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

Hypertension Clinical Trial

— CPCLINT  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05996601
• Other study ID #: CPINTCLI
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 28, 2023
• Est. completion date: July 2024

Study information

• Verified date: August 2023
• Source: University of Ibadan
• Contact: Akinniyi A Aje / Dr., PhD
• Phone: +2348035684484
• Email: aje123[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 400
• Est. completion date: July 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Hypertension
• Type 2 Diabetes Mellitus

Intervention

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

Locations

Country	Name	City	State
Nigeria	Department of Clinical Pharmacy and Pharmacy Administration, Faculty of Pharmacy, University of Ibadan.	Ibadan	Oyo

Sponsors (1)

Lead Sponsor	Collaborator
University of Ibadan

Country where clinical trial is conducted

Nigeria, 

References & Publications (4)

Adeloye D, Owolabi EO, Ojji DB, Auta A, Dewan MT, Olanrewaju TO, Ogah OS, Omoyele C, Ezeigwe N, Mpazanje RG, Gadanya MA, Agogo E, Alemu W, Adebiyi AO, Harhay MO. Prevalence, awareness, treatment, and control of hypertension in Nigeria in 1995 and 2020: A systematic analysis of current evidence. J Clin Hypertens (Greenwich). 2021 May;23(5):963-977. doi: 10.1111/jch.14220. Epub 2021 Feb 18. — View Citation

Milosavljevic A, Aspden T, Harrison J. Community pharmacist-led interventions and their impact on patients' medication adherence and other health outcomes: a systematic review. Int J Pharm Pract. 2018 Oct;26(5):387-397. doi: 10.1111/ijpp.12462. Epub 2018 Jun 21. — View Citation

Rajiah K, Sivarasa S, Maharajan MK. Impact of Pharmacists' Interventions and Patients' Decision on Health Outcomes in Terms of Medication Adherence and Quality Use of Medicines among Patients Attending Community Pharmacies: A Systematic Review. Int J Environ Res Public Health. 2021 Apr 21;18(9):4392. doi: 10.3390/ijerph18094392. — View Citation

Uloko AE, Musa BM, Ramalan MA, Gezawa ID, Puepet FH, Uloko AT, Borodo MM, Sada KB. Prevalence and Risk Factors for Diabetes Mellitus in Nigeria: A Systematic Review and Meta-Analysis. Diabetes Ther. 2018 Jun;9(3):1307-1316. doi: 10.1007/s13300-018-0441-1. Epub 2018 May 14. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood pressure control	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
Primary	Blood glucose control of participants	Fasting blood glucose in mg/dL measured at baseline, 3- and 6-month postintervention. would be compared.	6 months
Primary	Participants' level of disease knowledge and attitude	The knowledge and attitude scale in the semi-structured questionnaire would be evaluated at baseline, 3- and 6-month postintervention.	6 months
Primary	Participants' body mass index calculated by dividing weight in kilograms by the square of height in meters.	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
Primary	Medication adherence of participants using a 4-item medication adherence scale	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