Hearing AidNCT04017416
Controlled Trial of the I-PLAN Intervention
An observational study of Hearing Aid, run by University of Manchester at 1 site in United Kingdom.
Trial summary
That is a need for intervention to promote hearing aid use among adult patients with hearing aids. The aim of the present study was, for the first time, to evaluate the efficacy of the I-PLAN intervention to promote hearing aid use. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hearing Aid
- What is being tested?
- I-PLAN
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 160 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 2 Jan 2018to 31 Dec 2018
- How long will I take part?
- 6 Weeks
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study recruited adult patients who were first-time hearing aid users.
Who may be able to join
- had no previous personal experience of using a hearing aid
- were aged 18 years old or above
- attended initial hearing aid fitting appointment with study audiologists
- were native English speakers or had good understanding of English
- had sufficient mental capacity to provide informed consent based on audiologist's opinion were eligible to take part in this study
Who cannot join
- inability to complete the questionnaires due to age-related problems (for example; dementia) based on audiologist's opinion
- presence of medical contraindications for hearing aids as described by the British Academy of Audiology (BAA 2007)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Controlled Trial of the I-PLAN Intervention to Promote Hearing Aid Use Among First Time Adult Hearing Aid Users
That is a need for intervention to promote hearing aid use among adult patients with hearing aids. The aim of the present study was, for the first time, to evaluate the efficacy of the I-PLAN intervention to promote hearing aid use.
Read the detailed description
The I-PLAN is a behaviour change theory-based intervention to promote hearing aid use. It consists of; 1. information on consequences of using and not using a hearing aid, 2. a physical prompt as a reminder to hearing aid use and 3. a behavioural plan to use a hearing aid. The aim of this study was to test efficacy of the I-PLAN intervention, delivered face-to-face by study audiologists. 160 first-time hearing aid users were recruited at the hearing aid fitting appointment. Adult patients were allocated either to the I-PLAN group or Standard Care group. Adult patients were allocated to the groups based on the clinic schedules of study audiologists.
- Conditions
- Hearing Aid
- Being tested
- I-PLAN
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
I-PLANBehavioural
The I-PLAN is a behaviour change intervention that consists of; information on consequences of hearing aid use/non-use, reminder prompt and behavioural plan to promote hearing aid use.
| Study group | Role | What they receive |
|---|---|---|
| Standard Care | Audiologists in the standard care group were instructed to manage the patients in the same way as they would do in their routine clinics which were in accordance with national practice guidelines and were typical of National Healthcare Services (NHS) audiology departments across the UK. | |
| I-PLAN | Audiologists were instructed to deliver the I-PLAN in addition to standard care at the hearing aid fitting consultation. Receives: Behavioral: I-PLAN |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective hearing aid use based on Glasgow Hearing Aid Benefit Profile questionnaire
Self-reported hearing aid use with 5 response options (1-never/not all to 5 - all the time). Total score 5.
Measured: 6 weeks
Secondary outcomes (5)
Objective hearing aid use
Hearing aid use were measured from data-logging downloaded from hearing aid(s)
Measured: 6 weeks
International Outcome Inventory for Hearing Aids
Self-reported hearing aid benefit with five response options (from 1 to 5). Higher score indicate better outcomes
Measured: 6 weeks
Self-reported Hearing Handicap Inventory for the Elderly and for Adults - Screening version
Self-reported hearing aid benefit with three response options (yes- 4 points, sometimes- 2 points and no - 0 points). Higher scores indicate greater perceived hearing handicap
Measured: 6 weeks
Self-regulation in relation to hearing aid use
Self-reported self-regulation with a seven point Likert scale (1 strongly disagree to 7 strongly agree). Higher scores indicate greater self-regulation
Measured: 6 weeks
Habit formation
Self-reported habit formation with seven point Likert scale (1 strongly disagree to 7 strongly agree). Higher the scores indicate stronger habit
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2019
- Study start2 Jan 2018
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearing AidStudies of the same condition, open and under way.
- More trials run by University of ManchesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 160 participants (actual)
- Target duration
- 6 Weeks
Sponsor and investigators
- Lead sponsor
- University of Manchester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Noor Afzarini Hasnita Binti Ismail, University of Manchester
- Investigators
- Piers Dawes, PhD, Principal investigator, Manchester Centre for Audiology and Deafness
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04017416
- Sponsor's protocol ID
- 17/NW/0406
- Status last verified
- Jul 2019
- First submitted
- 4 Jul 2019
- Last updated
- 12 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Controlled Trial of the I-PLAN Intervention to Promote Hearing Aid Use Among First Time Adult Hearing Aid Users
- ClinicalTrials.gov ID
- NCT04017416
- Acronym / sponsor ID
- 17/NW/0406
- Conditions
- Hearing Aid
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- University of ManchesterUniversity, hospital or other
- Study start
- 2 Jan 2018 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 12 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
That is a need for intervention to promote hearing aid use among adult patients with hearing aids. The aim of the present study was, for the first time, to evaluate the efficacy of the I-PLAN intervention to promote hearing aid use.
Detailed description
The I-PLAN is a behaviour change theory-based intervention to promote hearing aid use. It consists of; 1. information on consequences of using and not using a hearing aid, 2. a physical prompt as a reminder to hearing aid use and 3. a behavioural plan to use a hearing aid. The aim of this study was to test efficacy of the I-PLAN intervention, delivered face-to-face by study audiologists. 160 first-time hearing aid users were recruited at the hearing aid fitting appointment. Adult patients were allocated either to the I-PLAN group or Standard Care group. Adult patients were allocated to the groups based on the clinic schedules of study audiologists.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 6 Weeks
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Care | – | –Audiologists in the standard care group were instructed to manage the patients in the same way as they would do in their routine clinics which were in accordance with national practice guidelines and were typical of National Healthcare Services (NHS) audiology departments across the UK. |
| I-PLAN | – | Behavioral: I-PLANAudiologists were instructed to deliver the I-PLAN in addition to standard care at the hearing aid fitting consultation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study recruited adult patients who were first-time hearing aid users.
Key inclusion criteria (5 listed)
- had no previous personal experience of using a hearing aid
- were aged 18 years old or above
- attended initial hearing aid fitting appointment with study audiologists
- were native English speakers or had good understanding of English
- had sufficient mental capacity to provide informed consent based on audiologist's opinion were eligible to take part in this study
Key exclusion criteria (2 listed)
- inability to complete the questionnaires due to age-related problems (for example; dementia) based on audiologist's opinion
- presence of medical contraindications for hearing aids as described by the British Academy of Audiology (BAA 2007)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| I-PLANThe I-PLAN is a behaviour change intervention that consists of; information on consequences of hearing aid use/non-use, reminder prompt and behavioural plan to promote hearing aid use. | Behavioural | I-PLAN |
Primary outcome
Subjective hearing aid use based on Glasgow Hearing Aid Benefit Profile questionnaire
Time frame: 6 weeks
Self-reported hearing aid use with 5 response options (1-never/not all to 5 - all the time). Total score 5.
5 secondary outcomes
Objective hearing aid use
Time frame: 6 weeks
International Outcome Inventory for Hearing Aids
Time frame: 6 weeks
Self-reported Hearing Handicap Inventory for the Elderly and for Adults - Screening version
Time frame: 6 weeks
Self-regulation in relation to hearing aid use
Time frame: 6 weeks
Habit formation
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2019.
- Individual participant dataSharing planned: Undecided
Related trials for Hearing Aid
Active, not recruiting
Performance of a Remote Microphone Compared to Hearing Aids Alone
Hearing Loss, Bilateral Sensorineural
RecruitingObservational study
Audiological Rehabilitation of Children With Unilateral Hearing Loss
Unilateral Hearing Loss
Not yet recruitingObservational study
New Hearing Aid Users and Their Social Participation
Hearing Loss, Hearing Aids
Recruiting
Barriers and Facilitators to OTC Hearing Aids Success
Hearing Loss, Sensorineural, Presbycusis
Not yet recruiting
Automated Text Message Reminders to Promote Hearing Aid Adoption
Hearing Loss
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Piers Dawes, PhD principal investigator
Manchester Centre for Audiology and Deafness
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hearing Aid, run by University of Manchester at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subjective hearing aid use based on Glasgow Hearing Aid Benefit Profile questionnaire (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2019.