Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000396729
Ethics application status
Approved
Date submitted
30/08/2021
Date registered
8/03/2022
Date last updated
17/04/2024
Date data sharing statement initially provided
8/03/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Sustainable Model of eARly Intervention and Tele-rehabilitation for children with Cerebral Palsy in rural Bangladesh (SMART CP) – a cluster randomized controlled trial
Scientific title
Effectiveness of a Sustainable Model of eARly Intervention and Tele-rehabilitation service to increase early intervention and rehabilitation service uptake among children with Cerebral Palsy in rural Bangladesh (SMART CP) – a cluster randomized controlled trial
Secondary ID [1] 305180 0
None
Universal Trial Number (UTN)
None
Trial acronym
SMART = Sustainable Model of eARly Intervention and Tele-rehabilitation
CP = Cerebral Palsy
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cerebral Palsy 323452 0
Condition category
Condition code
Neurological 321002 321002 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study will have two arms; one intervention arm (SMART CP model) and one control arm (care-as usual). The SMART CP model has been developed based on literature findings.

Intervention:
The SMART CP model will have three components a. Referral networks with Key Informants (KIs) and mPower (Mothers Power) groups b. SMART CP centre c. tele-rehabilitation service. The intervention will be provided over 12 months.

1. At village level-Primary Referral Network:

a. Key Informant (KIs): As part of the trial, local community volunteers (e.g. religious leaders, teachers, community health workers etc.) will be trained as KIs to identify children with CP from their community and act as a source of ongoing advocacy and referral. Led by CMs, the KIs will receive a day-long (5-6 hours) face-to-face workshop on the identification of children with suspected CP, disability sensitization, advocacy for a disability-inclusive society using flip charts, group work and role-play. Considering 1-2 KIs per village, this study will train around 1150 KIs. KIs will continue to screen for children with suspected CP and refer those children to sub-district level centre (i.e. SMART CP centre) over the trial period (12 months).

b. mPower (Mothers Power) groups: Each mPower group will be formed with 10 mothers of children with CP. These groups will meet on a weekly basis for 60 minutes to share information and experiences. The network will empower mothers/primary caregivers by enriching their knowledge about CP so that they can advocate for their child and facilitate the child’s participation at home, community, school and vocation. As part of this study, 48 mPower groups will be formed. The mPower group meetings will be arranged weekly over 12 months of the trial.

2. Sub-district level (SMART CP centre)– As part of the referral networks a sub-district level early diagnosis, early intervention and tele-rehabilitation service centre for children with CP will be established. Known as SMART CP centre, each facility will be equipped with basic physiotherapy equipment and staffed by a Diploma Physiotherapist (DP), a Community Rehabilitation Worker (CRW) and a Community Mobilizer (CM). The CRWs and CMs will be recruited locally and trained on early intervention protocol. Services at the centres will be made available for all children with CP at a nominal cost to make it sustainable. However, the cost of service will be waived up to 100% considering financial status of families of children with CP.

Each child recruited in the intervention arm will receive a 60-munites Goal Directed Training (GDT) session weekly at the SMART CP centres over 12 months. GDT is an activity-focused, goal-oriented and parents-led intervention. There will be four components of GDT;
(1) Goal selection: The GDT session will start with realistic and appropriately time-framed goals set up in collaboration with parents. Goals are basically some specific tasks that are needed for everyday life and which children with CP find challenging. These tasks could be gross motor, self-care, communication, play or school-based activities.
(2) Assessment: A detailed assessment will then be carried out to identify facilitating and limiting factors in achieving the goals. This will involve assessing the physical requirements of the selected task, the resources and equipment that are needed, and the settings in which the task is done.
(3) Intervention: Weekly GDT sessions will be conducted by CRWs under the supervision of DPs. The CRWs will guide parents/primary caregivers to scaffold the selected motor tasks so that the child could actively complete at least a part of the task. Parents will be encouraged to use their knowledge of their child’s play preferences to elicit self-generated motor activity. Additionally, the CMs will also assist parents to set up a motor-enriched play environment at home to promote the child’s self-generated movements, exploration, and task success during monthly home visits. Parents will be advised to practice through joyful play until the main goal is achieved.
(4) Outcome evaluation: CRWs will evaluate the adherence and compliance to the intervention by using attendance registers, checklists and probing questions (e.g. asking to demonstrate the interventions that s/he administered in last week) during GDT sessions and monthly home visits (by CMs). The extent to which a child’s goals are achieved will be monitored and recorded using a structured template.

3. Tele-rehabilitation- The SMART CP centres will be supported by a centralised tele-rehabilitation team including a trained Doctor, a Physiotherapist, a Speech Therapist and a Nutritionist. Each child recruited in the trial will receive a 30-minutes tele-rehabilitation session fortnightly over 12 months. The tele-rehabilitation team will oversee the services and interventions provided at the SMART CP centres and monitor the progression of interventions and outcomes. The first tele-rehabilitation session will be comprised of clinical assessment, goals setting and rehabilitation plan development for each child recruited in the trial. In the subsequent tele-rehabilitation sessions, the team will evaluate treatment progress and child’s goal attainments, make necessary amendments to the existing rehabilitation and guide DPs and CRWs to facilitate GDT.
Intervention code [1] 321578 0
Rehabilitation
Comparator / control treatment
The control arm will receive care as usual. Children with CP identified from control clusters will be provided basic education on early intervention and will be encouraged to access health care from locally available sources.
Control group
Active

Outcomes
Primary outcome [1] 328783 0
Change in service uptake: Proportion of children with CP attending the SMART CP centres and number of visits from intervention arm and control arm will be assessed the attendance register of SMART CP centres
Timepoint [1] 328783 0
At baseline (pre-enrolment) and endline (12 months post-enrolment)
Primary outcome [2] 329835 0
Change in service uptake: Number of visits to the SMART CP centres from intervention arm and control arm will be assessed using the attendance register of SMART CP centres
Timepoint [2] 329835 0
At baseline (pre-enrolment) and endline (12 months post-enrolment)
Secondary outcome [1] 400320 0
Number of children with CP identified: Total number of children with CP identified in intervention arm and control arm will be assessed by auditing the trial database.
Timepoint [1] 400320 0
At baseline (pre-enrolment)) and endline (12 months post-enrolment)
Secondary outcome [2] 400321 0
Age of CP diagnosis: The age of CP diagnosis among children with CP recruited at baseline and the age of CP diagnosis among the children with CP who will be referred to the SMART CP centres subsequently by primary referral networks (KIs and mPowers groups) will be compared between intervention and control arms. The age of CP diagnosis will be assessed by auditing the trial database.
Timepoint [2] 400321 0
At baseline (pre-enrolment) and endline (12 months post-enrolment)
Secondary outcome [3] 400322 0
Number of children with CP who received assistive devices: Access to assistive devices in children with CP recruited in intervention arm and control arm will be assessed by auditing the trial database.
Timepoint [3] 400322 0
At baseline (pre-enrolment) and endline (12 months post-enrolment)
Secondary outcome [4] 400324 0
Mortality rate among the identified children with CP: Number of children with CP died in intervention arm and control arm during the study period will be assessed by auditing the trial database.
Timepoint [4] 400324 0
At baseline (pre-enrolment) and endline (12 months post-enrolment)
Secondary outcome [5] 400325 0
Motor function: Motor function of children with CP recruited in intervention arm and control arm will be assessed by Gross Motor Function Classification System (GMFCS)
Timepoint [5] 400325 0
At baseline (pre-enrolment) and endline (12 months post-enrolment)
Secondary outcome [6] 400326 0
Nutritional status: Nutritional status of children with CP recruited in intervention arm and control arm will be measured by World Health Organization (WHO) standardised z scores
Timepoint [6] 400326 0
At baseline (pre-enrolment) and endline (12 months post-enrolment)
Secondary outcome [7] 404347 0
Stress, anxiety and depression of primary caregivers recruited in recruited in intervention arm and control arm will be assessed by Depression Anxiety and Stress Scale 21 (DASS-21)
Timepoint [7] 404347 0
At baseline (pre-enrolment) and endline (12 months post-enrolment)

Eligibility
Key inclusion criteria
1. Diagnosis of CP according to the Bangladesh CP Register and the Australian CP Register (ACPR)
2. Children with CP aged <18 years and mothers of children with CP
3. Capacity to give informed consent and willing to take part in the study
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Currently participating in another trial or intervention program
2. If there is any contraindication for GDT and rehabilitation therapy for children with CP

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The allocation of schedule will be concealed from potential participants and trial staff and investigators. The allocation of schedule will be computer generated by an Australia-based investigator.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The unit of randomization will be sub-districts and eight sub-districts will be grouped into homogeneous pairs considering socio-economic characteristics and prevalence of CP. From each pair, one intervention sub-district will be selected randomly using a computerised sequence generator, the remainder will serve as a control.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Intention-to-treat analysis will compare improvements in primary and other outcomes between groups controlling for baseline measures. To account for the intra-cluster correlation in calculating 95% Confidence Interval and p-value, we will use Sandwich estimate of standard error. Hypothesis testing will be done using appropriate statistical procedures based on the type of data. For example, a Chi-square test
will be used to measure the statistical difference between proportions of outcome among study arms. Baseline characteristics will be compared and adjusted using appropriate regression models. All analyses will be conducted using STATA 17 with the significance level set at p<0.05. Data manipulation and visualization will be done using R studio.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/04/2022
Actual
18/03/2022
Date of last participant enrolment
Anticipated
30/04/2022
Actual
30/07/2022
Date of last data collection
Anticipated
30/04/2023
Actual
15/09/2023
Sample size
Target
960
Accrual to date
Final
968
Recruitment outside Australia
Country [1] 24075 0
Bangladesh
State/province [1] 24075 0
Shahjdpur, Sirajganj, Rajshahi.

Funding & Sponsors
Funding source category [1] 309563 0
Charities/Societies/Foundations
Name [1] 309563 0
Cerebral Palsy Alliance
Country [1] 309563 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
CSF Global
Address
Flat B3, House 9, Road 2/1, Banani R/A, Dhaka-1213
Country
Bangladesh
Secondary sponsor category [1] 310564 0
None
Name [1] 310564 0
None
Address [1] 310564 0
None
Country [1] 310564 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309343 0
Human Research Ethics Committee of Asian Institute of Disability and Development
Ethics committee address [1] 309343 0
Ethics committee country [1] 309343 0
Bangladesh
Date submitted for ethics approval [1] 309343 0
11/02/2021
Approval date [1] 309343 0
08/04/2021
Ethics approval number [1] 309343 0
Southasia-hrec-2021-4-01
Ethics committee name [2] 310596 0
Bangladesh Medical Research Council
Ethics committee address [2] 310596 0
Ethics committee country [2] 310596 0
Bangladesh
Date submitted for ethics approval [2] 310596 0
20/09/2021
Approval date [2] 310596 0
30/01/2022
Ethics approval number [2] 310596 0
44020092021

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 113838 0
Prof Gulam Khandaker
Address 113838 0
Central Queensland Public Health Unit
Rural and District Wide Services | Central Queensland Hospital and Health Service | Queensland Government | 82-86 Bolsover Street Rockhampton QLD 4700
Country 113838 0
Australia
Phone 113838 0
+610749206948
Fax 113838 0
Email 113838 0
[email protected]
Contact person for public queries
Name 113839 0
Gulam Khandaker
Address 113839 0
Central Queensland Public Health Unit
Rural and District Wide Services | Central Queensland Hospital and Health Service | Queensland Government | 82-86 Bolsover Street Rockhampton QLD 4700
Country 113839 0
Australia
Phone 113839 0
+610749206948
Fax 113839 0
Email 113839 0
[email protected]
Contact person for scientific queries
Name 113840 0
Gulam Khandaker
Address 113840 0
Central Queensland Public Health Unit
Rural and District Wide Services | Central Queensland Hospital and Health Service | Queensland Government | 82-86 Bolsover Street Rockhampton QLD 4700
Country 113840 0
Australia
Phone 113840 0
+610749206948
Fax 113840 0
Email 113840 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
No participant data will be shared.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.