Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:39 AM
Ignite Modification Date:
2025-12-25 @ 12:39 AM
NCT ID:
NCT04229667
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
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04229667
Study Brief:
Protocol Section:
NCT04229667