Ignite Creation Date:
2025-12-25 @ 12:39 AM
Ignite Modification Date:
2025-12-31 @ 10:31 PM
Study NCT ID:
NCT04229667
Status:
TERMINATED
Last Update Posted:
2021-07-20
First Post:
2019-10-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Community Models for Hypertension and Diabetes Care for Refugees
Sponsor:
International Rescue Committee
Organization:
Study Overview
Official Title:
Optimising a Community-based Model for Case Identification, Monitoring, and Prevention of Hypertension and Diabetes Among Syrian Refugees in Jordan
Status:
TERMINATED
Status Verified Date:
2021-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
As a result of COVID-19, the intervention design changed and an RCT was no longer an appropriate study design for evaluation.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The project will investigate and improve a community health worker (CHW) based model for non-communicable disease (NCD) care in a humanitarian emergency.
Detailed Description:
Guidelines for public health approaches for non-communicable disease (NCD) in crises are not well developed. More broadly, NCD management in developing countries focuses on care at the health facility level without a community health worker focus (CHW), which may facilitate continuous care and monitoring.
Since the arrival of refugees from Syria in 2012, the International Rescue Committee (IRC) has provided primary health care, mobile outreach, and community-based empowerment programs for those in need in the northern governorates of Mafraq and Ramtha. The IRC runs health clinics, mobile medical teams, and community health volunteer (CHV) networks to provide care for refugees and Jordanians living in poverty.
This stepped-wedge observational study will follow the implementation of an improved CHV program which focuses on the monitoring of 'high-needs' patients in their households for complications, severe disease, and to avoid interruptions to treatment adherence. The stepped-wedge design will be undertaken to benefit from the phased rollout of the improved CHV intervention over a year-long period. The intervention will be scaled to 20 CHV-neighborhoods across Mafraq and Ramtha.
Primary objectives:
* To evaluate the impact of an improved CHV program that targets high-needs hypertension and diabetes patients on:
* Compliance with routine clinic visits.
* Adherence to medications (self-reported).
* Adherence behaviours (self-reported).
* Disease control outcomes (blood pressure control for hypertension patients; blood sugar control for diabetes patients).
Secondary objectives:
* To document the operations of the improved CHV program in terms of key operational indicators and health indicators.
* To produce lessons learned to improve the CHV program.
Study outcomes:
* Evidence of the effectiveness of the improved CHV strategy on clinic visit compliance, adherence, and patient outcomes.
* Improved guidance for developing and implementing an integrated model of primary care and community health worker networks in crises.
Since the arrival of refugees from Syria in 2012, the International Rescue Committee (IRC) has provided primary health care, mobile outreach, and community-based empowerment programs for those in need in the northern governorates of Mafraq and Ramtha. The IRC runs health clinics, mobile medical teams, and community health volunteer (CHV) networks to provide care for refugees and Jordanians living in poverty.
This stepped-wedge observational study will follow the implementation of an improved CHV program which focuses on the monitoring of 'high-needs' patients in their households for complications, severe disease, and to avoid interruptions to treatment adherence. The stepped-wedge design will be undertaken to benefit from the phased rollout of the improved CHV intervention over a year-long period. The intervention will be scaled to 20 CHV-neighborhoods across Mafraq and Ramtha.
Primary objectives:
* To evaluate the impact of an improved CHV program that targets high-needs hypertension and diabetes patients on:
* Compliance with routine clinic visits.
* Adherence to medications (self-reported).
* Adherence behaviours (self-reported).
* Disease control outcomes (blood pressure control for hypertension patients; blood sugar control for diabetes patients).
Secondary objectives:
* To document the operations of the improved CHV program in terms of key operational indicators and health indicators.
* To produce lessons learned to improve the CHV program.
Study outcomes:
* Evidence of the effectiveness of the improved CHV strategy on clinic visit compliance, adherence, and patient outcomes.
* Improved guidance for developing and implementing an integrated model of primary care and community health worker networks in crises.
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?: