Evaluation of Improved Outcomes Among Ambulatory Diabetes and/or Hypertensive Patients - an Intervention Study (CPCLINT)
- Conditions
- HypertensionType 2 Diabetes Mellitus
- Interventions
- Behavioral: Educational intervention
- Registration Number
- NCT05996601
- Lead Sponsor
- University of Ibadan
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 400
- 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
- Non-consented patients
- Patients not based at the study site
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Intervention arm Educational intervention All participants would undergo educational intervention by pharmacist.
- Primary Outcome Measures
Name Time Method Blood glucose control of participants 6 months Fasting blood glucose in mg/dL measured at baseline, 3- and 6-month postintervention. would be compared.
Blood pressure control 6 months Participants' blood pressure in mmHg measured at baseline, 3- and 6-month postintervention would be compared to find out if there are changes.
Participants' body mass index calculated by dividing weight in kilograms by the square of height in meters. 6 months Participants weight in kilograms and height in meters would be measured at baseline, 3- and 6-month postintervention. Their body mass index would be compared to find out if there are changes.
Medication adherence of participants using a 4-item medication adherence scale 6 months Participants' medication adherence would be evaluated at baseline, 3- and 6-month postintervention using Morisky, Green and Levine 4-item medication adherence scale.
Participants' level of disease knowledge and attitude 6 months The knowledge and attitude scale in the semi-structured questionnaire would be evaluated at baseline, 3- and 6-month postintervention.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Department of Clinical Pharmacy and Pharmacy Administration, Faculty of Pharmacy, University of Ibadan.
🇳🇬Ibadan, Oyo, Nigeria