Controlled Trial of the I-PLAN Intervention

NCT ID: NCT04017416

Last Updated: 2019-07-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

160 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-01-02

Study Completion Date

2018-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Hearing Aid

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

No interventions assigned to this group

I-PLAN

Audiologists were instructed to deliver the I-PLAN in addition to standard care at the hearing aid fitting consultation.

I-PLAN

Intervention Type BEHAVIORAL

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Manchester

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Noor Afzarini Hasnita Binti Ismail

Principle Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Piers Dawes, PhD

Role: PRINCIPAL_INVESTIGATOR

Manchester Centre for Audiology and Deafness

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Audiology Clinic

Manchester, , United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United Kingdom

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

17/NW/0406

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Evaluation of Hearing Aid Benefit
NCT05198713 COMPLETED NA
Motivational Interviewing in Hearing Aid Users
NCT04673565 ENROLLING_BY_INVITATION NA