Clinical trial NCT03721848: Impact of a Health and Mental Health Promotion Intervention Among Jordanians and Syrians.
Official title: Impact of Health Promotion Interventions on the Management and Secondary Prevention of Non-Communicable Diseases Among Jordanians and Syrians in Jordan.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mental Stress
Hypertension
Diabetes
Lead sponsor: University of Illinois at Urbana-Champaign
Sponsor class: OTHER
Collaborators: name: Americares
name: Royal Health Awareness Society
First posted: 2018-10-26
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: * 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
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility 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.

Primary outcomes:
measure: Health Behavior-Fruit Intake frequency (Assessing Change)
timeFrame: Baseline, Six Months, 12 Months, 18 months
measure: Health Behavior-Vegetable Intake (Assessing Change)
timeFrame: Baseline, Six Months, 12 Months, 18 months
measure: Health Behavior-Bread Intake (Assessing Change)
timeFrame: Baseline, Six Months, 12 Months, 18 months
measure: Incidence of Smoking (Assessing Change)
timeFrame: Baseline, Six Months, 12 Months, 18 months
measure: Health Behavior- Level of Physical Activity (Assessing Change)
timeFrame: Baseline, Six Months, 12 Months, 18 months
measure: Health Behavior-Amount of Red Meat Intake (Assessing Change)
timeFrame: Baseline, Six Months, 12 Months, 18 months
Secondary outcomes:
measure: Duke Health Profile (Assessing Change)
timeFrame: Baseline, Six Months, 12 Months, 18 months
measure: Blood Pressure (Assessing Change)
timeFrame: Baseline, Six Months, 12 Months, 18 months
measure: BMI (Assessing Change)
timeFrame: Baseline, Six Months, 12 Months, 18 months
measure: Laboratory tests: fasting blood glucose (Assessing Change)
timeFrame: Baseline, Six Months, 12 Months, 18 months
measure: Laboratory tests: HbA1c (Assessing Change)
timeFrame: Baseline, Six Months, 12 Months, 18 months
measure: Laboratory tests: total cholesterol (Assessing Change)
timeFrame: Baseline, Six Months, 12 Months, 18 months
measure: Health Behavior (Hypertension, Diabetes, Mental health, Nutrition) Knowledge Survey (Assessing Change)
timeFrame: Baseline, Six Months, 12 Months, 18 months
measure: Brief Trauma Questionnaire (Assessing Change)
timeFrame: Baseline, Six Months, 12 Months, 18 months
measure: Primary Care PTSD (Assessing Change)
timeFrame: Baseline, Six Months, 12 Months, 18 months
Other outcomes:
Locations:
city: Amman
country: Jordan
facility: Royal health Awareness Society
Study officials:
affiliation: University of Illinois at Chicago
name: Tara Powell, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Powell TM, Shin OJ, Li SJ, Hsiao Y. Post-traumatic stress, social, and physical health: A mediation and moderation analysis of Syrian refugees and Jordanians in a border community. PLoS One. 2020 Oct 23;15(10):e0241036. doi: 10.1371/journal.pone.0241036. eCollection 2020.