Disorders of ConsciousnessNCT06647433
What is the Perceived Role of Risk in DOC Healthcare.
An observational study of Disorders of Consciousness, run by University of Nottingham at 2 sites in United Kingdom.
Trial summary
Critical ethnography exploring how decisions are made on behalf of people in disorder of consciousness (DOC). Prospective longitudinal case study design including observation, field interview and video reflexive ethnography. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Disorders of Consciousness
- What is being tested?
- Observation
- How many people
- 40 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 1 May 2025to Jan 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: people in a doc
Who may be able to join
- People in a DOC:
- Working diagnosis of being in a DOC.
- Have an appropriate family member able to act as a consultee.
- Over 18 years of age.
- Family members and healthcare workers:
- conversational English.
Show all 9Show fewer
- able to give consent.
- over 18 years of age.
- Involved in decision making on behalf of a person in a DOC
Who cannot join
- Person in a Disorder of Consciousness
- Not in a DOC, diagnosis uncertain, or appears to be emerging.
- Clinically unstable or approaching the end of their life.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom2 sites, 2 recruiting
- Recruiting
Royal Hospital for Neurodisability
London, London, SW15 3SW
Clark, tclark@rhn.org.uk
- Not yet recruiting
University of Nottingham
Nottingham, NG7 2HA
Teresa Clark, +44 2087804500, teresa.clark@nottingham.ac.uk
About this study
Official title: What is the Perceived Role of Risk in the Healthcare Received by People in Disorders of Consciousness (DOC)?
Critical ethnography exploring how decisions are made on behalf of people in disorder of consciousness (DOC).
Prospective longitudinal case study design including observation, field interview and video reflexive ethnography.
- Conditions
- Disorders of Consciousness
- Being tested
- Observation
- Keywords
- Disorders of Consciousness, Decision making
- Medical subject headings
- Consciousness Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationOther
case study will be observed participants, methods will include observation, interview and video reflexive ethnography
What is being measured
The primary outcome is the main question the study is designed to answer.
Meaning based themes on what influences decision making in DOC
Thematic analysis (TA) will consolidate and develop themes across all data sources (i.e., interview and VRE transcripts, field notes). The planned TA approach will borrow theory from reflexive thematic analysis (Braun \& Clarke, 2022) and a critical realist TA approach which supports causal explanation development (Fryer, 2022). Causal research questions will be developed and refined throughout data collection and explored through TA.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2024
- Study start1 May 2025
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Disorders of ConsciousnessStudies of the same condition, open and under way.
- More trials run by University of NottinghamThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Collaborators
- Royal Hospital for Neuro-disability
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06647433
- Sponsor's protocol ID
- 24051
- Status last verified
- Mar 2025
- First submitted
- 16 Oct 2024
- Last updated
- 10 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- What is the Perceived Role of Risk in the Healthcare Received by People in Disorders of Consciousness (DOC)?
- ClinicalTrials.gov ID
- NCT06647433
- Acronym / sponsor ID
- 24051
- Conditions
- Disorders of Consciousness
- Keywords
- Disorders of Consciousness, Decision making
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Collaborators
- Royal Hospital for Neuro-disability
- Study start
- 1 May 2025 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 17 Oct 2024 (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.
Critical ethnography exploring how decisions are made on behalf of people in disorder of consciousness (DOC).
Prospective longitudinal case study design including observation, field interview and video reflexive ethnography.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- people in a doc
Key inclusion criteria (9 listed)
- People in a DOC:
- Working diagnosis of being in a DOC.
- Have an appropriate family member able to act as a consultee.
- Over 18 years of age.
- conversational English.
Key exclusion criteria (3 listed)
- Person in a Disorder of Consciousness
- Not in a DOC, diagnosis uncertain, or appears to be emerging.
- Clinically unstable or approaching the end of their life.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observationcase study will be observed participants, methods will include observation, interview and video reflexive ethnography | Other | – |
Primary outcome
Meaning based themes on what influences decision making in DOC
Time frame: 2 years
Thematic analysis (TA) will consolidate and develop themes across all data sources (i.e., interview and VRE transcripts, field notes). The planned TA approach will borrow theory from reflexive thematic analysis (Braun \& Clarke, 2022) and a critical realist TA approach which supports causal explanation development (Fryer, 2022). Causal research questions will be developed and refined throughout data collection and explored through TA.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2025.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Disorders of Consciousness, run by University of Nottingham at 2 sites in United Kingdom.
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 9 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 10 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Teresa Clark, PhD Candidate UON (800-555-5555, teresa.clark@nottingham.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Meaning based themes on what influences decision making in DOC (time frame: 2 years). 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 10 Jul 2025.