An investigation of the efficacy of a motherhood decision aid for women with epilepsy

An investigation of whether receiving a motherhood decision aid improves pregnancy knowledge and decisional self-efficacy, and reduces decisional conflict in women with epilepsy who are contemplating pregnancy, compared to not receiving a motherhood decision aid.

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12613001082796

Enrollment

Registered

2013-09-26

Start date

2013-10-03

Completion date

2013-11-13

Last updated

2020-01-13

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 study aims to test the efficacy of a decision-making tool, called a Decision Aid, for women with epilepsy who are in the process of deciding whether or not to have a child. It is hypothesised that women with epilepsy who receive the Decision Aid will report increased knowledge about pregnancy; reduced decisional conflict and increased decisional self-efficacy regarding their decision compared to women who do not receive the Decision Aid. In accordance with previous research, the Decision Aid is not expected to affect depression, anxiety or the direction of a woman's decision.

Interventions

About the Intervention: The intervention is a Decision Aid, which is an evidence-based tool designed to prepare patients to make specific and deliberate choices regarding their health care. The Decision Aid developed for this study is an online 50-page booklet in PDF format, developed especially for women with epilepsy according to the quality criteria outlined by the International Patient Decision Aids Standards Collaboration (IPDAS, Elwyn et al., 2006). The current Decision Aid describes the options available regarding whether or not to have a child (e.g., have children, not have children, have only 1 child, have multiple children), as well as describing the benefits and risks of these options, according to the available research on pregnancy and epilepsy. The Decision Aid is designed to help inform women with epilepsy of the relevant research and help them to consider what values are important to them using written exercises included throughout the resource. Decision aids are designed to supplement, not replace, clinician's counselling about health care options, and this is explained in the present Decision Aid. Mode of Administration and Duration: Participants who are randomly allocated to the group which receives the online Decision Aid (the intervention group) will be asked to read it all the way through. Participants in this group will receive the Decision Aid via email after completing some online questionnaires. It is estimated that reading the Decision Aid would take 1- 2 hours, depending on a participant's speed of reading. This group will also receive a phone call from a member of the research team to check that they have received the Decision Aid and to talk about the information and clarify anything that is unclear. The telephone conversation will take no more than 20 minutes.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Educational / counselling / training

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to 45 Years

Healthy volunteers

Inclusion criteria

Women with a diagnosis of epilepsy who are of childbearing age (18-45 years) who are undecided about whether or not to have children (or more children). Women must be proficient in the English language.

Exclusion criteria

Participants with a level of cognitive impairment that prevents them from being able to read the whole Decision Aid.

Outcome results