Voice Therapy for Benign Voice Disorders in the Elderly: A Randomized Controlled Trial Comparing Telepractice and Conventional Face-to-face Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 69
- 主要终点
- Change from Baseline of 10-item voice handicap index at 2 months
研究概览
简要总结
People over 55 years are high-risk with voice disorders. Voice disordered elderly need vocal training in order to improve communication efficiency and quality of life. However, participation in vocal training of elderly is often restricted by motivation, time of practice, and availability to hospital, which thus reduces treatment effects. The purpose of the study is to design a telecommunication vocal training system and a vocal training program for voice disordered elderly in Taiwan. The investigator proposed a 3-year consecutive study, including a single-blind, randomized controlled trial, to test the hypothesis that vocal training via telepractice for voice disordered elderly are not inferior to the standard face to face training.
详细描述
Randomization: per mutated block, 40 patients on each arms (experimental and control)
Allocation: sealed envelope indicating either of the 2 groups
Intervention: weekly vocal training, each course last for 30-40 minutes,lasting for 2 months
Outcome measurement: before treatment, 1 month, 3 months, and 6 months after treatment
Primary outcome: 10-item voice handicap index
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)
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patient equal or older than 55 years old
- •Voice Handicap Index-10 (VHI-10) score >10 point
- •accessibility to a network connection
排除标准
- •neurologic disorders
- •active pulomanory disease
- •mental disorder
研究组 & 干预措施
control
Vocal Training via face-to-face practice
干预措施: Vocal Training Via face-to face practice (Behavioral)
experimental
Vocal Training via Telepractice
干预措施: Vocal Training Via Telepractice (Behavioral)
结局指标
主要结局
Change from Baseline of 10-item voice handicap index at 2 months
时间窗: before treatment (after signing informed consent, prior to randomization) and within 2 weeks after the completion of voice therapy
min: 0(best); Max: 40(worst);
次要结局
未报告次要终点
研究者
Chi-Te Wang
Attending Physician
Far Eastern Memorial Hospital