Objective 1
Readability: How clear and accessible do participants find the Informed Consent document?
Use CaseDCT Design and Informed Consent
Leveraging the Patient Voice to Collect Parkinson’s Disease Patient and Caregiver Input on a DCT Informed Consent document
In preparation for a soon-to-launch decentralized clinical trial (DCT), our client wished to understand how participants react to and interpret the Informed Consent, particularly regarding the Study Purpose, Participant Responsibilities, and Potential Risks & Benefits.
Industry:Pharmaceutical
Type:Decentralized Clinical Trial (DCT)
TrialPulseDCT DesignInformed ConsentDecentralized Clinical TrialParkinson's DiseasePatient ExperienceVoice ResearchDocument Testing
Objective 2
Red flags: What questions or concerns does the Informed Consent document raise for trial participation?
Objective 3
Raising the bar: How could the Informed Consent document be improved or optimized to better support DCT recruitment and retention?
The inVibe Solution
The inVibe Solution
inVibe’s TrialPulse solution allowed our pharmaceutical client to quickly and efficiently deploy a voice-powered research study to validate and optimize the Informed Consent document.
- Voice-powered research methodology
- 48-hour rapid recruitment capability
- Automated phone interview system
- Advanced NLP tools
- Speech-emotion recognition capabilities
- Interactive online dashboard
- Multi-dimensional analysis (content, language patterns, emotional assessment)
How We Did It
1
Collect
Collect
Within 48 hours, inVibe recruited 20 Parkinson’s disease patients and loved ones. Participants joined automated phone interviews via computer or smartphone to share how they interpreted the informed consent, the hybrid design, and the required technology.
Participants
Total: 20 Parkinson’s disease patients and care partners across journey stages
Recruitment Time: 48 hours
Method: Automated phone interviews via computer or smartphone
Key Questions
Q1
Take a moment to share your overall thoughts regarding the document you just reviewed. What parts of the document stood out most to you – and for what reasons?
Q2
This study uses a unique design where part of the research occurs at the doctor’s office, and part takes place at your home. What do you think about this design? Would you be more likely to participate if more visits were at home or if more were at your doctor’s office? Why or why not?
Q3
The study asks you to wear a wrist device and use a tablet to complete certain study requirements at home. Do you have concerns about this portion of the study? And if so, what could improve the at-home parts of the research?
Q4
Let’s talk about the section regarding potential risks. Based on what you reviewed in the document, what are the biggest potential risks for participating in this trial? Do you see any of these risks as dealbreakers? Why or why not?
2
Analyze
inVibe’s analysts leveraged their language expertise and advanced NLP tools to process, evaluate and analyze multiple aspects of each response, including content, language, and emotion derived from speech-emotion recognition, allowing for deeper insights, faster.
Techniques
- Advanced NLP tools
- Language expertise analysis
- Speech-emotion recognition
Focus Areas
- What is Said: Content and themes
- How it’s Said: Language patterns and construction
- How it Sounds: Emotional assessment
3
Deliver
Deliver
The client was provided with an interactive report via an online dashboard, along with the voice data, transcripts, and a high-level analysis. An in-house analyst walked the client through the most meaningful data, supporting each insight with specific voice data.
- Interactive online dashboard housing voice data, transcripts, and analysis
- In-house analyst walkthrough supporting insights with participant voice moments
- Audiogram tools to create kinetic text videos
- Listening Labs interactive stories assembled from transcripts, audio, and charts
- Expert Perspective sessions led by inVibe analysts
Revised the hybrid DCT informed consent to clarify risks, explain procedures, and reassure participants about support.
The updated document now underpins recruitment and retention planning by addressing the concerns patients raised.
Insights & Next Steps
Key Insights & Recommendations
Based on the insights, inVibe recommended that the team take the following actions to optimize their informed consent.
Side effects
Patients expressed concern about the lack of details related to potential side-effects. This led them to make assumptions, which caused additional worry. inVibe recommended simple formatting and data visualization revisions to the Potential Risks and Discomforts section in order to simplify and clarify.
Decentralized design
Most patients felt the study’s hybrid design strikes the right balance of in-home and in-office visits for this patient population. inVibe recommended including references to technical support for digital aspects of the study in order to address minor concerns.
Risks of participation
The trial requirement for lumbar punctures was a red flag for some patients, who expressed confusion as to how such a procedure related to Parkinson’s. inVibe recommended explaining the diagnostic function of lumbar puncture procedures throughout the study to assuage concerns.
