Community Models for Hypertension and Diabetes Care for Refugees

NCT04229667 | Terminated

• 1 other identifier: H 1.00.020
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (5)

• Proportion of diabetes patients at intake (defined as random blood sugar >= 200 mg/dL at intake) demonstrating a change in random blood sugar (mmHg)

  As measured by point-of-care glucometer

  Every two months, through study completion (4 to 12 months depending on group)

• Proportion of hypertension patients at intake (defined as blood pressure >=140/90 mmHg at intake) demonstrating a change in systolic blood pressure (mmHg)

  As measured by electronic blood pressure monitor during household visit

  Every two months, through study completion (4 to 12 months depending on group)

• Proportion of patients demonstrating a change in self-reported medication adherence behaviors

  As measured by response to questions on adherence behaviors. This measure uses the Center for Adherence Support Evaluation (CASE) Adherence Index, wherein higher values on a scale of 1 to 6 indicate worse outcomes.

  Every two months, through study completion (4 to 12 months depending on group)

• Proportion of patients demonstrating a change in self-reported medication adherence actions (5-day)

  As measured the number of days during the last 5 days in which medication was not taken (during household visit)

  Every two months, through study completion (4 to 12 months depending on group)

• Proportion of patients demonstrating a change in self-reported medication adherence actions (30-day)

  As measured the number of days during the last 30 days in which medication was not taken (during household visit)

  Every two months, through study completion (4 to 12 months depending on group)

Secondary Outcomes (3)

• Proportion of hypertension patients at intake (defined as blood pressure >=140/90 mmHg at intake) demonstrating a change in diastolic blood pressure (mmHg)

  Every two months, through study completion (4 to 12 months depending on group)

• 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)

  Every two months, through study completion (4 to 12 months depending on group)

• 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)

  Every two months, through study completion (4 to 12 months depending on group)

Interventions

Improved Community Health Volunteer (CHV) program OTHER

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Adult (≥18 years of age) with clinically-diagnosed hypertension OR type II diabetes AND;
• Poor adherence, defined as:
• \- Missed ≥2 appointments in the past six months AND/OR;
• 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.
• Comorbid diabetes and hypertension:
• Disabled (house-bound)
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• International Rescue Committee: lead
• University of Southern California: collaborator
• Jordan University of Science and Technology: collaborator

Study Sites (1)

International Rescue Committee

New York, New York, 10168, United States

Location

MeSH Terms

Conditions

Hypertension; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2019
• First Posted: January 18, 2020
• Study Start: January 31, 2020
• Primary Completion: February 28, 2020
• Study Completion: February 28, 2020
• Last Updated: July 20, 2021

Record last verified: 2021-07

Locations

US (1)