Ignite Creation Date:
2024-05-06 @ 9:03 AM
Last Modification Date:
2024-10-26 @ 12:09 PM
Study NCT ID:
NCT02891200
Status:
COMPLETED
Last Update Posted:
2020-02-27
First Post:
2016-08-31
Brief Title:
Impact of a Peer Support Program Amongst COPD Patients and Their Caregivers
Sponsor:
Johns Hopkins University
Organization:
Johns Hopkins University
Study Overview
Official Title:
Comparing Effectiveness of Self-management and Peer Support Communication Programs Amongst Chronic Obstructive Pulmonary Disease COPD Patients and Their Family Caregivers
Status:
COMPLETED
Status Verified Date:
2020-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 strategiesstudy 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 11 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
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 strategiesstudy 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 11 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None