Evaluation of Selected Improved Outcomes Among Patients With Diabetes and/or Hypertension in Designated Community Pharmacies in a Metropolitan City - An Intervention Study
| Registry | NCT05996601, acronym CPCLINT |
|---|---|
| Status | Unknown |
| Phase | Not applicable |
| Study type | Interventional; na, single group, masking: none, health services research |
| Enrollment | 400 (Estimated) |
| Sponsor | University of Ibadan (Other) |
| Conditions | Type 2 Diabetes Mellitus, Hypertension |
| Interventions | Educational intervention (Behavioral) |
| Dates | start 2023-08-28 (estimated), primary completion 2024-04-01 (estimated), completion 2024-07-01 (estimated), first posted 2023-08-18, last updated 2023-08-18 |
| Locations | 1 site in Nigeria |
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All trials for Type 2 Diabetes Mellitus All trials for Hypertension All trials of Educational intervention
The goal of this interventional study is to compare improved outcomes among diabetes and/or hypertensive patients sequel to educational intervention. The study aims to answer the following questions:
* What are the patients' levels of health literacy, medication adherence, disease knowledge, attitude to disease, physical activity?
* Does educational intervention by pharmacists improve health outcomes of patients with diabetes and/or hypertension?
* Are there associations between patient-related variables such as health literacy, medication adherence, disease knowledge, attitude to disease? Participants' anthropometric measurements and point-of-care testing for disease monitoring e.g., blood pressure, blood glucose would be carried out. Baseline assessment of participants would be done to evaluate their levels of health literacy, medication adherence, disease knowledge, attitude to disease, physical activity.
Patients' baseline assessment would be carried out, after which they would receive educational materials and would be followed up by pharmacist. The baseline assessments would be repeated at three and six months after the intervention to measure the effectiveness of the intervention.
The anthropometric measurements would include weight, height, waist circumference, hip circumference, from which the body mass index and waist-hip ration would be calculated.
The assessment of the disease knowledge and attitude would be done using validated semi-structured questionnaires earlier designed by the principal investigator and used among ambulatory patients with diabetes and/or hypertension accessing care in tertiary healthcare facilities. The validated International Physical Activity Questionnaire (IPAQ) would be utilized for participants' physical activity assessment.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Intervention arm | Experimental | Behavioral: Educational intervention | All participants would undergo educational intervention by pharmacist. |
Sex: All, ages: 18 Years to any
Inclusion Criteria: * Minimum of 18 years of age * Patients must be diagnosed with diabetes and/or hypertension * Patients must be on at least one medication * Patients who access one of the selected community pharmacies for prescription refill Exclusion Criteria: * Non-consented patients * Patients not based at the study site
| Facility | City | Country | Status |
|---|---|---|---|
| Department of Clinical Pharmacy and Pharmacy Administration, Faculty of Pharmacy, University of Ibadan. | Ibadan, Oyo State | Nigeria |