Audiology Text-Messaging Intervention (Florence) to Improve Hearing Aid Use in NHS Adult Audiology Patients: A Feasibility Study With Proof-of-Concept and Embedded Process Evaluation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- WSAUD A/S
- 入组人数
- 70
- 试验地点
- 3
- 主要终点
- Self-reported hearing aid use
研究概览
简要总结
Over 18 million adults in the United Kingdom have significant hearing loss, linked to isolation, depression and comorbidities. Hearing aids are the main management option yet are frequently unused (~23%) or used irregularly (<40%), wasting NHS resources and reducing quality-of-life gains. Digital behaviour-change interventions can improve self-management between appointments. Florence, an NHS-endorsed text-messaging system, has been used in the management of other long-term conditions, but has not yet been applied within audiology. This study will test a standardised audiology text-message protocol, delivered via Florence, to support new NHS hearing aid users, aiming to improve adherence, outcomes, and cost-effectiveness. Outcomes assess trial feasibility (primary objective), proof-of concept for efficacy (secondary objective), and process evaluation (tertiary objective).
详细描述
Over 18 million adults in the UK have significant hearing loss, with prevalence and severity increasing with age. Hearing loss is a leading global cause of disability, associated with social isolation, depression, dementia, and reduced quality of life, and is more common among people with other long-term conditions such as diabetes, hypertension, and cardiovascular disease. Hearing aids are the standard clinical management, yet up to 23% of new users abandon them and <40% use them irregularly, resulting in wasted NHS resources and prolonging hearing difficulties.
Adjusting to hearing aids is a novel health behaviour, and behaviour-change interventions informed by health psychology can empower patients to manage their care, benefiting both patients and healthcare systems. Digital interventions, such as mobile text-messaging, are cost-effective ways to provide information and support between appointments and improve self-management.
Florence, an NHS-endorsed text-messaging system, has improved self-management in long-term conditions including hypertension, diabetes, and cancer, improving patient satisfaction and cost-effectiveness. It has not yet been applied in audiology. This feasibility study will examine a standardised audiology text-message protocol, delivered via Florence, for new NHS hearing aid users, addressing trial feasibility, proof-of-concept, and process evaluation objectives. Effective use could improve hearing aid adherence, quality of life, and save the NHS millions annually.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Blinding
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •WP1: Pilot Feasibility Study (n=60, 30 per group intervention/control (treatment as usual)) Inclusion criteria
- •Aged ≥18 years (no upper age limit)
- •Prescribed their first NHS acoustic hearing aid(s) for the primary concern of hearing loss
- •Able and willing to provide informed consent
- •Not currently participating in similar research
- •Access to a mobile device (This is not required to be a smart phone device)
排除标准
- •Registered on a pre-existing Florence text-messaging protocol.
- •Unable to read/understand English
- •WP2: Nested Process Evaluation (minimum n=10 patients, n=2 clinicians) Inclusion criteria (patients)
- •Aged ≥18 years (no upper age limit)
- •Prescribed their first NHS acoustic hearing aid(s) for the primary concern of hearing loss
- •Able and willing to provide informed consent
- •Exclusion criteria (patients)
- •Registered on a pre-existing Florence text-messaging protocol.
- •Unable to read/understand English
- •Inclusion criteria (clinicians)
- •Aged ≥18 years (no upper age limit)
- •Able and willing to provide informed consent
- •Exclusion criteria (clinicians)
- •Not meeting criteria for inclusion
研究组 & 干预措施
Hearing aids plus text-message protocol
Audiology text-message protocol: The experimental group will receive a minimum of 65 text-messages directly to their mobile telephone for the duration of the 14-week text-message protocol (2 weeks for Stage 1 protocol, 12 weeks for Stage 2 protocol) in addition to receiving the standard audiology treatment as usual (see Control: Standard audiological care (hearing aid provision - treatment as usual)).
干预措施: Audiology text-message protocol (Behavioral)
Standard audiological care (treatment as usual)
Participants allocated to the control group will receive treatment as usual. Treatment as usual is defined as standard treatment available to NHS audiology patients. This may include an audiological assessment, prescription of one/two hearing aids, and an optional face-to-face follow-up appointment.
结局指标
主要结局
Self-reported hearing aid use
时间窗: From enrollment to week 16 and 28
A bespoke single item question recording the self-reported average hours of daily hearing aid use over the past seven days. The question "On a typical day over the last seven days, how many hours did you use your hearing aid?" will be collected via participants' preferred contact method.
Glasgow Hearing Aid Benefit Profile (GHABP): (Gatehouse 1999)
时间窗: Week 1 (Part A) Week 16, 28 (Part B)
The GHABP is a 24-item scale consisting of six subscales. The subscales address hearing aid initial disability, hearing aid handicap, reported hearing aid use, reported hearing aid benefit, hearing aid satisfaction and hearing aid derived benefit. Each domain is measured on a five-point scale, and the mean score across four predefined situations is converted into a percentage. Participants will only be asked to complete Part A (preintervention) of the GHABP questionnaire at the baseline assessment (pre-hearing aid fitting). Part B (residual) will be completed at the 16 and 28 week follow up (post-hearing aid fitting).
次要结局
- Hearing Handicap Inventory for the Elderly/Adults (HHIE/A): (Ventry and Weinstein 1982)(Week 1, Week 16, 28)
- Auditory Lifestyle and Demand questionnaire (ALDQ): (Gatehouse 1999)(Week 1, Week 16, 28)
- International Outcome Inventory for Hearing Aids (IOI-HA) (Cox and Alexander 2002)(Week 16, 28)
- Hearing Related Lifestyle (HEARLI-Q) (Lelic, Wolters et al. 2022)(Week 16, 28 Week 1, Week 16, 28)
- Hearing related adaptive strategies (AStra) (Fischer 2024)(Week 1, Week 16, 28)
- Big Five Inventory (BFI) (John 1991)(Week 1)
- Short Assessment of Patient Satisfaction (SAPS) (Hawthorne, Sansoni et al. 2014)(Week 1, 28)
- Measure of Audiologic Rehabilitation Self-Efficacy for Hearing Aids (MARS-HA): (West and Smith 2007)(Week 1, Week 16, 28)
- Short Form Patient Activation Measure (PAM) (Hibbard, Mahoney et al. 2005)(Week 1, 3, 16, 28)
- Empowerment Audiology Questionnaire (EmpAQ-15) (Bennett, Larsson et al. 2024)(Week 1, 3, 16, 28)
- Expected Consequences of Hearing aid Ownership (ECHO): (Cox and Alexander 2000)(Week 1, 3, 16, 28)
- Stigma Consciousness Questionnaire for Hearing Loss (SCQ-HL): (Vincent, Gagné et al. 2017)(Week 1, 16, 28)
- Health Utilities Index (HUI-III) (Feeny, Furlong et al. 2002)(Week 1, 16, 28)
- Patient Global Impression Scale - Improvement (PGI-I) (Guy, 1976)(Week 16, 28)
- EQ-5D-3L (Oppe, Devlin et al. 2014)(Week 1, 16, 28)
- Data logging from the text-message intervention(Week 28)
研究者
Emma Broome
Senior Research Fellow
University of Nottingham