Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001580268
Ethics application status
Approved
Date submitted
2/07/2018
Date registered
24/09/2018
Date last updated
24/09/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Postnatal Support App for First Time Mothers about Maternal Self-Efficacy
Scientific title
A Randomised Controlled Trial of the Effectiveness of an APP-Based Postnatal Psychoeducational Program on maternal self-efficacy and depression in First Time Mothers
Secondary ID [1] 295065 0
Nil known
Universal Trial Number (UTN)
N/A
Trial acronym
N/A
Linked study record
N/A

Health condition
Health condition(s) or problem(s) studied:
Depression 308150 0
Anxiety 308904 0
Condition category
Condition code
Reproductive Health and Childbirth 307193 307193 0 0
Childbirth and postnatal care
Mental Health 307807 307807 0 0
Depression
Mental Health 307808 307808 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A two arm, non-blinded, randomised controlled trial with qualitative focus groups has been designed. The Intervention group will have access to the support for new mum’s application for 6 weeks post birth. Intervention groups will also receive standardised institutional postnatal care services.
The ‘Support for New Mums’ app has been developed in partnership with mental health, midwifery and child and family nursing experts, and postpartum women. It is an evidence based educational program aimed at improving first time mothers’ self-efficacy in newborn care, psychological well-being, and social support. The contents include information on newborn care, maternal self-care, and psychological challenges of the postpartum period such as the baby blues, postnatal depression, and rational and irrational thoughts. The information is presented using a variety of interactive media platforms including expert advice, online information, videos, journaling and user uploaded content, as well as weekly self-assessments.
The participants will be asked to access the app daily for six weeks. All the components and information in the app will be available to participants from the beginning of the study, and the participants decide which information to access based on their individual needs.
Participants adherence will be examined weekly by the research team using google analytics. Participants not engaging with the app for the week will be contacted by teephone or email to discuss any issues pertaining to adherence.
Phone and email support will be available as needed for the entire duration of the study.
Intervention code [1] 301438 0
Behaviour
Intervention code [2] 301705 0
Lifestyle
Comparator / control treatment
The intervention group accesses the smartphone app after baseline survey, and
technical support will be available as needed to participants. Both intervention and control group will receive standardised institutional postnatal care services. The follow services are available for participants to access in the region: hospital based midwifery home visiting program, hospital based postnatal clinic open four hours per week, lactation consultant clinic available one day per week and community based child and family health nursing services. The control group can access the app after the 6 month post-partum follow up.
Control group
Active

Outcomes
Primary outcome [1] 306548 0
Self-efficacy:
The revised Perceived Maternal Parental Self-Efficacy instrument (PMPS-E) will be used to measure maternal self-efficacy in newborn care. The PMPS-E is a 17-item instrument measuring self-efficacy of mothers performing the tasks associated with newborn care. Each item is rated on a four-point Likert scale. This instrument has been widely used in measuring maternal self-efficacy with internal consistency of 0.91.
Timepoint [1] 306548 0
At baseline (first postnatal week), 6 weeks postpartum (primary timepoint), 3 months postpartum and 6 months postpartum
Primary outcome [2] 306549 0
Depression:
The Edinburgh Postnatal Depression Scale (EPDS) which contains 10 items has been widely used to measure postnatal depression. The recommended cut off of 12 or 13 is used for screening probable cases of postnatal depression. The sensitivity of EPDS ranged from 68-80% with specificity 77%.
Timepoint [2] 306549 0
At baseline (first postnatal week), 6 weeks postpartum (primary timepoint), 3 months postpartum and 6 months postpartum
Secondary outcome [1] 348840 0
Anxiety:
The anxiety Hospital Anxiety and Depression Scale (HADS-A) will be used to measure mothers’ level of anxiety. HADS is one of the most commonly used and well-validated tools used to assess depression and anxiety symptoms, and has also been used to measure perinatal anxiety. Each item is rated using a Likert scale with a score from 0 to 3. The determination of the presence of anxiety or depressive symptoms requires a minimum score of 8/21 within the respective domains. The HADS has been validated among pregnant women with a sensitivity and specificity of 93% and 90%, respectively, for the anxiety subscale.
Timepoint [1] 348840 0
At baseline (first postnatal week), 6 weeks postpartum, 3 months postpartum and 6 months postpartum
Secondary outcome [2] 348841 0
Social support:
The perinatal infant social support scale is comprised of a 16-item Functional Social Support Measuring Scale (FSSMS) and 9-item Structural Social Support Measuring Scale (SSSMS), which contains 9-item questions measuring structural dimension of an individual’s social network with internal consistency of 0.80
Timepoint [2] 348841 0
At baseline (first postnatal week), 6 weeks postpartum, 3 months postpartum and 6 months postpartum
Secondary outcome [3] 348842 0
Maternal satisfaction:
The confidence in newborn care and postpartum care subscales of the Care in Obstetrics Measure for Testing Satisfaction (COMFORTS) scale will be used to assess mothers’ self-reported level of confidence and satisfaction with postnatal and infant care. The modified COMFORTS scale is comprised of 18 items with each rated using a 5 point Likert scale with a score from 1 to 5.
Timepoint [3] 348842 0
At baseline (first postnatal week), 6 weeks postpartum, 3 months postpartum and 6 months postpartum
Secondary outcome [4] 348843 0
Service utilisation and expenditure:
This is a composite secondary outcome measured by Healthcare Services Utilisation and Program-related Expenses Questionnaire (HSUPES) which is a participant self-reported questionnaire that will be used to capture the costs (e.g. costs related to health care services used by the postnatal mother related to maternal and infant health issues such as hospital admissions and outpatient contacts, health professional’s time; program related costs) at T2, T3 & T4. The study will take an “all-payer’ perspective, which means it will attempt to capture all resources which are used by the participants, regardless of who the payer is (e.g., government or consumer), as well as the program cost.
Timepoint [4] 348843 0
At 6 weeks postpartum, 3 months postpartum and 6 months postpartum
Secondary outcome [5] 352085 0
Experience of using "Support for New Mum" smartphone app
Participants within the intervention group will additionally be invited to participate in a focus group or individual interview to discuss their experience of the intervention.
Timepoint [5] 352085 0
At 3 months postpartum

Eligibility
Key inclusion criteria
The inclusion criteria is as follows;
• Aged18 years of age or older
• Ability to provide valid, informed consent
• Fluent in written and oral English language
• Be within the first 7 days postnatal
• Have personal ownership of a smartphone or device
• Have a valid email address and access to the internet
• Women who do not have a pre-existing pre-pregnancy or perinatal mental health disorder, specifically women with an 'Antenatal' Edinburgh Postnatal Depression Score of greater than or equal to a score of 13 (as this indicates that women may be at risk of perinatal depression)
• Any mode of birth (vaginal, instrumental or caesarean section)
• Birth of a live singleton infant (no multiples).
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
• Women not meeting any of the above inclusion criteria including women who have had pre-term infants (birth less than 37 weeks gestation) or gave birth to multiples (twins or triplets or more).
• Women who have infants admitted to Special Care Nursery (SCN) or Neonatal Intensive Care Unit (NICU) in the first 7 days following birth
• Infants that have congenital abnormalities or conditions

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)
Both experimental (quantitative) and descriptive (qualitative) methods will be employed.
A non-blinded, randomised controlled trial with a two-group pre-test and repeated post-tests design will be used. First-time mothers (primaparous women) will be randomly assigned into the control group who will receive standardised hospital and or community postnatal care services. This may consist of home visits, phone or follow up contact by midwives and or child and family health nursing services.
The control group will be asked to complete a suite project surveys at baseline, six weeks, three months and six months after enrolment in the study. The intervention group will receive usual facility based postnatal discharge maternity care and will additionally be provided with access to the "Support for New Mums" smartphone application at no cost for 6 weeks (standard defined postnatal time period). Women in the intervention group will also undertake project surveys at baseline, six weeks, three months and 6 months after enrolment in the study. Participants within the intervention group will additionally be invited to participate in a focus group or individual interview to discuss their experience of the intervention. The active study participant phase is from the first week post birth to six months post birth.
The randomisation allocation will be generated by the computer driven algorithm.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
After confirming the eligibility criteria and obtaining consent of participation, women recruited from each site will be randomised into intervention and control groups. Computer randomisation software will be used for the randomisation procedure with the assistance of the Clinical Research Design and Stats Support Unit at the Hunter Medical Research Institute. The RA will be responsible for notifying women of their group allocation.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Nill
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
An intention to treat analysis will be conducted including withdrawals and losses to follow up. Descriptive statistics for the primary and secondary outcome variables will be calculated. Continuous outcome variables will be evaluated for normality and transformations will be applied as necessary. Analysis of Variance (ANOVA) and Regression analysis with adjustments for confounding variables and with relative risk and 95% confidence intervals will be calculated for the primary outcomes. Significance will be set at 0.05. Data will be analysed in a Statistical Package such as for the Social Sciences (SPSS) or Stata data analysis and statistical software with the assistance of the Clinical Research Design and Stats Support Unit at the Hunter Medical Research Institute. All qualitative data will be combined for the purposes of analysis. Qualitative data analysis will follow a simple qualitative descriptive approach. Qualitative descriptive analysis uses an inductive approach to draw conclusions and develop descriptive themes.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
27/09/2018
Actual
Date of last participant enrolment
Anticipated
30/06/2020
Actual
Date of last data collection
Anticipated
31/12/2020
Actual
Sample size
Target
174
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 11298 0
Port Macquarie Base Hospital - Port Macquarie
Recruitment postcode(s) [1] 23187 0
2444 - Port Macquarie

Funding & Sponsors
Funding source category [1] 299647 0
Government body
Name [1] 299647 0
Mid North Coast Local Health District Research Support Grant
Country [1] 299647 0
Australia
Funding source category [2] 299983 0
Other Collaborative groups
Name [2] 299983 0
Hunter Medical Research Institute
Country [2] 299983 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Hunter Medical Research Institute
Address
Lot 1, Kookaburra Circuit
New Lambton Heights NSW
2035
Country
Australia
Secondary sponsor category [1] 298975 0
Government body
Name [1] 298975 0
Mid North Coast Local Health District
Address [1] 298975 0
Morton Street
Port Macquarie NSW
2444
Country [1] 298975 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300546 0
Hunter New England Human Research Ethics Committee [EC00403]
Ethics committee address [1] 300546 0
Locked Bag No.1
New Lambton NSW
2305
Ethics committee country [1] 300546 0
Australia
Date submitted for ethics approval [1] 300546 0
11/08/2017
Approval date [1] 300546 0
24/04/2018
Ethics approval number [1] 300546 0
17/08/16/4.09

Summary
Brief summary
The aim of this pilot feasibility study is to test the efficiency of the Support for New Mums smartphone application (app) on maternal self-efficacy, psychological well-being, social support and maternal satisfaction from hospital discharge to 6 months post birth. The cost-effectiveness of the intervention will also be evaluated as compared to routine postnatal care.
Trial website
Nill
Trial related presentations / publications
Nill
Public notes
Nill

Contacts
Principal investigator
Name 84014 0
Prof Sally Chan
Address 84014 0
School of Nursing and Midwifery
The University of Newcastle
University Drive, Callaghan NSW
2308
Country 84014 0
Australia
Phone 84014 0
+61 2 4921 6770
Fax 84014 0
Email 84014 0
[email protected]
Contact person for public queries
Name 84015 0
Prof Sally Chan
Address 84015 0
School of Nursing and Midwifery
The University of Newcastle
University Drive, Callaghan NSW
2308
Country 84015 0
Australia
Phone 84015 0
+61 2 4921 6770
Fax 84015 0
Email 84015 0
[email protected]
Contact person for scientific queries
Name 84016 0
Prof Sally Chan
Address 84016 0
School of Nursing and Midwifery
The University of Newcastle
University Drive, Callaghan NSW
2308
Country 84016 0
Australia
Phone 84016 0
+61 2 4921 6770
Fax 84016 0
Email 84016 0
[email protected]

No information has been provided regarding IPD availability


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.