Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000523505
Ethics application status
Approved
Date submitted
11/05/2015
Date registered
26/05/2015
Date last updated
26/05/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Motherhood Choices Decision Aid for Women with Rheumatoid Arthritis Increases Knowledge and Reduces Decisional Conflict: A Randomized Controlled Study
Scientific title
The Motherhood Choices Decision Aid for Women with Rheumatoid Arthritis Increases Knowledge and Reduces Decisional Conflict: A Randomized Controlled Study
Secondary ID [1] 286492 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Rheumatoid Arthritis 294700 0
Condition category
Condition code
Inflammatory and Immune System 295374 295374 0 0
Rheumatoid arthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The decision aid (DA) was developed by a team of researchers at the University of Western Sydney, The University of Sydney, and Arthritis New South Wales. The DA is a 45-page resource available in electronic or paper versions, and contains three distinct sections: 1) Information on RA, conception, pregnancy, and parenting; 2) decision making activities, and; 3) resources. Specifically, it provides women with information about RA and its effects, the impact of RA and medications on conception, pregnancy and motherhood, the impact of pregnancy on RA, and ‘women’s stories’. The booklet also contains worksheets to assist women in the decision making process, including a decision tree, scales to rate the pros and cons of each option, identifying support networks, a knowledge checklist, and a note taking section. Development of the DA was conducted based on the Ottawa Decision Support Framework and following the guidelines of the IPDAS Collaboration.
The DA is currently listed on the Ottawa Hospital Research Institute Patient Decision Aid website: https://decisionaid.ohri.ca/AZsumm.php?ID=1787
The electronic version of the DA (i.e. in the form of a PDF) was the only intervention used in the current study. The participants were not provided with any further intervention(s).
Intervention code [1] 291586 0
Behaviour
Comparator / control treatment
Women in the control condition were not provided access to the decision aid until the end of the study.
Once the trial had ceased, the women in the control group were sent an electronic copy of the DA via email. That is, once all post-intervention data was collected, follow-ups were conducted, and preliminary data was analysed (i.e. to ensure the DA resulted in no harm to participants). Identically to women in the DA group, women in the group received no other resources or treatments.
Control group
Active

Outcomes
Primary outcome [1] 294744 0
RA knowledge: measured using Pregnancy in Rheumatoid Arthritis Questionnaire (PiRAQ) which includes questions that correspond to components of the Decision Aid including:
general knowledge about RA, the physical and psychosocial effects of RA, effects of RA on fertility and pregnancy, the effects of RA medicines during conception, pregnancy and breastfeeding, postnatal considerations, and parenting with RA.
Timepoint [1] 294744 0
Baseline and 4 to 12 weeks post intervention (Decision Aid). Follow up timeframe depended on participants' rate of completion (DA use and survey response).
Primary outcome [2] 294849 0
Decisional conflict: measured using the Decisional Conflict Scale (DCS).
Timepoint [2] 294849 0
Baseline and 4 to 12 weeks post intervention (Decision Aid). Follow up timeframe dependent on participants' completion.
Secondary outcome [1] 313985 0
Anxiety- measured using anxiety component of The Hospital Anxiety and Depression Scale (HADS).
Timepoint [1] 313985 0
Baseline and 4 to 12 weeks post intervention (Decision Aid). Follow up timeframe depended on participants' rate of completion (DA use and survey response).
Secondary outcome [2] 314812 0
Depression- measured using the depression component of The Hospital Anxiety and Depression Scale (HADS)
Timepoint [2] 314812 0
Baseline and 4 to 12 weeks post intervention (Decision Aid). Follow up timeframe depended on participants' rate of completion (DA use and survey response).
Secondary outcome [3] 314813 0
The Arthritis Self-Efficacy Scale (ASES) is a self-administered, disease specific questionnaire developed to measure perceived self-efficacy in people with chronic arthritis.
Timepoint [3] 314813 0
Baseline and 4 to 12 weeks post intervention (Decision Aid). Follow up timeframe depended on participants' rate of completion (DA use and survey response).

Eligibility
Key inclusion criteria
Eligible women were those diagnosed with Rheumatoid Arthritis and currently under the care of a rheumatologist.
Minimum age
18 Years
Maximum age
45 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Males
Individuals without clinical diagnosis of rheumatoid arthritis
Women not considering motherhood options

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)
Participant recruitment took place over a 12-month period via online advertising including a Google ad campaign, social media, media releases, website content and relevant Arthritis websites (including Arthritis NSW), and print advertising including general practitioner newsletters, posters, and flyers distributed to rheumatology clinics.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
As women provided consent, a member of the research team allocated participant identification numbers using the Bernoulli function in Excel to randomly allocate all participants to either the DA or control groups.
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
Analyses were conducted using IMB SPSS Statistics (21.0), with statistical significance set at p < .05 (two-tailed). Baseline differences between the DA and control groups were assessed using an independent samples t-test. Primary and secondary outcomes were analysed using a series of 2 (group: intervention and no intervention) x 2 (time: pre and post) mixed between-within subjects analysis of variance (ANOVA). Analyses were conducted on each measure (PiRAQ, DCS, ASES, HADS-A, and HADS-D), including the DCS subscales, and questions measuring RA-Complicated Decision and Decisional Certainty. A power analysis using the G*Power 3 computer program revealed a total sample size of 130 subjects was required to detect moderate effects (0.13) with 95% power using a within-between repeated measures ANOVA.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/01/2010
Actual
2/07/2009
Date of last participant enrolment
Anticipated
31/12/2010
Actual
23/11/2011
Date of last data collection
Anticipated
Actual
Sample size
Target
130
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,WA,VIC
Recruitment outside Australia
Country [1] 6830 0
United Kingdom
State/province [1] 6830 0
Unknown
Country [2] 6831 0
United States of America
State/province [2] 6831 0
Unknown

Funding & Sponsors
Funding source category [1] 291056 0
Government body
Name [1] 291056 0
Australian Research Council
Country [1] 291056 0
Australia
Primary sponsor type
Individual
Name
Associate Professor Tanya Meade
Address
School of Social Science and Psychology
University of Western Sydney
Locked Bag 1797
Penrith 2751 Australia
Country
Australia
Secondary sponsor category [1] 289801 0
University
Name [1] 289801 0
University of Western Sydney

University of Sydney
Address [1] 289801 0
University of Western Sydney
Locked Bag 1797
Penrith 2751 Australia

University of Sydney
NSW 2006 Australia
Country [1] 289801 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292644 0
University of Western Sydney Human Ethics Committee
Ethics committee address [1] 292644 0
Office of Research Services
University of Western Sydney
Locked Bag 1797
Penrith NSW 2751
Ethics committee country [1] 292644 0
Australia
Date submitted for ethics approval [1] 292644 0
Approval date [1] 292644 0
25/05/2009
Ethics approval number [1] 292644 0
H6884

Summary
Brief summary
Arthritis NSW has identified that there is a need for more information and support for women faced with family decisions in the context of their RA. Therefore the aim of this project was to develop a Decision Aid (DA) resource (printed booklet and an online version) for women with Rheumatoid Arthritis (RA) who were contemplating pregnancy. In order to evaluate the effectiveness of the DA, a randomised control trial (n = 200) was conducted with women diagnosed with RA, aged between 20-45 and who may be contemplating pregnancy.
Trial website
Trial related presentations / publications
Meade, T., Sharpe, L., Hallab, L., Aspanell, D., Manolios, N. (2012). Navigating Motherhood Choices in the context of Rheumatoid Arthritis: Women’s Stories. Musculoskeletal Care, 11(2), 73-82. doi: 10.1002/msc.1031.

Meade, T, Sharpe, L, Aspanell, D, Manolios, N. (2012). Rheumatoid arthritis and motherhood: development of a resource to support women and their partners when contemplating family, Arthritis Matters Magazine, Summer Edition 2012, p 10.

This research will also be presented at the 14th European Congress of Psychology in Milan on the 7-10 of July 2015.
Public notes

Contacts
Principal investigator
Name 56370 0
A/Prof Tanya Meade
Address 56370 0
School of Social Science and Psychology
University of Western Sydney
Locked Bag 1797
Penrith 2751 Australia
Country 56370 0
Australia
Phone 56370 0
+61 02 9772 6266
Fax 56370 0
+61 02 9772 6736
Email 56370 0
[email protected]
Contact person for public queries
Name 56371 0
A/Prof Tanya Meade
Address 56371 0
School of Social Science and Psychology
University of Western Sydney
Locked Bag 1797
Penrith 2751 Australia
Country 56371 0
Australia
Phone 56371 0
+61 02 9772 6266
Fax 56371 0
+61 02 9772 6736
Email 56371 0
[email protected]
Contact person for scientific queries
Name 56372 0
A/Prof Tanya Meade
Address 56372 0
School of Social Science and Psychology
University of Western Sydney
Locked Bag 1797
Penrith 2751 Australia
Country 56372 0
Australia
Phone 56372 0
+61 02 9772 6266
Fax 56372 0
+61 02 9772 6736
Email 56372 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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseThe motherhood choices decision aid for women with rheumatoid arthritis increases knowledge and reduces decisional conflict: A randomized controlled trial.2015https://dx.doi.org/10.1186/s12891-015-0713-0
N.B. These documents automatically identified may not have been verified by the study sponsor.