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.: PACTR202407526791115 Date of Approval: 31/07/2024
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Feasibility of a mHealth intervention among stroke caregivers
Official scientific title Feasibility of a mHealth intervention among stroke caregivers: Protocol for a pilot randomized controlled trial
Brief summary describing the background and objectives of the trial Caregivers play an important role in the rehabilitation of stroke patients. The sudden onset and protracted nature of stroke may lead to significant psychological distress for patients and their caregivers. An association exists between caregivers’ distress and patients’ outcomes. In West Africa, the healthcare system is overwhelmed by limited manpower and material resources. Despite the proliferation of mobile technology, its application in alleviating caregivers’ distress in low- and middle-income countries is still developing. Aim: To assess the feasibility of reducing the psychological distress of caregivers of stroke patients through a phone-based intervention in Nigeria and Ghana.
Type of trial Non-Randomised
Acronym (If the trial has an acronym then please provide) COPE
Disease(s) or condition(s) being studied Circulatory System,Mental and Behavioural Disorders,Nervous System Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Early detection /Screening
Anticipated trial start date 18/07/2024
Actual trial start date 24/07/2024
Anticipated date of last follow up 30/10/2024
Actual Last follow-up date 22/11/2024
Anticipated target sample size (number of participants) 268
Actual target sample size (number of participants) 260
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Non-randomised Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group standard of care and general information monthly three months short text messages 123 Placebo
Experimental Group PHONE CALLS AND SHORT TEXT MESSAGES MONTHLY 3 MONTHS A pre-post design will be used to test the feasibility of the intervention as described above. Fifty individuals per site will be selected to participate in the intervention. The intervention will be delivered through phone calls and text messages. The initial survey conducted in phase one will serve as the pre-intervention or baseline data for the participants recruited to participate in this study. The intervention will last for twelve weeks. 100
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Inclusion criteria: the inclusion criteria for participants will include: 1. Caregivers of patients with a confirmed diagnosis of stroke for at least a month 2. All unpaid primary caregivers of stroke patients aged 18-60 years 3. Caregivers who visit the outpatient department with their patient 4. Should have provided care for at least 1 month Exclusion criteria: the exclusion criteria for participants will include: 1. Caregivers of patients too ill to participate in a study 2. Caregivers who cannot provide consent 3. Caregivers with a history of psychiatric illness 4. Caregivers who do not have mobile phones Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 65 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 17/03/2024 University of Ilorin Teaching Hospital health research ethics committee
Ethics Committee Address
Street address City Postal code Country
241102, Old Jebba Road, Oke Ose, Ilorin, Kwara State, Nigeria ILORIN 241102 Nigeria
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 06/06/2024 KORLE BU TEACHING HOSPITAL SCIENTIC AND TECHNICAL COMMITTEE
Ethics Committee Address
Street address City Postal code Country
Guggisberg Ave, Accra, Ghana ACCRA GA104 Ghana
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome ● Primary outcomes for this study are: o Reduction in Psychological distress among caregivers of stroke patients at 12 weeks from onset of intervention o Recruitment yield for psychologically distressed caregivers o Acceptability of the intervention o Retention at 12th week and 16th week o Estimation of sample size to inform an RCT monthly after the intervention
Secondary Outcome • ● Secondary outcomes for this study include: o Reduction in Psychological distress among caregivers of stroke patients at 16 weeks from onset of intervention. o Improved coping strategies among caregivers of stroke patients at 12 weeks from onset of intervention. o Improved coping strategies among caregivers of stroke patients at 16 weeks from onset of intervention. monthly after the intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
UNIVERSITY OF ILORIN TEACHING HOSPITAL 241102 Old Jebba Road, Oke Ose, Ilorin, Kwara State, Nigeria Ilorin Kwara state 241102 Nigeria
Korle bu teaching Hospital Guggisberg Ave, Accra, Ghana Accra Ghana GA107 Ghana
FUNDING SOURCES
Name of source Street address City Postal code Country
NEW YORK UNIVERSITY SCHOOL OF MEDICINE 550 1st Ave., New York, NY 10016, New York NY 10016 United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor NYU School of Global Public Health NYU School of Global Public Health 708 Broadway New York, NY 10003 New York NY 10003 United States of America University
COLLABORATORS
Name Street address City Postal code Country
Busola Ogunmodede 241102, University of Ilorin teaching hospital, Nigeria Ilorin 241102 Nigeria
Emmanuel Adebayo Oduduwa Road, Ibadan 200132, Oyo, University of Ibadan, Nigeria Ibadan 200132 Nigeria
ANAS ISMAIL Bayero University, Gwarzo road, Kano, Nigeria Kano 7001 Nigeria
Emmauella Tagoe Accra, Korle Bu Teaching Hospital, Ghana Accra GA-029-42 Ghana
Aba Folson , Greater Accra Regional Hospital, Ghana Accra GP 473 Ghana
Tayo Bamidele 1032 W Sheridan Rd, Chicago, IL 60660, United States, Layola University, USA Chicago IL 60660 United States of America
Adesola Ogunniyi University of Ibadan, Ibadan Nigeria IBADAN 200132 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator ANAS ISMAIL aismail.rad@buk.edu.ng +2348039275786 Bayero University, Kano, Nigeria
City Postal code Country Position/Affiliation
Kano 70001 Nigeria Professor of Radiology Bayero University Kano Nigeria
Role Name Email Phone Street address
Scientific Enquiries Busola Ogunmodede busolajane@yahoo.com +2348137875019 Old Jebba Road, Oke Ose, Ilorin, Kwara State, Nigeria
City Postal code Country Position/Affiliation
Ilorin 240243 Nigeria Consultant Psychiatrist
Role Name Email Phone Street address
Public Enquiries EMMANUELLA Tagoe drendtagoe@gmail.com +233242282573 Guggisberg Ave, Accra, Ghana
City Postal code Country Position/Affiliation
ACCRA GA-221-15 Ghana SPECIALIST PHYSICIAN
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Example IPD Sharing Statement Title of the Study: [Feasibility of a mHealth intervention among stroke caregivers] Principal Investigator(s): • Busola Ogunmodede, University of Ilorin, Nigeria • Emmanuel Adebayo, University of Ibadan, Nigeria • Anas Ismail, Department of Radiology, Bayero University, Kano, Nigeria • Emmauella Tagoe, Korle Bu Teaching Hospital, Ghana • Aba Folson, Greater Accra Regional Hospital, Ghana • Tayo Bamidele, Layola University, USA • Adesola Ogunniyi, University of Ibadan, Ibadan Nigeria Contact Information: [Dr ANAS ISMAIL, Department of Radiology, Bayero University, Kano, Nigeria. Email: aismail.rad@buk.edu.ng. Telephone: +2348039275786] 1. IPD Sharing Statement: • Will IPD be shared? Yes • What IPD will be shared? De-identified participant data and statistical analysis results. • With whom will the data be shared? Researchers (upon request). • By what mechanism will the data be made available? (data repository, upon request, within a secure data enclave). 2. Conditions for Data Sharing: • Data Use Agreement (DUA): A DUA may be required, outlining the terms and conditions for data use, including confidentiality and data protection measures. • Ethical Approval: Data sharing will be subject to obtaining ethical approval where necessary. • Request Process: Describe the process for requesting the data, including any forms or documentation required. Timeline for Data Availability: • When will the data be available? Data will be available six months after publication of the main study findings. • How long will the data be available? Data will be available for five years following the initial release. 4Additional Information: • Data Security Measures: Data will be stored in an encrypted format and access will be granted through secure login credentials. • Potential Limitations: Sensitive health information will be excluded from the shared dataset to protect participant privacy. Contact Information for Data Requests: • Dr. Anas Ismail, Email: a Informed Consent Form,Study Protocol 10-12 months will be provided on request
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