scholarly journals Protocol for a randomised controlled trial of a web-based healthy relationship tool and safety decision aid for women experiencing domestic violence (I-DECIDE)

2015 ◽  
Vol 15 (1) ◽  
Author(s):  
Kelsey Hegarty ◽  
Laura Tarzia ◽  
Elizabeth Murray ◽  
Jodie Valpied ◽  
Cathy Humphreys ◽  
...  
2007 ◽  
Vol 8 (1) ◽  
Author(s):  
Rhodri Evans ◽  
Glyn Elwyn ◽  
Adrian Edwards ◽  
Robert Newcombe ◽  
Paul Kinnersley ◽  
...  

BMJ Open ◽  
2020 ◽  
Vol 10 (2) ◽  
pp. e031739
Author(s):  
Alexandra Benoit ◽  
Michael Grynberg ◽  
Rémy Morello ◽  
Nathalie Sermondade ◽  
Guillaume Grandazzi ◽  
...  

IntroductionChemotherapy may cause infertility in young survivors of breast cancer. Various fertility preservation techniques increase the likelihood of survivors becoming genetic mothers. Disclosure of cancer diagnosis may impact decision making about fertility preservation. This protocol will develop and test the effectiveness of a web-based decision aid for helping women with breast cancer to make well-informed choices about fertility preservation.Methods and analysisThis study will be conducted in three phases using mixed methods. In phase I, the aim is to develop a web-based patient decision aid (PDA) in French with a steering committee and using a focus group of five women already treated for breast cancer. In phase II, the face validity of the decision aid will be assessed using questionnaires. In phase III, the PDA will be assessed by a two-arm randomised controlled trial. This will involve a quantitative evaluation of the PDA in clinical practice comparing the quality of the decision-making process between usual care and the PDA. The primary outcome will be informed choice and its components. The secondary outcomes will be decisional conflict and anxiety. Data will be collected during and after an oncofertility consultation. Phase III is underway. Since September 2018, 52 participants have been enrolled in the study and have completed the survey. We expect to have results by February 2020 for a total of 186 patients.Ethics and disseminationThis study protocol was approved by the Ouest V Research Ethics Board. Results will be spread through peer-reviewed publications, and reported at suitable meetings.Trial registration numberThe ClinicalTrials.gov registry .(NCT03591848).


2012 ◽  
Vol 12 (1) ◽  
Author(s):  
Martine HP Ickenroth ◽  
Janaica EJ Grispen ◽  
Nanne K de Vries ◽  
Geert-Jan Dinant ◽  
Glyn Elwyn ◽  
...  

2019 ◽  
Vol 76 (9) ◽  
pp. 595-602 ◽  
Author(s):  
Elizabeth Stratton ◽  
Isabella Choi ◽  
Rafael calvo ◽  
Ian Hickie ◽  
Claire Henderson ◽  
...  

ObjectivesMaking decisions about disclosing a mental illness in the workplace is complicated. Decision aid tools are designed to help an individual make a specific choice. We developed a web-based decision aid to help inform decisions about disclosure for employees. This study aimed to examine the efficacy of this tool.MethodWe conducted a randomised controlled trial with recruitment, randomisation and data collection all online. Participants had access to the intervention for 2 weeks. Assessments occurred at baseline, postintervention and 6 weeks’ follow-up. The primary outcome was decisional conflict. Secondary outcomes were stage and satisfaction of decision-making and mental health symptoms.Results107 adult employees were randomised to READY (n=53) or the control (n=54). The sample was predominantly female (83.2%). Participants using READY showed greater reduction in decisional conflict at postintervention (F(1,104)=16.8, p<0.001) (d=0.49, 95% CI 0.1 to 0.9) and follow-up (F(1,104)=23.6, p<0.001) (d=0.61, 95% CI 0.1 to 0.9). At postintervention the READY group were at a later stage of decision-making (F(1,104)=6.9, p=0.010) which was sustained, and showed a greater reduction in depressive symptoms (F(1,104)=6.5, p=0.013). Twenty-eight per cent of READY users disclosed, and reported a greater improvement in mental health than those who did not disclose.ConclusionsREADY provides a confidential, flexible and effective tool to enhance employee’s decision-making about disclosure. Its use led to a comparative improvement in depressive symptoms compared with the current information provided by a leading mental health non-governmental organisation, without apparent harm. READY seems worth evaluating in other settings and, if these results are replicated, scaling for wider use.Trial registration numberACTRN12618000229279.


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