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Internet-based Pre-fitting Counseling of Persons With Hearing Impairment

This study has been completed.
Sponsor:
Collaborator:
Swansea University
Information provided by (Responsible Party):
Thomas Lunner, Linkoeping University
ClinicalTrials.gov Identifier:
NCT01611129
First received: May 14, 2012
Last updated: April 16, 2013
Last verified: April 2013
History of Changes
  Purpose

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.


Condition Intervention
Disability Evaluation
 Behavioral: Internet-based counseling

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Linkoeping University:

Primary Outcome Measures:
  • Hearing Handicap Questionnaire (HHQ) [ Time Frame: One week pre-treatment, One week post treatment, Six-moths follow-up ] [ Designated as safety issue: No ]

    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) [ Time Frame: One week pre-treatment, One week post treatment, Six moths follow-up ] [ Designated as safety issue: No ]

    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) [ Time Frame: One week pre-treatment, One week post treatment, Six months follow-up ] [ Designated as safety issue: No ]
    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) [ Time Frame: One week pre-treatment, One week post treatment, Six months follow-up ] [ Designated as safety issue: No ]
    Change from baseline in acceptance of hearing loss one week post treatment. Hearing Impairment Acceptance Questionnaire (HIAQ) - Change from baseline.


Enrollment: 80
Study Start Date: November 2012
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: reading about hearing loss and its management
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.
 Behavioral: Internet-based counseling
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.
Experimental: Internet-based counseling
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.
 Behavioral: Internet-based counseling
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01611129

Locations
Sweden
The Swedish Institute for Disability Research, Linköping University
Linköping, Sweden, 58185
United Kingdom
Department of Vision and Hearing Sciences, Anglia Ruskin University
Swansea, United Kingdom, CB1 1PT
Sponsors and Collaborators
Thomas Lunner
Swansea University
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Thomas Lunner, Professor, Linkoeping University
ClinicalTrials.gov Identifier: NCT01611129     History of Changes
Other Study ID Numbers: FAS-IT-03
Study First Received: May 14, 2012
Last Updated: April 16, 2013
Health Authority: United Kingdom: National Health Service

Keywords provided by Linkoeping University:
Disability Evaluation

Additional relevant MeSH terms:
Deafness
Hearing Loss
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
 Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on May 22, 2013