Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202508676372514 Date of Registration: 12/08/2025
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Clinical Trial of Collaboratively Developed Written Medicines Information Leaflets in Hypertensive Patients
Official scientific title Clinical Trial of Collaboratively Developed Written Medicines Information Leaflets in Hypertensive Patients
Brief summary describing the background and objectives of the trial Adherence to medicines for hypertension in Nigeria is a major public health challenge. Many patients fail to take their medications consistently due to factors such as limited health literacy, poor understanding of hypertension as a chronic condition, cost of drugs, side effects, forgetfulness, cultural beliefs, and lack of adequate counselling. Non-adherence often leads to uncontrolled blood pressure and increased risk of complications such as stroke and heart disease. Written medicine information (WMI) could play a valuable role in improving adherence by reinforcing verbal counselling, providing reminders, and clarifying how and why medicines should be taken. Clear WMI can help patients better understand their treatment, manage side effects, and appreciate the importance of lifelong therapy. However, the commercially available medicine inserts in Nigeria are often poorly designed for patients, being overly technical, lengthy, and written in complex medical jargon or small fonts that are difficult to read. This makes them largely inaccessible to patients with low literacy levels, undermining their potential benefit. A patient-friendly approach to written medicines information, using simple language, pictograms, and culturally relevant explanations, could therefore significantly support adherence among Nigerian patients with hypertension. Objectives: 1. To assess patients’ knowledge of their medicines for hypertension and their adherence to medicine taking. 2. To evaluate available written medicines information for readability and usefulness. 3. To collaboratively develop written medicine information with patients. 4. To observe the effect of collaboratively developed written medicine information on clinical, humanistic, and economic outcomes in hypertensive patients
Type of trial RCT
Acronym (If the trial has an acronym then please provide) CToWMI
Disease(s) or condition(s) being studied Cardiology
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Education /Training
Anticipated trial start date 01/10/2023
Actual trial start date 11/03/2024
Anticipated date of last follow up 31/03/2025
Actual Last follow-up date
Anticipated target sample size (number of participants) 224
Actual target sample size (number of participants)
Recruitment status Active, not recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Permuted block randomization Allocation Sequence/Code was not concealed Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Collaboratively developed written medicine information Written medicine information based on the medicine prescribed to the patient was provided at every encounter with the pharmacist Six months Patients in the intervention arm were counselled by the pharmacist with the aid of collaboratively developed written medicine information (WMI), and received the same WMI at the end of every visit. This WMI leaflet is a collaboratively developed material designed to support patient understanding and adherence to prescribed medication. It was created through a multi-stakeholder process involving patients and validated by healthcare professionals (pharmacists and doctors). The content was tailored using plain language principles to enhance readability, with input from target users to ensure cultural relevance, clarity, and usefulness. The design emphasises simple sentence structures, clear headings, practical instructions, and, where appropriate, has visual aids such as pictograms. This approach aims to overcome the limitations of conventional medicine inserts, which are often overly technical and difficult for many patients to understand. By engaging end-users in the development process, the leaflet reflects real-world patient needs, improving comprehension, engagement, and medication adherence, particularly in low-literacy or multilingual settings. 112
Control Group Usual care At every pharmacist encounter Six months Patients will receive usual care, as they have always received during their clinic visits. 112 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Age (18 to 85 years) 2. Patients on Pharmacotherapy for at least six (6) months 1. Patient must be ambulatory at the time of recruitment 2. The patient must be literate and able to read in the English language 3. Patient must be free of comorbid conditions or not using any medicine for the comorbid condition at the time of recruitment. 80 and over: 80+ Year,Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 85 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 05/10/2023 Lagos University Teaching Hospital Health Research Ethics Board
Ethics Committee Address
Street address City Postal code Country
Room 107, LUTH administrative building, LUTH, Idi-Araba, Lagos Lagos 100254 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Medication adherence Baseline, 1 month, 3 months and 6 months
Secondary Outcome Blood pressure changes, knowledge of medicine for hypertension, Hypertension-related Quality of life, health-beliefs about medicines for hypertension. baseline, 1 month, 3 month and 6 month.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Covenant University Health Centre Covenant University, number 10, Idiroko road, Ota Ota 112104 Nigeria
University of Lagos Medical Centre University road, Akoka Lagos 1000001 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Oluwatosin Adeyemi 12 Fasheun street, Ago Palace Way, Okota Lagos 100254 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Oluwatosin Adeyemi 12 Dr Fasheun drive, Ago Palace way, Okota Lagos 1000254 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
Professor Rebecca Soremekun University of Lagos Lagos 100254 Nigeria
Dr. Olubusola Olugbake University of Lagos Lagos 100254 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Oluwatosin Adeyemi cadeyemi@unilag.edu.ng +2348036985621 12 Dr Fasheun drive, Ago Palace way, Okota
City Postal code Country Position/Affiliation
Lagos 100254 Nigeria University of Lagos
Role Name Email Phone Street address
Scientific Enquiries Rebecca Soremekun rsoremekun@unilag.edu.ng +2348033186457 Staff quarters, University of Lagos, Akoka
City Postal code Country Position/Affiliation
Lagos 100254 Nigeria University of Lagos
Role Name Email Phone Street address
Scientific Enquiries Olubusola Olugbake oolugbake@unilag.edu.ng 08023142929 University of Lagos, Akoka
City Postal code Country Position/Affiliation
Lagos 100254 Nigeria University of Lagos
Role Name Email Phone Street address
Public Enquiries Oluwatosin Adeyemi cadeyemi@unilag.edu.ng 08036985621 12 Dr Fasheun street, Ago Palace Way, Okota
City Postal code Country Position/Affiliation
Lagos 100254 Nigeria University of Lagos
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes De-identified individual participant data (IPD) and related trial results will be made available to qualified researchers 3 years after the primary completion date of the study. Data will be shared upon reasonable request and following approval by a data access committee. Researchers must submit a methodologically sound research proposal outlining the planned use of the data. Access will be granted under a data use agreement to ensure ethical and appropriate use. Study Protocol 3 years post-trial end date. Data will be shared with qualified researchers affiliated with recognised institutions. Proposals must include study objectives, a statistical analysis plan, and publication intentions.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Inclusion criteria 07/08/2025 To clarify the requirements for the inclusion criteria. All adult patients (age >17 years) diagnosed with primary hypertension who had been on pharmacotherapy for at least 6 months. 1. Age (18 to 85 years) 2. Patients on Pharmacotherapy for at least six (6) months
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Age group 07/08/2025 To indicate the minimum age recruited within the ticked ages. Adult: 19 Year-44 Year, Middle Aged: 45 Year(s)-64 Year(s), Aged: 65+ Year(s), 80 and over: 80+ Year Adolescent: 13 Year-18 Year, Adult: 19 Year-44 Year, Middle Aged: 45 Year(s)-64 Year(s), Aged: 65+ Year(s), 80 and over: 80+ Year
Section Name Field Name Date Reason Old Value Updated Value
Funding Source FundingSources List 07/08/2025 To clarify the actual name of the Source of funding. Oluwatosin Adeyemi, 12 Fasheun street, Ago Palace Way, Okota, Lagos, 100254, Nigeria, Self Funded,