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

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ClinicalTrials.gov Identifier: NCT01611129
Recruitment Status : Completed
First Posted : June 4, 2012
Last Update Posted : April 17, 2013
Sponsor:
Collaborator:
Swansea University
Information provided by (Responsible Party):
Thomas Lunner, Linkoeping University

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.

Condition or disease Intervention/treatment Phase
Disability Evaluation Behavioral: Internet-based counseling Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
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
Study Start Date : November 2012
Actual Primary Completion Date : February 2013
Actual Study Completion Date : February 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. Hearing Handicap Questionnaire (HHQ) [ Time Frame: One week pre-treatment, One week post treatment, Six-moths follow-up ]

    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 :
  1. Hospital Anxiety and Depression Scale (HADS) [ Time Frame: One week pre-treatment, One week post treatment, Six moths follow-up ]

    Change from baseline in reported depression and anxiety symptoms one week post treatment.

    Hospital Anxiety and Depression Scale (HADS) - Change from baseline


  2. University of Rhode Island Change Assessment Scale (URICA) [ Time Frame: One week pre-treatment, One week post treatment, Six months follow-up ]
    Change from baseline in readiness for change one week post treatment. University of Rhode Island Change Assessment Scale (URICA) - Change from baseline.

  3. Hearing Impairment Acceptance Questionnaire (HIAQ) [ Time Frame: One week pre-treatment, One week post treatment, Six months follow-up ]
    Change from baseline in acceptance of hearing loss one week post treatment. Hearing Impairment Acceptance Questionnaire (HIAQ) - Change from baseline.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Thomas Lunner, Professor, Linkoeping University
ClinicalTrials.gov Identifier: NCT01611129     History of Changes
Other Study ID Numbers: FAS-IT-03
First Posted: June 4, 2012    Key Record Dates
Last Update Posted: April 17, 2013
Last Verified: April 2013

Keywords provided by Thomas Lunner, Linkoeping University:
Disability Evaluation

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