Community Models for Hypertension and Diabetes Care for Refugees

NCT ID: NCT04229667

Last Updated: 2021-07-20

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 600 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-01-31
• Study Completion Date: 2020-02-28

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.

Conditions

Hypertension; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2; Comorbidities and Coexisting Conditions

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Interventions

Improved Community Health Volunteer (CHV) program

Multi-modal intervention targeting intensive household monitoring of "high-needs" patients using monthly visits to measure blood pressure and blood sugar, adherence to treatments and compliance with clinics visits, and motivational interviewing to facilitate behavior change and psychosocial support.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

Adult (≥18 years of age) with clinically-diagnosed hypertension OR type II diabetes AND;

1. Poor adherence, defined as:

• Missed ≥2 appointments in the past six months AND/OR;

2. Poor disease control:

Hypertension: Blood pressure >160/90 (EHS/ESC Grade II/III) with or without therapy, on their last measurement in clinic AND/OR; Evidence of hypertensive end organ damage including ischemic heart disease, left ventricular hypertrophy on ECG, eGFR < 60, hypertensive retinopathy, heart failure, myocardial infarction AND/OR; Type II diabetes: HbA1C is >8.5% OR random blood glucose >200 mg/dL with or without insulin/pill therapy AND/OR; Patient has comorbidity and/or evidence of diabetic end organ damage, including ischemic heart disease, left ventricular hypertrophy on ECG, eGFR < 60, retinopathy, heart failure, myocardial infarction, poorly healing wounds (e.g., diabetic foot), amputation, blindness and eye problems.

3. Comorbid diabetes and hypertension:

4. Disabled (house-bound)

5. Type I diabetes (insulin-dependent): all adult cases of insulin-dependent diabetes (likely type I diabetes), due to the nature of treatment interruption which causes rapid decompensations.

Exclusion Criteria

• Pregnancy
• Hospitalization for the majority of the study period
• Patients who leave the study neighborhood or repatriate to Syria

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Southern California

OTHER

Sponsor Role: collaborator

Jordan University of Science and Technology

OTHER

Sponsor Role: collaborator

International Rescue Committee

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

International Rescue Committee

New York, New York, United States

Countries

United States

Other Identifiers

H 1.00.020

Identifier Type: -

Identifier Source: org_study_id