Cognitive DysfunctionNCT03258606
Characteristics and Outcomes of a Capacity-to-Consent Assessment Service
An observational study of Cognitive Dysfunction, run by National Institutes of Health Clinical Center (CC) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 years and older
- Conditions the study is for
- Cognitive Dysfunction
- How many people
- 1,098 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jun 2017to 9 Apr 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All individuals who came to the NIH Clinical Center for possible enrollment in research whose capacity to consent or assent was evaluated by the Bioethics Consultation Service (BCS), the Human Subjects Protection Unit (HSPU), or the Ability to Consent Assessment Team (ACAT), and all surrogate decision makers of individuals who were unable to consent and were allowed by protocol to give surrogate consent.
Who may be able to join
- Participant ages 7 to 99
- Participants must have undergone some type of capacity evaluation, consent or assent monitoring, or surrogate assessment, by the BCS, HSPU, or ACAT.
- Children (or adults) who were seen by the consultation service for the purposes of either evaluating their ability to assent or for assent monitoring
Who cannot join
- -Pregnant women or prisoners will not be included
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
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.
Read more
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 at details of capacity evaluations.
Personal data will not be extracted from existing records.
Read the detailed description
Objective: To characterize the process and outcomes of capacity assessments of individuals who may be unable to consent to participate in research.
Study population: all individuals who came to the NIH Clinical Center for possible enrollment in research whose capacity to consent or assent was evaluated by the Bioethics Consultation Service (BCS), the Human Subjects Protection Unit (HSPU), or the Ability to Consent Assessment Team (ACAT), and all surrogate decision makers of individuals who were unable to consent and were allowed by protocol to give surrogate consent.
Design: Retrospective record review
Outcome measures: The primary outcome measure will be whether prospective research participants were judged to be able to consent or not. Secondary measures will include: whether the consulting team considered it ethically acceptable to enroll the participant in research; how consent was obtained for doing so; and descriptive features of the consults such as the Institute that requested the consult, protocols for which consults were requested, and diseases that prompted capacity assessments, among other descriptive characteristics.
- Conditions
- Cognitive Dysfunction
- Keywords
- Surrogate, Decision Making, Capacity to Consent, Cognitive Impairment, Enrollment, Natural History
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Individuals with affected capacity to consent | Individuals with who were unable to consent and were allowed by protocol to give surrogate consent. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Whether prospective research participants were judged to be able toconsent or not.
Whether the consulting team considered it ethically acceptable to enroll the participant in research and how consent was obtained for doing so.
Measured: At record review
Secondary outcomes (2)
Other measures that will be collected include demographics, results of the evaluation, kinds of research conducted and content of capacity assessments.
Other measures that will be collected include demographics, results of the evaluation, kinds of research conducted and content of capacity assessments.
Measured: At record review
Whether the consulting team considered it ethically acceptable toenroll the participant in research and how consent was obtained for doing so.
Whether the consulting team considered it ethically acceptable to enroll the participant in research and how consent was obtained fordoing so.
Measured: At record review
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2017
- Study start26 Jun 2017
- Primary completion10 Aug 2018
- Study completion9 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,098 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institutes of Health Clinical Center (CC)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Marion Danis, M.D., Principal investigator, National Institutes of Health Clinical Center (CC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03258606
- Sponsor's protocol ID
- 999917119
- Other IDs
- 17-CC-N119
- Status last verified
- Feb 2023
- First submitted
- 22 Aug 2017
- Last updated
- 24 Feb 2023
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characteristics and Outcomes of a Capacity-to-Consent Assessment Service
- ClinicalTrials.gov ID
- NCT03258606
- Acronym / sponsor ID
- 999917119
- Conditions
- Cognitive Dysfunction
- Keywords
- Surrogate, Decision Making, Capacity to Consent, Cognitive Impairment, Enrollment, Natural History
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,098 participants (actual)
- Lead sponsor
- National Institutes of Health Clinical Center (CC)US National Institutes of Health
- Study start
- 26 Jun 2017 (actual)
- Primary completion
- 10 Aug 2018 (actual)
- Study completion
- 9 Apr 2021 (actual)
- First posted
- 23 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 at details of capacity evaluations.
Personal data will not be extracted from existing records.
Detailed description
Objective: To characterize the process and outcomes of capacity assessments of individuals who may be unable to consent to participate in research.
Study population: all individuals who came to the NIH Clinical Center for possible enrollment in research whose capacity to consent or assent was evaluated by the Bioethics Consultation Service (BCS), the Human Subjects Protection Unit (HSPU), or the Ability to Consent Assessment Team (ACAT), and all surrogate decision makers of individuals who were unable to consent and were allowed by protocol to give surrogate consent.
Design: Retrospective record review
Outcome measures: The primary outcome measure will be whether prospective research participants were judged to be able to consent or not. Secondary measures will include: whether the consulting team considered it ethically acceptable to enroll the participant in research; how consent was obtained for doing so; and descriptive features of the consults such as the Institute that requested the consult, protocols for which consults were requested, and diseases that prompted capacity assessments, among other descriptive characteristics.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Individuals with affected capacity to consent | – | –Individuals with who were unable to consent and were allowed by protocol to give surrogate consent. |
Who may qualify
- Ages
- 7 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All individuals who came to the NIH Clinical Center for possible enrollment in research whose capacity to consent or assent was evaluated by the Bioethics Consultation Service (BCS), the Human Subjects Protection Unit (HSPU), or the Ability to Consent Assessment Team (ACAT), and all surrogate decision makers of individuals who were unable to consent and were allowed by protocol to give surrogate consent.
Key inclusion criteria (3 listed)
- Participant ages 7 to 99
- Participants must have undergone some type of capacity evaluation, consent or assent monitoring, or surrogate assessment, by the BCS, HSPU, or ACAT.
- Children (or adults) who were seen by the consultation service for the purposes of either evaluating their ability to assent or for assent monitoring
Key exclusion criteria (1 listed)
- -Pregnant women or prisoners will not be included
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Whether prospective research participants were judged to be able toconsent or not.
Time frame: At record review
Whether the consulting team considered it ethically acceptable to enroll the participant in research and how consent was obtained for doing so.
2 secondary outcomes
Other measures that will be collected include demographics, results of the evaluation, kinds of research conducted and content of capacity assessments.
Time frame: At record review
Whether the consulting team considered it ethically acceptable toenroll the participant in research and how consent was obtained for doing so.
Time frame: At record review
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marion Danis, M.D. principal investigator
National Institutes of Health Clinical Center (CC)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cognitive Dysfunction, run by National Institutes of Health Clinical Center (CC) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Whether prospective research participants were judged to be able toconsent or not. (time frame: At record review). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2023.