Remote care of cochlear implant users

Completed

• Conditions: Deafness; Ear, Nose and Throat

• Registration Number: ISRCTN14644286
• Lead Sponsor: niversity of Southampton

Brief Summary

2016 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/27178980 2018 results in http://bmjopen.bmj.com/content/8/4/e019640

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-10-20
• Study Completion: 2016-07-31
• Last Update Posted: 11 June 2018

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Aged 18 years or over
2. Living in the United Kingdom
3. Cochlear implant user (any device, unilateral or bilateral) for at least 6 months
4. Able to give informed consent
5. Sufficient English to understand study documentation and participate in testing
6. Access to a computer or device with internet access

Exclusion Criteria

1. Not been using a cochlear implant user for at least 6 months
2. Living outside the United Kingdom
3. Aged less than 18 years
4. Unable to give informed consent
5. Insufficient English to understand study documentation and participate in testing
6. No access to a computer or device with internet access
7. Possessing any medical condition or known disability that would limit their capacity to use the online support tool

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change (from day of entry into study to 6 months after remote care introduced) in patient activation measured using the Patient Activation Measure (PAM®) and the custom-designed cochlear implant patient empowerment measure in both the control and treatment arms.

Secondary Outcome Measures

Name	Time	Method
1. Stability of hearing measured by change (from day of entry into study to 6 months after remote care introduced) in speech recognition measured using BKB sentences, the Triple Digit Test, the Spatial Speech Qualities questionnaire and self-report of hearing ability on the long-term follow-up questionnaire in both the control and treatment arms.<br>2. Stability of quality of life measured by change (from day of entry into study to 6 months after remote care introduced) in quality of life in measured using the Health Utilities Index mark 3 in both the control and treatment arms.<br>3. Patient preference in treatment arm reported qualitatively from feedback in online support tool and in focus groups<br>4. Clinician preference measured qualitatively from three interviews with up to 10 members of clinical staff