ArticleContemporary clinical trials communications2018
Phase II Randomised Controlled Trial of a patient decision-aid website to improve treatment decision-making for young adults with bipolar II disorder: A feasibility study protocol.
Article in Contemporary clinical trials communications, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
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6 authors at 2 institutions in 1 country.
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No grant is acknowledged in the PubMed record.
Abstract
BACKGROUND/
aimsThis paper describes the protocol for a feasibility study for a parallel Phase II randomised control trial (RCT) aiming to evaluate a novel decision-aid website (e-DA) to support young adults with bipolar II disorder (BPII), and their families. MATERIAL AND
methodsThe e-DA was developed according to the International Patient Decision-Aid Standards (IPDAS). Participants will be 40 young adults (18-30 years) referred to a specialist outpatient clinical facility, who have a confirmed clinical diagnosis of BPII. Participants will be randomised (1:1) to receive access to the clinic's online factsheets/website with (Intervention) or without (Control) the e-DA. A series of validated and purpose-designed questionnaires will be administered at baseline (T0), immediately post-decision (T1), and 3 months post-decision (T2). Questionnaires assess key decision-making constructs related to decision-making quality, including: decisional conflict, subjective and objective treatment knowledge, values-based informed choice, concordance between preferred/actual decision-making involvement, preparation for decision-making, and decisional regret. Self-report symptom severity and anxiety will ascertain the safety of e-DA use. The focus of analyses will be to assess effect sizes, in order to guide a future RCT. DISCUSSION: This feasibility study will evaluate a world first, evidence-based online decision-support resource, a DA website, for young adults with BPII and their families who are deciding on treatment options for relapse prevention. Findings will determine the e-DA's feasibility in RCT procedures (i.e., outpatient clinical setting) and provide estimates of effect sizes on outcomes related to improving treatment decision-making and patient outcomes in a sample of potential end-users, compared to usual care.
trial registrationThis trial is registered with the Australian New Zealand Clinical Trials Registry (ANZCTR) - ACTRN12617000840381.
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