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:
2025-12-24 @ 11:03 PM
Ignite Modification Date:
2025-12-24 @ 11:03 PM
NCT ID:
NCT04087369
Eligibility Criteria:
Inclusion Criteria:
1. Adult patients aged 18 or older that screen into Nyaya Health Nepal/Possible's chronic disease program for the following conditions: Hypertension, Type II Diabetes Mellitus, COPD, and Asthma OR
2. Adult patients aged 18 or older with end-organ pathology resulting from the aforementioned conditions including the following: Chronic Kidney Disease, Ischemic Heart Disease, Cerebrovascular Disease AND
3. Healthcare staff; mid-level providers serving at district/primary health center-level facility; community health workers serving village clusters, Nyaya Health Nepal/Possible and Government of Nepal/Ministry of Health and Population employees involved in study design, program implementation, data collection, or data analysis processes.
* Note, study populations 1 and 2 must reside in either Achham or Dolakha (Nepal) districts.
* Patients must have a noncommunicable note in electronic medical record system at least twice (indicating at least one follow-up visit) and must have minimum 12 weeks in between baseline/endline clinical measures (indicating patients have been followed up for at least 3 months and have 3 months of exposure to intervention).
* Patients do not need to have been in study for all 3 years. Duration of exposure to intervention will depend on stepped implementation design.
Patients may be identified at Bayalpata Hospital (Achham, Nepal) or Charikot Primary Health Center (Dolakha, Nepal) by facility clinicians. Community health workers can also identify hypertensive patients and refer them to the facility for diagnosis confirmation. Patient enrollment will not be restricted by economic status or caste. Patients will not be recruited exclusively to participate in the study but will undergo routine evaluations, entering the final diagnosis in electronic health record system, tracking progress at each patient contact, the frequency for which is determined by the clinician's recommendation per World Health Organization Package of Essential Noncommunicable disease intervention protocols and the patient's availability. Patients will receive longitudinal care via the community health workers at their homes and at the hospitals by mid-level providers and staff physicians. Their receipt of care is not contingent upon their enrollment in the study; they receive care per routine service delivery.
Exclusion Criteria:
1. Patients migrate from the study are before completion of any of the Package of Essential Noncommunicable disease interventions
2. Patients explicitly request exclusion from the study and decline to consent to the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04087369
Study Brief:
Protocol Section:
NCT04087369