Trial Review

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12623000957695
Ethics application status
Approved
Date submitted
7/08/2023
Date registered
4/09/2023
Date last updated
4/09/2023
Date data sharing statement initially provided
4/09/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Digitally supported repeated remote training for district healthcare providers targeting early essential newborn care skills: A pilot cluster randomised trial in Lao People's Democratic Republic (PDR)
Scientific title
Efficacy of digitally supported repeated remote training for district healthcare providers targeting early essential newborn care skills: A pilot cluster randomised trial in Lao PDR
Secondary ID [1] 310312 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Newborn care 331029 0
Condition category
Condition code
Public Health 327823 327823 0 0
Health service research
Reproductive Health and Childbirth 327921 327921 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Both groups will receive the initial Early Essential Newborn Care (EENC) coaching provided by provincial facilitators. This is a two-day coaching session that includes inductive lectures, practical exercises, and knowledge and skill assessments on the management of breathing and non-breathing babies.

After the initial coaching, participating district healthcare providers in the intervention group will:
• Receive an explanation of how to implement self-practice and receive mobile-based supportive supervision.
• Join a group social networking service (SNS) via WhatsApp to share videos with central and provincial facilitators,
• Conduct bi-weekly practice on the EENC (management of breathing and non-breathing babies) using mannikins alongside their clinical duties for three months. There is no minimum or maximum duration for each practice.
• Send videos of their performance during the practice sessions to provincial facilitators bi-weekly, using the SNS. The SNS service will be available for 3 months.
• Receive feedback from provincial facilitators via the group SNS.
• Recieve bi-weekly automated message reminders to repeat the above process.

As central facilitators are also members of this group, they can also provide individual feedback to the provincial facilitators, regarding the comments they provided to district staff.
A study-specific self-report questionnaire will be sent to district staff and facilitators bi-weekly to monitor adherence to the intervention, and WhatsApp logs will be reviewed to ensure regular interaction within the SNS,
Intervention code [1] 326693 0
Behaviour
Intervention code [2] 326796 0
Treatment: Other
Comparator / control treatment
Both groups will receive the initial EENC coaching provided by provincial facilitators. This is a two-day coaching session that includes inductive lectures, practical exercises, and knowledge and skill assessments on the management of breathing and non-breathing babies. The control group will not receive any additional training interventions after completion of the EENC training.
Control group
Active

Outcomes
Primary outcome [1] 335673 0
The potential effectiveness of the intervention regarding knowledge of essential newborn care amongst district healthcare providers. A written test that has been developed by World Health Organization Western Pacific Region for the EENC coaching will be used (EENC module 2-coaching for the first embrace- facilitator's guide, Pre- and post-coaching assessments).
Timepoint [1] 335673 0
3 months post-baseline
Primary outcome [2] 335773 0
The potential effectiveness of the intervention regarding skill level in essential newborn care amongst district healthcare providers. A skill test that has been developed by World Health Organization Western Pacific Region for the EENC coaching will be used (EENC module 2-coaching for the first embrace- facilitator's guide, Observational checklists for breathing and non-breathing babies).
Timepoint [2] 335773 0
3 months post-baseline
Secondary outcome [1] 425152 0
Percentage of healthcare providers at each district hospital who performed the self-practice every two weeks. It will be assessed by the audit of WhatsApp logs.
Timepoint [1] 425152 0
3 months post-baseline
Secondary outcome [2] 425552 0
Resources required in the intervention group will be collected every two weeks using a study-specific questionnaire. The interview will also be conducted at 3 months post-baseline to collect resources used for the intervention at each facility. The interview will be conducted in a focus group discussion (FGD) format using a semi-structured, study-specific questionnaire. The FGD will be conducted by a member of the research team. The approximate duration of each FGD will be 90 minutes. The FGD will be audio recorded.
Timepoint [2] 425552 0
3 months post-baseline
Secondary outcome [3] 425553 0
Enablers of the intervention
It will be collected through interviews. The interview will be conducted at 3 months post-baseline to collect resources used for the intervention at each facility. The interview will be conducted in a focus group discussion (FGD) format using a semi-structured, study-specific questionnaire. The FGD will be conducted by a member of the research team. The approximate duration of each FGD will be 90 minutes. The FGD will be audio recorded.
Timepoint [3] 425553 0
3 months post-baseline
Secondary outcome [4] 425896 0
Number of video recordings that contain whole procedure for management of breathing and non-breathing baby, uploaded by each healthcare provider. It will be assessed by the audit of WhatsApp logs
Timepoint [4] 425896 0
3 months post-baseline
Secondary outcome [5] 425897 0
Number of video recordings that received feedback by a provincial facilitator. It will be assessed by the audit of WhatsApp logs.
Timepoint [5] 425897 0
3 months post-baseline
Secondary outcome [6] 425898 0
Number of interactions happened between facilitators and district participants in the social-networking group. It will be assessed by the audit of WhatsApp logs
Timepoint [6] 425898 0
3 months post-baseline
Secondary outcome [7] 425899 0
Acceptability of the intervention
It will be collected through interviews. The interview will be conducted at 3 months post-baseline to collect resources used for the intervention at each facility. The interview will be conducted in a focus group discussion (FGD) format using a semi-structured, study-specific questionnaire. The FGD will be conducted by a member of the research team. The approximate duration of each FGD will be 90 minutes. The FGD will be audio recorded.
Timepoint [7] 425899 0
3 months post-baseline
Secondary outcome [8] 425900 0
Perceived effectiveness of the intervention,
It will be collected through interviews. The interview will be conducted at 3 months post-baseline to collect resources used for the intervention at each facility. The interview will be conducted in a focus group discussion (FGD) format using a semi-structured, study-specific questionnaire. The FGD will be conducted by a member of the research team. The approximate duration of each FGD will be 90 minutes. The FGD will be audio recorded.
Timepoint [8] 425900 0
3 months post-baseline
Secondary outcome [9] 425901 0
Barriers to implementation
It will be collected through interviews. The interview will be conducted at 3 months post-baseline to collect resources used for the intervention at each facility. The interview will be conducted in a focus group discussion (FGD) format using a semi-structured, study-specific questionnaire. The FGD will be conducted by a member of the research team. The approximate duration of each FGD will be 90 minutes. The FGD will be audio recorded.
Timepoint [9] 425901 0
3 months post-baseline

Eligibility
Key inclusion criteria
Healthcare providers who are responsible for providing newborn care, who have attended the initial EENC coaching and who can be present throughout the study period.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
No exclusion criteria.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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 sample size was determined based on the feasibility of the pilot study. As this is a pilot trial of a novel intervention, it is not powered to detect a definitive difference in the primary outcomes.

The pilot study will include 4 clusters (district hospitals). We expect to recruit all health care providers from each of the 4 district hospitals (the number varied from 12 to 14), 53 in total. In a cluster randomised design, the effect size that can be detected with this sample size would be 1.7 with a cluster size of 13, number of clusters in each group of 2 and inter-cluster correlation of 0.08. The standard deviation of the skill test in the previous study was 5.6 so the trial would be able to detect a difference of 9.5 points in the skill score (out of a total score of 62) with a two-sided type I error rate of 5% and 80% power.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
2/10/2023
Actual
Date of last participant enrolment
Anticipated
30/10/2023
Actual
Date of last data collection
Anticipated
29/01/2024
Actual
Sample size
Target
53
Accrual to date
Final
Recruitment outside Australia
Country [1] 25694 0
Lao People's Democratic Republic
State/province [1] 25694 0
Huaphanh and Khammouan provinces

Funding & Sponsors
Funding source category [1] 314522 0
Government body
Name [1] 314522 0
Japan Society for the Promotion of Science
Country [1] 314522 0
Japan
Primary sponsor type
Other Collaborative groups
Name
Burnet
Address
85 Commercial Rd, Melbourne VIC 3004
Country
Australia
Secondary sponsor category [1] 316469 0
Hospital
Name [1] 316469 0
Mahosot Hospital
Address [1] 316469 0
Quai Fa Ngum,Vientiane, Lao PDR
Country [1] 316469 0
Lao People's Democratic Republic

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313563 0
Alfred Hospital Ethics Committee
Ethics committee address [1] 313563 0
Ethics committee country [1] 313563 0
Australia
Date submitted for ethics approval [1] 313563 0
13/07/2023
Approval date [1] 313563 0
01/08/2023
Ethics approval number [1] 313563 0
415/23

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

Contacts
Principal investigator
Name 128562 0
Dr Sayaka Horiuchi
Address 128562 0
1. Burnet Institute
85 Commercial Rd, Melbourne VIC 3004

2. University of Yamanashi
1110, Shimokato, Chuo-shi, Yamanashi, Japan
Country 128562 0
Australia
Phone 128562 0
+61 421829124
Fax 128562 0
Email 128562 0
[email protected]
Contact person for public queries
Name 128563 0
Sayaka Horiuchi
Address 128563 0
1. Burnet Institute
85 Commercial Rd, Melbourne VIC 3004

2. University of Yamanashi
1110, Shimokato, Chuo-shi, Yamanashi, Japan
Country 128563 0
Australia
Phone 128563 0
+61 421829124
Fax 128563 0
Email 128563 0
[email protected]
Contact person for scientific queries
Name 128564 0
Sayaka Horiuchi
Address 128564 0
1. Burnet Institute
85 Commercial Rd, Melbourne VIC 3004

2. University of Yamanashi
1110, Shimokato, Chuo-shi, Yamanashi, Japan
Country 128564 0
Australia
Phone 128564 0
+61 421829124
Fax 128564 0
Email 128564 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
Due to the limited number of participants in the study, we are not going to share individual data to avoid the risk of identification.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
19937Ethical approval  [email protected] 386376-(Uploaded-07-08-2023-10-09-37)-Study-related document.pdf



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.