Clinical trial NCT05996601: Evaluation of Improved Outcomes Among Ambulatory Diabetes and/or Hypertensive Patients - an Intervention Study (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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Hypertension
Keywords: Diabetes
Hypertension
Interventional study
Health literacy
Physical activity
Medication adherence
Pharmacist
Community pharmacy
Lead sponsor: University of Ibadan
Sponsor class: OTHER
First posted: 2023-08-18
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Blood pressure control
timeFrame: 6 months
measure: Blood glucose control of participants
timeFrame: 6 months
measure: Participants' level of disease knowledge and attitude
timeFrame: 6 months
measure: Participants' body mass index calculated by dividing weight in kilograms by the square of height in meters.
timeFrame: 6 months
measure: Medication adherence of participants using a 4-item medication adherence scale
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Ibadan
country: Nigeria
facility: Department of Clinical Pharmacy and Pharmacy Administration, Faculty of Pharmacy, University of Ibadan.
state: Oyo
Study officials:
affiliation: University of Ibadan, Nigeria.
name: Aduke E Ipingbemi, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
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.
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.
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.