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

NCT ID: NCT05996601

Last Updated: 2023-08-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-28

Study Completion Date

2024-07-31

Brief Summary

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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

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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.

Conditions

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Type 2 Diabetes Mellitus Hypertension

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Intervention arm

All participants would undergo educational intervention by pharmacist.

Group Type EXPERIMENTAL

Educational intervention

Intervention Type BEHAVIORAL

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

Interventions

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Educational intervention

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Ibadan

OTHER

Sponsor Role lead

Responsible Party

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Akinniyi Akinbiyi Aje

Experiential Training Coordinator and Sub-Dean Undergraduate (Integrated)

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Aduke E Ipingbemi, PhD

Role: STUDY_DIRECTOR

University of Ibadan, Nigeria.

Locations

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

Ibadan, Oyo State, Nigeria

Site Status

Countries

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Nigeria

Central Contacts

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Akinniyi A Aje / Dr., PhD

Role: CONTACT

+2348035684484 ext. +234

Modupe O Aroyewun / Pharm, B. Pharm

Role: CONTACT

+2348061572544 ext. +234

Facility Contacts

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Titilayo O Fakeye / Prof, PhD

Role: primary

+2348052234484 ext. +234

References

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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.

Reference Type BACKGROUND
PMID: 33600078 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29761289 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29927005 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33918990 (View on PubMed)

Other Identifiers

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CPINTCLI

Identifier Type: -

Identifier Source: org_study_id

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