Ignite Creation Date:
2025-12-25 @ 4:05 AM
Ignite Modification Date:
2025-12-27 @ 10:07 PM
Study NCT ID:
NCT01780402
Status:
COMPLETED
Last Update Posted:
2016-10-06
First Post:
2013-01-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Hand Feeding Techniques for Persons With Dementia
Sponsor:
Duke University
Organization:
Study Overview
Official Title:
Comparison of Hand Feeding Techniques for Persons With Dementia Living in the Nursing Home
Status:
COMPLETED
Status Verified Date:
2016-10
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:
The purpose of this study is to test three hand feeding techniques that can be used to provide feeding assistance to persons with dementia - direct hand feeding, hand-over-hand feeding, and hand-under-hand feeding.
Detailed Description:
Proposed Aim 1: To collect pilot data related to using three hand feeding techniques for feeding persons with dementia (PWD) in the nursing home (NH) setting: (1) direct hand feeding; (2) hand-over-hand feeding; and, (3) hand-under-hand feeding. Primary outcomes are impact on frequency of aversive feeding behaviors, meal intake, and time spent assisting with feeding.
Proposed Aim 2: Evaluate implementation of the hand feeding intervention for larger randomized study of feeding techniques.
Aim 2a: Conduct a process evaluation for method of recruiting, screening, and obtaining informed consent of legally authorized representatives (LARs)/ assent of PWD.
Aim 2b: Establish fidelity to treatment for all three hand feeding interventions.
Proposed Aim 2: Evaluate implementation of the hand feeding intervention for larger randomized study of feeding techniques.
Aim 2a: Conduct a process evaluation for method of recruiting, screening, and obtaining informed consent of legally authorized representatives (LARs)/ assent of PWD.
Aim 2b: Establish fidelity to treatment for all three hand feeding interventions.
Study Oversight
Has Oversight DMC:
True
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?: