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Internet-based Self-help Program for Vestibular Rehabilitation in Chronic Dizziness

Primary Purpose

Vertigo

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Internet-based self-help program
Sponsored by
Helse Møre og Romsdal HF
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vertigo focused on measuring Rehabilitation, Telerehabilitation, Internet, Norway

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Satisfy diagnostic criteria for persistent positional perceptual dizziness (PPPS) or satisfy criteria with a duration of <3 months
  • Vertigo symptom scale (VSS-SF) >12

Exclusion Criteria:

  • Cognitive dysfunction that is so pronounced that it will make participation difficult
  • Unable to read, understand Norwegian
  • Severe medical or psychiatric illness (including substance abuse) that reduces the patient's ability to follow the VR program

Sites / Locations

  • Molde sykehus

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Follows the internet-based self-help program

Arm Description

Outcomes

Primary Outcome Measures

user experience ease of use
semi-structured conversation interview with score tools. The ease of use of the course will be scored in a 7 question questionnaire, rated 1-7 from very good to very bad. The questions are whether the program worked well, was boring, if it was the right dose of exercises, if the text was understandable, instructive, how was the yield and degree of subjective improvement. Participants will also be asked for preparation suggestions.
Symptom change
The Niigata persistent positional perceptual dizziness (PPPD) Questionnaire (NPQ) contains 12 questions in which patients answer questions about provocation from three aggravating factors of PPPD (upright posture / gait, movement and visual stimulation). Each factor is evaluated using questions that score the severity from 0 (none) to 6 (unbearable) ailments
Symptom change
VSS - vertigo symptom score form. Consists of 15 questions. Each answer is scored on a 5-point scale (0-4), and a measure of the severity of the symptoms is obtained by summing. The total score ranges from 0-60, higher scores indicate more serious problems. Severe dizziness is defined as ≥ 12 points on the total scale. The scale includes two subscales: 8 selected questions related to vertigo and balance (score ranging from 0-32), and 7 selected questions related to autonomic anxiety symptoms (score ranging from 0-28)

Secondary Outcome Measures

Full Information

First Posted
June 29, 2020
Last Updated
February 9, 2021
Sponsor
Helse Møre og Romsdal HF
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1. Study Identification

Unique Protocol Identification Number
NCT04458376
Brief Title
Internet-based Self-help Program for Vestibular Rehabilitation in Chronic Dizziness
Official Title
Internet-based Self-help Program for Vestibular Rehabilitation in Chronic Dizziness; a Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
September 1, 2020 (Actual)
Primary Completion Date
February 9, 2021 (Actual)
Study Completion Date
February 9, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Helse Møre og Romsdal HF

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Chronic dizziness,or persistent positional perceptual dizziness (PPPS) is a common condition that results in impaired quality of life and work ability of those affected. Vestibular Rehabilitation (VR) is an evidence-based and recommended treatment for chronic dizziness. The treatment involves training in specific exercises that challenge the balance system and eventually improve dizziness. The main challenge with this treatment is that it is usually best provided with individual follow-up of therapists trained in the method. Limited resources and the lack of dissemination of this knowledge mean that only a minority of patients receive adequate treatment. An internet-based self-help program in vestibular rehabilitation has been developed in Norwegian with demonstration and instructions of exercises. The program has six lessons, together lasting for six weeks. Patients are given the opportunity to exercise at home, without the use of treatment resources and without spending time traveling to the treatment site. Patients will have access through their general practitioner or health institution at no extra cost. If it turns out that the program works according to the intention, the investigators will be able to offer VR to a large number of PPPS patients who previously would not receive treatment for their condition. The aim of the pilot study is to find out if the internet program for PPPS works as intended and evaluate incoming data and make changes to the program. In addition, the investigators will gain experience in using the program before designing a randomized clinical trial (RCT). The aim of such an RCT would be to compare this internet based treatment to traditional treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vertigo
Keywords
Rehabilitation, Telerehabilitation, Internet, Norway

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Consecutively recruited at Department of Neurology at Molde County hospital, outpatient clinic.
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Follows the internet-based self-help program
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Internet-based self-help program
Intervention Description
The program is divided into six short weekly lessons providing information about chronic dizziness and vestibular rehabilitation, and demonstrating the exercises by video. The program is freely available in the Norwegian electronic handbook for physicians (NEL). The participants in the study will receive the internet address after inclusion in the study.
Primary Outcome Measure Information:
Title
user experience ease of use
Description
semi-structured conversation interview with score tools. The ease of use of the course will be scored in a 7 question questionnaire, rated 1-7 from very good to very bad. The questions are whether the program worked well, was boring, if it was the right dose of exercises, if the text was understandable, instructive, how was the yield and degree of subjective improvement. Participants will also be asked for preparation suggestions.
Time Frame
3 months
Title
Symptom change
Description
The Niigata persistent positional perceptual dizziness (PPPD) Questionnaire (NPQ) contains 12 questions in which patients answer questions about provocation from three aggravating factors of PPPD (upright posture / gait, movement and visual stimulation). Each factor is evaluated using questions that score the severity from 0 (none) to 6 (unbearable) ailments
Time Frame
3 months
Title
Symptom change
Description
VSS - vertigo symptom score form. Consists of 15 questions. Each answer is scored on a 5-point scale (0-4), and a measure of the severity of the symptoms is obtained by summing. The total score ranges from 0-60, higher scores indicate more serious problems. Severe dizziness is defined as ≥ 12 points on the total scale. The scale includes two subscales: 8 selected questions related to vertigo and balance (score ranging from 0-32), and 7 selected questions related to autonomic anxiety symptoms (score ranging from 0-28)
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Satisfy diagnostic criteria for persistent positional perceptual dizziness (PPPS) or satisfy criteria with a duration of <3 months Vertigo symptom scale (VSS-SF) >12 Exclusion Criteria: Cognitive dysfunction that is so pronounced that it will make participation difficult Unable to read, understand Norwegian Severe medical or psychiatric illness (including substance abuse) that reduces the patient's ability to follow the VR program
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Torstein Hole, md phd
Organizational Affiliation
Møre og Romsdal Hospital Trust
Official's Role
Study Director
Facility Information:
Facility Name
Molde sykehus
City
Molde
Country
Norway

12. IPD Sharing Statement

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Internet-based Self-help Program for Vestibular Rehabilitation in Chronic Dizziness

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