NCT00732797

Brief Summary

The investigators primary aim is to test whether or not provision of the self-help booklet teaching VR exercises, with up to one hour of telephone support from a vestibular therapist, will be more effective than routine care in reducing symptoms in dizzy patients in primary care. The investigators will also explore the extent to which patients may benefit from the self-help booklet without support. The investigators will determine whether these models of delivery are less costly than routine care of dizzy patients, as they should reduce the number of patients seeking referral to secondary care for unnecessary assessments.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
337

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2008

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 7, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 12, 2008

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2008

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

January 18, 2022

Status Verified

January 1, 2022

Enrollment Period

2.3 years

First QC Date

August 7, 2008

Last Update Submit

January 3, 2022

Conditions

Dizziness

Keywords

DizzinessSelf-managementbooklet-basedvestibular rehabilitation

Outcome Measures

Primary Outcomes (1)

  • Self-reported measures of dizziness

    Measured at beseline, 12 weeks and 1 year.

Secondary Outcomes (1)

  • Quality of life effects of dizziness

    Measured at baseline, 12 weeks and 1 year.

Study Arms (3)

Routine Care

NO INTERVENTION

Participants will receive routine care.

Booklet

ACTIVE COMPARATOR

Participants will receive self-treatment booklets, but no expert telephone support.

Behavioral: Self-treatment booklet

Booklet &Therapist Support

ACTIVE COMPARATOR

Participants will receive self-treatment booklets, and up to an hour's expert telephone support.

Behavioral: Self-treatment bookletBehavioral: Remote telephone support

Interventions

Self-treatment bookletBEHAVIORAL

A booklet outlining vestibular rehabilitation exercises

BookletBooklet &Therapist Support
Remote telephone supportBEHAVIORAL

Up to an hour's remote support from an expert vestibular therapist

Booklet &Therapist Support

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Be 18 years or over
  • Be registered with a participating GP
  • Must have visited their GP for dizziness in the last 2 years
  • Must complete the consent form, and baseline questionaire indicating they are still suffering from dizziness and that quick head movements make them dizzy.

You may not qualify if:

  • Non-Labyrinthe cause of dizziness identified by GP
  • Medical contraindications from making normal head movements
  • Serious co-morbidity
  • Moved away from practice
  • Recently deceased
  • Non-English speakers, and unable to read/write in English.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hampshire PCT and Berkshire PCT

Southampton, United Kingdom

Location

Related Publications (3)

  • Muller I, Kirby S, Yardley L. Understanding patient experiences of self-managing chronic dizziness: a qualitative study of booklet-based vestibular rehabilitation, with or without remote support. BMJ Open. 2015 May 18;5(5):e007680. doi: 10.1136/bmjopen-2015-007680.

    PMID: 25986639DERIVED

  • Yardley L, Barker F, Muller I, Turner D, Kirby S, Mullee M, Morris A, Little P. Clinical and cost effectiveness of booklet based vestibular rehabilitation for chronic dizziness in primary care: single blind, parallel group, pragmatic, randomised controlled trial. BMJ. 2012 Jun 6;344:e2237. doi: 10.1136/bmj.e2237.

    PMID: 22674920DERIVED

  • Yardley L, Kirby S, Barker F, Little P, Raftery J, King D, Morris A, Mullee M. An evaluation of the cost-effectiveness of booklet-based self-management of dizziness in primary care, with and without expert telephone support. BMC Ear Nose Throat Disord. 2009 Dec 29;9:13. doi: 10.1186/1472-6815-9-13.

    PMID: 20098640DERIVED

MeSH Terms

Conditions

Dizziness

Condition Hierarchy (Ancestors)

Sensation DisordersNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Lucy Yardley

    University of Sothampton

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 7, 2008

First Posted

August 12, 2008

Study Start

October 1, 2008

Primary Completion

January 1, 2011

Study Completion

June 1, 2011

Last Updated

January 18, 2022

Record last verified: 2022-01

Locations

GB(1)