Feasibility and effectiveness of Ida Telecare tools for audiology patients
| ISRCTN | ISRCTN11296341 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11296341 |
| Protocol serial number | 35810 |
| Sponsor | Nottingham University Hospitals NHS Trust, Research & Innovation |
| Funder | Ida Institute |
- Submission date
- 30/10/2017
- Registration date
- 17/01/2018
- Last edited
- 05/10/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Ear, Nose and Throat
Plain English summary of protocol
Plain English summary as of 24/09/2018:
Background and study aims
The Ida Institute has developed a range of easy-to-use online tools designed to help people with hearing loss prepare for audiology appointments, make important decisions related to their hearing healthcare, and successfully manage everyday communication. Thinking about these things ahead of time can help patients feel better prepared when deciding with the clinician how best to manage their hearing loss. Patients who make choices that are right for them (such as obtaining a hearing aid, or not), are more likely to live well with their hearing loss. This study will assess how adults attending an NHS audiology clinic use the Ida telecare tools and when (feasibility) and how effective the 'Why Improve My Hearing?' tool is at improving their outcomes (effectiveness). The feasibility part of the study will look at how often the tools are used by patients by also identifing what the ‘active ingredients’ of the tools are to change health behaviour, and anything that helps or hinders patients’ use of the tools. The effectiveness part of the study is interested to see if patients who complete the 'Why Improve My Hearing?' Tool before they visit the audiology clinic have better outcomes compared to people who do not. We will also have in-depth discussions with patients and audiologists about what they think of the Tool.
Who can participate?
Adults aged 18 and older who have hearing loss.
What does the study involve?
The Ida Telecare Platform use unique telecare tools that help improve communication, improving hearing, effective tips and tricks for successful communications and common difficulties and solutions. Participants are randomly allocated to one of the two sub-studies (feasibility or effectiveness). Those in the feasibility study select whether or not they wish to use any (or all) of the Ida telephone tolls prior to the hearing assessment, hearing air fitting and follow-up appointments. Those in the effectiveness complete the ‘Why Improve My Hearing’ telecare tool prior to their hearing assessment appointment. This is discussed with the audiologist. The feasibility study assesses if the tools are usable and the participants and audiologists perceptions and experiences of using the telecare tools. The effectiveness of the study is assessed by looking at the benefits of the hearing aids, quality of life, social participation, patient activation, readiness to take up hearing aids and the consequences of hearing aids.
What are the possible benefits and risks of participating?
Participants may benefit from improvements in their communication. It is not expected that this research will pose any risk to participants. None of the tools, quantitative outcome measures or qualitative data collection methods are likely to cause any harm, distress or adverse reaction to adults with hearing loss. There are no likely ethical, legal or management issues arising from this research. Study participants will have ample time to complete tools and outcomes, including breaks where required.
Where is the study run from?
NIHR Nottingham Biomedical Research Unit
When is the study starting and how long is it expected to run for?
September 2017 to August 2018
Who is funding the study?
Ida Institute (UK)
Who is the main contact?
Dr Helen Henshaw (Scientific)
helen.henshaw@nottingham.ac.uk
Previous plain English summary:
Background and study aims
The Ida Institute has developed a range of easy-to-use online tools designed to help people with hearing loss prepare for audiology appointments, make important decisions related to their hearing healthcare, and successfully manage everyday communication. Thinking about these things ahead of time can help patients feel better prepared when deciding with the clinician how best to manage their hearing loss. Patients who make choices that are right for them (such as obtaining a hearing aid, or not), are more likely to live well with their hearing loss. This study will assess how adults attending an NHS audiology clinic use the Ida telecare tools and when (feasibility) and how effective the 'Why Improve My Hearing?' tool is at improving their outcomes (effectiveness). The feasibility part of the study will look at how often the tools are used by patients by also identifing what the ‘active ingredients’ of the tools are to change health behaviour, and anything that helps or hinders patients’ use of the tools. The effectiveness part of the study is interested to see if patients who complete the 'Why Improve My Hearing?' Tool before they visit the audiology clinic have better outcomes compared to people who do not. We will also have in-depth discussions with patients and audiologists about what they think of the Tool.
Who can participate?
Adults aged 18 and older who have hearing loss.
What does the study involve?
The Ida Telecare Platform use unique telecare tools that help improve communication, improving hearing, effective tips and tricks for successful communications and common difficulties and solutions. Participants are randomly allocated to one of the two sub-studies (feasibility or effectiveness). Those in the feasibility study select whether or not they wish to use any (or all) of the Ida telephone tolls prior to the hearing assessment, hearing air fitting and follow-up appointments. Those in the effectiveness complete the ‘Why Improve My Hearing’ telecare tool prior to their hearing assessment appointment. This is discussed with the audiologist. The feasibility study assesses if the tools are usable and the participants and audiologists perceptions and experiences of using the telecare tools. The effectiveness of the study is assessed by looking at the benefits of the hearing aids, quality of life, social participation, patient activation, readiness to take up hearing aids and the consequences of hearing aids.
What are the possible benefits and risks of participating?
Participants may benefit from improvements in their communication. It is not expected that this research will pose any risk to participants. None of the tools, quantitative outcome measures or qualitative data collection methods are likely to cause any harm, distress or adverse reaction to adults with hearing loss. There are no likely ethical, legal or management issues arising from this research. Study participants will have ample time to complete tools and outcomes, including breaks where required.
Where is the study run from?
Queens Medical Centre (UK)
When is the study starting and how long is it expected to run for?
June 2017 to August 2018
Who is funding the study?
Ida Institute (UK)
Who is the main contact?
Dr Helen Henshaw (Scientific)
helen.henshaw@nottingham.ac.uk
Contact information
Scientific
Otology and Hearing Group, Division of Clinical Neuroscience
School of Medicine, University of Nottingham.
NIHR Nottingham Biomedical Research Centre
Ropewalk House
113 The Ropewalk
Nottingham
NG1 5DU
United Kingdom
 ORCID ID |
0000-0002-0547-4403 |
|---|
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised; Both; Design type: Treatment, Education or Self-Management, Validation of investigation /therapeutic procedures |
| Secondary study design | Randomised controlled trial |
| Participant information sheet | ISRCTN11296341_PIS_V3.0_13Nov17.pdf |
| Scientific title | Feasibility and effectiveness of Ida Telecare tools for NHS Audiology patients |
| Study objectives | Sub-study 1 aim: The aim of this study is to assess uptake, feasibility and mechanisms of benefit of the Ida Telecare tools in patients attending Nottingham Audiology Service for the first-time. Sub-study 2 Aim: The aim of this study is to evaluate the effectiveness of the Ida ‘Why Improve My Hearing?’ Telecare tool in first-time NHS audiology patients, compared to standard care. |
| Ethics approval(s) | South Central – Oxford C Research Ethics Committee, 10/10/2017, ref: 17IH006 |
| Health condition(s) or problem(s) studied | Specialty: Ear, nose and throat, Primary sub-specialty: Ear, nose and throat; UKCRC code/ Disease: Ear/ Other disorders of ear |
| Intervention | This study consists of two single-centre sub-studies assessing: 1. Feasibility of implementing the Ida Telecare platform within an NHS adult audiology service 2. Effectiveness of the Ida Telecare tool ‘Why Improve My Hearing?’, in a cohort of first-time NHS audiology patients Both sub-studies use mixed-methods (integrating quantitative and qualitative methodologies), which is considered advantageous in the evaluation of patient-centered care, providing an in-depth understanding of the patient experience (Agency for Healthcare Research and Quality 2013). All participants invited to direct referral hearing assessment appointments at Nottingham Audiology Service between September 2017 and February 2018 receive a study information pack alongside their appointment confirmation letter. The pack contains a study invitation letter, the participant information sheet and a reply slip with a pre-paid addressed envelope for return. Upon receipt of completed reply slips, eligible patients are randomised to one of the two intervention sub-studies (feasibility or effectiveness) using minimised allocation based on gender (male/female) and age: (younger <70 years old/older 70 years old or greater). The minimised allocation is generated and maintained by a researcher not directly involved in patient recruitment or testing using OxMaR software. Participants are contacted by a researcher (by telephone) to answer any questions they may have about the study. The researcher then sends an informed consent form for the patient to complete and return by email or post. Recruitment takes place for a fixed duration of 6 months. If the recruitment target of n=56 patients for sub-study 2 has been reached before the end of the 6-month recruitment period, all subsequent patients returning reply slips are automatically allocated to the feasibility study (sub-study 1). The Ida Telecare Platform Ida telecare (http://idainstitute.com/toolbox/telecare/). There are 6 unique telecare tools: 1. Living well Online The individual identifies when communication (with/without hearing aids) is most easy and difficult and which steps they can take to improve communication. 2. My Turn to Talk for Adults The individual identifies their most important communication partners and questions they wish to discuss. 3. Tinnitus Thermometer The individual explains how they are experiencing their tinnitus at the time of the appointment and what expectations they have. 4. Why Improve My Hearing? The individual reflects on how improved hearing and communication would change their everyday life. 5. Top Tips for Managing Conversation The individual learns effective tips and tricks for successful communication and hears from other people with hearing loss how they apply the methods. 6. Dilemma Game The individual reviews common difficulties in communication situations and reviews possible solutions while being encouraged to think up their own. Sub-study 1, Feasibility: Patients select whether or not they wish to use any (or all) of the Ida telecare tools (total n=6) prior to their hearing assessment, hearing aid fitting and follow-up appointments. Sub-study 2, Effectiveness: Patients complete the ‘Why Improve My Hearing’ telecare tool prior to their hearing assessment appointment. A copy is made available within the appointment and is discussed with the audiologist. |
| Intervention type | Other |
| Primary outcome measure(s) |
Sub-study 1: Feasibility |
| Key secondary outcome measure(s) |
Sub-study 2, Effectiveness: |
| Completion date | 31/08/2018 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 56 |
| Total final enrolment | 57 |
| Key inclusion criteria | 1. Adults aged ≥18 years (no upper age limit) 2. Ability to offer informed consent 3. Fluent in the English language (written and spoken) 4. Access to the Internet |
| Key exclusion criteria | Previously prescribed hearing aids |
| Date of first enrolment | 02/10/2017 |
| Date of final enrolment | 29/06/2018 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Derby Road
Nottinghamshire
Nottingham
NG7 2UH
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Other |
| IPD sharing plan | The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | Sub-study 2 qualitative study results | 23/02/2022 | 22/04/2022 | Yes | No |
| Results article | Sub-study 2 randomised clinical trial results | 18/04/2022 | 22/04/2022 | Yes | No |
| Participant information sheet | version V3.0 | 13/11/2017 | 17/01/2018 | No | Yes |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Protocol file | version 3.0 | 13/11/2017 | 05/10/2022 | No | No |
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
Additional files
- ISRCTN11296341_PIS_V3.0_13Nov17.pdf
- Uploaded 17/01/2018
- ISRCTN11296341_PROTOCOL_V3.0_13Nov17.pdf
- Protocol file
Editorial Notes
05/10/2022: Uploaded protocol (not peer reviewed).
22/04/2022: The following changes have been made:
1. Publication references added.
2. The total final enrolment number has been added.
24/09/2018: The follow changes were made to the trial record:
1. The plain English summary was updated.
2. The recruitment start date was changed from 16/10/2017 to 02/10/17.
3. The recruitment end date was changed from 25/03/2018 to 29/06/2018.
4. The overall trial start date was changed from 14/06/2017 to 01/09/2017.
17/01/2018: The ISRCTN prospective/retrospective flag compares the date of registration with the recruitment start date and does not include any grace period. The registration of this study was requested through the NIHR Portfolio and was finalised within 6 months of the recruitment starting.
