NCT07207733

Brief Summary

Brief Summary - PcyCare (Pregnancy Care Aplication) (with expert participants) Objective: This study aims to evaluate the feasibility and usefulness of the PcyCare self-directed education platform for pregnant women. This platform provides information on nutrition, pregnancy warning signs, mental health, and childbirth preparation. Key questions: Is PcyCare easy to use for pregnant women? Do the platform's materials and features help improve participants' understanding of pregnancy and childbirth? How do subject matter experts and information technology experts assess the quality of the platform's content and features? Procedure: Pregnant women will use PcyCare for one week, accessing educational materials, watching videos, and completing interactive quizzes. Their understanding and experience will be evaluated through feasibility and satisfaction questionnaires. Content experts (midwifery lecturers/practicing midwives) and media/IT experts will assess the suitability of the platform's content and features through expert reviews and provide suggestions for improvement. Expected results: Information about ease of use, content quality, effectiveness of interactive features, and input from experts to refine the platform before wider trials.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable pregnancy

Timeline
Completed

Started Sep 2025

Shorter than P25 for not_applicable pregnancy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2025

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

September 11, 2025

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 11, 2025

Completed
8 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 19, 2025

Completed
17 days until next milestone

First Posted

Study publicly available on registry

October 6, 2025

Completed
Last Updated

October 6, 2025

Status Verified

September 1, 2025

Enrollment Period

10 days

First QC Date

September 11, 2025

Last Update Submit

September 27, 2025

Conditions

Keywords

Pregnancy carePrenatal educationSelf-learning platformFeasibility studyDigital health intervention

Outcome Measures

Primary Outcomes (1)

  • Usability of PcyCare Platform by Pregnant Women assessed using a Custom User Experience Questionnaire

    The assessment evaluated PcyCare platform usability by pregnant women using a 30-item feasibility questionnaire across six dimensions: navigation, interactivity, material accessibility, comfort, usefulness, and overall satisfaction. The form covered respondent identity and quantitative ratings on a 4-point Likert scale (1=Not appropriate to 4=Very appropriate). Scores ranged from 30-120, with feasibility defined as ≥3.00 (Feasible), 2.50-2.99 (Conditionally Feasible), and \<2.50 (Not Feasible). Ten pregnant women participated. Results showed strong validity: 22 items scored I-CVI=1.00, 8 items I-CVI=0.75, yielding S-CVI=0.93. This indicates the instrument demonstrates high content validity and effectively measures user experiences and platform feasibility.

    1 weeks after initial use of the PcyCare platform

Secondary Outcomes (1)

  • Content Quality Evaluation of PcyCare Platform by Subject Matter Experts using Content Validity Index (CVI)

    Performed immediately after the platform is tested by experts (1 week)

Other Outcomes (1)

  • Technical Feasibility and Media Quality Evaluation by Information Technology and Media Experts using Structured Expert Review Questionnaire

    1 Week

Study Arms (1)

PcyCare (Pregnancy Care) Users

EXPERIMENTAL

Participants in this arm, consisting of pregnant women, used the PcyCare self-directed education platform for one week. Participants accessed educational modules covering nutrition, pregnancy warning signs, mental health, and childbirth preparation. This intervention included interactive content, instructional videos, and quizzes. Data on ease of use, participant satisfaction, and increased understanding were collected through questionnaires. In addition, input from expert assessors in the fields of obstetrics and information technology will be used to assess the quality of the content and the suitability of the platform.

Device: PcyCare: Self-Directed Education Platform for Pregnant Women

Interventions

This intervention involves the use of the PcyCare self-directed education platform by pregnant women for one week. Participants will access educational modules on nutrition, pregnancy warning signs, mental health, and childbirth preparation. The platform includes interactive content, instructional videos, and quizzes to enhance participants' understanding. Data on ease of use, satisfaction, and increased understanding will be collected through questionnaires. In addition, midwives/practicing midwives and information technology/media experts will assess the quality of the platform's content and features through expert reviews to evaluate the platform's suitability and improvements before wider trials.

Also known as: PcyCare Self-Learning Educational Platform, Digital Pregnancy Care Platform
PcyCare (Pregnancy Care) Users

Eligibility Criteria

Age20 Years - 35 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPregnant Women (Female)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Pregnant women aged 20-35 years
  • Gestational age between 12 and 36 weeks
  • Able to read and understand the language used in the PcyCare platform
  • Owns a smartphone, tablet, or computer with internet access
  • Provides informed consent to participate

You may not qualify if:

  • High-risk pregnancy requiring intensive medical care
  • Severe psychiatric or cognitive disorders that would prevent platform use
  • Participation in another conflicting educational or intervention study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Disctrict

Semarang, Central Java, 50009, Indonesia

Location

Study Officials

  • Nurul Jannah, M.Tr.Keb

    Lincoln University College Malaysia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
Not applicable. This study does not involve masking or blinding as all participants and expert reviewers are aware of the intervention.
Purpose
DEVICE FEASIBILITY
Intervention Model
SINGLE GROUP
Model Details: Participants will use the PcyCare self-learning educational platform for one week. There is no randomization, crossover, or control group. The study aims to evaluate the feasibility, usability, and content quality of the platform based on feedback from pregnant women as primary users and expert reviewers, including maternal health specialists and IT/media experts.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Feasibility Study of PcyCare (Pregnancy Care) : A Self-Learning Educational Platform for Pregnant Women

Study Record Dates

First Submitted

September 11, 2025

First Posted

October 6, 2025

Study Start

September 1, 2025

Primary Completion

September 11, 2025

Study Completion

September 19, 2025

Last Updated

October 6, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

The individual participant data (IPD) from this study will not be shared outside the research team to protect the privacy and confidentiality of pregnant participants. Data contain sensitive personal health information, and sharing it could risk participant identification. Any future decision to share data will comply with applicable privacy regulations and ethical guidelines.

Locations