DizzinessNCT00732797
A Trial of Booklet Based Self Management of Dizziness
A study testing Self-treatment booklet and Remote telephone support in people with Dizziness, run by University of Southampton at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dizziness
- What is being tested?
- Self-treatment booklet and Remote telephone support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 337 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 2008to Jun 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Cost-effectiveness of Booklet-based Self-management of Dizziness in Primary Care, With and Without Expert Telephone Support
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.
Read the detailed description
Chronic dizziness has a prevalence of up to 25% in the community, and 1 in 10 working age adults and 1 in 5 older people report some degree of handicap due to dizziness. Dizziness can lead to reduced quality of life, anxiety and emotional distress, loss of fitness, unsteadiness and vulnerability to falling. Reviews of the management of dizziness have concluded that no medication has well-established value or is suitable for long-term use, and vestibular rehabilitation (VR) is now recommended as the treatment of choice. Professor Lucy Yardley has carried out trials showing that chronic dizziness can be treated effectively using a self-help booklet to teach patients vestibular rehabilitation exercises that promote neurological adaptation and skill and confidence in balance. These exercises are carried out for 10 minutes twice daily at home, and involve gently increasing the speed of making normal head movements. However, brief support from a trained nurse was provided in these trials, and this model of managing dizzy patients has not been taken up due to a lack of skills and resources in primary care.
We have received funding to evaluate the cost-effectiveness of two new models of delivery of vestibular rehabilitation. Our primary aim is to test the hypothesis that provision of the self-help booklet teaching vestibular rehabilitation exercises, with up to one hour of remote telephone support from an expert vestibular therapist, will be more effective than routine care in reducing symptoms (and therefore also disability and handicap) in dizzy patients in primary care. We will also explore the extent to which patients may benefit from provision of the self-help booklet without support. We 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.
This trial involves patients taking part in either a 12 week self-treatment programme (with or without telephone support from an expert vestibular therapist) or routine care, and completing questionnaires before and after the self-treatment, and also one year later. We will recruit 330 participants with dizziness who are registered with 30 general practices around Southampton and Berkshire. The trial will be carried out approximately between June 2008 and June 2011.
- Conditions
- Dizziness
- Being tested
- Self-treatment booklet, Remote telephone support
- Keywords
- Dizziness, Self-management, booklet-based, vestibular rehabilitation
- Medical subject headings
- Dizziness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-treatment bookletBehavioural
A booklet outlining vestibular rehabilitation exercises
Remote telephone supportBehavioural
Up to an hour's remote support from an expert vestibular therapist
| Study group | Role | What they receive |
|---|---|---|
| Routine Care | No intervention | Participants will receive routine care. |
| Booklet | Active comparator | Participants will receive self-treatment booklets, but no expert telephone support. Receives: Behavioral: Self-treatment booklet |
| Booklet &Therapist Support | Active comparator | Participants will receive self-treatment booklets, and up to an hour's expert telephone support. Receives: Behavioral: Self-treatment booklet; Behavioral: Remote telephone support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-reported measures of dizziness
Measured: Measured at beseline, 12 weeks and 1 year.
Secondary outcomes (1)
Quality of life effects of dizziness
Measured: Measured at baseline, 12 weeks and 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2008 (estimated)
- Study startOct 2008
- Primary completionJan 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 337 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southampton
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lucy Yardley, Principal investigator, University of Sothampton
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00732797
- Sponsor's protocol ID
- PB-PG-0107-12069
- Other IDs
- 08/H0504/31
- Status last verified
- Jan 2022
- First submitted
- 7 Aug 2008
- Last updated
- 18 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 25986639Yardley 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.
PubMed 22674920Yardley 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.
PubMed 20098640
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Cost-effectiveness of Booklet-based Self-management of Dizziness in Primary Care, With and Without Expert Telephone Support
- ClinicalTrials.gov ID
- NCT00732797
- Acronym / sponsor ID
- PB-PG-0107-12069
- Conditions
- Dizziness
- Keywords
- Dizziness, Self-management, booklet-based, vestibular rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 337 participants (actual)
- Lead sponsor
- University of SouthamptonUniversity, hospital or other
- Study start
- Oct 2008
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 12 Aug 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Chronic dizziness has a prevalence of up to 25% in the community, and 1 in 10 working age adults and 1 in 5 older people report some degree of handicap due to dizziness. Dizziness can lead to reduced quality of life, anxiety and emotional distress, loss of fitness, unsteadiness and vulnerability to falling. Reviews of the management of dizziness have concluded that no medication has well-established value or is suitable for long-term use, and vestibular rehabilitation (VR) is now recommended as the treatment of choice. Professor Lucy Yardley has carried out trials showing that chronic dizziness can be treated effectively using a self-help booklet to teach patients vestibular rehabilitation exercises that promote neurological adaptation and skill and confidence in balance. These exercises are carried out for 10 minutes twice daily at home, and involve gently increasing the speed of making normal head movements. However, brief support from a trained nurse was provided in these trials, and this model of managing dizzy patients has not been taken up due to a lack of skills and resources in primary care.
We have received funding to evaluate the cost-effectiveness of two new models of delivery of vestibular rehabilitation. Our primary aim is to test the hypothesis that provision of the self-help booklet teaching vestibular rehabilitation exercises, with up to one hour of remote telephone support from an expert vestibular therapist, will be more effective than routine care in reducing symptoms (and therefore also disability and handicap) in dizzy patients in primary care. We will also explore the extent to which patients may benefit from provision of the self-help booklet without support. We 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.
This trial involves patients taking part in either a 12 week self-treatment programme (with or without telephone support from an expert vestibular therapist) or routine care, and completing questionnaires before and after the self-treatment, and also one year later. We will recruit 330 participants with dizziness who are registered with 30 general practices around Southampton and Berkshire. The trial will be carried out approximately between June 2008 and June 2011.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Routine Care | No intervention | –Participants will receive routine care. |
| Booklet | Active comparator | Behavioral: Self-treatment bookletParticipants will receive self-treatment booklets, but no expert telephone support. |
| Booklet &Therapist Support | Active comparator | Behavioral: Self-treatment booklet, Behavioral: Remote telephone supportParticipants will receive self-treatment booklets, and up to an hour's expert telephone support. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- Non-Labyrinthe cause of dizziness identified by GP
- Medical contraindications from making normal head movements
- Serious co-morbidity
- Moved away from practice
- Recently deceased
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self-treatment bookletA booklet outlining vestibular rehabilitation exercises | Behavioural | Booklet, Booklet &Therapist Support |
| Remote telephone supportUp to an hour's remote support from an expert vestibular therapist | Behavioural | Booklet &Therapist Support |
Primary outcome
Self-reported measures of dizziness
Time frame: Measured at beseline, 12 weeks and 1 year.
1 secondary outcome
Quality of life effects of dizziness
Time frame: Measured at baseline, 12 weeks and 1 year.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2022.
- Derived from this study: PubMed 25986639Muller 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.
- Derived from this study: PubMed 22674920Yardley 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.
- Derived from this study: PubMed 20098640Yardley 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lucy Yardley principal investigator
University of Sothampton
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-treatment booklet and Remote telephone support in people with Dizziness, run by University of Southampton at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-reported measures of dizziness (time frame: Measured at beseline, 12 weeks and 1 year.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00732797, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2022.