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Trial registered on ANZCTR


Registration number
ACTRN12613001082796
Ethics application status
Approved
Date submitted
26/09/2013
Date registered
26/09/2013
Date last updated
24/06/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
An investigation of the efficacy of a motherhood decision aid for women with epilepsy
Scientific title
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.
Secondary ID [1] 283303 0
Nil.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
epilepsy 290187 0
pregnancy 290188 0
Condition category
Condition code
Neurological 290575 290575 0 0
Epilepsy
Reproductive Health and Childbirth 290576 290576 0 0
Normal pregnancy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 288023 0
Other interventions
Comparator / control treatment
Standard treatment: women in this group do not receive the Decision Aid until after the study is completed.

Participants who are randomly allocated to the control group will not receive the Decision Aid immediately. Once their involvement in the study is over (approximately two weeks after first participating in the study), they will be sent a copy of the Decision Aid via email for their information.
Control group
Active

Outcomes
Primary outcome [1] 290593 0
Knowledge levels: assessed by mean scores (% correct answers) on a Knowledge Questionnaire containing 15 multiple-choice items which assess participants' knowledge about a range of epilepsy and pregnancy-related issues that are addressed in the Decision Aid. In the absence of an existing tool for women with epilepsy regarding pregnancy and child rearing, this questionnaire was developed by the researchers. It was based on the format of a knowledge questionnaire used in the only other published validation study of a motherhood Decision Aid for women with a chronic disabling medical condition (Multiple Sclerosis) (Prunty et al., 2008).
Timepoint [1] 290593 0
Baseline and two weeks post-intervention.
Primary outcome [2] 290594 0
Decisional self-efficacy: assessed by mean scores on the Decision Self-Efficacy Scale (O'Connor, 1995a). This scale determines the level of self-confidence and belief that participants have in their own ability to make a decision.
Timepoint [2] 290594 0
Baseline and two weeks post-intervention.
Primary outcome [3] 290595 0
Decisional conflict: assessed by mean scores on the Decision Conflict Scale 4th Edition (O'Connor, 1995b). This instrument evaluates patients’ decisions regarding a range of healthcare decisions.
Timepoint [3] 290595 0
Baseline and two weeks post-intervention.
Secondary outcome [1] 304863 0
Depression: assessed by mean scores on the Center for Epidemiologic Studies Depression Scale (CES-D; Radloff, 1977).
Timepoint [1] 304863 0
Baseline and two weeks post-intervention.
Secondary outcome [2] 304864 0
Anxiety: assessed by the mean scores on the Generalized Anxiety Disorder (GAD)-7 Scale (Spitzer, Kroenke, & Williams, 2006). There are currently no instruments specifically validated for assessing anxiety disorders in people with epilepsy. The GAD-7 has been shown to be a reliable and valid self-report anxiety measure for anxiety in the general population (Lowe et al. 2008) and in primary care patients (Spitzer, Kroenke & Williams, 2006).
Timepoint [2] 304864 0
Baseline and two weeks post-intervention.

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
45 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants with a level of cognitive impairment that prevents them from being able to read the whole Decision Aid.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Once participants have completed the baseline questionnaires online and their responses indicate their eligibility for the study, participants will be randomly allocated by the researcher (Amanda McGrath) to either the intervention group (those receiving the Decision Aid at the start) or the control group (those who do not receive the Decision Aid until after the study is completed). Allocation will be concealed until the time of each participant's allocation using sequential sealed opaque envelopes. Participants will then be sent an email from Ms McGrath, notifying them to which group they have been randomly allocated and the next steps for the study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A list of participant numbers will be linked in advance to a series of random numbers 1-2. The sequence of random numbers will be generated through randomizer.com and concealed until after the assessment.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
As a large-scale randomised control trial is beyond the scope of this research project, a pilot study is planned. In their validation study of a motherhood decision aid for women with Multiple Sclerosis, Prunty et al. (2008) found that their decision aid had large effects on knowledge (ES = 0.89) and decisional conflict (ES=0.72) and a moderate effect on decisional self-efficacy (ES=0.51). According to G-power, based on these effect sizes, we would need 13 participants per group to get an effect on knowledge, 18 for decisional conflict and 33 for self-efficacy, with 80% power and an alpha of 0.05. Hence, the study will aim for 33 participants per group (i.e., N = 66). Eligible women will be those diagnosed with epilepsy between the ages of 18 to 45, who are currently undecided about motherhood.

Baseline differences between the intervention and control group will be calculated using parametric (for continuous variables) and non-parametric (for dichotomous variables) t-tests to identify covariates. A series of (group: intervention vs. no intervention) x 2 (time: pre vs. post) mixed model ANCOVAs will be conducted using statistical software, to determine the effectiveness of the intervention.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
30/09/2013
Actual
3/10/2013
Date of last participant enrolment
Anticipated
Actual
13/11/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
66
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 288038 0
Self funded/Unfunded
Name [1] 288038 0
The study is being conducted in fulfilment of the requirements for a Master of Science degree at the University of Sydney, as undertaken by one of the researchers, Amanda McGrath.

No monetary funding has been received or is planned for this study.
Country [1] 288038 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
The University of Sydney
NSW 2006
Country
Australia
Secondary sponsor category [1] 286762 0
None
Name [1] 286762 0
Address [1] 286762 0
Country [1] 286762 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289961 0
The University of Sydney Human Research Ethics Committee
Ethics committee address [1] 289961 0
Ethics committee country [1] 289961 0
Australia
Date submitted for ethics approval [1] 289961 0
Approval date [1] 289961 0
23/09/2013
Ethics approval number [1] 289961 0
2013/791

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 43278 0
Prof Louise Sharpe
Address 43278 0
Brennan McCallum Building (A18)
The University of Sydney
NSW 2006
Country 43278 0
Australia
Phone 43278 0
+61 2 9351 4558
Fax 43278 0
+61 2 9351 7328
Email 43278 0
[email protected]
Contact person for public queries
Name 43279 0
Amanda McGrath
Address 43279 0
Brennan McCallum Building (A18)
The University of Sydney
NSW 2006
Country 43279 0
Australia
Phone 43279 0
+61 410 477 935
Fax 43279 0
Email 43279 0
[email protected]
Contact person for scientific queries
Name 43280 0
Amanda McGrath
Address 43280 0
Brennan McCallum Building (A18)
The University of Sydney
NSW 2006
Country 43280 0
Australia
Phone 43280 0
+61 410 477 935
Fax 43280 0
Email 43280 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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