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

Study Overview
=================
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.

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

Conditions
-----------------
Disability Evaluation

Intervention / Treatment
-----------------
* Behavioral: Internet-based counseling


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: reading about hearing loss and its management<br>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<br>* 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.<br>|
| Experimental: Internet-based counseling<br>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<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | One week pre-treatment, One week post treatment, Six-moths follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | One week pre-treatment, One week post treatment, Six moths follow-up | 
| 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. | One week pre-treatment, One week post treatment, Six months follow-up | 
| 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. | One week pre-treatment, One week post treatment, Six months follow-up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Disability Evaluation