mHealth Technologies for Hearing Aid Users (m2Hear)

NHS Trust

Status: Completed

Conditions: Hearing Loss

Treatments: Other: Mobile-enabled RLOs (mRLOs)

Study type: Observational

Funder types: Other

Identifiers

NCT03136718

213341 (Other Identifier)

16IH003

17/EE/0117 (Other Identifier)

Details and patient eligibility

About

This study will establish the feasibility of a theoretically-driven, personalised educational intervention delivered through mobile technologies in first-time hearing aid users. Namely, the C2Hear (https://www.youtube.com/C2HearOnline) multimedia videos, or Reusable Learning Objects (RLOs) (Ferguson et al., 2015; 2016), will be repurposed into short 'bite-sized' mobile-enabled RLOs (mRLOs).The development of the intervention will be based on a recently developed comprehensive model of health behaviour change (COM-B) (Michie et al., 2014). The intervention will be tailored to individuals' needs, and incorporate greater user interactivity and self-evaluation.

Full description

Research question: Is it feasible for first-time hearing aid users to use a personalised educational intervention delivered through mobile technologies in their everyday life?

Objectives: To establish the feasibility of the intervention by evaluating delivery, accessibility, usability, acceptability, and adherence in first-time hearing aid users. To establish suitable outcome measures to evaluate the effectiveness of the intervention in a future randomised controlled trial.

Study Design: Single centre, feasibility.

Naïve first-time hearing aid users will try out the intervention away from the laboratory. Following 10-12 weeks of independent use, the investigators will assess how the participants used the intervention using a mixed-methods approach across two parallel stages:

Stage 1. The investigators will assess the feasibility of the intervention in first-time hearing aid users, who will be invited to take part in semi-structured interviews. Using the COM-B model (Michie et al., 2014) as the framework underpinning the interviews, delivery, accessibility, usability, acceptability, and adherence of the intervention will be evaluated. Transcribed audio-recordings will be analysed using thematic analysis (Braun & Clarke, 2006). A total of 15 participants is typically sufficient to achieve data saturation (the point in data collection when no new information emerges) using this qualitative methodology (Guest et al., 2006). To allow for 18% attrition (Ferguson et al., 2016), 18 patients will be. To prevent potential confounding of the interviews, participants will not be required to complete quantitative outcome measures used in stage 2.

Stage 2. The investigators will assess which outcome measures are suitable to assess the intervention in terms how well it supported users to make changes to their behaviour. First-time hearing aid users will complete outcome measures by interview. Outcomes were selected based on the World Health Organisation's International Classification of Functioning, Disability and Health (ICF) (WHO, 2001), which provides a theoretical framework upon which to measure the success of amplification using hearing aids. At least 50 participants are required to allow for sufficient between- and within-subject variability in order to calculate important change scores for each outcome measure. To allow for 18% attrition 59 patients will be recruited.

Enrollment: 94 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• First-time hearing aid users (or if previous users, but not having worn hearing aids for more than 3 years)
• Familiar with mobile technologies (e.g. owns a smartphone or tablet device, or uses one regularly)
• English as a first spoken language or a good understanding of English. It is important that participants can understand the content of the resources and work with the interactive elements, as well as be able to answer outcome questionnaires, to ensure valid data are collected.

Exclusion criteria

• Unable to complete the questionnaires without assistance due to age-related problems (e.g. cognitive decline or dementia), to ensure valid data are collected.

Trial design

94 participants in 1 patient group

First-time hearing aid users

Description:

Individuals using hearing aids for the first-time (or if previous users, have not having worn hearing aids for more than 3 years) will have access to the mobile-enabled RLOs (mRLOs) intervention, which will be given to the participants shortly after their hearing aid is fitted.

Treatment:

Other: Mobile-enabled RLOs (mRLOs)