Impact of a Health and Mental Health Promotion Intervention Among Jordanians and Syrians.

University of Illinois at Urbana-Champaign

Status: Completed

Conditions: Mental Stress; Hypertension; Diabetes

Treatments: Behavioral: Healthy community clinic NCD; Behavioral: Healthy community clinic NCD+MH

Study type: Interventional

Funder types: Other

Identifiers

NCT03721848

17390 (Other Identifier)

Details and patient eligibility

About

Given the heightened risk of NCDs and mental health issues, it is critical for Jordanians and Syrian refugees to have access to prevention based health services. To address this need, the following project seeks to examine the capacity of Primary Care Health Centers to provide preventive services to empower patients to manage NCDs and potential mental health issues for those who are experiencing distress.

The primary research question in this evaluation study is:

Does prevention-based health and mental health services in primary health clinics improve health status of Jordanians and Syrian refugees?

This research proposal will consist of three study conditions examining:

• Condition 1: an existing NCD preventive intervention consisting of 24 sessions, which are 45 minutes covering diabetes, hypertension, obesity, reproductive health, cardiovascular diseases, allergies and smoking;
• Condition 2: The existing NCD preventive intervention with 4 added mental health awareness sessions covering traumatic stress reactions, individual strategies for coping with stress and traumatic events and collective strategies for coping with stress and trauma;
• Condition 3: Treatment as usual

A group randomized study will be conducted in three clinics with patients of the respective clinics. The clinics will be identified prior to the study based on similar demographics, service utilization and staff capacity. Once the three clinics are identified they will be selected to one of the three study conditions. This research will be conducted in collaboration with the University of Illinois (UIUC), AmeriCares, and the Royal Health Awareness Society (RHAS) of Jordan. AmeriCares will work as the operational humanitarian organization collaborating with and providing support to RHAS and UIUC. RHAS's healthy community clinic is a community-based health project launched in 2011 conducted with the Ministry of Health (MOH). The project aims to build the capacity of participating Health Centers to provide better preventative services to empower patients to manage their diseases and reduce future complications. The Healthy Community Clinic, established within existing MOH facilities, provides medical practitioners with the training and resources necessary to implement management and prevention-based care to patients in underserved communities.

Enrollment: 600 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:Eligible patients are referred to the study through the treating MOH physicians at the health centers. Through an initial screening process, patients will be assessed for eligibility via inclusion/exclusion criteria by trained nurses. As stated, the nurses will be trained in the data collection procedures by the Research Manager and potential subjects will be fully informed that they can still receive health care services even if they have no interest in participating in the research. This information will be received through the patient information and self-report.

1. Inclusion Criteria (at least two of the following):

   • Obesity, defined as BMI ≥ 30
   • Fasting blood glucose ≥ 100 ml/dl
   • Systolic blood pressure ≥ 120 mmHg and/or diastolic blood pressure ≥ 80 mmHg
   • Self-reported uncontrolled dyslipidaemia, cholesterol >240, LDL >190, HDL < 40 ad/or TG >500
   • Asthma
   • Diabetes
   • Hypertension

   Exclusion Criteria:

2. Exclusion criteria:

   • Renal dysfunction: also known as renal insufficiency or renal failure; assessed by self-report
   • Heart failure: also known as congestive heart disease or chronic heart failure; assessed by self-report
   • Functional disability: defined as any long-term activity limitation due to disease or injury; assessed by self-report
   • Liver dysfunction: also known as liver failure, acute or chronic; assessed by self-report
   • Uncontrolled Resistant Hypertension: defined as blood pressure remaining above the threshold despite lifestyle modifications and concurrent use of at least three antihypertensive medications from different classes with one being a diuretic10-11assessed by self-report
   • Pregnant women
   • Uncontrolled Hypothyroidism * Pregnant women are excluded because it would be almost impossible to find any reduction in pregnant women weight and that will show a negative impact of HCC intervention on weight reduction. Therefore, inclusion of pregnant women could be a confounding factor to the study.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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600 participants in 3 patient groups

Healthy Community Clinic: NCD+MH

Experimental group

Description:

The arm of this study consists of a 28 session intervention, which are 45 minutes and meet 2-3 times a month providing health awareness on non-communicable diseases diabetes, hypertension, obesity, reproductive health, cardiovascular diseases, allergies; smoking; traumatic stress reactions, individual strategies for coping with stress and traumatic events and collective strategies for coping with stress and trauma.

Treatment:

Behavioral: Healthy community clinic NCD+MH

Healthy Community Clinic: NCD

Active Comparator group

Description:

The arm of this study consists of a 24 session intervention, which are 45 minutes and meet 2 times a month providing health awareness on non-communicable disease diabetes, hypertension, obesity, reproductive health, cardiovascular diseases, allergies; smoking.

Treatment:

Behavioral: Healthy community clinic NCD

Treatment as usual

No Intervention group

Description:

This is treatment as usual where there is no intervention, but patients attend the clinic for treatment of non-communicable diseases.