Controlled Trial of the I-PLAN Intervention
1 other identifier
observational
160
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jan 2018
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 2, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2018
CompletedFirst Submitted
Initial submission to the registry
July 4, 2019
CompletedFirst Posted
Study publicly available on registry
July 12, 2019
CompletedJuly 12, 2019
July 1, 2019
12 months
July 4, 2019
July 11, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
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.
6 weeks
Secondary Outcomes (5)
Objective hearing aid use
6 weeks
International Outcome Inventory for Hearing Aids
6 weeks
Self-reported Hearing Handicap Inventory for the Elderly and for Adults - Screening version
6 weeks
Self-regulation in relation to hearing aid use
6 weeks
Habit formation
6 weeks
Study Arms (2)
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.
Interventions
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.
Eligibility Criteria
This study recruited adult patients who were first-time hearing aid users.
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Audiology Clinic
Manchester, M20 2LR, United Kingdom
Study Officials
- PRINCIPAL INVESTIGATOR
Piers Dawes, PhD
Manchester Centre for Audiology and Deafness
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Target Duration
- 6 Weeks
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principle Investigator
Study Record Dates
First Submitted
July 4, 2019
First Posted
July 12, 2019
Study Start
January 2, 2018
Primary Completion
December 31, 2018
Study Completion
December 31, 2018
Last Updated
July 12, 2019
Record last verified: 2019-07