PregnancyPcyCareNCT07207733
Feasibility Study of PcyCare (Pregnancy Care) : A Self-Learning Educational Platform for Pregnant Women
A study testing PcyCare: Self-Directed Education Platform for Pregnant Women in people with Pregnancy, run by Nurul Jannah, M.Tr.Keb at 1 site in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy
- What is being tested?
- PcyCare: Self-Directed Education Platform for Pregnant Women
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Sep 2025to 19 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Brief Summary - PcyCare (Pregnancy Care Aplication) (with expert participants)
Objective:
Read more
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.
Read the detailed description
Detailed Description The PcyCare platform was developed as a self-directed educational medium for pregnant women, with the aim of improving understanding of nutrition, pregnancy warning signs, mental health, and childbirth preparation. This study aims to evaluate the feasibility, ease of use, and content quality of the platform prior to wider implementation, while also obtaining input from experts for platform refinement.
This study involved 10 pregnant women as primary users. During the one-week study period, participants accessed the platform via smartphone or computer, read educational materials, watched interactive videos, and completed quizzes. Researchers collected data through feasibility and satisfaction questionnaires and assessed participants' understanding before and after using the platform. This activity aimed to determine whether the platform was easy to use and could improve pregnant women's understanding.
In addition, the study also involved 8 subject matter experts (midwifery lecturers/practicing midwives) and 5 information technology/media experts as evaluators of the platform's content and features. The experts assessed the scientific accuracy, completeness of the material, language, cultural appropriateness, visual quality, and interactivity of the platform using a special assessment instrument (expert review). Input from experts will be used to improve and refine the platform before it is tested more widely.
The results of the study are expected to provide information on ease of use, content quality, effectiveness of interactive features, and recommendations for improvement from experts. This study will serve as a basis for improving the feasibility and quality of PcyCare, so that the platform can be used as an effective and safe self-education medium for pregnant women at various educational and socio-cultural levels.
- Conditions
- Pregnancy
- Being tested
- PcyCare: Self-Directed Education Platform for Pregnant Women
- Keywords
- Pregnancy care, Prenatal education, Self-learning platform, Feasibility study, Digital health intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PcyCare: Self-Directed Education Platform for Pregnant WomenDevice
Also called PcyCare Self-Learning Educational Platform, Digital Pregnancy Care Platform
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: PcyCare: Self-Directed Education Platform for Pregnant Women |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
The content quality of the PcyCare platform was evaluated using a 28-item questionnaire completed by 8 subject matter experts. The items covered ten key aspects: scientific accuracy, content completeness, language clarity, cultural and local relevance, visual/media support, interactivity and self-learning, timeliness and consistency, practical usefulness, information safety, and overall evaluation. Each item was rated on a 4-point Likert scale (1=Not Relevant to 4=Highly Relevant), with scores ranging from 28-112. Feasibility was interpreted as ≥3.00 (Feasible), 2.50-2.99 (Conditionally Feasible), and <2.50 (Not Feasible). Results showed strong validity: 21 items had I-CVI=1.00, 7 items had I-CVI=0.75, and the S-CVI was 0.94, confirming excellent overall content validity of the expert assessment instrument.
Measured: Performed immediately after the platform is tested by experts (1 week)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2025
- Study start1 Sep 2025
- Primary completion11 Sep 2025
- Study completion19 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nurul Jannah, M.Tr.Keb
- Sponsor type
- University, hospital or other
- Collaborators
- Lincoln University College Malaysia
- Responsible party
- Sponsor-investigator, Nurul Jannah, M.Tr.Keb, Lincoln University College
- Investigators
- Nurul Jannah, M.Tr.Keb, Principal investigator, Lincoln University College Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07207733
- Sponsor's protocol ID
- LUC20230708005
- Other IDs
- LUC20230708005
- Acronym
- PcyCare
- Status last verified
- Sep 2025
- First submitted
- 11 Sep 2025
- Last updated
- 6 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study of PcyCare (Pregnancy Care) : A Self-Learning Educational Platform for Pregnant Women
- ClinicalTrials.gov ID
- NCT07207733
- Acronym / sponsor ID
- PcyCare / LUC20230708005
- Conditions
- Pregnancy
- Keywords
- Pregnancy care, Prenatal education, Self-learning platform, Feasibility study, Digital health intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Nurul Jannah, M.Tr.KebUniversity, hospital or other
- Collaborators
- Lincoln University College Malaysia
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 11 Sep 2025 (actual)
- Study completion
- 19 Sep 2025 (actual)
- First posted
- 6 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Detailed Description The PcyCare platform was developed as a self-directed educational medium for pregnant women, with the aim of improving understanding of nutrition, pregnancy warning signs, mental health, and childbirth preparation. This study aims to evaluate the feasibility, ease of use, and content quality of the platform prior to wider implementation, while also obtaining input from experts for platform refinement.
This study involved 10 pregnant women as primary users. During the one-week study period, participants accessed the platform via smartphone or computer, read educational materials, watched interactive videos, and completed quizzes. Researchers collected data through feasibility and satisfaction questionnaires and assessed participants' understanding before and after using the platform. This activity aimed to determine whether the platform was easy to use and could improve pregnant women's understanding.
In addition, the study also involved 8 subject matter experts (midwifery lecturers/practicing midwives) and 5 information technology/media experts as evaluators of the platform's content and features. The experts assessed the scientific accuracy, completeness of the material, language, cultural appropriateness, visual quality, and interactivity of the platform using a special assessment instrument (expert review). Input from experts will be used to improve and refine the platform before it is tested more widely.
The results of the study are expected to provide information on ease of use, content quality, effectiveness of interactive features, and recommendations for improvement from experts. This study will serve as a basis for improving the feasibility and quality of PcyCare, so that the platform can be used as an effective and safe self-education medium for pregnant women at various educational and socio-cultural levels.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| PcyCare (Pregnancy Care) Users | Experimental | Device: PcyCare: Self-Directed Education Platform for Pregnant WomenParticipants 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. |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PcyCare: Self-Directed Education Platform for Pregnant WomenAlso: PcyCare Self-Learning Educational Platform, Digital Pregnancy Care PlatformThis 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. | Device | PcyCare (Pregnancy Care) Users |
Primary outcome
Usability of PcyCare Platform by Pregnant Women assessed using a Custom User Experience Questionnaire
Time frame: 1 weeks after initial use of the PcyCare platform
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 secondary outcome
Content Quality Evaluation of PcyCare Platform by Subject Matter Experts using Content Validity Index (CVI)
Time frame: Performed immediately after the platform is tested by experts (1 week)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2025.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nurul Jannah, M.Tr.Keb principal investigator
Lincoln University College Malaysia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PcyCare: Self-Directed Education Platform for Pregnant Women in people with Pregnancy, run by Nurul Jannah, M.Tr.Keb at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Usability of PcyCare Platform by Pregnant Women assessed using a Custom User Experience Questionnaire (time frame: 1 weeks after initial use of the PcyCare platform). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2025.