A Digital Health App to Assess Decisional Capacity to Provide Informed Consent: Protocol for a Randomized Controlled...

Area of Science:

• Clinical Trials
• Digital Health
• Informed Consent

Background:

• Robust informed consent is crucial for human subject research, ensuring participants understand studies and can make autonomous decisions.
• Assessing and supporting participants' decisional capacity is essential for ethical research participation.
• Existing methods to enhance consent processes have limitations; novel approaches are needed.

Purpose of the Study:

• To evaluate a tablet-based digital health app designed to support decision-making during the informed consent process.
• To compare participant engagement and satisfaction with the app-assisted consent versus standard consent procedures.
• To identify factors influencing individual responses to the digital consent decision aid.

Main Methods:

• A two-arm randomized controlled trial (RCT) involving approximately 100 individuals with fragile X syndrome.
• Participants will be recruited from homes across the United States.
• The study will compare a digital health app intervention against standard consent practices.

Main Results:

• Data analysis is scheduled for completion by late 2018.
• Results will indicate the effectiveness of the digital app in improving the consent process.

Conclusions:

• Developing and testing a novel digital consent decision aid can enhance understanding of technology's role in optimizing decisional capacity.
• This research aims to improve the alignment between participants' decision-making abilities and the complexities of the consent process.
• Findings will inform the development of more effective and supportive informed consent strategies in clinical research.