Persistent Postural Perceptual DizzinessNCT04260568
How do Individuals Respond to a Diagnosis of 3PD
An observational study of Persistent Postural Perceptual Dizziness and Vestibular Disease, run by Guy's and St Thomas' NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Persistent Postural Perceptual Dizziness, Vestibular Disease, Chronic Dizziness
- What is being tested?
- Semi-structured interviews
- How many people
- 13 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 8 Nov 2019to 22 Jan 2020
- Phase
- Observational
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
- No healthy volunteers
- Adult, Older adult
Study population: Patients with Persistent Postural Perceptual Dizziness (3PD)
Who may be able to join
- Patients who attend the balance clinic at Guy's Hospital and are diagnosed with Persistent Postural Perceptual Dizziness (3PD).
Who cannot join
- Patients who do not speak English or have special communication needs.
- Patients with cognitive impairment.
- Patients with acute severe psychiatric disorder (e.g. psychosis)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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').
- Being tested
- Semi-structured interviews
- Keywords
- PPPD, dizziness, Illness perceptions, qualitative
- Medical subject headings
- Vestibular Diseases, Dizziness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Semi-structured interviewsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Persistent Postural Perceptual Dizziness | Semi-structured interviews Receives: Other: Semi-structured interviews |
What is being measured
The primary outcome is the main question the study is designed to answer.
Experiences and views of patients with a new diagnosis of 3PD
To explore what people understand about the diagnosis of 3PD and how their own meanings affect their expectations and illness perceptions.
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2020
- Study start8 Nov 2019
- Primary completion22 Jan 2020
- Study completion22 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Persistent Postural Perceptual DizzinessStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guy's and St Thomas' NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- King's College London
- Responsible party
- Sponsor
- Investigators
- Louisa Murdin, Principal investigator, Guy's and St Thomas' NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04260568
- Sponsor's protocol ID
- 269319
- Status last verified
- Feb 2020
- First submitted
- 5 Feb 2020
- Last updated
- 31 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No