Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000364875
Ethics application status
Approved
Date submitted
19/01/2021
Date registered
31/03/2021
Date last updated
10/03/2022
Date data sharing statement initially provided
31/03/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
TEDI-Prem: Telehealth for Early Developmental Intervention
in babies born very preterm
Scientific title
The effect of telehealth for early intervention on neurodevelopmental outcomes of infants born very preterm and their parent’s well-being: a randomised controlled trial (TEDI-Prem)
Secondary ID [1] 303212 0
APP1199780
Universal Trial Number (UTN)
Trial acronym
TEDI-Prem
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Preterm birth 320353 0
motor impairment 320354 0
neurodevelopmental impairment 320355 0
maternal mental health 320356 0
cognitive impairment 320357 0
language impairment 320358 0
socio-emotional impairment 320359 0
Condition category
Condition code
Physical Medicine / Rehabilitation 318265 318265 0 0
Physiotherapy
Reproductive Health and Childbirth 318635 318635 0 0
Complications of newborn
Mental Health 318636 318636 0 0
Other mental health disorders
Physical Medicine / Rehabilitation 318637 318637 0 0
Occupational therapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Brief name: TEDI-Prem
Why: Infants in the intervention group will be treated through collaboration between a physiotherapist/occupational therapist and one (or both, if available) parent. The principles and goals of the intervention are related to the deficits commonly seen in infants born preterm, with large doses of practice to support postural control and learning, visual, motor, and object interactions. TEDI-Prem is designed to facilitate parents to promote sensorimotor exploration during play, following training and support over the first year of life beginning in the NICU and extending into the home based upon successful interventions.
What, where, when and how much: The intervention will be delivered in 3 phases:
Phase 1: 4 face-to-face, one-on-one, sessions in hospital for 30-45min. Topics will centre around understanding and responding to infant behaviour, promoting development through enhanced parent child interaction and demonstrating intervention activities. Toys will be used to facilitate motor, cognitive and language development with parents coached on appropriate interactions. If the infant is transferred to another hospital during the intervention, sessions will be delivered at the new hospital (if a participating study site) via telehealth or face-to-face. If the infant is discharged home or transferred to a non-participating hospital prior to completion of Phase 1, it will be delivered by telehealth.
Phase 2: 6 sessions, at home via telehealth, one-on-one, for 45-60min up to 6 months’ corrected age (CA) (0.25, 1, 2, 3, 4, 6 months’ CA). During these sessions, the therapist will coach the parent to deliver intervention activities with their infant for a minimum of 20 minutes per day, 5 times per week. Parents will be coached to establish a routine for developmental play, including recognising when their child is ready to interact socially and their child’s responses to interactions. Sessions will focus on advancing the parent-provided interventions with a focus on gross motor skills.
Phase 3: 3 sessions, at home via telehealth, one-on-one, for 45-60min, up to 12 months’ CA (8, 10, 11.5 months’ CA). Sessions will focus on integration into local services depending on the needs of the infant and family. Parents will be coached to establish a routine for developmental play, including different types of play (e.g. fine motor, language and cognitive).
All phases include psychosocial education and content to promote parental well-being and support parental mental health, and have been developed by a multidisciplinary team including psychologists. Further, parent/s will have access to a website (purpose built) which will contain study specific content on intervention activities and supplemental content to facilitate the sessions. The website will include short videos, information handouts and their home program. The website can be accessed at anytime throughout the program, with parents encouraged to view content during each TEDI-Prem session. The time needed to complete online content will be dependant on the family, with a minimum of 10 minutes for each session across all phases. Telehealth will include video-consults so that the therapist can see the infant and coach the parent/s on appropriate early intervention based upon the infant and family’s goals and needs.
Who provided: Physiotherapist/Occupational therapist who has completed training specific to delivering TEDI-Prem (which includes online modules and face-face training). These therapists will have >2 years experience in paediatrics.
Tailoring: the intervention has core principles which are individualised to the infant and family needs.
How well: To measure parent compliance with TEDI-Prem, at the beginning of each session the parent will be asked what has been successful since the last visit and whether there have been any challenges with delivering the intervention. Parents of infants in both groups will complete questionnaires on play positions to monitor whether they are implementing play throughout the day in a variety of positions as part of their intervention program for TEDI-Prem or as part of usual care. Access to other interventions, including discipline and dosage, will be assessed at baseline, 3, 6, 12, 18 and 24 months for both groups. Website analytics, including number of times and duration parents spend on the TEDI-Prem website will be collected for participants in the intervention group.
Fidelity of the therapists delivering TEDI-Prem will be assessed in a variety of ways. All therapists in this study will complete an on-line training module. Fidelity will be facilitated through regular staff meetings and audit of home programs and progression. Adherence of therapists to the intervention outlined in the study protocol will be assessed using three video-recorded sessions , one for Phase 1, one for Phase 2 and one for Phase 3 for each infant. Adherence will be measured by the frequency with which the intervention therapist demonstrates, talks about, or brainstorms with a parent about the TEDI-Prem key principles and strategies.
Intervention code [1] 319523 0
Rehabilitation
Intervention code [2] 319524 0
Prevention
Intervention code [3] 319525 0
Early detection / Screening
Comparator / control treatment
Infants enrolled in both groups will receive usual care in the neonatal nursery and community as it is unethical to withhold care. Typical services in the neonatal nursery include on-site access to paediatric allied health (social work support, physiotherapy, occupational, or speech therapy assessments (as per Defining levels of care for Victorian newborn services, 2015, page 13-15) and access to appropriate follow-up and referral to local early intervention programs as deemed necessary by the medical team.
Control group
Active

Outcomes
Primary outcome [1] 326248 0
Motor development: The Bayley Scales of Infant and Toddler Development- 4th Edition (Bayley-IV) total motor composite standard score
Timepoint [1] 326248 0
12 months’ corrected age
Secondary outcome [1] 390730 0
Cognitive development: The Bayley-IV Cognitive composite scores
Timepoint [1] 390730 0
12 and 24 months' corrected age
Secondary outcome [2] 390731 0
Language development: The Bayley-IV Language composite score and receptive and expressive scaled scores
Timepoint [2] 390731 0
12 and 24 months' corrected age
Secondary outcome [3] 390732 0
Motor development: The Bayley-IV Cognitive composite scores

Timepoint [3] 390732 0
24 months' corrected age
Secondary outcome [4] 390733 0
Behaviour development: The Infant Toddler Social Emotional Assessment (ITSEA)
Timepoint [4] 390733 0
12 and 24 months' corrected age
Secondary outcome [5] 390736 0
Infant quality of life: The Toddler and Infant Questionnaire (TANDI) completed by the primary caregiver

Timepoint [5] 390736 0
12 and 24 months’ corrected age
Secondary outcome [6] 390739 0
Primary caregiver depression and anxiety: The Depression Anxiety Stress Scales (DASS-21)
Timepoint [6] 390739 0
12 and 24 months' corrected age
Secondary outcome [7] 390740 0
Parenting self-efficacy: The Karitane Parenting Confidence Scale
Timepoint [7] 390740 0
12 and 24 months' corrected age
Secondary outcome [8] 390742 0
Primary Caregiver Quality of Life: The Short Form Assessment of Quality of Life (SF-6D)
Timepoint [8] 390742 0
12 and 24 months' corrected age
Secondary outcome [9] 390744 0
Parent-infant interaction: The Emotional Availability Scale (EAS)
Timepoint [9] 390744 0
12 and 24 months corrected age
Secondary outcome [10] 390746 0
Allied Health Utilisation: A purpose built questionnaire on access to allied health services, including discipline and frequency
Timepoint [10] 390746 0
Cumulative utilisation data from birth to 12 and 24 months corrected age will be assessed.
Secondary outcome [11] 390748 0
Cost-effectiveness: The cumulative costs of the TEDI-Prem program (training materials, delivering care, overheads) and downstream cost (health care, family productivity, and out-of-pocket) will be collected over the 24-month follow-up period from using a composite of questionnaires on access to allied health therapy and supplemented by Medicare linkage data.
Timepoint [11] 390748 0
12 and 24 months' corrected age
Secondary outcome [12] 390749 0
Measure of Process of Care: The Measure of processes of care (MPOC) to assess parent’s perceptions of the extent to which specific family centred behaviours or actions of health care professionals occur.
Timepoint [12] 390749 0
12 months' corrected age
Secondary outcome [13] 392024 0
Health Care Utilisation: Medicare linkage data from birth to 24 months’ CA will be collected.
Timepoint [13] 392024 0
Cumulative utilisation data from birth to 12 and 24 months corrected age will be assessed

Eligibility
Key inclusion criteria
Infants admitted to the nurseries at The Royal Women’s, Royal Children’s, Monash Children’s, Joan Kirner Women’s and Children’s and Northern Hospitals, Victoria, Australia who are:
• Born <32 weeks’ gestational age
• Medically stable and not ventilator-dependent at recruitment (minimum age for enrolment 34 weeks' and maximum 40 weeks’ postmenstrual age)
• Have one caregiver who speaks and can read English (as the web content and intervention materials are in English)
• Able to participate in early intervention program for a 12 month period

There is no age limit of parents/caregivers who are eligible for participation.
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Infants with a diagnosis of a congenital abnormality known to affect neurodevelopment, who require specific intervention such as infants with Trisomy 21.
• Infants who are planning to move overseas/interstate prior to primary outcome assessment at 12 months’ CA.
• Parent not wanting to engage in telehealth intervention.

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)
Allocation will be concealed as we are using a web-based randomisation program.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be computer generated using block randomisation with variable block sizes and stratified by site of recruitment and multiple birth. Infants from multiple births will be randomised to the same arm due to the nature of the intervention. Participating infants will be randomised to the TEDI-Prem intervention or standard care group in a 1:1 ratio, using web-based randomisation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The primary outcome is the Bayley-IV Motor Composite score at 12 months, which has a mean of 100 and standard deviation of 15. Whilst there is no reported minimum clinically important improvement on the Bayley-IV, a difference of 5 points represents a SMD of 1/3 between groups, and is considered clinically important and consistent with previous RCTs in the field that have changed clinical practice. In order to achieve 90% power to identify a SMD of 1/3 based on a two-sided t-test with a 5% significance level, we require 190 participants per group assuming that the observations are independent. Given that our sample will be children born <32 weeks we would expect approximately 20% to be multiple births. Assuming an intra-class correlation coefficient of 0.2 between multiple births, this equates to a design effect of 1.04, hence we need to recruit 198 per group to have 190 effective participants. Allowing for 15% loss to follow-up (conservative estimate – previous studies by our team have >90% follow-up), we aim to randomise a total of 466 infants over 30 months.

Differences between groups in the primary outcome will be examined using linear regression, fitted via generalised estimating equations to account for multiple births and adjusted for site.

Differences between groups in secondary outcomes will be examined using linear regression for continuous outcomes and logistic regression for binary outcomes. All models will be fitted via generalised estimating equations to account for multiple births and adjusted for site.

Cost-effectiveness will be presented as cost per quality-adjusted life year, taking both child and parent quality of life into account. Population projections will be made based on the trial results as if the trial were to be rolled out nationally to assist decision making and planning of care.

For subgroup analysis, regressions will be repeated using the relevant subgroup (i.e. social risk, gestational age, neurological diagnosis) as an interaction term.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/05/2021
Actual
17/01/2022
Date of last participant enrolment
Anticipated
31/10/2023
Actual
Date of last data collection
Anticipated
31/12/2025
Actual
Sample size
Target
466
Accrual to date
20
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 18460 0
The Royal Women's Hospital - Parkville
Recruitment hospital [2] 18461 0
The Royal Childrens Hospital - Parkville
Recruitment hospital [3] 18462 0
Monash Children’s Hospital - Clayton
Recruitment hospital [4] 18463 0
The Northern Hospital - Epping
Recruitment hospital [5] 18464 0
Western Hospital - Footscray - Footscray
Recruitment postcode(s) [1] 32570 0
3052 - Parkville
Recruitment postcode(s) [2] 32571 0
3168 - Clayton
Recruitment postcode(s) [3] 32572 0
3076 - Epping
Recruitment postcode(s) [4] 32573 0
3011 - Footscray

Funding & Sponsors
Funding source category [1] 307616 0
Government body
Name [1] 307616 0
Department of Health - Medical Research Future Fund
Country [1] 307616 0
Australia
Primary sponsor type
University
Name
The University of Melbourne
Address
161 Barry Street,
Parkville, Victoria, 3052
Country
Australia
Secondary sponsor category [1] 308310 0
None
Name [1] 308310 0
Address [1] 308310 0
Country [1] 308310 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307667 0
Royal Children's Hospital Melbourne Human Research Ethics Committee
Ethics committee address [1] 307667 0
Ethics committee country [1] 307667 0
Australia
Date submitted for ethics approval [1] 307667 0
26/10/2020
Approval date [1] 307667 0
20/11/2020
Ethics approval number [1] 307667 0
HREC/67604/RCHM-2020

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

Contacts
Principal investigator
Name 108066 0
Prof Alicia Spittle
Address 108066 0
The University of Melbourne
7th Floor Alan Gilbert Building
161 Barry Street, Parkville, Victoria, 3052
Country 108066 0
Australia
Phone 108066 0
+61413599862
Fax 108066 0
Email 108066 0
aspittle@unimelb.edu.au
Contact person for public queries
Name 108067 0
Alicia Spittle
Address 108067 0
The University of Melbourne
7th Floor Alan Gilbert Building
161 Barry Street, Parkville, Victoria, 3052
Country 108067 0
Australia
Phone 108067 0
+61 413599862
Fax 108067 0
Email 108067 0
aspittle@unimelb.edu.au
Contact person for scientific queries
Name 108068 0
Alicia Spittle
Address 108068 0
The University of Melbourne
7th Floor Alan Gilbert Building
161 Barry Street, Parkville, Victoria, 3052
Country 108068 0
Australia
Phone 108068 0
+61413599862
Fax 108068 0
Email 108068 0
aspittle@unimelb.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Consent not obtained from participants


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
11219Study protocol    Plan to publish study protocol in open access jour... [More Details]



Results publications and other study-related documents

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