Impact of a Peer Support Program Amongst COPD Patients and Their Caregivers
| Status: | Recruiting |
|---|---|
| Conditions: | Chronic Obstructive Pulmonary Disease |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 40 - Any |
| Updated: | 2/13/2019 |
| Start Date: | April 17, 2017 |
| End Date: | December 30, 2019 |
| Contact: | Hanan Aboumatar, MD, MPH |
| Email: | habouma1@jhmi.edu |
| Phone: | 410-637-7152 |
Comparing Effectiveness of Self-management and Peer Support Communication Programs Amongst Chronic Obstructive Pulmonary Disease (COPD) Patients and Their Family Caregivers
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.
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.
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.
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.
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
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