Hearing aid effectiveness after aural rehabilitation - individual versus group (HEARING) trial: RCT design and baseline characteristics

<p>Abstract</p> <p>Background</p> <p>Hearing impairment is the most common body system disability in veterans. In 2008, nearly 520,000 veterans had a disability for hearing loss through the Department of Veterans Affairs (VA). Changes in eligibility for hearing aid services, along with the aging population, contributed to a greater than 300% increase in the number of hearing aids dispensed from 1996 to 2006. In 2006, the VA committed to having no wait times for patient visits while providing quality clinically-appropriate care. One approach to achieving this goal is the use of group visits as an alternative to individual visits. We sought to determine: 1) if group hearing aid fitting and follow-up visits were at least as effective as individual visits, and 2) whether group visits lead to cost savings through the six month period after the hearing aid fitting. We describe the rationale, design, and characteristics of the baseline cohort of the first randomized clinical trial to study the impact of group versus individual hearing aid fitting and follow-up visits.</p> <p>Methods</p> <p>Participants were recruited from the VA Puget Sound Health Care System Audiology Clinic. Eligible patients had no previous hearing aid use and monaural or binaural air-conduction hearing aids were ordered at the evaluation visit. Participants were randomized to receive the hearing aid fitting and the hearing aid follow-up in an individual or group visit. The primary outcomes were hearing-related function, measured with the first module of the Effectiveness of Aural Rehabilitation (Inner EAR), and hearing aid adherence. We tracked the total cost of planned and unplanned audiology visits over the 6-month interval after the hearing aid fitting.</p> <p>Discussion</p> <p>A cohort of 659 participants was randomized to receive group or individual hearing aid fitting and follow-up visits. Baseline demographic and self-reported health status and hearing-related measures were evenly distributed across the treatment arms.</p> <p>Outcomes after the 6-month follow-up period are needed to determine if group visits were as least as good as those for individual visits and will be reported in subsequent publication.</p> <p>Trial Registration</p> <p>NCT00260663</p

Structured patient education: the Diabetes X-PERT Programme makes a difference

Aims. To develop a patient-centred, group-based self-management programme (X-PERT), based on theories of empowerment and discovery learning, and to assess the effectiveness of the programme on clinical, lifestyle and psychosocial outcomes. Methods. Adults with Type 2 diabetes (n= 314), living in Burnley, Pendle or Rossendale, Lancashire, UK were randomized to either individual appointments (control group) (n= 157) or the X-PERT Programme (n= 157). X-PERT patients were invited to attend six 2-h group sessions of self-management education. Outcomes were assessed at baseline, 4 and 14 months. Results. One hundred and forty-nine participants (95%) attended the X-PERT Programme, with 128 (82%) attending four or more sessions. By 14 months the X-PERT group compared with the control group showed significant improvements in the mean HbA1c(-0.6% vs. + 0.1%, repeated measures ANOVA, P< 0.001). The number needed to treat (NNT) for preventing diabetes medication increase was 4 [95% confidence interval (CI) 3, 7] and NNT for reducing diabetes medication was 7 (95% CI 5, 11). Statistically significant improvements were also shown in the X-PERT patients compared with the control patients for body weight, body mass index (BMI), waist circumference, total cholesterol, self-empowerment, diabetes knowledge, physical activity levels, footcare, fruit and vegetable intake, enjoyment of food and treatment satisfaction. Conclusions. Participation in the X-PERT Programme by adults with Type 2 diabetes was shown at 14 months to have led to improved glycaemic control, reduced total cholesterol level, body weight, BMI and waist circumference, reduced requirement for diabetes medication, increased consumption of fruit and vegetables, enjoyment of food, knowledge of diabetes, self-empowerment, self-management skills and treatment satisfaction