Comparing Face-to-face Group Voice Therapy to Telepractice Group Voice Therapy for Muscle Tension Dysphonia: A Non-inferiority Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 168
- 试验地点
- 1
- 主要终点
- Change in patient-related outcome measure
研究概览
简要总结
The goal of this clinical trial is to compare face-to-face group voice therapy to telepractice group voice therapy for muscle tension dysphonia (MTD). The main questions it aims to answer are:
- The effectiveness of telepractice voice therapy for MTD using a randomized controlled trial study design.
- The effectiveness of telepractice group voice therapy using a randomized controlled trial study design.
Participants will receive telepractice group voice therapy or face-to-face group voice therapy. Researchers will compare telepractice group voice therapy to face-to-face group voice therapy for patients with MTD to see if it has the same effectiveness.
详细描述
STUDY OBJECTIVES
-
Primary Objectives
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To evaluate the effectiveness of telepractice voice therapy for MTD using a randomized controlled trial study design.
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To evaluate the effectiveness of telepractice group voice therapy using a randomized controlled trial study design.
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Secondary Objectives
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To compare therapy dropout rate and treatment schedule adherence rate of the two modes of group voice therapy (comparing telepractice to face-to-face mode).
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To conduct cost-analysis to compare the health-service cost and patient-related cost of the telepractice and face-to-face group voice therapy.
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To further investigate the role of group climate in contributing to treatment outcome in group voice therapy.
BACKGROUND
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
Due to the nature of this study, where the mode of therapy received is obvious to the patients, double blinding is not possible. However, single blinding will be adopted in this study. Although all outcome measures data collection will be conducted by the study team clinicians, the coding of data, video and audio analysis will be conducted anonymously by research staff members who do not have knowledge about the group assignments and the time-point of the data collection.
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
- •Above or equal to 18 years of age;
- •Diagnosis of primary MTD or secondary MTD where voice therapy is the primary mode of treatment, such as vocal fold nodules;
- •Chinese-speaking subjects only.
排除标准
- •Dysphonia of neurogenic or psychogenic origin;
- •Secondary muscle tension dysphonia in which voice therapy is not the primary treatment modality, such as vocal polyp, vocal cyst, granuloma, papilloma;
- •Low computer literacy or without social or family support for telepractice;
- •Patients who are not capable of making own consent;
- •Patients who are receiving other modalities of treatment which is not part of this current study, such as traditional Chinese medicine.
结局指标
主要结局
Change in patient-related outcome measure
时间窗: Baseline (before the intervention), 2 weeks follow-up, 3 months follow-up, 6 months follow-up
The Chinese Voice-Handicap Index (VHI-30) is a reliable patient-related outcome measure. It provides an overall measurement of a person's vocal function and how it influences on a person's everyday functioning and experience. VHI-30 has 30 items. Each item is rated on a scale from with 0 as never, 1 as almost never, 2 as sometimes, 3 as almost always, and 4 as always. Statistical analysis: Two-way repeated measures of ANOVA to compare between group performance. To allow for non-inferiority analysis, the 95% confidence interval of the difference in VHI scores between the two groups will be calculated. The upper limit of the 95% CI will be used to determine whether the difference between group is within the non-inferiority margin.
Change in acoustic voice analysis
时间窗: Baseline (before the intervention), 2 weeks follow-up, 3 months follow-up, 6 months follow-up
The Computerized Speech Lab system will be used to measure parameters including jitter, shimmer, and noise-to-harmonic ratio and cepstral peak prominence. Statistical analysis: Acoustic analysis will be conducted using two-way repeated measures of ANOVA. Non-inferiority analysis will be also conducted.
Change in laryngeal imaging
时间窗: Baseline (before the intervention), 2 weeks follow-up, 3 months follow-up, 6 months follow-up
Videostroboscopy will be conducted to identify anatomical and physiological outcomes. These include presence of laryngeal pathology, laryngeal physiological patterns. Two experienced laryngologists blinded to the patient's information will rate the video recordings. Statistical analysis: Reliability measures will be applied using intraclass correlation for both intra and interrater reliability. Perceptual evaluation of voice will be conducted using two-way repeated measures of ANOVA. Non-inferiority analysis will be also conducted.
Change in perceptual evaluation of voice
时间窗: Baseline (before the intervention), 2 weeks follow-up, 3 months follow-up, 6 months follow-up
Patients' voice quality will be assessed using the Cantonese Perceptual Evaluation of Voice scale (Thomas Law, Lee, Lam, van Hasselt, \& Tong, 2013). Two experienced speech-language pathologists blinded to the patient's information will rate the audio recordings. Statistical analysis: Reliability measures will be applied using intraclass correlation for both intra and interrater reliability. Perceptual evaluation of voice will be conducted using two-way repeated measures of ANOVA. Non-inferiority analysis will be also conducted.
Change in aerodynamic measures
时间窗: Baseline (before the intervention), 2 weeks follow-up, 3 months follow-up, 6 months follow-up
Maximum phonation time will be measured. Statistical analysis: Aerodynamic measure will be conducted using two-way repeated measures of ANOVA. Non-inferiority analysis will be also conducted.
次要结局
- Therapy dropout rate and treatment schedule adherence rate(Immediately after the intervention)
- Group climate(Immediately after the intervention)
- Cost analysis(Immediately after the intervention)
研究者
Thomas Law
Assistant Professor & Deputy Chief of Division
Chinese University of Hong Kong