- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06647433
What is the Perceived Role of Risk in DOC Healthcare.
July 4, 2025 updated by: University of Nottingham
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.
Study Overview
Study Type
Observational
Enrollment (Estimated)
40
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Teresa Clark, PhD Candidate UON
- Phone Number: 800-555-5555
- Email: teresa.clark@nottingham.ac.uk
Study Contact Backup
- Name: Alison Edgley
- Phone Number: 800-555-5555
- Email: alison.edgley@nottingham.ac.uk
Study Locations
-
-
-
London, United Kingdom, SW15 3SW
- Recruiting
- Royal Hospital for Neurodisability
-
Contact:
- Clark
- Email: tclark@rhn.org.uk
-
Nottingham, United Kingdom, NG7 2HA
- Not yet recruiting
- University of Nottingham
-
Contact:
- Teresa Clark
- Phone Number: +44 2087804500
- Email: teresa.clark@nottingham.ac.uk
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
people in a doc
Description
Inclusion Criteria:
- 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.
- able to give consent.
- over 18 years of age.
- Involved in decision making on behalf of a person in a DOC
Exclusion Criteria:
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 1, 2025
Primary Completion (Estimated)
January 1, 2027
Study Completion (Estimated)
January 1, 2027
Study Registration Dates
First Submitted
October 16, 2024
First Submitted That Met QC Criteria
October 16, 2024
First Posted (Actual)
October 17, 2024
Study Record Updates
Last Update Posted (Actual)
July 10, 2025
Last Update Submitted That Met QC Criteria
July 4, 2025
Last Verified
March 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 24051
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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