Evaluation of Improved Outcomes Among Ambulatory Diabetes and/or Hypertensive Patients - an Intervention Study (CPCLINT) (CPCLINT)

August 14, 2023 updated by: Akinniyi Akinbiyi Aje, University of Ibadan

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Akinniyi A Aje / Dr., PhD
  • Phone Number: +234 +2348035684484
  • Email: aje123@gmail.com

Study Contact Backup

  • Name: Modupe O Aroyewun / Pharm, B. Pharm
  • Phone Number: +234 +2348061572544
  • Email: dupsydaniel@gmail.com

Study Locations

  • Nigeria
    • Oyo
      • Ibadan, Oyo, Nigeria, 200005
        • Department of Clinical Pharmacy and Pharmacy Administration, Faculty of Pharmacy, University of Ibadan.
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention arm
All participants would undergo educational intervention by pharmacist.
Behavioral: Educational intervention
Educational materials would be given to all the participants. They would also be followed up by pharmacist.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months
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.
6 months
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.
6 months
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.
6 months
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.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Ibadan

Investigators

  • Study Director: Aduke E Ipingbemi, PhD, University of Ibadan, Nigeria.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 28, 2023

Primary Completion (Estimated)

April 1, 2024

Study Completion (Estimated)

July 1, 2024

Study Registration Dates

First Submitted

August 3, 2023

First Submitted That Met QC Criteria

August 14, 2023

First Posted (Actual)

August 18, 2023

Study Record Updates

Last Update Posted (Actual)

August 18, 2023

Last Update Submitted That Met QC Criteria

August 14, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CPINTCLI

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

I might not share this based on sensitive nature of data to be collected. However, the group data generated would be shared through publications in peer-reviewed journals for public consumption.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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