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Clinical Trials/NCT05996601
NCT05996601
Not yet recruiting
Not Applicable

Evaluation of Selected Improved Outcomes Among Patients With Diabetes and/or Hypertension in Designated Community Pharmacies in a Metropolitan City - An Intervention Study

University of Ibadan1 site in 1 country400 target enrollmentAugust 28, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Type 2 Diabetes Mellitus
Sponsor
University of Ibadan
Enrollment
400
Locations
1
Primary Endpoint
Blood glucose control of participants
Status
Not yet recruiting
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 28, 2023
End Date
July 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Akinniyi Akinbiyi Aje

Experiential Training Coordinator and Sub-Dean Undergraduate (Integrated)

University of Ibadan

Eligibility Criteria

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

Outcomes

Primary Outcomes

Blood glucose control of participants

Time Frame: 6 months

Fasting blood glucose in mg/dL measured at baseline, 3- and 6-month postintervention. would be compared.

Blood pressure control

Time Frame: 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.

Time Frame: 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

Time Frame: 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

Time Frame: 6 months

The knowledge and attitude scale in the semi-structured questionnaire would be evaluated at baseline, 3- and 6-month postintervention.

Study Sites (1)

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