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NCT03258606 · ClinicalTrials.gov registry record
Characteristics and Outcomes of a Capacity-to-Consent Assessment Service
A clinical trial of Cognitive Dysfunction, sponsored by National Institutes of Health Clinical Center (CC).
- Completed
- Registry status
- 1,098
- Enrollment target
- 1
- Study location
NCT03258606: Completed study of Cognitive Dysfunction, sponsored by National Institutes of Health Clinical Center (CC).
NCT03258606 is a study of Cognitive Dysfunction that has completed, run by National Institutes of Health Clinical Center (CC). The registered enrollment target is 1,098 participants, below the 1,969-participant average among 45 other Cognitive Dysfunction trials with a reported enrollment target (44% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03258606, a study of Cognitive Dysfunction, has completed, sponsored by National Institutes of Health Clinical Center (CC).
- COMPLETED
- Registry status
- 1,098 participants
- Enrollment target
- 1
- Study location
Study Summary
Background: Many medical conditions such as Alzheimer s disease limit the ability of people to think clearly. For medical scientists to best study these medical conditions, they need to enroll some people who may not be able to consent to participate in research on their own. Before these individuals enroll in research it is important to assess whether they are able to consent or whether someone else will need to consent for them. The NIH Clinical Center has a team that performs these assessments. A team like this can be useful for two reasons. First, it helps to protect the rights of research participants. Second, it makes it possible to study medical conditions that could not be studied otherwise. In this study we will look back at the records of the NIH Clinical Center team to review the process and results of these assessments. We expect to learn how the capacity assessments were done. We will learn what factors make people more or less able to consent. We will learn who consented for the research participants when they could not consent on their own, for example a spouse or an adult child. These results are likely to be useful to other researchers who wish to study diseases that limit cognitive ability. Objective: To study the process and outcomes of capacity assessments of people who may not be able to consent to research. Eligibility: People of all ages, genders, races, ethnicities, and languages whose ability to consent was assessed at the NIH Clinical Center at some time during the years 1999-2016. Design: This study will only review existing records. There will not be any active participants. Records will be reviewed for research only. This will take place in the Clinical Center. It will be done by staff of the Department of Bioethics and the Human Subjects Protection Unit (HSPU). The study will collect data from the Bioethics Consult database. It will also collect data from HSPU records. Researchers will look at demographic data. They will look
Primary Outcome
Whether the consulting team considered it ethically acceptable to enroll the participant in research and how consent was obtained for doing so.
Conditions Studied
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,098 participants |
| Start Date | 2017-06-26 |
| Est. Completion | 2021-04-09 |
What the finished NCT03258606 record still lists
NCT03258606 is an observational study that tracks outcomes without assigning an intervention. Its 1,098 participants enrollment target places it among the larger protocols in the corpus, below the 1,969-participant average among 45 other Cognitive Dysfunction trials with a reported enrollment target (44% lower).
The record links to 1 condition, with Cognitive Dysfunction appearing as the primary indexed condition, and to 0 interventions.
NCT03258606 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT03258606 about?
NCT03258606 is a clinical study titled "Characteristics and Outcomes of a Capacity-to-Consent Assessment Service". Background: Many medical conditions such as Alzheimer s disease limit the ability of people to think clearly. For medical scientists to best study these medical conditions, they need to enroll some people who may not be able to consent to participate in research on their own. Before these individua...
What is the current status of trial NCT03258606?
This trial is currently completed. The enrollment target is 1,098 participants. The study started on 2017-06-26. Estimated completion is 2021-04-09.
What conditions does trial NCT03258606 study?
This clinical trial studies the following conditions: Cognitive Dysfunction.
Who is sponsoring clinical trial NCT03258606?
This trial is sponsored by National Institutes of Health Clinical Center (CC), which has 338 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03258606 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03258606's enrollment target sits among peer trials
1,098 5th of 45 higher than 41 of 45 other Cognitive Dysfunction trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cognitive Dysfunction trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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