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

NCT ID: NCT03721848

Last Updated: 2019-08-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 600 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-30
• Study Completion Date: 2019-04-30

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.

Conditions

Mental Stress; Hypertension; Diabetes

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Healthy Community Clinic: NCD+MH

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.

Group Type: EXPERIMENTAL

Healthy community clinic NCD+MH

Intervention Type: BEHAVIORAL

NCD+MH Awareness Intervention Overview:

i. Patients are assigned, at minimum, one health awareness lecture per month with a total of 28 lectures possible ii. Patients attend lectures on specific topics given by MoH staff, mainly nurses.

iii. Topics tackled include: Diabetes, Hypertension, Asthma, Cardiovascular Disease, Reproductive Health, Healthy Nutrition, Smoking, Emotional Wellness, Stress Relief and Positive Coping.

iv. Group nutrition and physical fitness counselling are incorporated into most health awareness lectures

Healthy Community Clinic: NCD

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.

Group Type: ACTIVE_COMPARATOR

Healthy community clinic NCD

Intervention Type: BEHAVIORAL

i. Patients are assigned, at minimum, one health awareness lecture per month with a total of 24 lectures possible ii. Patients attend lectures on specific topics given by MoH staff, mainly nurses.

iii. Topics tackled include: Diabetes, Hypertension, Asthma, Cardiovascular Disease, Reproductive Health, Healthy Nutrition, and Smoking iv. Group nutrition and physical fitness counselling are incorporated into most health awareness lectures

Treatment as usual

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Healthy community clinic NCD+MH

NCD+MH Awareness Intervention Overview:

i. Patients are assigned, at minimum, one health awareness lecture per month with a total of 28 lectures possible ii. Patients attend lectures on specific topics given by MoH staff, mainly nurses.

iii. Topics tackled include: Diabetes, Hypertension, Asthma, Cardiovascular Disease, Reproductive Health, Healthy Nutrition, Smoking, Emotional Wellness, Stress Relief and Positive Coping.

iv. Group nutrition and physical fitness counselling are incorporated into most health awareness lectures

Intervention Type: BEHAVIORAL

Healthy community clinic NCD

i. Patients are assigned, at minimum, one health awareness lecture per month with a total of 24 lectures possible ii. Patients attend lectures on specific topics given by MoH staff, mainly nurses.

iii. Topics tackled include: Diabetes, Hypertension, Asthma, Cardiovascular Disease, Reproductive Health, Healthy Nutrition, and Smoking iv. Group nutrition and physical fitness counselling are incorporated into most health awareness lectures

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Americares

OTHER

Sponsor Role: collaborator

Royal Health Awareness Society

UNKNOWN

Sponsor Role: collaborator

University of Illinois at Urbana-Champaign

OTHER

Sponsor Role: lead

Responsible Party

Tara Powell

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tara Powell, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Illinois at Chicago

Locations

Royal health Awareness Society

Amman, , Jordan

Countries

Jordan

References

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.

Reference Type: DERIVED

PMID: 33095832 (View on PubMed)

Other Identifiers

17390

Identifier Type: -

Identifier Source: org_study_id