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.: PACTR202110860145835 Date of Approval: 18/10/2021
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title ADHERENCE TO ANTIGLAUCOMA MEDICATION AND EFFECT OF TELEPHONE REMINDERS ON ADHERENCE AMONGST GLAUCOMA PATIENTS ATTENDING UNIVERSITY COLLEGE HOSPITAL, IBADAN
Official scientific title ADHERENCE TO ANTIGLAUCOMA MEDICATION AND EFFECT OF TELEPHONE REMINDERS ON ADHERENCE AMONGST GLAUCOMA PATIENTS ATTENDING UNIVERSITY COLLEGE HOSPITAL, IBADAN
Brief summary describing the background and objectives of the trial Glaucoma is the second leading cause of blindness in Nigeria. Antiglaucoma Medications (AGM) are often the first line of therapy administered to patients. Studies have shown that adherence to glaucoma medications are poor, however interventions have been shown to improve adherence. Purpose: To determine adherence to antiglaucoma medications and effect of telephone reminders on adherence amongst glaucoma patients at the University College Hospital, Ibadan, in order to provide evidence that would guide appropriate and cost effective interventions for improving antiglaucoma medication adherence. Objectives: 1. Assess baseline medication adherence among glaucoma patients at the UCH Ibadan 2. Assess the effect of phone SMS reminders on AGM adherence at the UCH 3. Determine the factors affecting antiglaucoma medication adherence at the UCH 4. To make evidence-based recommendations for improving adherence among glaucoma patients in Nigeria
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Eye Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial phone reminders-SMS to remind patients to use their medication
Anticipated trial start date 18/01/2021
Actual trial start date 01/02/2021
Anticipated date of last follow up 29/03/2021
Actual Last follow-up date 12/04/2021
Anticipated target sample size (number of participants) 118
Actual target sample size (number of participants) 118
Recruitment status Not yet 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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using by using procedures such as coin-tossing or dice-rolling Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Phone SMS Reminder daily Phone SMS Reminder 66 days the intervention group would receive daily structured Phone SMS Reminder to use their topical antiglaucoma medication 59
Control Group None Stand glaucoma care protocol Follow-up in clinic 66 days after recruitment None 59 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• Consenting glaucoma patients • Glaucoma patients 18 years and older • Glaucoma patients who have been using eye drops to treat glaucoma for > 3 months • Patients with mobility or cognitive impairment that will affect their self-drug administration • Patients who live in very far off locations and are not likely to come for follow up • Patients who do not have a mobile phone Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 80 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 04/01/2021 UIUCH
Ethics Committee Address
Street address City Postal code Country
Queen Elizabeth Ibadan 200222 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Adherence rate to antiglaucoma medication, effect of phone SMS reminder on adherence, factors affecting adherence at presentation and 66 days thereafter
Secondary Outcome Relationship between Belief About Medicines and glaucoma medication adherence At presentation
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
University College Hospital Queen Elizabeth Ibadan 200222 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Anibe Samuel Ata Queen Elizabeth Ibadan 200222 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Anibe Ata Flat B128, Queen Elizabeth Street Ibadan 200222 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Anibe Ata dranibeata@yahoo.com +2348035480606 Queen Elizabeth Street
City Postal code Country Position/Affiliation
Ibadan 200222 Nigeria Senior Registrar
Role Name Email Phone Street address
Scientific Enquiries Olusola Olawoye solaolawoye@yahoo.com +2348023890063 Queen Elizabeth
City Postal code Country Position/Affiliation
Ibadan 200222 Nigeria Consultant University College Hospital Ibadan
Role Name Email Phone Street address
Public Enquiries Charles Bekibele cob150@yahoo.com +2348033233564 Queen Elizabeth
City Postal code Country Position/Affiliation
Ibadan 200222 Nigeria Consultant University College Hospital Ibadan
Role Name Email Phone Street address
Scientific Enquiries Tarela Sarimiye tsarimiye@yahoo.com +2348169209533 Queen Elizabeth
City Postal code Country Position/Affiliation
Ibadan 200222 Nigeria Consultant University College Hospital Ibadan
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol Immediately following publication, No end date Researchers who provide a methodologically sound proposal
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