What is the Perceived Role of Risk in DOC Healthcare.

NCT06647433 | Recruiting

• 1 other identifier: 24051
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Disorders of Consciousness

Keywords

Disorders of Consciousness; Decision making

Outcome Measures

Primary Outcomes (1)

• 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.

  2 years

Interventions

Observation OTHER

case study will be observed participants, methods will include observation, interview and video reflexive ethnography

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

people in a doc

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Nottingham: lead
• Royal Hospital for Neuro-disability: collaborator

Study Sites (2)

Royal Hospital for Neurodisability

London, London, SW15 3SW, United Kingdom

RECRUITING

University of Nottingham

Nottingham, NG7 2HA, United Kingdom

NOT YET RECRUITING

MeSH Terms

Conditions

Consciousness Disorders

Interventions

Observation

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Central Study Contacts

Teresa Clark, PhD Candidate UON

CONTACT

800-555-5555; teresa.clark@nottingham.ac.uk

Alison Edgley

CONTACT

800-555-5555; alison.edgley@nottingham.ac.uk

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2024
• First Posted: October 17, 2024
• Study Start: May 1, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: July 10, 2025

Record last verified: 2025-03

Locations

GB (2)