Ignite Creation Date:
2024-05-06 @ 5:59 PM
Last Modification Date:
2024-10-26 @ 2:39 PM
Study NCT ID:
NCT05502042
Status:
COMPLETED
Last Update Posted:
2024-01-18
First Post:
2022-08-12
Brief Title:
Case Management and Peer Support Groups for Prophylaxis Adherence in Rheumatic Heart Disease
Sponsor:
Childrens Hospital Medical Center Cincinnati
Organization:
Childrens Hospital Medical Center Cincinnati
Study Overview
Official Title:
Case Managers and Peer Support Groups CAMPS for Prophylaxis Adherence in Rheumatic Heart Disease
Status:
COMPLETED
Status Verified Date:
2024-01
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:
CAMPS
Brief Summary:
The objective of CAMPS is to test and evaluate scalable models of secondary antibiotic adherence support for children newly diagnosed with rheumatic heart disease
Aim 1 Determine 1-year BPG adherence rates of children newly diagnosed with latent RHD in Uganda randomized to two support strategies 1 Usual care Arm 1 2 peer group case manager strategy Arm 2
Aim 2 Explore patient reported outcomes including treatment satisfaction patient health-related quality of life and care giver quality of life in relation to support strategy and adherence
Aim 1 Determine 1-year BPG adherence rates of children newly diagnosed with latent RHD in Uganda randomized to two support strategies 1 Usual care Arm 1 2 peer group case manager strategy Arm 2
Aim 2 Explore patient reported outcomes including treatment satisfaction patient health-related quality of life and care giver quality of life in relation to support strategy and adherence
Detailed Description:
While significant strides have been made in echo screening for early detection of RHD and establishment of RHD registries these efforts are diluted by poor adherence to secondary antibiotic prophylaxis SAP In a systematic review by Kevat et al which included 20 global programs only 20 were able to maintain patients on at least 80 adherence the minimum acceptable level Other studies demonstrate similar findings with adherence ranging from as low as 20 up to 75 These studies demonstrate that non-adherence undermines most global SAP programs
Despite low adherence to RHD secondary prophylaxis globally studies have demonstrated that ideal RHD SAP adherence can be achieved but within the confines of strict trial conditions GOAL Trial Currently there is a dearth of research into pragmatic scalable approaches to improve RHD SAP adherence In their systematic review of effectiveness and integration of RHD prevention and control programs Abrams et al advise that prevention and treatment programs should be integrated into general health systems and strengthen local systems Case Managers and Peer Support Groups CAMPS will be a pragmatic randomized trial of two support strategies for rheumatic heart disease secondary antibiotic prophylaxis integrated into routine care Hence CAMPS will address the gap that exists between ideal adherence achieved within the confines of a strict research trial and practical and scalable solutions that can be translated to real-world settings
Despite low adherence to RHD secondary prophylaxis globally studies have demonstrated that ideal RHD SAP adherence can be achieved but within the confines of strict trial conditions GOAL Trial Currently there is a dearth of research into pragmatic scalable approaches to improve RHD SAP adherence In their systematic review of effectiveness and integration of RHD prevention and control programs Abrams et al advise that prevention and treatment programs should be integrated into general health systems and strengthen local systems Case Managers and Peer Support Groups CAMPS will be a pragmatic randomized trial of two support strategies for rheumatic heart disease secondary antibiotic prophylaxis integrated into routine care Hence CAMPS will address the gap that exists between ideal adherence achieved within the confines of a strict research trial and practical and scalable solutions that can be translated to real-world settings
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