Impact of a Peer Support Program Amongst COPD Patients and Their Caregivers

NCT02891200 | Completed Results

• 1 other identifier: IRB00114571
• Study Type: interventional
• Target: 292
• Locations: 1 country
• Sites: 2

Brief Summary

The study is to compare the effectiveness of two health communication and dissemination strategies that are designed to engage patients and family caregivers in successfully managing COPD in 'real-world' settings. Both strategies aim to advance patient understanding of COPD, its treatment options, and self-care tasks; support them in coping with the disease; and enable them to adopt a variety of positive behaviors, including adherence to treatment plans, smoking cessation, joining pulmonary rehabilitation programs, and assuming an active, healthy lifestyle. One strategy relies on the healthcare professional (HCP) as the primary communicator about COPD self-management (HCP arm), whereas the other uses a dual approach that involves both healthcare professionals and peer mentors delivering such communication (HCP plus Peer arm). Peer mentors are COPD patients and caregivers who have successfully managed COPD and have received foundational training on peer mentoring. Specifically, the study aims are to : 1) Conduct a randomized controlled trial in which the 'HCP' and 'HCP plus Peer' strategies are tested in 'real-world' healthcare settings; 2) compare the impact of these strategies on patient satisfaction, experience, activation, self- efficacy, self-care behavior, health status, quality of life, use of Emergency Department (ED) and hospital services, and survival; and, 3) compare the impact of these strategies on caregiver satisfaction, experience, self-efficacy, stress, and coping skills.

Conditions

COPD

Outcome Measures

Primary Outcomes (1)

• Change in Health-related Quality of Life at 6 Months

  Change in health-related quality of life (HRQoL) at 6 months post-enrollment from baseline. The HRQoL is measured using the St. George Respiratory Questionnaire (SGRQ), a validated instrument that will be administered to participant by a trained research team member. SGRQ measures health-related quality of life among patients with respiratory diseases. It is a 40 items questionnaire grouped into three domains (Symptoms, Activity, and Impacts). The overall summary score is calculated by summing the weights of all items with positive response in the questionnaire and dividing that by sum of weights for all items, times 100. Total scores range from 0 to 100. Higher score reflect worse quality of life and a decrease in score indicates improvement HRQoL . Change in score was calculated as the total score at 6 month post-enrollment minus total score at baseline ( i.e at enrollment ). Minimum clinically important difference (MCID) for SGRQ is a 4-point improvement (i.e decrease in score).

  enrollment to 6 months

Secondary Outcomes (10)

• Combined Number of COPD-related Hospitalizations and ED Visits Per Participant at 6 Months

  Measured at 6 months post enrollment

• Combined Number of COPD-related Hospitalizations and ED Visits Per Participant at 9 Months

  Measured at 9 months post enrollment

• Combined Number of COPD-related Hospitalizations and ED Visits Per Participant at 3 Months

  Measured at 3 months post enrollment

• Combined Number of All-cause Hospitalizations and ED Visits Per Participant at 6 Months

  Measured at 6 months post enrollment

• Combined Number of All-cause Hospitalizations and ED Visits Per Participant at 9 Months

  Measured at 9 months post enrollment

Study Arms (2)

Healthcare professional (HCP) Arm

EXPERIMENTAL

Healthcare professional (HCP) Arm includes a trained respiratory therapist who will provide COPD self-management education and support via an in-person session and written materials .

Other: HCP support

HCP plus Peer arm

EXPERIMENTAL

HCP plus Peer arm involves delivering of HCP support as in HCP Arm , along with adding Peer Support Program services. This program is offered to participants by especially trained 'peer mentors' with oversight from a social worker.

Other: Peer support program; Other: HCP support

Interventions

Peer support program OTHER

The Peer Support Program offers education and support to participants by especially trained 'peer mentors' with oversight from a social worker.

HCP plus Peer arm

HCP support OTHER

Healthcare professional (HCP) support will be provided by a trained respiratory therapist who will provide COPD self-management education and support via an in-person session and written materials .

HCP plus Peer arm; Healthcare professional (HCP) Arm

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 40 years or older
• Has a physician diagnosis of COPD AND is on treatment for it ( defined as receiving treatment at hospital or clinic for COPD)

You may not qualify if:

• Cognitive dysfunction impairing ability to provide informed consent and follow instructions
• Active substance abuse or unstable psychiatric condition
• Terminal illness (i.e. less than 6 months life expectancy) that is non-COPD related
• Planning to move from area
• Living at a facility, such as Hospice or nursing home
• Unable to provide contact information
• Does not understand English

Sponsors & Collaborators

• Johns Hopkins University: lead
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (2)

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, 21224, United States

Location

Howard County General Hospital

Columbia, Maryland, 21044, United States

Location

Related Publications (1)

• Aboumatar H, Garcia Morales EE, Jager LR, Naqibuddin M, Kim S, Saunders J, Bone L, Linnell J, McBurney M, Neiman J, Riley M, Robinson N, Rand C, Wise R. Comparing Self-Management Programs with and without Peer Support among Patients with Chronic Obstructive Pulmonary Disease: A Clinical Trial. Ann Am Thorac Soc. 2022 Oct;19(10):1687-1696. doi: 10.1513/AnnalsATS.202108-932OC.

  PMID: 35442179 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Principle Investigator
• Organization: Johns Hopkins University

habouma1@jhmi.edu

410-637-7152

Study Officials

• Hanan Aboumatar, MD, MPH

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2016
• First Posted: September 7, 2016
• Study Start: April 17, 2017
• Primary Completion: June 29, 2019
• Study Completion: November 4, 2019
• Last Updated: February 27, 2020
• Results First Posted: February 27, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)