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.: PACTR202306542386770 Date of Approval: 05/06/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Implementation of a caregiver-led training program for caregivers of children with cerebral palsy in rural Malawi: A feasibility study
Official scientific title A feasibility randomised controlled trial comparing outcomes of a caregiver-led and a therapist-led training programme for caregivers of children with cerebral palsy in rural Malawi: A pilot study
Brief summary describing the background and objectives of the trial Sub-study: “Limited efficacy of a caregiver-led training programme for caregivers of children with cerebral palsy in a rural setting in Malawi” The pilot RCT is a second phase of an implementation study that is being conducted to assess the feasibility of implementing a caregiver-led training programme for caregivers of children with cerebral palsy. Cerebral Palsy (CP) is one of the most disabling conditions in children and requires lifelong comprehensive and consistent inputs of therapies. In Malawi, CP is very common, accounting for a quarter of all children with physical impairments. However, in Malawi and similar low-income countries, there is a critical shortage of rehabilitation professionals. In Malawi, the only cadre of rehabilitation professionals available is physiotherapists and the physiotherapist-population ratio is 0.8 per 100 000. As a result, children with CP receive inadequate therapy leading to severe disability and low quality of life for them and their families. Caregiver training is a key and crucial important aspect of rehab in low-resource setting to strengthen home programmes since contacts with therapists are limited. However, training caregivers is itself time consuming and therapists are unable to effectively manage this. There is a growing recognition of caregivers and the communities as a useful human resource that rightly engaged could help support the rehabilitation workforce and improve access to service. Several interventions are underway in several low resource settings mostly focussed on early identification and intervention of children with disabilities including CP. They include active engagement of caregivers in early identification exercises or aspects of interventions. Some key researchers have even recommended task shifting the role of caregiver training to trained caregivers coined “expert caregivers” to enhance authentic positive peer influences. Few of the current (ongoing) studies in Africa are investigating the involvement of caregivers as training facilitators (i.e., as a task-sharing/shifting strategy). Therefore, this study aims to determine the short-term effects of a caregiver-led training programme for caregivers of children with CP in a rural setting in Malawi. This will be in form of a pilot randomised controlled trial. Caregivers on one arm will be trained by “expert caregivers” and on the other arm caregivers will be trained by therapists. There will be three levels of outcome measurement: at the level of the caregiver, at the level of the child and then a comparison of outcomes between the control and the intervention group. Objective: 1. To determine the “limited efficacy” of a caregiver-led training programme on the knowledge, self-efficacy and quality of life of caregivers of children with CP in Namwera, Mangochi, Malawi. 2. To determine the “limited efficacy” of a caregiver-led training programme on the activity and participation levels of children with CP whose caregivers were trained in Namwera, Mangochi Malawi. 3. To compare training outcomes between caregivers of children with CP trained by “expert caregivers” and caregivers trained by therapists in Namwera, Mangochi Malawi.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Paediatrics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Education /Training
Anticipated trial start date 01/05/2023
Actual trial start date 15/05/2023
Anticipated date of last follow up 21/07/2023
Actual Last follow-up date 31/08/2023
Anticipated target sample size (number of participants) 80
Actual target sample size (number of participants) 83
Recruitment status Completed
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
Parallel: different groups receive different interventions at same time during study Randomised Stratified allocation where factors such as age, gender, center, or previous treatment are used in the stratification Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Delivery of the carer to carer training programme by a therapist Once a week Seven weeks It comprises seven workshops delivered by physiotherapists, each lasting between 2-2.5 hours. Each of the sessions includes ice-breaker activities that are based on themes of psychosocial support, a larger section of practical experiential demonstrations, and group discussions. Module one on what cerebral palsy is, its causes, and expected outcomes. Module two on looking at cerebral palsy as a way of life. Module three is on getting active and preparing the child's body, module four is on eating and feeding principles and techniques, module five is on communication, module six on play and its role in caregiving, module seven on understanding cerebral visual impairment The entire package and delivery model is the same as that of the experimental group. The only difference is that on this arm the intervention package is delivered by physiotherapists while in the experimental group the intervention package is delivered by "expert caregivers" The difference lies in "who" delivers the intervention and this is the fundamental essence of the trial 40 Active-Treatment of Control Group
Experimental Group Carer to Carer Training Programme once a week seven weeks It comprises seven workshops delivered by "expert caregivers" , each lasting between 2-2.5 hours. Each of the sessions includes ice-breaker activities that are based on themes of psychosocial support, a larger section of practical experiential demonstrations, and group discussions. Module one on what cerebral palsy is, its causes, and expected outcomes. Module two on looking at cerebral palsy as a way of life. Module three is on getting active and preparing the child's body, module four is on eating and feeding principles and techniques, module five is on communication, module six on play and its role in caregiving, module seven on understanding cerebral visual impairment The entire package and delivery model is the same as that of the control group. The only difference is that the intervention package on this arm is delivered by "expert caregivers" while in the control group the package is delivered by "physiotherapists" The difference lies in "who" delivers the intervention and that is the fundamental essence of the trial 40
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Primary caregiver Caregiver of a child with a confirmed diagnosis of cerebral palsy Unable to commit to a weekly participation 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 12/05/2023 Human Research Ethics Committee Medical
Ethics Committee Address
Street address City Postal code Country
Cnr Yord Road Parktown Johannesburg 2050 South Africa
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 28/09/2023 College of Medicine Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Mahatma Gandhi Road Blantyre 312225 Malawi
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Pediatric Quality of Life Family Impact Measure Baseline, which is before commencement of study and Endline which is after the seven week training and atleast a three week follow up period
Secondary Outcome Knowledge of cerebral palsy Baseline, which is before the beginning of the training intervention and at endline which is after the seven week-training and atleast a three week follow up period
Secondary Outcome Pediatric Evaluation of Disability Inventory which is before the beginning of the training intervention and at endline which is after the seven week-training and atleast a three week follow up period
Secondary Outcome Parent-reported Child Participation using the Child and Adolescent Scale of Participation which is before the beginning of the training intervention and at endline which is after the seven week-training and atleast a three week follow up period
Secondary Outcome Caregiver self efficacy which is before the beginning of the training intervention and at endline which is after the seven week-training and atleast a three week follow up period
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Tiyende Pamodzi Group in Namwera rural area in Mangochi district in the southern region of Malawi Not applicable Mangochi Malawi
FUNDING SOURCES
Name of source Street address City Postal code Country
The Consortium for Advanced Research Training in Africa Manga Off Kirawa Road Nairobi 00100 Kenya
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Consortium for Advanced Research Training in Africa Manga Close Off Kirawa Road Nairobi 00100 Kenya PhD fellowship
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Takondwa Bakuwa tbakuwa@kuhes.ac.mw 265993672960 Mahatma Gandhi Road
City Postal code Country Position/Affiliation
Blantyre 31222 Malawi Lecturer in department of rehabilitation at the Kamuzu University of Health Sciences and PhD student at the University of Witwatersrand
Role Name Email Phone Street address
Public Enquiries Natasha Chingoni nchingoni21@gmail.com 265993772244 Mahatma Gandhi
City Postal code Country Position/Affiliation
Blantyre 312225 Malawi Research Assistant
Role Name Email Phone Street address
Scientific Enquiries Wiedaad Slemming wiedaad.slemming@wits.ac.za 27720356281 St Andrews Road
City Postal code Country Position/Affiliation
Johannesburg 2193 South Africa Senior Lecturer in the department of Paediatrics and Child Health
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes De-identified data on the following: demographics and informed consent, level of knowledge on CP and self efficacy, self -reported quality of life and parent/caregiver-report on child activity and participation (questionnaire based) Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol The projected time for completion of data collection and analysis is September 2023. Data will be available from September 2023 to September 2025 Controlled access to raw (de-identified) data files and extracts per requirements of the data access commitees and research ethics committees at the academic institutions overseeing the research ( College of Medicine Research Ethics Committee at the Kamuzu University of Health Sciences in Malawi) and the ( Human Research Ethics Committee(medical) at the University of Witwatersrand in South Africa) Applicants seeking access to raw data should have ethical justification fo doing so and will be permitted upon review of request and approval by the ethical committees and also upon signing of data sharing agreements. Open access to published data and links to data collection tools will be made available though an open access journal.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes 16/08/2024
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 16/08/2024
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information