NCT05996601

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for not_applicable type-2-diabetes-mellitus

Timeline
Completed

Started Aug 2023

Shorter than P25 for not_applicable type-2-diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 3, 2023

Completed
15 days until next milestone

First Posted

Study publicly available on registry

August 18, 2023

Completed
10 days until next milestone

Study Start

First participant enrolled

August 28, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2024

Completed
Last Updated

August 18, 2023

Status Verified

August 1, 2023

Enrollment Period

7 months

First QC Date

August 3, 2023

Last Update Submit

August 14, 2023

Conditions

Type 2 Diabetes MellitusHypertension

Keywords

DiabetesHypertensionInterventional studyHealth literacyPhysical activityMedication adherencePharmacistCommunity pharmacy

Outcome Measures

Primary Outcomes (5)

  • 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

  • Blood glucose control of participants

    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

    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.

    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

    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

Study Arms (1)

Intervention arm

EXPERIMENTAL

All participants would undergo educational intervention by pharmacist.

Behavioral: Educational intervention

Interventions

Educational interventionBEHAVIORAL

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

Intervention arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Non-consented patients
  • Patients not based at the study site

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Clinical Pharmacy and Pharmacy Administration, Faculty of Pharmacy, University of Ibadan.

Ibadan, Oyo State, 200005, Nigeria

Location

Related 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.

    PMID: 33600078BACKGROUND

  • 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.

    PMID: 29761289BACKGROUND

  • 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.

    PMID: 29927005BACKGROUND

  • 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.

    PMID: 33918990BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2HypertensionDiabetes MellitusMotor ActivityMedication Adherence

Interventions

Early Intervention, Educational

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesVascular DiseasesCardiovascular DiseasesBehaviorPatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth Behavior

Intervention Hierarchy (Ancestors)

Child Health ServicesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesPreventive Health Services

Study Officials

  • Aduke E Ipingbemi, PhD

    University of Ibadan, Nigeria.

    STUDY DIRECTOR

Central Study Contacts

Akinniyi A Aje / Dr., PhD

CONTACT

+2348035684484aje123@gmail.com

Modupe O Aroyewun / Pharm, B. Pharm

CONTACT

+2348061572544dupsydaniel@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Experiential Training Coordinator and Sub-Dean Undergraduate (Integrated)

Study Record Dates

First Submitted

August 3, 2023

First Posted

August 18, 2023

Study Start

August 28, 2023

Primary Completion

April 1, 2024

Study Completion

July 1, 2024

Last Updated

August 18, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

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.

Locations

NG(1)