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NCT Number: NCT06647433

What is the Perceived Role of Risk in DOC Healthcare.

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Royal Hospital for Neurodisability, London, United Kingdom

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

observation

Other

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

Primary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Alison Edgley

CONTACT

[email protected]

800-555-5555

Teresa Clark, PhD Candidate UON

CONTACT

[email protected]

800-555-5555

Sponsors and collaborators

Lead sponsor

University of Nottingham

Other

Collaborators

  • Royal Hospital for Neuro-disability

Registry information

Official study title

What is the Perceived Role of Risk in the Healthcare Received by People in Disorders of Consciousness (DOC)?

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Oct 17, 2024
Registry last updated
Jul 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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