UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063470 |
|---|---|
| Receipt number | R000071819 |
| Scientific Title | A Cluster Randomized Controlled Trial to Evaluate the Effect of a Smartphone Application for Obstetric Healthcare Providers on the Mental Health of Obstetric Healthcare Providers and Postnatal Mothers in Tanzania |
| Date of disclosure of the study information | 2026/10/30 |
| Last modified on | 2026/10/29 22:55:46 |
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Basic information
Public title
Evaluation of a Smartphone Application for Postnatal Care and Mental Health Support for Maternity Healthcare Providers and Mothers in Tanzania
Acronym
Tanzania Postnatal Care App Study
Scientific Title
A Cluster Randomized Controlled Trial to Evaluate the Effect of a Smartphone Application for Obstetric Healthcare Providers on the Mental Health of Obstetric Healthcare Providers and Postnatal Mothers in Tanzania
Scientific Title:Acronym
Tanzania Postnatal Care App Study
Region
| Africa |
Condition
Condition
Postnatal care attendance and mental health of maternity healthcare providers and postpartum mothers
Classification by specialty
| Obstetrics and Gynecology | Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to evaluate the effects of a mobile application for healthcare providers on the mental health of healthcare providers, postnatal care attendance, the mental health of postpartum women, and health outcomes.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Whether mothers attended postnatal care on day 2 and at 1 month postpartum.
Key secondary outcomes
1) Depression, Anxiety and Stress Scale-21 (DASS-21)
2) Training Needs Analysis Questionnaire (TNAQ)
3) International Confederation of Midwives (ICM) Core Competencies
4) Knowledge of postnatal danger signs, maternal nutritional status, breastfeeding, and newborn care
5) Attitudes toward recommended postnatal care practices, perceived social norms, behavioral control, and intentions to attend appropriate postnatal care
6) Edinburgh Postnatal Depression Scale (EPDS)
7) Infant health status, feeding practices, and weight gain
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
In the intervention group, maternity healthcare providers use a mobile application based on 19 selected items from the WHO guidelines on maternal and newborn care for a positive postnatal experience to provide care to mothers. The application includes content on postnatal nutrition, infant feeding, mental health, and family support. Maternity healthcare providers in the intervention facilities use the mobile application for two months.
Interventions/Control_2
In the control group, mothers receive standard care from maternity healthcare providers who do not use the mobile application.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Cluster randomized controlled trial
(1) Maternity healthcare providers
1) Healthcare providers working in the obstetrics and gynecology departments of participating facilities
2) Healthcare providers with at least 6 months of work experience at the participating facility
3) Those who provide consent to participate in the study
(2) Pregnant and postpartum women
1) Women aged 18 years or older with a normal pregnancy in the third trimester (28 weeks of gestation or later)
2) Those who provide consent to participate in the study
2. Qualitative study
1) Those who used the application in the intervention group
2) Those who provide consent to participate in the study
Key exclusion criteria
1) Cluster randomized controlled trial
(1) Maternity healthcare providers
(a) Non-regular staff members (e.g., interns and nursing students)
(b) Those receiving psychiatric care and taking psychotropic medications at the time of data collection
(c) Those who do not own a smartphone
(2) Pregnant and postpartum women
(a) Those receiving psychiatric treatment or taking antipsychotic medications
(b) Those returning to their hometown for childbirth
2) Qualitative study
(a) Those who did not use the application during the study period
Target sample size
180
Research contact person
Name of lead principal investigator
| 1st name | Yoko |
| Middle name | |
| Last name | Shimpuku |
Organization
Hiroshima University
Division name
Graduate School of Biomedical and Health Sciences Program of Health Sciences
Zip code
734-8553
Address
1 Chome-2-3- Kasumi, Minami Ward, Hiroshima, Japan
TEL
082-257-555
yokoshim@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Dorkasi |
| Middle name | |
| Last name | Mwakawanga |
Organization
Muhimbili University of Health and Allied Sciences
Division name
School of Nursing, Department of Community Health Nursing
Zip code
11103
Address
P.O. Box 65001, Dar es Salaam, Tanzania
TEL
+255-22-2150302
Homepage URL
dorkasmwakawanga@gmail.com
Sponsor or person
Institute
Muhimbili University of Health and Allied Sciences
Institute
Department
Personal name
Beatrice Mwilike
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Committee for Clinical Research of Hiroshima University
Address
Kasumi 1-2-3 Minami-Ku, Hiroshima
Tel
082-257-1947
iryo-sinsa@office.hiroshima-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
アマナ病院、テメケ病院、ムワナニャマラ病院
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 10 | Month | 30 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2026 | Year | 08 | Month | 28 | Day |
Date of IRB
| 2026 | Year | 10 | Month | 28 | Day |
Anticipated trial start date
| 2026 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 10 | Month | 30 | Day |
Last modified on
| 2026 | Year | 10 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071819
