Cochlear implant home care

Telemedicine for adults with cochlear implants in the UK: empowering patients to manage their own hearing healthcare

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN51668922

Enrollment

2750

Registered

2018-06-22

Start date

2019-06-11

Completion date

Unknown

Last updated

2022-04-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Deafness Ear, Nose and Throat Hearing loss, unspecified

Interventions

This project introduces a new care pathway choice to adults using cochlear implants: cochlear implant home care. The patients choosing this pathway will be given access to: 1. Home he

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patient inclusion criteria: 1. Person using cochlear implant (any device, unilateral or bilateral) 2. Living in the UK 3. Aged 18 years or more 4. Able to give informed consent to data sharing 5. Access to a computer or device with internet access 6. Willing and able to comply with a cochlear implant home care pathway Health professional inclusion criteria: Staff at participating cochlear implant centre

Exclusion criteria

Exclusion criteria: Patient exclusion criteria: 1. Those that do not fulfil the inclusion criteria plus any medical condition or known disability that would limit their capacity to use the telemedicine tools 2. Patients using other cochlear implant online/app telemedicine tools

Design outcomes

Primary

Measure	Time frame
Primary outcome number 1: What is the impact of the roll out of the new care pathway on users of the programme (staff and people with cochlear implants)? The impact of the roll out of the new care pathway on users of the programme will be evaluated by capturing the view of patients, staff and stakeholders by qualitatively investigating how the new pathway works in terms of feasibility and acceptability at each participating centre using: 1. Focus groups, comprising of a focus group for staff members and a focus group for patients each with up to 20 people 2. Patient interviews on a one to one basis 3. Case studies carried out by staff on selected patients, which will be anonymised to the research and evaluation team. These will be analysed for themes These will take place after introduction of the remote care tools and will be led and scheduled by the independent evaluators Wessex Academic Health Science Network (Wessex AHSN). Primary outcome number 2: Does the new care pathway increase empowerment for people with cochlear implants while having no detrimental effect on their hearing and quality of life? The effects of the new care pathway on the users’ state of empowerment related to their healthcare, quality of life and hearing will be measured by collecting data over the course of the roll out of the new pathway using: 1. Locally collected data 2. Quantitative information in the form of staff and patient reports of their experience of the new pathway using R-outcomes 3. Quantitative data in the form of dashboards will be used to inform progress 4. Service level activity captured in appointment schedules, staff contact logs and data provided through the CHOICE app and clinician portal. This will be used to investigate: 4.1. Change in use of outpatient appointments as a conseq	—

Measure

Time frame

Primary outcome number 1: What is the impact of the roll out of the new care pathway on users of the programme (staff and people with cochlear implants)? The impact of the roll out of the new care pathway on users of the programme will be evaluated by capturing the view of patients, staff and stakeholders by qualitatively investigating how the new pathway works in terms of feasibility and acceptability at each participating centre using: 1. Focus groups, comprising of a focus group for staff members and a focus group for patients each with up to 20 people 2. Patient interviews on a one to one basis 3. Case studies carried out by staff on selected patients, which will be anonymised to the research and evaluation team. These will be analysed for themes These will take place after introduction of the remote care tools and will be led and scheduled by the independent evaluators Wessex Academic Health Science Network (Wessex AHSN). Primary outcome number 2: Does the new care pathway increase empowerment for people with cochlear implants while having no detrimental effect on their hearing and quality of life? The effects of the new care pathway on the users’ state of empowerment related to their healthcare, quality of life and hearing will be measured by collecting data over the course of the roll out of the new pathway using: 1. Locally collected data 2. Quantitative information in the form of staff and patient reports of their experience of the new pathway using R-outcomes 3. Quantitative data in the form of dashboards will be used to inform progress 4. Service level activity captured in appointment schedules, staff contact logs and data provided through the CHOICE app and clinician portal. This will be used to investigate: 4.1. Change in use of outpatient appointments as a conseq

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Secondary

Measure	Time frame
Current secondary outcome measures as of 10/10/2019: Secondary outcomes: evaluation of the roll out in the context of the below: The use of remote care programme from patients and staff will be collected using R-outcomes survey tool (Benson et al., 2010), which will gather data as follows: 1. The Health Confidence Score (HCS) measures people's capability to look after their own health, with dimensions for confidence about knowledge, self-management, ability to get help and shared decision-making (Benson, Potts, & Bowman, 2016). This will be done continually throughout the roll out the remote care pathway 2. The health status score (HowRu) is a short generic health status (health-related quality of life) measure, with four dimensions for pain and discomfort, mental distress, disability and dependence, each rated on four levels. HowRu has been validated against SF-12 and EQ-5D-5L and at the individual patient level (Benson, Potts, Whatling, & Patterson, 2013; Benson et al., 2010; Hendriks et al., 2015). This will be done continually throughout the roll out the remote care pathway 3. The Personal Wellbeing Score (PWS) covers satisfaction, worthwhileness, happiness and anxiety, based on the ONS-4 Personal Wellbeing standard, used in the Annual Population Survey for Great Britain (Office for National Statistics, 2015). This will be done continually throughout the roll out the remote care pathway In order to be able to compare the results from previous projects the following measures will also be carried out: 1. Patient activation will be measured using the Patient Activation Measures (PAM) at the point of entry to the remote care pathway and at the end of the project or after 6 months 2. The CI-EMP questionnaire will be used to measure how empowered people are to manage their own cochlear implant care at the point of entry to the remote care p	—

Measure

Time frame

Current secondary outcome measures as of 10/10/2019: Secondary outcomes: evaluation of the roll out in the context of the below: The use of remote care programme from patients and staff will be collected using R-outcomes survey tool (Benson et al., 2010), which will gather data as follows: 1. The Health Confidence Score (HCS) measures people's capability to look after their own health, with dimensions for confidence about knowledge, self-management, ability to get help and shared decision-making (Benson, Potts, & Bowman, 2016). This will be done continually throughout the roll out the remote care pathway 2. The health status score (HowRu) is a short generic health status (health-related quality of life) measure, with four dimensions for pain and discomfort, mental distress, disability and dependence, each rated on four levels. HowRu has been validated against SF-12 and EQ-5D-5L and at the individual patient level (Benson, Potts, Whatling, & Patterson, 2013; Benson et al., 2010; Hendriks et al., 2015). This will be done continually throughout the roll out the remote care pathway 3. The Personal Wellbeing Score (PWS) covers satisfaction, worthwhileness, happiness and anxiety, based on the ONS-4 Personal Wellbeing standard, used in the Annual Population Survey for Great Britain (Office for National Statistics, 2015). This will be done continually throughout the roll out the remote care pathway In order to be able to compare the results from previous projects the following measures will also be carried out: 1. Patient activation will be measured using the Patient Activation Measures (PAM) at the point of entry to the remote care pathway and at the end of the project or after 6 months 2. The CI-EMP questionnaire will be used to measure how empowered people are to manage their own cochlear implant care at the point of entry to the remote care p

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Countries

England, United Kingdom

Contacts

Public ContactHelen Cullington

H.Cullington@southampton.ac.uk+44 (0)2380597606

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 13, 2026