ANZCTR - Registration

Registration number

ACTRN12625000252415p

Ethics application status

Submitted, not yet approved

Date submitted

26/03/2025

Date registered

7/04/2025

Date last updated

7/04/2025

Date data sharing statement initially provided

7/04/2025

Type of registration

Prospectively registered

Titles & IDs

Public title

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.

Scientific title

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.

Secondary ID [1]

none

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

diabetes

contraception

pregnancy planning

Condition category

Condition code

Reproductive Health and Childbirth

Fetal medicine and complications of pregnancy

Reproductive Health and Childbirth

Contraception

Metabolic and Endocrine

Diabetes

Public Health

Health service research

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

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)

Intervention code [1]

Prevention

Comparator / control treatment

Pre- and post-intervention study design
Participants pre-intervention will act as their own control.

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Change in women’s knowledge of contraception measured by the proportion and number of women who are able to identify contraceptive agents with at least 90% efficacy in preventing pregnancy post-intervention

Timepoint [1]

Questionnaires will be performed at - baseline - 1 month post-reproductive planning conversation - 6 month post-reproductive planning conversation - 2 years post-reproductive planning conversation - 5 years post-reproductive planning conversation Most of the questions in the follow-up questionnaires are the same as in the baseline questionnaire. However, the baseline questionnaire contains some demographic data questions and questions about pregnancy history and contraception use. The follow-up questionnaires include questions asking whether women have had the reproductive planning conversation with their GPs, and whether they have watched the videos In addition, the 6-month, 2-year and 5-year follow-up questionnaires, ask women whether they have a pregnancy since the baseline questionnaire and details of the pregnancy.

Primary outcome [2]

Change in women’s knowledge of pregnancy planning, measured by the change in the proportion and number of women who can identify 2 or more key steps in pregnancy planning (improving glycaemic control measured by HbA1c less than or equal to 6.5%, starting high-dose folic acid, stopping teratogenic medications)

Timepoint [2]

The 1-month follow-up questionnaire will be administered 1 month after the completion date of the reproductive planning conversation. If the reproductive planning intervention has not occurred by 3 months post-recruitment, the 1-month post-intervention questionnaire will be administered at that 4-month post-recruitment (3 months plus 1 month post-reproductive planning conversation).

Secondary outcome [1]

For women who become pregnant, change in the number and proportion of women who are taking sufficient iodine supplements (150ug daily)

Timepoint [1]

Questionnaires will be administered at 6-month, 2-year and 5-year post-reproductive conversation intervention. If the reproductive planning conversation intervention has not occurred by 3 months post-recruitment: - the 6-month post-intervention questionnaire will be administered at 9 months after recruitment (3 months post recruitment plus 6 months) - the 2-year post-intervention questionnaire will be administered at 2 years and 3 months after recruitment (3 months post recruitment plus 2 years) - the 5-year post-intervention questionnaire will be administered at 5 years and 3 months after recruitment (3 months post recruitment plus 5 years)

Secondary outcome [2]

For women who become pregnant, change in the number and proportion of women who are taking folic acid supplements (5 mg daily or 2nd daily)

Timepoint [2]

Questionnaires will be administered at 6-month, 2-year and 5-year post-reproductive conversation intervention. If the reproductive planning conversation intervention has not occurred by 3 months post-recruitment: - the 6-month post-intervention questionnaire will be administered at 9 months after recruitment (3 months post recruitment plus 6 months) - the 2-year post-intervention questionnaire will be administered at 2 years and 3 months after recruitment (3 months post recruitment plus 2 years) - the 5-year post-intervention questionnaire will be administered at 5 years and 3 months after recruitment (3 months post recruitment plus 5 years)

Secondary outcome [3]

Behaviour change: for women not wanting to become pregnant or planning a pregnancy, the change in the proportion (and number) of women using a more effective contraceptive agent than pre-intervention.

Timepoint [3]

Questionnaires will be administered at 6-months post-reproductive planning conversation. If the reproductive planning conversation intervention has not occurred by 3 months post-recruitment, the 6-month post-intervention questionnaire will be administered at 9 months after recruitment (3 months post-recruitment plus 6 months)

Secondary outcome [4]

For women who become pregnant, change in the number and proportion of women who achieve HbA1c in 3 months prior to or in 1st trimester of pregnancy less than or equal to 6.5% and less than or equal to 7%

Timepoint [4]

Questionnaires will be administered at 6-month, 2-year and 5-year post-reproductive conversation intervention. If the reproductive planning conversation intervention has not occurred by 3 months post-recruitment: - the 6-month post-intervention questionnaire will be administered at 9 months after recruitment (3 months post recruitment plus 6 months) - the 2-year post-intervention questionnaire will be administered at 2 years and 3 months after recruitment (3 months post recruitment plus 2 years) - the 5-year post-intervention questionnaire will be administered at 5 years and 3 months after recruitment (3 months post recruitment plus 5 years)

Secondary outcome [5]

Behaviour change: For women who become pregnant, change in the number and proportion of women who are seeing an endocrinologist or diabetes educator.

Timepoint [5]

Questionnaires will be administered at 6-month, 2-year and 5-year post-reproductive conversation intervention. If the reproductive planning conversation intervention has not occurred by 3 months post-recruitment: - the 6-month post-intervention questionnaire will be administered at 9 months after recruitment (3 months post recruitment plus 6 months) - the 2-year post-intervention questionnaire will be administered at 2 years and 3 months after recruitment (3 months post recruitment plus 2 years) - the 5-year post-intervention questionnaire will be administered at 5 years and 3 months after recruitment (3 months post recruitment plus 5 years)

Secondary outcome [6]

Behaviour change: The mean HbA1c for women in the 3 months prior to or in 1st trimester of pregnancy pre-intervention compared with post intervention

Timepoint [6]

6-months, 2-years and 5-years post-reproductive planning conversation

Secondary outcome [7]

Change in the proportion and number of women who have adverse pregnancy outcomes out of the number who become pregnant. Examples of adverse events are miscarriage, stillbirth, fetal malformation. They will be assessed through the follow up questionnaires completed by women. Confirmation will be sought from the GP eMR.

Timepoint [7]

Questionnaires will be administered at 6 months, 2 years and 5 years post-reproductive planning conversation. The 6 months, 2 years and 5 years follow-up questionnaires, ask women whether they have a pregnancy since the baseline questionnaire and details of the pregnancy.

Secondary outcome [8]

For women who become pregnant, change in the number and proportion of women who report a planned pregnancy rather than unplanned

Timepoint [8]

Questionnaires will be administered at 6-month, 2-year and 5-year post-reproductive planning conversation intervention. If the reproductive planning conversation intervention has not occurred by 3 months post-recruitment: - the 6-month post-intervention questionnaire will be administered at 9 months after recruitment (3 months post recruitment plus 6 months) - the 2-year post-intervention questionnaire will be administered at 2 years and 3 months after recruitment (3 months post recruitment plus 2 years) - the 5-year post-intervention questionnaire will be administered at 5 years and 3 months after recruitment (3 months post recruitment plus 5 years)

Secondary outcome [9]

Behaviour change: For women who become pregnant, change in the number and proportion of women who have been referred to diabetes clinic at the local maternity hospital

Timepoint [9]

Questionnaires will be administered at 6-month, 2-year and 5-year post-reproductive conversation intervention. If the reproductive planning conversation intervention has not occurred by 3 months post-recruitment: - the 6-month post-intervention questionnaire will be administered at 9 months after recruitment (3 months post recruitment plus 6 months) - the 2-year post-intervention questionnaire will be administered at 2 years and 3 months after recruitment (3 months post recruitment plus 2 years) - the 5-year post-intervention questionnaire will be administered at 5 years and 3 months after recruitment (3 months post recruitment plus 5 years)

Secondary outcome [10]

Behaviour change: For women who become pregnant, change in the number and proportion of women who ceased teratogenic medication.

Timepoint [10]

Questionnaires will be administered at 6-month, 2-year and 5-year post-reproductive conversation intervention. If the reproductive planning conversation intervention has not occurred by 3 months post-recruitment: - the 6-month post-intervention questionnaire will be administered at 9 months after recruitment (3 months post recruitment plus 6 months) - the 2-year post-intervention questionnaire will be administered at 2 years and 3 months after recruitment (3 months post recruitment plus 2 years) - the 5-year post-intervention questionnaire will be administered at 5 years and 3 months after recruitment (3 months post recruitment plus 5 years)

Eligibility

Key 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.

Minimum age

16 Years

Maximum age

49 Years

Sex

Females

Can healthy volunteers participate?

No

Key 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.

Study design

Statistical methods / analysis

Recruitment

Recruitment status

Not yet recruiting

Date of first participant enrolment

Anticipated

15/04/2025

Actual

Date of last participant enrolment

Anticipated

31/12/2025

Actual

Date of last data collection

Anticipated

1/06/2031

Actual

Sample size

Target

50

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Department of Endocrinology Trust Fund at Nepean Hospital.

Country [1]

Australia

Primary sponsor type

University

Name

The University of Sydney

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Country [1]

Ethics approval

Ethics application status

Submitted, not yet approved

Ethics committee name [1]

The University of Sydney Human Research Ethics Committee

Ethics committee address [1]

human.ethics@sydney.edu.au

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

18/11/2024

Approval date [1]

Ethics approval number [1]

Summary

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.

Trial website

Public notes

Contacts

Principal investigator

Name

A/Prof Emily Hibbert

Address

Department of Endocrinology, Nepean Hospital, Nepean Clinical School, Faculty of Medicine and Health, The University of Sydney, Level 3, 62 Derby Street, Kingswood, NSW, 2747.

Country

Australia

Phone

+61247344754

Email

[email protected]

Contact person for public queries

Name

Ya Yun Siow

Address

Ya Yun Siow, Department of Endocrinology, Nepean Hospital, Nepean Clinical School, Faculty of Medicine and Health, The University of Sydney, Level 3, 62 Derby Street, Kingswood, NSW, 2747

Country

Australia

Phone

+612411667913

Email

[email protected]

Contact person for scientific queries

Name

Emily Hibbert

Address

A/Prof Emily Hibbert, Department of Endocrinology, Nepean Hospital, Nepean Clinical School, Faculty of Medicine and Health, The University of Sydney, Level 3, 62 Derby Street, Kingswood, NSW, 2747

Country

Australia

Phone

+61247344754

Email

[email protected]

Trial Review

Documents added manually

Documents added automatically