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EMPOWERED-GP: Evaluating the Effectiveness of Education through online Media around Pregnancy planning and cOntraception for Women's EmpoweRmEnt in Diabetes in General Practice: a feasibility, acceptability and efficacy study.

EMPOWERED-GP: Evaluating the Effectiveness of Education through online Media around Pregnancy planning and cOntraception for Women's EmpoweRmEnt in Diabetes in General Practice: a feasibility, acceptability and efficacy study.

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12625000252415
Enrollment
50
Registered
2025-04-07
Start date
2025-04-15
Completion date
2025-12-31
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This project aims to improve the engagement of general practitioners (GPs) in discussions with women of reproductive age with pre-existing diabetes mellitus, regarding preconception care (PCC) and effective contraception to address the risks associated with elevated HbA1c levels. The research includes an audit of eMRs from the past 5 years, and a knowledge assessment questionnaire, pre- and post-implementation. The implementation phase involves an eMR alert system to assist GPs in assessing participants' pregnancy intentions within the next 12 months, while educational resources will be provided to participants. The results of this study will inform clinical practice and public health measures at NBMLHD and around Australia on improving PCC and effective contraception among women of reproductive age with pre-existing diabetes in GP setting. A specific Medicare item for these consultations could also facilitate audit and incentivize GP.

Interventions

1. A brief reproductive planning conversation instigated by a general practitioner (GP) with women with diabetes. Topics to be covered include: - key steps in pregnancy planning and effective contraceptive methods - complications with poorly controlled glycemic levels during pregnancy. GPs will be prompted to initiate the conversation by being alerted through the electronic medical record (eMR) to the fact that they are seeing a women with diabetes of reproductive age. The conversation shoul

1. A brief reproductive planning conversation instigated by a general practitioner (GP) with women with diabetes. Topics to be covered include: - key steps in pregnancy planning and effective contraceptive methods - complications with poorly controlled glycemic levels during pregnancy. GPs will be prompted to initiate the conversation by being alerted through the electronic medical record (eMR) to the fact that they are seeing a women with diabetes of reproductive age. The conversation should be revisited yearly. Women may choose to or not to book a follow up visit their GP for further discussion on reproductive planning. The duration of the conversation is expected to be be less than or equal to 15 minutes. The mode of administration will be one-on-one face-to-face consultation. Strategies to monitor adherence to the intervention will be the 1-month follow up questionnaire (in which a question asking the conversation has occurred) and an audit of the GP eMR. 2. Provision of access to the educational online video resources regarding contraception and pregnancy planning for women with diabetes on the National Diabetes Services Scheme (NDSS) website. There are 2 online video resources, in which each of them are 13 minutes in duration. Viewing these will be at the participants discretion. They may view them as frequently as they wish. Strategies to monitor adherence to the intervention will be the 1-month and 6-month follow up questionnaire (in which a question asking whether they have seen the videos)

Sponsors

The University of Sydney
Lead SponsorUniversity

Study design

Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Educational / counselling / training
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
16 Years to 49 Years
Healthy volunteers
No

Inclusion criteria

INCLUSION CRITERIA (WOMEN PARTICIPANTS) 1. Women with pre-existing diabetes 2. Female sex assigned at birth 3. Of reproductive age 16 - 49 years old 4. Has capacity to provide informed consent, participate and comply with the study requirements 5. Has access to a mobile phone or computer capable of receiving text messages and viewing online videos. INCLUSION CRITERIA (GENERAL PRACTITIONERS) 1. General Practitioners with electronic medical records for audit purposes. 2. General Practitioners with practices equipped to send text messages to potential women participants.

Exclusion criteria

EXCLUSION CRITERIA (WOMEN PARTICIPANTS) 1. Women without diabetes 2. Women under 16 years of age or older than 49 years of age 3. Women who are currently pregnant 4. Women who have had gestational diabetes, which resolved post-partum 5. Women who have been diagnosed as having undergone menopause 6. Women from non-English speaking backgrounds who do not have an English comprehension level adequate to understand the consent process, the content of a reproductive planning conversation or the content of educational videos and booklets 7. Women who lack capacity (eg. cognitive impairment due to any reason) to provide informed consent as determined by their treating clinician 8. Women who do not have access to a mobile phone or computer capable of receiving text messages and viewing online videos EXCLUSION CRITERIA (GENERAL PRACTITIONERS) 1. General Practitioners who do not have electronic medical records for audit purposes. 2. General Practitioners with practices not equipped to send text messages to women participants.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026