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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05996601
Acronym
CPCLINT
Enrollment
400
Registered
2023-08-18
Start date
2023-08-28
Completion date
2024-07-31
Last updated
2023-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension, Type 2 Diabetes Mellitus

Keywords

Diabetes, Hypertension, Interventional study, Health literacy, Physical activity, Medication adherence, Pharmacist, Community pharmacy

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.

Interventions

BEHAVIORALEducational intervention

Educational materials would be given to all the participants. They would also be followed up by pharmacist.

Sponsors

University of Ibadan
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Blood pressure control6 monthsParticipants' blood pressure in mmHg measured at baseline, 3- and 6-month postintervention would be compared to find out if there are changes.
Blood glucose control of participants6 monthsFasting blood glucose in mg/dL measured at baseline, 3- and 6-month postintervention. would be compared.
Participants' level of disease knowledge and attitude6 monthsThe knowledge and attitude scale in the semi-structured questionnaire would be evaluated at baseline, 3- and 6-month postintervention.
Participants' body mass index calculated by dividing weight in kilograms by the square of height in meters.6 monthsParticipants 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 scale6 monthsParticipants' medication adherence would be evaluated at baseline, 3- and 6-month postintervention using Morisky, Green and Levine 4-item medication adherence scale.

Countries

Nigeria

Contacts

Primary ContactAkinniyi A Aje / Dr., PhD
aje123@gmail.com+2348035684484
Backup ContactModupe O Aroyewun / Pharm, B. Pharm
dupsydaniel@gmail.com+2348061572544

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026