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

Disability Evaluation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01611129
• Other study ID #: FAS-IT-03
• Status: Completed
• Phase: N/A
• First received: May 14, 2012
• Last updated: April 16, 2013
• Start date: November 2012
• Est. completion date: February 2013

Study information

• Verified date: April 2013
• Source: Linkoeping University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: National Health Service
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Deafness
• Disability Evaluation
• Hearing Loss

Intervention

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.

Locations

Country	Name	City	State
Sweden	The Swedish Institute for Disability Research, Linköping University	Linköping
United Kingdom	Department of Vision and Hearing Sciences, Anglia Ruskin University	Swansea

Sponsors (2)

Lead Sponsor	Collaborator
Thomas Lunner	Swansea University

Countries where clinical trial is conducted

Sweden,  United Kingdom, 

References & Publications (1)

Manchaiah VK, Stephens D, Andersson G, Rönnberg 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No