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

Primary Purpose

Type 2 Diabetes Mellitus, Hypertension

Status
Not yet recruiting
Phase
Not Applicable
Locations
Nigeria
Study Type
Interventional
Intervention
Educational intervention
Sponsored by
University of Ibadan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Type 2 Diabetes Mellitus focused on measuring Diabetes, Hypertension, Interventional study, Health literacy, Physical activity, Medication adherence, Pharmacist, Community pharmacy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention arm

Arm Description

All participants would undergo educational intervention by pharmacist.

Outcomes

Primary Outcome Measures

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.
Blood glucose control of participants
Fasting blood glucose in mg/dL measured at baseline, 3- and 6-month postintervention. would be compared.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
August 3, 2023
Last Updated
August 14, 2023
Sponsor
University of Ibadan
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1. Study Identification

Unique Protocol Identification Number
NCT05996601
Brief Title
Evaluation of Improved Outcomes Among Ambulatory Diabetes and/or Hypertensive Patients - an Intervention Study (CPCLINT)
Acronym
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

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 28, 2023 (Anticipated)
Primary Completion Date
April 2024 (Anticipated)
Study Completion Date
July 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Ibadan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus, Hypertension
Keywords
Diabetes, Hypertension, Interventional study, Health literacy, Physical activity, Medication adherence, Pharmacist, Community pharmacy

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention arm
Arm Type
Experimental
Arm Description
All participants would undergo educational intervention by pharmacist.
Intervention Type
Behavioral
Intervention Name(s)
Educational intervention
Intervention Description
Educational materials would be given to all the participants. They would also be followed up by pharmacist.
Primary Outcome Measure Information:
Title
Blood pressure control
Description
Participants' blood pressure in mmHg measured at baseline, 3- and 6-month postintervention would be compared to find out if there are changes.
Time Frame
6 months
Title
Blood glucose control of participants
Description
Fasting blood glucose in mg/dL measured at baseline, 3- and 6-month postintervention. would be compared.
Time Frame
6 months
Title
Participants' level of disease knowledge and attitude
Description
The knowledge and attitude scale in the semi-structured questionnaire would be evaluated at baseline, 3- and 6-month postintervention.
Time Frame
6 months
Title
Participants' body mass index calculated by dividing weight in kilograms by the square of height in meters.
Description
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.
Time Frame
6 months
Title
Medication adherence of participants using a 4-item medication adherence scale
Description
Participants' medication adherence would be evaluated at baseline, 3- and 6-month postintervention using Morisky, Green and Levine 4-item medication adherence scale.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Akinniyi A Aje / Dr., PhD
Phone
+2348035684484
Ext
+234
Email
aje123@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Modupe O Aroyewun / Pharm, B. Pharm
Phone
+2348061572544
Ext
+234
Email
dupsydaniel@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aduke E Ipingbemi, PhD
Organizational Affiliation
University of Ibadan, Nigeria.
Official's Role
Study Director
Facility Information:
Facility Name
Department of Clinical Pharmacy and Pharmacy Administration, Faculty of Pharmacy, University of Ibadan.
City
Ibadan
State/Province
Oyo
ZIP/Postal Code
200005
Country
Nigeria
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Titilayo O Fakeye / Prof, PhD
Phone
+2348052234484
Ext
+234
Email
titifakeye@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
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.
Citations:
PubMed Identifier
33600078
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.
Results Reference
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PubMed Identifier
29761289
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.
Results Reference
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PubMed Identifier
29927005
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.
Results Reference
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PubMed Identifier
33918990
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.
Results Reference
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Evaluation of Improved Outcomes Among Ambulatory Diabetes and/or Hypertensive Patients - an Intervention Study (CPCLINT)

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