ArticleJMIR research protocols2018
A Digital Health App to Assess Decisional Capacity to Provide Informed Consent: Protocol for a Randomized Controlled Trial.
Article in JMIR research protocols, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02465931 (Decisional Capacity and Informed Consent in Fragile X Syndrome), which is not on this map. Cited by 3 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Decisional Capacity and Informed Consent in Fragile X Syndrome
Who cites it
3 citing papers in PubMed.
- Supplementing Consent for a Prospective Longitudinal Cohort Study of Infants With Antenatal Opioid Exposure: Development and Assessment of a Digital Tool.JMIR formative research · 2025Observational
- Guidelines for the Creation of Accessible Consent Materials and Procedures: Lessons from Research with Autistic People and People with Intellectual Disability.Autism in adulthood · 2025Article
- Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors.
Funding
Abstract
backgroundAny study with human subjects must have a robust consent process to ensure that participants understand the study and can decide whether they want to be involved. Investigators must determine whether a potential study participant is able to make an informed decision and what modifications or supports are needed to maximize participation in decision making. A variety of approaches have been used to modify consent forms and the consent process to increase the research participants' decisional capacity. This protocol describes a randomized controlled trial (RCT) of a digital health app to support decision making among individuals contemplating providing consent to participate in a clinical trial.
objectiveThe objective of this RCT will be to determine if the use of a tablet-based app facilitates greater participation in and satisfaction with the consent process compared with standard practice and identify which individual factors are associated with better response to the decision aid. We hypothesize that the tablet-based version of the consent process will promote more informed decision making, including decisions that are more consistent with individual preferences and values expressed during qualitative data collection.
methodsA two-arm RCT will be conducted in a sample of approximately 100 individuals with fragile X syndrome in their homes across the United States.
resultsData analysis will be completed by late 2018.
conclusionsBy developing and testing a novel consent decision aid, we will have a better understanding of whether and how technological support can optimize the fit between the decisional capacity and the decisional process.
trial registrationClinicalTrials.gov NCT02465931; https://clinicaltrials.gov/ct2/show/NCT02465931 (Archived by WebCite at http://www.webcitation.org/72Q3xJQAw). INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/10360.
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