last Update Posted (ACTUAL): October 31, 2022
• Last Update Submitted That Met QC Criteria: October 28, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: Adherence; Clinical Decision Support; COPD; Telerehabilitation; Pulmonary Rehabilitation
• Other Study ID Numbers: GCO 18-1637; R61HL143317-01 (NIH)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No