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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02891200
Recruitment Status : Completed
First Posted : September 7, 2016
Results First Posted : February 27, 2020
Last Update Posted : February 27, 2020
Sponsor:
Collaborator:
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
Johns Hopkins University

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.

Condition or disease Intervention/treatment Phase
COPD Other: Peer support program Other: HCP support Not Applicable

Detailed Description:

Chronic Obstructive Pulmonary Disease (COPD) is a prevalent global condition that results in high mortality, morbidity, symptom burden, and functional limitations that impact the quality of life. COPD is the third leading cause of death in the US and a leading cause of hospitalizations. COPD patients report unmet needs in regards to information about their disease and how to manage and cope with it at an intellectual, emotional, and social level. Many COPD patients lack the information and skills that they need to correctly use their inhaled medications, manage 'breathlessness episodes', and detect early signs of a COPD exacerbation. Pulmonary rehabilitation programs are established to help COPD patients increase their exercise capacity and reduce fatigue and dyspnea with daily activity. While clinical trials testing these programs have demonstrated significant improvements in health-related quality of life and reduced dyspnea and fatigue amongst participants, it remains unclear how best to engage and motivate patients to participate in them.

Self-management support interventions which involve "collaboratively helping patients acquire and practice the skills needed to carry out disease-specific medical regimens, change their health behavior to adjust their roles for optimal function, improve day-to-day control of their disease, and improve their well-being", have been demonstrated in several trials to improve health-related quality of life, and reduce symptom burden, hospitalizations, and ED visits amongst COPD patients. However, it is still unclear which self-management support strategies employed in 'real world' settings are most effective in engaging, motivating, and enabling patients to successfully follow recommended treatments, adopt desired health behaviors, and thus achieve the desired improvements in their health outcomes.

The planned study design is a single- blinded randomized controlled trial to compare the effectiveness of two strategies for engaging and supporting COPD patients and their family caregivers in self-management of COPD. The two strategies/study arms are: 1) the 'HCP arm' where the healthcare professional (HCP) is the primary communicator about COPD self-management with the patient participants; and 2) the 'HCP plus Peer arm', where both healthcare professionals and peer mentors engage with study participants in conversations about COPD self-management using multiple channels including one- to- one and group conversations. Participants will be randomized in a 1:1 ratio into the two study arms. The trial will be conducted amongst COPD patients coming to the hospital or clinic at two study sites within Johns Hopkins Healthcare System. Recruitment from both sites and multiple settings allows for a more representative COPD patient population to be enrolled in the study, thus increasing the external validity of study findings.

The research study will answer the research question: Amongst COPD patients and their caregivers, would a dual strategy that combines healthcare professional and peer mentor delivery of COPD self- management education and support result in greater improvements in health status and quality of life, and reductions in acute healthcare services' utilization, compared to relying on healthcare professionals alone in these communications? Would such dual strategy result in reduced caregiver stress and improved coping and satisfaction? The study hypothesis is that the dual strategy of using 'HCP plus peer support' to engage and support COPD patients and caregivers will have superior outcomes to the 'HCP only' strategy in the following areas : a) Improved health- related quality of life and reduced numbers of COPD-related hospital and ED visits; b) improved patient activation, self-efficacy, and self-care behaviors; c) improved family caregivers' satisfaction and self- efficacy. These improvements will be noted at 3, 6, and 9 months compared to baseline.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 292 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Other
Official Title: Comparing Effectiveness of Self-management and Peer Support Communication Programs Amongst Chronic Obstructive Pulmonary Disease (COPD) Patients and Their Family Caregivers
Actual Study Start Date : April 17, 2017
Actual Primary Completion Date : June 29, 2019
Actual Study Completion Date : November 4, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caregivers

Arm Intervention/treatment
Experimental: Healthcare professional (HCP) Arm
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
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 .

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

Other: HCP support
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 .




Primary Outcome Measures :
  1. Change in Health-related Quality of Life at 6 Months [ Time Frame: enrollment to 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).


Secondary Outcome Measures :
  1. Combined Number of COPD-related Hospitalizations and ED Visits Per Participant at 6 Months [ Time Frame: Measured at 6 months post enrollment ]

    All hospitalizations and ED visits discharge diagnoses are reviewed and those that are COPD-related are counted from time of participant enrollment into study till 6 months afterwards. A visit is coded as COPD-related if:

    1. The principle discharge diagnosis was any of the following : J41.0 ; J41.1; J41.8; J42; J43.0; J43.1; J43.2; J43.8; J43.9; J44.0; J44.1; J44.9.

      Or

    2. The principle discharge diagnosis was respiratory failure AND the visit had a secondary diagnosis of J44.0 or J44.1 . The respiratory failure codes are J96.00; J96.01; J96.02; J96.20; J96.21; J96.22; J96.90; J96.91; J96.92; R06.03; R09.2 .

  2. Combined Number of COPD-related Hospitalizations and ED Visits Per Participant at 9 Months [ Time Frame: Measured at 9 months post enrollment ]

    All hospitalizations and ED visits discharge diagnoses are reviewed and those that are COPD-related are counted from time of participant enrollment into study till 9 months afterwards. A visit is coded as COPD-related if:

    1. The principle discharge diagnosis was any of the following : J41.0 ; J41.1; J41.8; J42; J43.0; J43.1; J43.2; J43.8; J43.9; J44.0; J44.1; J44.9.

      Or

    2. The principle discharge diagnosis was respiratory failure AND the visit had a secondary diagnosis of J44.0 or J44.1 . The respiratory failure codes are J96.00; J96.01; J96.02; J96.20; J96.21; J96.22; J96.90; J96.91; J96.92; R06.03; R09.2 .

  3. Combined Number of COPD-related Hospitalizations and ED Visits Per Participant at 3 Months [ Time Frame: Measured at 3 months post enrollment ]

    All hospitalizations and ED visits discharge diagnoses are reviewed and those that are COPD-related are counted from time of participant enrollment into study till 3 months afterwards. A visit is coded as COPD-related if:

    1. The principle discharge diagnosis was any of the following : J41.0 ; J41.1; J41.8; J42; J43.0; J43.1; J43.2; J43.8; J43.9; J44.0; J44.1; J44.9.

      Or

    2. The principle discharge diagnosis was respiratory failure AND the visit had a secondary diagnosis of J44.0 or J44.1 . The respiratory failure codes are J96.00; J96.01; J96.02; J96.20; J96.21; J96.22; J96.90; J96.91; J96.92; R06.03; R09.2 .

  4. Combined Number of All-cause Hospitalizations and ED Visits Per Participant at 6 Months [ Time Frame: Measured at 6 months post enrollment ]
    All hospitalizations and ED visits will be counted from time of participant enrollment into study till 6 months afterwards.

  5. Combined Number of All-cause Hospitalizations and ED Visits Per Participant at 9 Months [ Time Frame: Measured at 9 months post enrollment ]
    All hospitalizations and ED visits will be counted from time of participant enrollment into study till 9 months afterwards.

  6. Combined Number of All-cause Hospitalizations and ED Visits Per Participant at 3 Months [ Time Frame: Measured at 3 months post enrollment ]
    All hospitalizations and ED visits will be counted from time of participant enrollment into study till 3 months afterwards.

  7. Change in Health-related Quality of Life at 9 Months [ Time Frame: enrollment to 9 months ]
    Change in health-related quality of life (HRQoL) at 9 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 9 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).

  8. Mortality Rate [ Time Frame: Measured at 6 months post enrollment ]
    Assessed at 6 months

  9. Mortality Rate [ Time Frame: Measured at 9 months post enrollment ]
    Assessed at 9 months

  10. Mortality Rate [ Time Frame: Measured at 3 months post enrollment ]
    Assessed at 3 months



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02891200


Locations
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United States, Maryland
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, United States, 21224
Howard County General Hospital
Columbia, Maryland, United States, 21044
Sponsors and Collaborators
Johns Hopkins University
Patient-Centered Outcomes Research Institute
Investigators
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Principal Investigator: Hanan Aboumatar, MD, MPH Johns Hopkins University
  Study Documents (Full-Text)

Documents provided by Johns Hopkins University:
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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT02891200    
Other Study ID Numbers: IRB00114571
First Posted: September 7, 2016    Key Record Dates
Results First Posted: February 27, 2020
Last Update Posted: February 27, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No