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Implement and Test Visual Consent Template and Process

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The investigators plan to conduct a stepped wedge randomized control trial to implement and test the consent template and process in three studies. Randomization will occur at the research coordinator/research team level. Each participating research team member will begin in the standard consent arm of the study. Subsequently, they will be randomized to the visual key information page arm at staggered time points to undergo training and begin using the visual key information page with patients who are eligible for the selected research study.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• Written informed consent was obtained to participate in the study and HIPAA authorization for release of personal health information.

∙ Participant is willing and able to comply with study procedures based on the judgment of the investigator.

∙ Age ≥ 18 years at the time of consent.

∙ Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1.

∙ Consent to a mandatory pre-study biopsy if archival tissue is not available or sufficient.

∙ Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen.

⁃ Washington University:

‣ Returning Research Results That Indicate Risk of Alzheimer Disease Dementia to Healthy Participants in Longitudinal Studies (WeSHARE)

• Participants of the Knight Alzheimer Disease Research Center.

∙ Participants with available results from an Alzheimer Disease blood biomarker test.

∙ Participants who agreed to be contacted for additional research studies.

⁃ University of Utah:

‣ Huntsman Cancer Institute Total Cancer Care

• Participants who have been diagnosed with any type of tumor or cancer.

∙ Participants with genetic predispositions or family history of cancer or tumors.

∙ Participant volunteers willing to share samples and data for research.

⁃ Eligibility Criteria for Research Staff:

• Research staff/coordinators of one of the three participating trials at Washington University, University of Utah, or University of North Carolina at Chapel Hill.

Locations
United States
Missouri
Washington University School of Medicine
RECRUITING
St Louis
North Carolina
University of North Carolina at Chapel Hill School of Medicine
RECRUITING
Chapel Hill
Utah
University of Utah Huntsman Cancer Institute (HCI)
RECRUITING
Salt Lake City
Contact Information
Primary
Mary Politi, Ph.D.
mpoliti@wustl.edu
314-747-1967
Backup
Krista Cooksey, B.A.
kcooksey@wustl.edu
314-747-5657
Time Frame
Start Date: 2025-03-10
Estimated Completion Date: 2026-06-30
Participants
Target number of participants: 515
Treatments
Active_comparator: Research Staff: Standard Consent
Each participating research team member will begin in the standard consent arm of the study. The standard consent consists of a summary using text only.
Experimental: Research Staff: Visual Consent
After beginning in the standard consent arm, the research staff will then be randomized to the visual key information page arm at staggered time points to undergo training and begin using the visual key information page with patients who are eligible for the selected research study. Research staff will also complete a baseline survey to assess feasibility, acceptability, and appropriateness of using visual consent pages as well as their institution's willingness and ability to implement using visual key information pages into routine care. Research staff will also complete a post-study survey on attitudes toward consent, the intervention (feasibility, acceptability, appropriateness of the intervention), organizational readiness for participant engagement, and willingness to continue the invention.
Experimental: Participants: Visual Consent
Participants will view the visual consent summary and will complete surveys with measures of knowledge, satisfaction with the information, decisional conflict, and potential covariates (i.e., demographics and health literacy).
Active_comparator: Participants: Standard Consent
Participants will view the standard consent consisting of summary text only and will complete surveys with measures of knowledge, satisfaction with the information, decisional conflict, and potential covariates (i.e., demographics and health literacy).
Related Therapeutic Areas
Sponsors
Leads: Washington University School of Medicine
Collaborators: Agency for Healthcare Research and Quality (AHRQ)

This content was sourced from clinicaltrials.gov