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.: PACTR202310751607000 Date of Approval: 24/10/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effectiveness of a short message reminder on compliance to follow up after cataract surgery in an outreach setting
Official scientific title Effectiveness of a short message reminder on compliance to follow up after cataract surgery in an outreach setting
Brief summary describing the background and objectives of the trial INTRODUCTION: Cataract is defined as the gradual clouding of the crystalline lens and is the leading cause of blindness worldwide. Globally, cataract is the commonest cause of blindness, and cataract surgery has been shown to be one of the most cost-effective health-care interventions. Patients follow-up visit rates vary greatly across developing countries from as low as 27% in China to as high as 93% in Latin America. Studies have suggested that improvement of postoperative follow-up is critical to enhancing cataract surgical outcomes. Community eye outreach programs have played a very important role in improving access to surgeries. Loss to follow up has been shown to be one of the major drawbacks of outreach based surgery which could pose challenges to prompt diagnosis and management of postoperative complications. AIM:  To evaluate the effectiveness of a mobile phone short message service (SMS) reminder on adherence to post-op follow up and the visual outcome of patients who had cataract surgery in an outreach setting with a view to improving eye care delivery. METHODOLOGY: This study is a randomized controlled trial (RCT) evaluating the effectiveness of a short message reminder among cataract patients who will be assigned randomly to receive SMS reminders about an up-coming appointment and those who will not receive SMS reminders after cataract surgery in outreach setting. Data will be analyzed using MS Excel spread sheet and Stata MP Version 17 (StataCorp). Results will be presented in tables and charts. Variables will be compared using chi-square and statistical significance determined at p< 0.5. SPECIFIC OBJECTIVES: 1- To assess whether a mobile phone short message service (SMS) reminder will improve follow-up compliance for patients operated for cataract in an outreach setting. 2- To identify factors responsible for poor compliance to follow up after cataract surgery. 3- To determine the visual outcome of cataract surgery in patients operated in an outreach setting. 4- To identify factors responsible for poor visual outcome after cataract surgery in an outreach setting.
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 Prevention
Anticipated trial start date 01/09/2023
Actual trial start date 15/09/2023
Anticipated date of last follow up 31/01/2024
Actual Last follow-up date
Anticipated target sample size (number of participants) 125
Actual target sample size (number of participants)
Recruitment status 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
Single Group Randomised Permuted block randomization Sealed opaque envelopes Masking/blinding used Care giver/Provider
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group SMS reminder Four follow up visit : one day post- operatively; week one ; four to six weeks and twelve weeks post operatively. The study participants will be divided into two (2) groups, with 63 participants in the Intervention group and also 63 participants in the control group respectively. A short message service (SMS) Reminder Will be sent to the experimental Group on each follow up visit while the control group will not receive any reminder. 63
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Patients that are 18 years and older who present to the Hospital and diagnosed to have operable cataract. 2. Patients or a member of the household that have access to a cell phone capable of receiving SMS text messages. 3. Patients with no formal education but can be assisted by a literate spouse, family member, or other person. 4. Consent to participate to participate in the study. 1. Patients with cataract and with no perception of light preoperatively. 2. Patients with traumatic cataract or any ocular comorbidity such as glaucoma, corneal opacity. 3. Patients that developed major post-operative complication(s) that may need adjustment in follow up visit will be excluded from the study. 4. Severely debilitated patients, psychotic or deaf and dumb persons with cataract will be excluded from the study. Adult: 19 Year-44 Year 18 Year(s) 100 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 06/10/2022 National Eye Center Ethical Committee
Ethics Committee Address
Street address City Postal code Country
Off Nnamdi Azikiwe Way P.M.B 2267 Kaduna Nigeria Kaduna 800266 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Primary outcome measure:Effectiveness of SMS Reminder on follow up visit 3 months post operatively
Secondary Outcome Visual outcome after cataract surgery in an outreach setting 3 months after surgery
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
King Fahad Bin AbdulAziz Women and Children Hospital Samaru Area Gusau Gusau Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Zamfara Eye Care Program King Fahad Bin AbdulAziz Women and Children Hospital Samaru Area Gusau Gusau Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Principal investigator Off Nnamdi Azikiwe Way National Eye Center Kaduna Kaduna Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Abdulkarim Abubakar abdulkarimabubakar77@yahoo.com +2348032559893 National Eye Center Kaduna
City Postal code Country Position/Affiliation
Kaduna Nigeria Principal investigator
Role Name Email Phone Street address
Public Enquiries Amina Hassan Wali aminahkt@gmail.com +2348037862194 National Eye Center Kaduna
City Postal code Country Position/Affiliation
Kaduna Nigeria Supervisor
Role Name Email Phone Street address
Scientific Enquiries Umar Murtala murtalau@gmail.com +2348065291515 National Eye Center Kaduna
City Postal code Country Position/Affiliation
Kaduna Nigeria Supervisor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data will be available. Individual participant data collected during the trial will be to anyone who wishes to access the data. Informed Consent Form,Statistical Analysis Plan,Study Protocol Individual participant data sharing will begin 3 months and end 5 years following publication. Will be provided
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