Clinical trial NCT04229667: Community Models for Hypertension and Diabetes Care for Refugees
Official title: Optimising a Community-based Model for Case Identification, Monitoring, and Prevention of Hypertension and Diabetes Among Syrian Refugees in Jordan
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Hypertension
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Comorbidities and Coexisting Conditions
Lead sponsor: International Rescue Committee
Sponsor class: OTHER
Collaborators: name: University of Southern California
name: Jordan University of Science and Technology
First posted: 2020-01-18
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult (≥18 years), Syrian refugee or vulnerable Jordanian patients with type 1 or type 2 diabetes mellitus and/or hypertension and considered to have "high-needs", living in the IRC-clinic catchment areas of Ramtha and Mafraq, Jordan

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.

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

Primary outcomes:
measure: Proportion of diabetes patients at intake (defined as random blood sugar >= 200 mg/dL at intake) demonstrating a change in random blood sugar (mmHg)
timeFrame: Every two months, through study completion (4 to 12 months depending on group)
measure: Proportion of hypertension patients at intake (defined as blood pressure >=140/90 mmHg at intake) demonstrating a change in systolic blood pressure (mmHg)
timeFrame: Every two months, through study completion (4 to 12 months depending on group)
measure: Proportion of patients demonstrating a change in self-reported medication adherence behaviors
timeFrame: Every two months, through study completion (4 to 12 months depending on group)
measure: Proportion of patients demonstrating a change in self-reported medication adherence actions (5-day)
timeFrame: Every two months, through study completion (4 to 12 months depending on group)
measure: Proportion of patients demonstrating a change in self-reported medication adherence actions (30-day)
timeFrame: Every two months, through study completion (4 to 12 months depending on group)
Secondary outcomes:
measure: Proportion of hypertension patients at intake (defined as blood pressure >=140/90 mmHg at intake) demonstrating a change in diastolic blood pressure (mmHg)
timeFrame: Every two months, through study completion (4 to 12 months depending on group)
measure: Proportion of patients demonstrating a change in disease control (defined as blood pressure <140/90 mmHg; <150/90 for patients aged ≥80 years), among patients with hypertension at intake (defined as blood pressure >=140/90 mmHg at intake)
timeFrame: Every two months, through study completion (4 to 12 months depending on group)
measure: Proportion of patients demonstrating a change in disease control (defined as random blood sugar <200 mg/dL mmHg), among patients with diabetes at intake (defined as random blood sugar >=200 mg/dL at intake)
timeFrame: Every two months, through study completion (4 to 12 months depending on group)
Other outcomes:
Locations:
city: New York
country: United States
facility: International Rescue Committee
state: New York
Study officials:
References: