Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06536985
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-25
Brief Title:
Oral Frailty a Prevalent Syndrome in the Senior Population Manifests as a Decline in Oral Functions Often Coupled With Diminished Cognitive and Physical Capabilities
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effect of an Oral Frailty Measures Program in Institutionalized Elders a Study Protocol of a Cluster-Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Oral frailty a prevalent syndrome in the senior population manifests as a decline in oral functions often coupled with diminished cognitive and physical capabilities This condition significantly impacts the elderlys quality of life Our study aims to assess a hybrid oral health promotion program grounded in the theory of goal achievement that integrates both face-to-face counseling and digital health interventions The goal is to determine its efficacy in alleviating oral frailty among residents of nursing homesThis study is structured as a 16-week prospective cluster-randomized controlled trial It will engage 92 seniors aged 65 years and older To uphold the integrity and impartiality of the research a blinding protocol is employed for all participants outcome evaluators and statistical analysts ensuring they remain unaware of the subjects group assignments Drawing from the theory of goal achievement we have crafted a comprehensive oral health promotion strategy that blends in-person guidance with digital health initiatives over a 16-week period Following informed consent participants will be randomly allocated to the control or intervention group at the outset of the study The primary outcome measure will focus on oral function encompassing tongue pressure masticatory function pronunciation abilities and subjective experiences of eating and swallowing difficulties Supplementary assessments will include frailty scales social support scales nutritional screening scales and self-efficacy scales pertinent to oral health in the elderly These will be conducted at intervals throughout the intervention every 4 weeks and at a 1-month post-intervention follow-up
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None