NCT01611129

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2012

Shorter than P25 for not_applicable

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 14, 2012

Completed
21 days until next milestone

First Posted

Study publicly available on registry

June 4, 2012

Completed
5 months until next milestone

Study Start

First participant enrolled

November 1, 2012

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
Last Updated

April 17, 2013

Status Verified

April 1, 2013

Enrollment Period

3 months

First QC Date

May 14, 2012

Last Update Submit

April 16, 2013

Conditions

Disability Evaluation

Keywords

Disability Evaluation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Hospital Anxiety and Depression Scale (HADS)

    One week pre-treatment, One week post treatment, Six moths follow-up

  • University of Rhode Island Change Assessment Scale (URICA)

    One week pre-treatment, One week post treatment, Six months follow-up

  • Hearing Impairment Acceptance Questionnaire (HIAQ)

    One week pre-treatment, One week post treatment, Six months follow-up

Study Arms (2)

reading about hearing loss and its management

ACTIVE COMPARATOR

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

Internet-based counseling

EXPERIMENTAL

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

Interventions

Internet-based counselingBEHAVIORAL

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.

Internet-based counselingreading about hearing loss and its management

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Ages over 18 years old
  • Have symptoms of hearing difficulty
  • Access to internet

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

The Swedish Institute for Disability Research, Linköping University

Linköping, 58185, Sweden

Location

Department of Vision and Hearing Sciences, Anglia Ruskin University

Swansea, CB1 1PT, United Kingdom

Location

Related Publications (2)

  • 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.

    PMID: 23347711BACKGROUND

  • 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.

    PMID: 24708677DERIVED

Related Links

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 14, 2012

First Posted

June 4, 2012

Study Start

November 1, 2012

Primary Completion

February 1, 2013

Study Completion

February 1, 2013

Last Updated

April 17, 2013

Record last verified: 2013-04

Locations

GB(1)SE(1)