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.: PACTR202108476131561 Date of Registration: 02/08/2021
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title A Multi-Center Randomized Controlled Trial of Behavioral, Educational and Mixed Interventions for Improving Adherence to Glaucoma Medications
Official scientific title A Multi-Center Randomized Controlled Trial of Behavioral, Educational and Mixed Interventions for Improving Adherence to Glaucoma Medications
Brief summary describing the background and objectives of the trial Background: Glaucoma is one of the most important ocular pathologies and the second leading cause of irreversible blindness globally. The management of glaucoma calls for the achievement of a targeted intraocular pressure (IOP) which remains the most paramount objective since IOP is currently the only modifiable risk factor. Adherence to medication is a complex challenge in the management of glaucoma. Since the effectiveness of ocular therapies can only be achieved through medication adherence, the need to use Behavioral, Educational and Mixed interventions in addressing non-adherence to glaucoma medication is essential. General aim: To test the effectiveness of behavioral, educational and mixed interventions in improving adherence to glaucoma medications among adult glaucoma patients.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) BEM GLAUCOMA MEDICATION ADHERENCE TRIAL
Disease(s) or condition(s) being studied Eye Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 01/09/2021
Actual trial start date 10/09/2021
Anticipated date of last follow up 31/03/2022
Actual Last follow-up date 31/05/2022
Anticipated target sample size (number of participants) 160
Actual target sample size (number of participants) 160
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 a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Care giver/Provider,Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group BEM GLAUCOMA MEDICATION ADHERENCE INTERVENTION AT EACH APPOINTMENT SCHEDULE SIX MONTHS The interventions to be administered will consist of Educational, Behavioral and a Mixed intervention model (BEM). The Behavioral interventions will include; the use of a reminder application on android platform (the KPM Eye App), SMS text messages, whats app messaging, telephone calls and motivational counseling sessions at the clinic. The educational interventions will be in the form of oral education and written materials. This will involve; face-to-face patient education on glaucoma, instructions on the proper use of glaucoma medications, the use of leaflets and pamphlets for providing information on the need for adherence. The mixed intervention approach will use both behavioral and educational interventions described above for improving adherence to glaucoma medication. 80
Control Group STANDARD ROUTINE CARE FOR GLAUCOMA PATIENTS AT EACH APPOINTMENT SCEDULE SIX MONTHS STANDARD ROUTINE CARE FOR GLAUCOMA PATIENTS 80 Historical
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Previously diagnosed adult glaucoma patients aged 18 to 70 years. 2. Diagnosed of glaucoma for one or more years. 3. Prescribed and advised to use topical anti-glaucoma medications. 4. Patients who have used topical anti-glaucoma medications for one or more years. 5. Patients who are non-adherent (the extent to which medication intake behaviour by patients does not corresponds with the recommendations of the health care provider) to glaucoma medication. 1. Glaucoma diagnosed patients who underwent glaucoma surgery as this was thought to be a motivator for medication adherence. 2. Patients with coexisting psychiatric disorders. Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 70 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 14/06/2021 INSTITUTIONAL REVIEW BOARD KORLE BU TEACHING HOSPITAL
Ethics Committee Address
Street address City Postal code Country
KORLE BU, ACCRA ACCRA 233 Ghana
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The primary outcome measure for this study is the effectiveness of the interventions at three months, and six months intervals, respectively. At three months, and six months intervals, respectively.
Secondary Outcome The secondary outcomes include changes in clinical outcomes such as intraocular pressure fluctuations, prevalence of non-adherence and possible predictors (demographic and clinical characteristics) of non-adherence. At baseline, three months, and six months intervals, respectively.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
The Korle Bu Teaching Hospital The Eye Centre at the Korle Bu Teaching Hospital, Korle Bu, Accra. ACCRA 233 Ghana
The Emmanuel Eye Clinic Emmanuel Eye Clinic, East Legon, Accra, Ghana. ACCRA 233 Ghana
The Inter Star Eye Clinic The Inter-Star Eye Clinic, Osu, Accra. ACCRA 233 Ghana
Saint Thomas Eye Clinic Saint Thomas Eye Clinic, Mataheko, ACCRA 233 Ghana
FUNDING SOURCES
Name of source Street address City Postal code Country
BENJAMIN ABAIDOO UNIVERSITY OF GHANA MEDICAL SCHOOL, KORLE BU ACCRA 233 Ghana
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor BENJAMIN ABAIDOO UNIVERSITY OF GHANA MEDICAL SCHOOL, KORLE BU, ACCRA ACCRA 0233 Ghana Individual
Secondary Sponsor BENJAMIN ABAIDOO UNIVERSITY OF GHANA MEDICAL SCHOOL, KORLE BU, ACCRA ACCRA 0233 Ghana Individual
COLLABORATORS
Name Street address City Postal code Country
PROFESSOR PERCY KHATHUTSHELO MASHIGE Block E, University of KwaZulu-Natal, Westville Campus Durban 4051 South Africa
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator BENJAMIN ABAIDOO benjamin_abaidoo@yahoo.com 0233277818746 UNIVERSITY OF GHANA MEDICAL SCHOOL, KORLE BU, ACCRA
City Postal code Country Position/Affiliation
ACCRA 0233 Ghana CHIEF RESEARCH ASSISTANT UNIVERSITY OF GHANA MEDICAL SCHOOL
Role Name Email Phone Street address
Public Enquiries DANIEL ANKRAH rdo@kbth.gov.gh 023303026 Institutional Review Board, Korle-Bu Teaching Hospital, Korle Bu, Accra
City Postal code Country Position/Affiliation
ACCRA 0233 Ghana Chairman of the Institutional Review Board Korle Bu Teaching Hospital
Role Name Email Phone Street address
Scientific Enquiries Percy Khathutshelo Mashige mashigek@ukzn.ac.za 0027312607986 Block E, University of KwaZulu-Natal, Westville Campus
City Postal code Country Position/Affiliation
Durban 0027 South Africa Professor University of KwaZulu Natal Westville Campus
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data sharing statement: 1. Data to be shared includes individual participant data that underlie the results reported in published articles, after de-identification (text, tables, figures, and appendices). 2. Other documents that will be available includes; study protocol, statistical analysis plan, analytic Code. 3. Data will be available immediately following publication, No end date. 4. Data will be shared with researchers who provide a methodologically sound proposal. 5. The types of analyses required will be analysis intended to achieve aims in the approved proposal. 6. Date will be made available to users when the request is directed to benjamin_abaidoo@yahoo.com. 7. Data requestors will need to sign a data access agreement which will be provided to them upon request. Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol Data will be available immediately following publication, No end date. Request for information about this trials is open to all interested persons. 1. The data should not be requested for commercial purposes. 2. Request should be for academic purposes. 3. The statistical analysis permitted for this trail data is sequential and meta analysis. 4. The purposes and justifications for the request should be well explained.
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