Informatics Framework for Pulmonary Rehabilitation

COPD Clinical Trial

— CHIEF-PR  

Official title:

Comprehensive Health Informatics Engagement Framework for Pulmonary Rehab

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03981783
• Other study ID #: GCO 18-1637
• Secondary ID: R61HL143317-01
• Status: Recruiting
• Phase: N/A
• Start date: June 11, 2020
• Est. completion date: August 31, 2023

Study information

• Verified date: October 2022
• Source: Icahn School of Medicine at Mount Sinai
• Contact: Joseph Finkelstein, MD
• Phone: 212-659-9596
• Email: Joseph.Finkelstein[@]mssm.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: August 31, 2023
• Est. primary completion date: February 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• COPD

Intervention

Behavioral:
• Best available care (BAC)
Eligible patients are assigned to a standard pulmonary rehabilitation program
• Telerehabilitation (TH)
Eligible patients are assigned to a pulmonary telerehabilitation program

Locations

Country	Name	City	State
United States	Mount Sinai Hospital	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

References & Publications (6)

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. — View Citation

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. Epub 2009 Sep 24. — View Citation

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. Review. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	6 minute walking distance	The distance covered over a time of 6 minutes	12 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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