Short and Long Term Effect and Cost-utility of High Intensity vs. Low Intensity Speech Intervention in Children With Cleft Palate
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Incremental cost-utility ratio
研究概览
简要总结
Achieving speech that is understandable and acceptable to others is the key outcome in cleft treatment. Therefore, speech therapy provided by a speech-language pathologist is necessary. This intervention is traditionally provided twice per week for 30 minutes for months or even years by first-line speech-language pathologists. Unfortunately, this low intensity intervention is based on a historical context rather than scientific evidence. This means that current speech therapy knows several shortcomings including poor outcomes, treatment fatigue and high costs related to year-long therapy. Because of these issues, the use of high intensity speech intervention is proposed. Even though solid proof-of-concepts exist for this model, it has not yet found its way into clinical practice.
Before this intensity can be implemented and utilized in clinical practice, the effect of this novel program on a larger societal scale must be determined. This project will compare the effect of high intensity and low intensity speech intervention in children with a cleft palate in terms of speech, quality of life, and cost-utility as provided by first-line speech-language pathologists by conducting a large-scale randomized controlled trial. The final goal is to utilize this program in clinical practice and to create awareness of the benefits for children with a cleft palate among stakeholders.
详细描述
Objective 1: Conduct a large-scale randomized controlled trial to compare the short- and long-term sustainable effects of two different speech intervention intensities (i.e. high intensity speech intervention: 5x30 min/week during 2x4 weeks (2x10 hours) and low intensity speech intervention: 2x30 min/week during 20 weeks (20 hours)) on the speech and quality of life in Belgian Dutch-speaking children with a cleft palate with or without a cleft lip. Speech intervention will be provided by first-line speech language pathologists in private practices who will receive thorough training before the onset of the trial.
Hypothesis 1: Based on the state-of-the-art and our proof-of-concept, it is assumed that 20 hours of high intensity speech intervention will lead to superior speech outcomes and health-related quality of life compared to 20 hours of low intensity speech intervention.
Objective 2: To compare the cost-utility in quality-adjusted life years of two different speech intervention intensities (i.e. high intensity speech intervention: 5x30 min/week during 2x4 weeks (2x10 hours) and low intensity speech intervention: 2x30 min/week during 20 weeks (20 hours)) in Belgian Dutch-speaking children with a cleft palate with or without a cleft lip. Demonstrating the cost-effectiveness of high intensity speech intervention will facilitate implementation and utilization of this protocol in clinical practice as less money has to be spent in order to gain one life year in full health (QALY) when providing high intensity speech intervention compared to low intensity speech intervention.
Hypothesis 2: Besides the superior speech outcomes and health related quality of life in a shorter intervention time (cfr. hypothesis 1), it is hypothesized that less money has to be spent in order to gain one life year in full health (QALY) in the high intensity intervention group. In other words, it is hypothesized that high intensity intervention will be more cost-effective compared to low intensity speech intervention.
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
- 4 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Belgian Dutch-speaking children with a cleft palate with or without a cleft lip
- •Aged between 4 and 12 years,
- •Presence of at least one compensatory speech error in their speech based on the perceptual assessment of one experienced speech-language pathologist
排除标准
- •Children with syndromic clefts
- •Oronasal fistula
- •Velopharyngeal insufficiency
- •Hearing disabilities based on pure tone audiometry (>25 dB HL)
- •Cognitive and/or related learning disabilities or neuromuscular disorders
结局指标
主要结局
Incremental cost-utility ratio
时间窗: After a 12-week rest period (high intensity arm), at 3 months post-intervention
The cost-utility of the high intensity speech intervention compared to the low intensity speech intervention will be examined by calculating the ratio of the incremental costs to the incremental health effects (QALYs) called the incremental cost-utility ratio (ICUR), calculated as Cost intervention - Cost control / Effect intervention - Effect control. The EQ-5D-Youth version will be used for children aged 8-12 years and the EQ-5D proxy version for children aged 4-7 years to collect information on HRQoL ("utilities"). Cost information will be obtained using a self-reported questionnaire on health care use.
Incremental cost-effectiveness ratio
时间窗: After a 12-week rest period (high intensity arm), at 3 months post-intervention
The cost-effectiveness of the high intensity speech intervention compared to the low intensity speech intervention will be examined by calculating the ratio of the incremental costs to the incremental health effects (percentage correctly produced consonants) called the incremental cost-effectiveness ratio (ICER), calculated as Cost intervention - Cost control / Effect intervention - Effect control. The effectiveness will be estimated using the primary outcome (percentage correctly produced consonants) obtained from the randomized controlled trial. Cost information will be obtained using a self-reported questionnaire on health care use.
Consonant proficiency
时间窗: Assessment 2 weeks pre-intervention, immediately pre-intervention, after 10 hours of therapy, after a 12-week rest period, immediately post-intervention, at 1 week post-intervention, at 2 weeks post-intervention, at 3 months post-intervention
Consonant proficiency will be measured in terms of percentage correctly produced consonants (%)
次要结局
- Intelligibility in Context(Assessment immediately pre-intervention, after 10 hours of therapy, after a 12-week rest period, immediately post-intervention, at 3 months post-intervention)
- Health-related quality of life(Assessment immediately pre-intervention, after 10 hours of therapy, after a 12-week rest period, immediately post-intervention, at 3 months post-intervention)
- Communication attitudes of children aged 6 years and older(Assessment immediately pre-intervention, after 10 hours of therapy, after a 12-week rest period, immediately post-intervention, at 3 months post-intervention)
- Speech Function(Assessment immediately pre-intervention, after 10 hours of therapy, after a 12-week rest period, immediately post-intervention, at 3 months post-intervention)
- Speech Distress(Assessment immediately pre-intervention, after 10 hours of therapy, after a 12-week rest period, immediately post-intervention, at 3 months post-intervention)
- Communication attitudes of children aged 4 and 5 years(Assessment immediately pre-intervention, after 10 hours of therapy, after a 12-week rest period, immediately post-intervention, at 3 months post-intervention)