Controlled Trial of the I-PLAN Intervention

Hearing Aid Clinical Trial

Official title:

Controlled Trial of the I-PLAN Intervention to Promote Hearing Aid Use Among First Time Adult Hearing Aid Users

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04017416
• Other study ID #: 17/NW/0406
• Status: Completed
• Start date: January 2, 2018
• Est. completion date: December 31, 2018

Study information

• Verified date: July 2019
• Source: University of Manchester
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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)

Related Conditions & MeSH terms

• Hearing Aid

Intervention

Behavioral:
• I-PLAN
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.

Locations

Country	Name	City	State
United Kingdom	Audiology Clinic	Manchester

Sponsors (1)

Lead Sponsor	Collaborator
University of Manchester

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Objective hearing aid use	Hearing aid use were measured from data-logging downloaded from hearing aid(s)	6 weeks
Secondary	International Outcome Inventory for Hearing Aids	Self-reported hearing aid benefit with five response options (from 1 to 5). Higher score indicate better outcomes	6 weeks
Secondary	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	6 weeks
Secondary	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	6 weeks
Secondary	Habit formation	Self-reported habit formation with seven point Likert scale (1 strongly disagree to 7 strongly agree). Higher the scores indicate stronger habit	6 weeks