- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04260568
How do Individuals Respond to a Diagnosis of 3PD
How do Individuals Make Sense of and Respond to a Diagnosis of Persistent Postural Perceptual Dizziness (3PD)
No studies have explored how patients with chronic dizziness react to a diagnosis of Persistent Postural Perceptual Dizziness (3PD) and their beliefs and representations of the diagnostic label. Investigating the experience of diagnostic labelling from the perspective of patients will allow clinicians to recognise whether this is a helpful term to adopt and ways to improve the clinical consultation.
This is a qualitative study that will consist of semi-structured interviews with people with a new diagnosis of 3PD. The main objective of the study is to explore how patients react to this diagnostic label, what they understand about their diagnosis and how their own meanings affect their expectations and illness perceptions. Between 12-15 patients will be recruited from the balance clinic at Guy's Hospital, London, UK. The qualitative data will be analysed using thematic analysis which will draw on pragmatic interpretive descriptive methodology.
Study Overview
Status
Intervention / Treatment
Detailed Description
Semi-structured interviews will be conducted with patients, following a topic guide, which may be updated iteratively during the data collection period in response to ideas that may be generated. The topic guide explores key topics: (1) the patient's narrative; (2) the illness experience; (3) receiving the diagnosis; (4) their understanding of the 3PD label and beliefs; (5) expectations of recovery and treatment; (6) psychological and emotional factors; and (7) free comments. The interviews will be audio recorded and transcribed verbatim.
Data will be analysed using inductive thematic analysis. Analysis will be conducted concurrently with data collection, allowing themes to be explored inductively as they emerge. Analysis will be performed by a multidisciplinary group consisting of a medical student, audio-vestibular physician and physiotherapist.
Analysis will be conducted with the aid of the latest version of computer software NVIVO for Windows. The medical student will lead the analysis, generating the initial codes which will then be discussed in data analysis meetings held regularly over the data collection and analysis period until the group are happy with the coding and themes generated. Data collection and analysis will be approached with critical reflexivity in order to reduce the risk of bias. The team will ensure the analysis is grounded in the data.
Patients will be included if they meet the diagnostic criteria for Persistent Postural Perceptual Dizziness (3PD). Patients will be excluded if they;
- Do not speak English or have special communication needs.
- Have cognitive impairment.
- Have acute severe psychiatric disorder (e.g. psychosis).
The investigators plan to interview a minimum of 12 participants and review the need for further interviews up to 15 participants if there are new themes developing (i.e. if the investigators have not reached data 'saturation').
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
London, United Kingdom, SE1 9RT
- Louisa Murdin
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
• Patients who attend the balance clinic at Guy's Hospital and are diagnosed with Persistent Postural Perceptual Dizziness (3PD).
Exclusion Criteria:
- Patients who do not speak English or have special communication needs.
- Patients with cognitive impairment.
- Patients with acute severe psychiatric disorder (e.g. psychosis)
Study Plan
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Persistent Postural Perceptual Dizziness
Semi-structured interviews
|
Patients with a diagnosis of 3PD will be sought from a multidisciplinary balance clinic.
Consenting participants will take part in a face-to-face interview about their diagnosis.
Data collection will consist of recorded semi-structured interviews, which will be transcribed.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Experiences and views of patients with a new diagnosis of 3PD
Time Frame: 5 months
|
To explore what people understand about the diagnosis of 3PD and how their own meanings affect their expectations and illness perceptions.
|
5 months
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Louisa Murdin, Guy's and St Thomas' NHS Foundation Trust
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 269319
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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