Ignite Creation Date:
2024-05-06 @ 8:27 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06381713
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-20
First Post:
2024-04-08
Brief Title:
Effect and Cost-utility of of High Intensity vs Low Intensity Speech Intervention in Children With Cleft Palate
Sponsor:
University Ghent
Organization:
University Ghent
Study Overview
Official Title:
Short and Long Term Effect and Cost-utility of High Intensity vs Low Intensity Speech Intervention in Children With Cleft Palate
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Detailed Description:
Objective 1 Conduct a large-scale randomized controlled trial to compare the short- and long-term sustainable effects of two different speech intervention intensities ie high intensity speech intervention 5x30 minweek during 2x4 weeks 2x10 hours and low intensity speech intervention 2x30 minweek 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 ie high intensity speech intervention 5x30 minweek during 2x4 weeks 2x10 hours and low intensity speech intervention 2x30 minweek 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
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 ie high intensity speech intervention 5x30 minweek during 2x4 weeks 2x10 hours and low intensity speech intervention 2x30 minweek 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None