Internet-based Pre-fitting Counseling of Persons With Hearing Impairment
Primary Purpose
Disability Evaluation
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Internet-based counseling
Sponsored by
About this trial
This is an interventional treatment trial for Disability Evaluation focused on measuring Disability Evaluation
Eligibility Criteria
Inclusion Criteria:
- Ages over 18 years old
- Have symptoms of hearing difficulty
- Access to internet
Exclusion Criteria:
- HHQ results too low (i.e., below 20),
- Participants using hearing aids
- Those with additional disabilities (e.g., visual impairment, learning disability, dementia, and so on) which may affect individuals' ability to participate in an internet-based program
Sites / Locations
- The Swedish Institute for Disability Research, Linköping University
- Department of Vision and Hearing Sciences, Anglia Ruskin University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
reading about hearing loss and its management
Internet-based counseling
Arm Description
General self-reading reading about hearing loss and its management This would run for 30 days and the participants have to manage their own time.
This would involve 4 stages of designated internet sessions and additional tasks which the patients can complete in their own time. This programme should be completed within 30 days.
Outcomes
Primary Outcome Measures
Hearing Handicap Questionnaire (HHQ)
Change from baseline in reported emotional and social consequences due to hearing impairment one week post treatment.
Hearing Handicap Questionnaire (HHQ) - Change from baseline
Secondary Outcome Measures
Hospital Anxiety and Depression Scale (HADS)
Change from baseline in reported depression and anxiety symptoms one week post treatment.
Hospital Anxiety and Depression Scale (HADS) - Change from baseline
University of Rhode Island Change Assessment Scale (URICA)
Change from baseline in readiness for change one week post treatment. University of Rhode Island Change Assessment Scale (URICA) - Change from baseline.
Hearing Impairment Acceptance Questionnaire (HIAQ)
Change from baseline in acceptance of hearing loss one week post treatment. Hearing Impairment Acceptance Questionnaire (HIAQ) - Change from baseline.
Full Information
NCT ID
NCT01611129
First Posted
May 14, 2012
Last Updated
April 16, 2013
Sponsor
Thomas Lunner
Collaborators
Swansea University
1. Study Identification
Unique Protocol Identification Number
NCT01611129
Brief Title
Internet-based Pre-fitting Counseling of Persons With Hearing Impairment
Official Title
Use of the 'Patient Journey' Model in the Internet-based Pre-fitting Counseling of a Person With Hearing Impairment: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
November 2012 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
February 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Thomas Lunner
Collaborators
Swansea University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to determine whether the use of 'patient journey' model in internet-based counseling of a person with hearing impairment is a feasible approach in management of emotional and social consequences, anxiety and depression, readiness to change and acceptance of hearing loss.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Disability Evaluation
Keywords
Disability Evaluation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
reading about hearing loss and its management
Arm Type
Active Comparator
Arm Description
General self-reading reading about hearing loss and its management This would run for 30 days and the participants have to manage their own time.
Arm Title
Internet-based counseling
Arm Type
Experimental
Arm Description
This would involve 4 stages of designated internet sessions and additional tasks which the patients can complete in their own time. This programme should be completed within 30 days.
Intervention Type
Behavioral
Intervention Name(s)
Internet-based counseling
Intervention Description
Stage 1 - introduction to the concept of the patient journey and presenting the participants series of questions which may help them to explore their journey through hearing loss; Stage 2 - patient journey model of PHI and 2 case examples will be presented. The PHI will be advised to compare their journey to the model presented and identify the similarities and differences; Stage 3 - communication partners' journey model will be presented and the PHI will be asked to consider how interactions between each other may affect various things in the physical, mental and social domains; and Stage 4 - patients will be encouraged to think about how the PHI & CP may influence each other during their journey through hearing loss, how they can overcome some of the difficulties they may be experiencing and to think about the potential benefits and the challenges from the audiological management.
Primary Outcome Measure Information:
Title
Hearing Handicap Questionnaire (HHQ)
Description
Change from baseline in reported emotional and social consequences due to hearing impairment one week post treatment.
Hearing Handicap Questionnaire (HHQ) - Change from baseline
Time Frame
One week pre-treatment, One week post treatment, Six-moths follow-up
Secondary Outcome Measure Information:
Title
Hospital Anxiety and Depression Scale (HADS)
Description
Change from baseline in reported depression and anxiety symptoms one week post treatment.
Hospital Anxiety and Depression Scale (HADS) - Change from baseline
Time Frame
One week pre-treatment, One week post treatment, Six moths follow-up
Title
University of Rhode Island Change Assessment Scale (URICA)
Description
Change from baseline in readiness for change one week post treatment. University of Rhode Island Change Assessment Scale (URICA) - Change from baseline.
Time Frame
One week pre-treatment, One week post treatment, Six months follow-up
Title
Hearing Impairment Acceptance Questionnaire (HIAQ)
Description
Change from baseline in acceptance of hearing loss one week post treatment. Hearing Impairment Acceptance Questionnaire (HIAQ) - Change from baseline.
Time Frame
One week pre-treatment, One week post treatment, Six months follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Ages over 18 years old
Have symptoms of hearing difficulty
Access to internet
Exclusion Criteria:
HHQ results too low (i.e., below 20),
Participants using hearing aids
Those with additional disabilities (e.g., visual impairment, learning disability, dementia, and so on) which may affect individuals' ability to participate in an internet-based program
Facility Information:
Facility Name
The Swedish Institute for Disability Research, Linköping University
City
Linköping
ZIP/Postal Code
58185
Country
Sweden
Facility Name
Department of Vision and Hearing Sciences, Anglia Ruskin University
City
Swansea
ZIP/Postal Code
CB1 1PT
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
23347711
Citation
Manchaiah VK, Stephens D, Andersson G, Ronnberg J, Lunner T. Use of the 'patient journey' model in the internet-based pre-fitting counseling of a person with hearing disability: study protocol for a randomized controlled trial. Trials. 2013 Jan 24;14:25. doi: 10.1186/1745-6215-14-25.
Results Reference
background
PubMed Identifier
24708677
Citation
Manchaiah V, Ronnberg J, Andersson G, Lunner T. Use of the 'patient journey' model in the internet-based pre-fitting counseling of a person with hearing disability: lessons from a failed clinical trial. BMC Ear Nose Throat Disord. 2014 Apr 7;14(1):3. doi: 10.1186/1472-6815-14-3.
Results Reference
derived
Links:
URL
https://www.iterapi.se/sites/journey/
Description
Related Info
Learn more about this trial
Internet-based Pre-fitting Counseling of Persons With Hearing Impairment
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