Type 2 Diabetes MellitusCPCLINTNCT05996601
Evaluation of Improved Outcomes Among Ambulatory Diabetes and/or Hypertensive Patients - an Intervention Study (CPCLINT)
A study testing Educational intervention in people with Type 2 Diabetes Mellitus and Hypertension, run by University of Ibadan at 1 site in Nigeria.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes Mellitus, Hypertension
- What is being tested?
- Educational intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteNigeria
- Study dates
- 28 Aug 2023to Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Non-consented patients
- Patients not based at the study site
Trial locations and contacts
1 site in 1 country.
Nigeria1 site
Department of Clinical Pharmacy and Pharmacy Administration, Faculty of Pharmacy, University of Ibadan.
Ibadan, Oyo State, 200005
Titilayo O Fakeye / Prof, PhD, +2348052234484 ext. +234, titifakeye@gmail.com
About this study
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
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.
Read the 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.
- Conditions
- Type 2 Diabetes Mellitus, Hypertension
- Being tested
- Educational intervention
- Keywords
- Diabetes, Hypertension, Interventional study, Health literacy, Physical activity, Medication adherence, Pharmacist, Community pharmacy
- Medical subject headings
- Diabetes Mellitus, Type 2, Hypertension, Diabetes Mellitus, Motor Activity, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational interventionBehavioural
Educational materials would be given to all the participants. They would also be followed up by pharmacist.
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm | Experimental | All participants would undergo educational intervention by pharmacist. Receives: Behavioral: Educational intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Blood glucose control of participants
Fasting blood glucose in mg/dL measured at baseline, 3- and 6-month postintervention. would be compared.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2023
- Study start28 Aug 2023 (estimated)
- Primary completionApr 2024 (estimated)
- Study completionJul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Ibadan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Akinniyi Akinbiyi Aje, University of Ibadan
- Investigators
- Aduke E Ipingbemi, PhD, Study director, University of Ibadan, Nigeria.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05996601
- Sponsor's protocol ID
- CPINTCLI
- Acronym
- CPCLINT
- Status last verified
- Aug 2023
- First submitted
- 3 Aug 2023
- Last updated
- 18 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 33600078Uloko 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.
PubMed 29761289Milosavljevic 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.
PubMed 29927005Rajiah 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.
PubMed 33918990
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05996601
- Acronym / sponsor ID
- CPCLINT / CPINTCLI
- Conditions
- Type 2 Diabetes Mellitus, Hypertension
- Keywords
- Diabetes, Hypertension, Interventional study, Health literacy, Physical activity, Medication adherence, Pharmacist, Community pharmacy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- University of IbadanUniversity, hospital or other
- Study start
- 28 Aug 2023 (estimated)
- Primary completion
- Apr 2024 (estimated)
- Study completion
- Jul 2024 (estimated)
- First posted
- 18 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | Experimental | Behavioral: Educational interventionAll participants would undergo educational intervention by pharmacist. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Non-consented patients
- Patients not based at the study site
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Educational interventionEducational materials would be given to all the participants. They would also be followed up by pharmacist. | Behavioural | Intervention arm |
Primary outcome
Blood pressure control
Time frame: 6 months
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
Time frame: 6 months
Fasting blood glucose in mg/dL measured at baseline, 3- and 6-month postintervention. would be compared.
Participants' level of disease knowledge and attitude
Time frame: 6 months
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.
Time frame: 6 months
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
Time frame: 6 months
Participants' medication adherence would be evaluated at baseline, 3- and 6-month postintervention using Morisky, Green and Levine 4-item medication adherence scale.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2023.
- Background: PubMed 33600078Adeloye 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.
- Background: PubMed 29761289Uloko 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.
- Background: PubMed 29927005Milosavljevic 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.
- Background: PubMed 33918990Rajiah 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.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aduke E Ipingbemi, PhD study director
University of Ibadan, Nigeria.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational intervention in people with Type 2 Diabetes Mellitus and Hypertension, run by University of Ibadan at 1 site in Nigeria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Nigeria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Akinniyi A Aje / Dr., PhD (+2348035684484 ext. +234, aje123@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood pressure control (time frame: 6 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05996601, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2023.