Clinical trial NCT03912779: Evaluation of Self-management Education in First Time Hearing Aid Users
Official title: The Role of Interactive Hearing Aid Self-management Education on Self-efficacy for Hearing Aid(s), Readiness for Action and Hearing Aid Knowledge in First Time Hearing Aid Users
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hearing Loss
Keywords: First time hearing aid user
Lead sponsor: Nottingham University Hospitals NHS Trust
Sponsor class: OTHER
Collaborators: name: Aston University
First posted: 2019-04-11
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The study will assess the impact of a hearing aid self-management intervention in first time hearing aid users compared to standard hearing aid self-management. Namely, the C2Hear multimedia videos, or Reusable Learning Objects (RLOs) will be used as the self-management intervention. A departmental hearing aid booklet (standard clinical care) will be used as the control intervention.

The study will determine the role of these RLOs in self-efficacy for hearing aid(s), hearing aid knowledge and readiness for action compared with standard hearing aid self-management education (hearing aid booklet) in groups of first time hearing aid users. Both groups will receive the education at the earliest audiology appointment (hearing assessment), helping to distinguish any impact of earlier education delivery.

Detailed description: Research question: To assess the role of interactive hearing aid self-management education on self-efficacy for hearing aid(s), readiness for action and hearing aid knowledge in first time hearing aid users.

Objectives:

Primary research question:

- Does the early delivery of interactive hearing aid self-management education improve self-efficacy for hearing aid(s) compared with standard care in first-time hearing aid users?

Secondary research questions:

i. Does the early delivery of interactive hearing aid self-management education improve readiness for hearing aids (their chosen intervention) compared with standard care in first-time hearing aid users?

ii. Does the early delivery of interactive hearing aid education improve hearing aid knowledge compared with standard care in first-time hearing aid users?

Study design:

A single centre, prospective study with two randomised arms; intervention group (access to RLOs in DVD/ or online format, patients' preference) and control (standard hearing aid education booklet).

Prospective first-time hearing aid users will be invited to take part in the study at hearing assessment, where they will be randomised to either the control or intervention group. Following 6-8 weeks of independent use prior to receiving hearing aids, study investigators will assess the impact of each education type on individuals self-efficacy for hearing aids, readiness for action and hearing aid knowledge.

Comparisons will be made to previous evaluation of the RLOs to allow exploration of the impact of earlier hearing aid self-management education on self-report measures.

Eligibility criteria: Inclusion Criteria:

* Adults aged \> 18 years
* Prospective first-time hearing aid users (defined as no hearing aid use in the last 2 years)
* English as their spoken language or good understanding of English

Exclusion Criteria:

* Those unable to complete study questionnaires due to age-related problems (e.g. cognitive decline)

Primary outcomes:
measure: Measure of Audiologic Rehabilitation Self-efficacy for Hearing Aids score (West and Smith, 2007)
timeFrame: Change from Baseline self-efficacy for hearing aids up to 8 weeks
Secondary outcomes:
measure: Hearing aid self-efficacy using Ida Motivational Line Tools (Ida Institute, 2013)
timeFrame: Change from Baseline self-efficacy for hearing aids up to 8 weeks
measure: Hearing Aid and Communication Knowledge (HACK: Ferguson et al., 2015)
timeFrame: Up to 8 weeks
measure: Readiness for hearing rehabilitation (action); Ida Motivational Line Tools Question 1 (Ida Institute, 2013)
timeFrame: Change from Baseline readiness up to 8 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Nottingham University Hospitals NHS Trust
name: Melanie Ferguson
role: PRINCIPAL_INVESTIGATOR
References: