Improving Clinical Efficiency by Reducing Scheduled Follow-ups Using Cochlear America's Population Mean Mapping Strategy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Speech perception scores
研究概览
简要总结
The study is about the importance of each follow-up visit after activating a new cochlear implant in addition to evaluating the effectiveness and efficiency of a new programming strategy from Cochlear Americas. Investigators are looking for patients who have recently selected Cochlear Americas as their cochlear implant manufacturer of choice for their upcoming surgery. The aim of this study is to determine if 1) patient outcomes remain stable when reducing follow-up appointments and 2) Cochlear's population mean mapping can produce similar outcomes with patients while additionally reducing appointment times. The hypothesis is that using population mean mapping and reducing the number of follow-up visits after activation will yield similar performance outcomes to a standard of care while decreasing the length of appointment times and number of appointments needed for each patient.
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
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Postlingually deafened
- •Adults (18+)
- •New cochlear implant recipients with Cochlear Americas devices; identified prior to activation
- •Able to perform follow-up testing tasks (repeating words/sentences, indicating they heard a sound stimulus, completing questionnaires)
- •English speakers
排除标准
- •Patients who select other cochlear implant manufactured devices
- •Pre-lingually deafened
- •Multiple disabilities
- •Unable to perform follow-up testing tasks (repeating words/sentences, indicating they heard a sound stimulus, completing questionnaires)
- •Non-English speakers
- •Children under the age of 18
研究组 & 干预措施
Population mean mapping, traditional follow-up
New programming strategy
干预措施: Population mean mapping (Other)
Population mean mapping, without 1 week follow-up
Reduction in the number of follow-up visits and new programming strategy.
干预措施: Changes in traditional follow-up (Other)
Population mean mapping, without 1 week follow-up
Reduction in the number of follow-up visits and new programming strategy.
干预措施: Population mean mapping (Other)
Traditional mapping*, without 1 week follow-up
Reduction in the number of follow-up visits.
干预措施: Changes in traditional follow-up (Other)
Traditional mapping, traditional follow-up
Traditional follow-up plan
结局指标
主要结局
Speech perception scores
时间窗: 1-year
Speech perception scores via CNC word lists (percentages) at each visit. Scores are from 0 to 100% with 100% being the best.
Duration of programming session
时间窗: 1-year
Time spent programming (seconds) at each visit
次要结局
- Quality of Life questionnaire(1-year)
- Soundfield detection thresholds(1-year)
- programming levels(1-year)
研究者
Julie G. Arenberg, CCC-A
Principal Investigator
Massachusetts Eye and Ear Infirmary