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.: PACTR202308767234235 Date of Approval: 25/08/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Impact Of Short Messaging Service (SMS)-Based Interventions on Medication Adherence Among Clinic Attendees at Risk of Stroke: A Randomized Controlled Trial
Official scientific title Clinical Efficacy of Short Messaging Service (SMS)-Facilitated Interventions for Enhancing Medication Adherence Among Individuals at Stroke Risk: A Prospective Randomized Controlled Trial"
Brief summary describing the background and objectives of the trial The major contributing factor to the development of stroke in hypertensive and diabetic patients is poor medication adherence. Stroke, also called cerebrovascular accident is the commonest preventable cause of long-term disability. Hypertension and diabetes mellitus are major modifiable risk factors for stroke. Prevention of stroke is much more economical and desirable than the management of its sequelae. Hence, the need for adequate health education on stroke prevention practices, identification and optimal control of risk factors The application of mobile technologies in healthcare (mHealth) is quite promising and has the potential to reduce healthcare costs, improve medication adherence and treatment outcomes via personalised health services and follow-up The objective of this study is to investigate the efficacy of short message service (SMS) based intervention in improving medication adherence in diabetic and hypertensive patients.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Cardiology,Circulatory System,Nervous System Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 28/08/2023
Actual trial start date
Anticipated date of last follow up 28/12/2023
Actual Last follow-up date
Anticipated target sample size (number of participants) 150
Actual target sample size (number of participants) 150
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
Single Group Randomised Simple randomization using a randomization table created by a computer software program Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Care giver/Provider
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group SMS Text Messages 3 Months Baseline (Pre-intervention) Recruitment of study participants will take place over 12 weeks during which prospective subjects will be screened using the eligibility criteria. With a sample size of 150 and a weekly clinic attendance of 30-40 with hypertension and/or diabetes, we anticipate that about 15 clinic attendees will consent to the study weekly. We expect that this sample size will be completed between 9-12 weeks of recruitment. Intervention Intervention group As an adjunct to the usual treatment in clinic, the intervention group will receive text messages through their personal cellphone twice daily for 12 weeks. The text messages would have been reviewed by experts in cardiology, endocrinology, neurology, psychiatry and pharmacy for quality assessment. The text messages will contain: ● reminders to take their medications ● information on lifestyle modification behaviour and stroke prevention practices ● counsel for patients to make clinic appointments. The intervention group will be encouraged to reply and make enquiries about their medical condition via the helpline through which the text will be sent. A token will be sent weekly as an incentive and to augment any costs 150
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
● Age ≥ 18 years old and able to give informed consent ● Documented clinical diagnosis of hypertension and/or diabetes mellitus being treated with a prescribed medication ● Ability to read and communicate in English language ● Possession of personal cell phone that patient has access to all times ● Ability to receive, comprehend and reply to an SMS in English ● Individuals who have had a stroke ● Biological impairment in reading or responding to SMS such as, but not limited to, loss of vision, visual field cuts, aphasia ● Individuals with a diagnosed organ dysfunction or malignancy ● Pregnant women ● Those who will not be available in Nigeria for follow-up for the next 12 weeks 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 07/03/2023 UIUCH Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Queen Elizabeth II Road Ibadan 200212 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome 1. To measure baseline and post-intervention medication adherence of study participants using a validated scale 2. To compare baseline and post-intervention mean medication adherence scores for the intervention and control groups 3 months after start of receiving SMS
Secondary Outcome Secondary Outcome 1. Stroke prevention knowledge and practices between clinic attendees who receive SMS based medication reminders and those who do not. 2. Difference in health-related quality of life (HRQOL), if any, between clinic attendees who receive SMS based medication reminders and those who do not. 3 months after start of receiving SMS
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
University College Hospital Queen Elizabeth II Road Ibadan 200212 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Royal Society of Tropical medicine and Hygiene in Collaboration with National Institute of Health Care Research High Holborn London .... United Kingdom
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Daniel Ehis Aigbonoga School of Nursing Road Ibadan 200212 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Daniel Aigbonoga aigbonogadaniel@gmail.com +2348162329757 School of Nursing Road
City Postal code Country Position/Affiliation
Ibadan 200212 Nigeria Member of College Research and Innovation Hub
Role Name Email Phone Street address
Scientific Enquiries Adesola Ogunniyi aogunniyi@com.ui.edu.ng +2348038094173 Queen Elizabeth II Road
City Postal code Country Position/Affiliation
Ibadan 200212 Nigeria Consultant University College Hospital
Role Name Email Phone Street address
Public Enquiries Oluwafemi Popoola oapopoola@com.ui.edu.ng +2348131733285 Queen Elizabeth II Road
City Postal code Country Position/Affiliation
Ibadan 200212 Nigeria University College Hospital
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual Participant Data (IPD) Sharing Statement: In accordance with the principles of transparency, scientific rigor, and ethical responsibility, my Organization, College Research and Innovation Hub, College of Medicine, university of Ibadan and my Research team is committed to facilitating the sharing of de-identified individual trial participant data (IPD) from our clinical trial titled Impact Of Short Messaging Service (SMS) Based Interventions On Medication Adherence Among Clinic Attendees At Risk Of Stroke: A Randomized Controlled Trial IPD Description: The IPD collected during the course of this clinical trial comprise a valuable resource that can contribute to the advancement of medical knowledge and patient care. These data include [brief description of the types of data collected, e.g., Biodata such as Hospital number, Age, Gender, Occupation, Marital status, Religion, Ethnic group, Phone number; Clinical information such as Medical condition (Hypertension, Diabetes), Family History, Co-morbidities, Risk factors (Smoking, Alcohol), Drug History, Morisky Medication Adherence (MMAS-8) score and Health related quality of life .Assessment of stroke prevention knowledge and practices among hypertensive and diabetic patients. Assessment of stroke free status using the "Questionnaire for verifying stroke-free status (QVSFS)". Our commitment to sharing IPD is guided by the belief that collaborative data sharing fosters scientific progress, enables independent verification of results, and promotes the development of innovative medical interventions. IPD Sharing Plan: 1. Data De-identification: Before sharing, all individual participant data will undergo a thorough de-identification process to remove any personally identifiable information (PII) in accordance with applicable data protection regulations and standards. 2. Data Availability: De-identified IPD will be made available to qualified researchers, investigators, and organizations upon request. Access wi Informed Consent Form,Study Protocol It will be available by the end of December 2023 Controlled request before publication of manuscript and open request after publication of manuscript
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