Comparison of Hand Feeding Techniques for Persons With Dementia

Not Applicable

Completed

• Conditions: Dementia

• Registration Number: NCT01780402
• Lead Sponsor: Duke University

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.

Study Timeline

• Study Start: 2012-03
• Study First Submitted: 2013-01-29
• Study First Submitted QC: 2013-01-29
• Study First Posted: 2013-01-31
• Primary Completion: 2014-09
• Study Completion: 2014-10
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-05
• Last Update Posted: 2016-10-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Resident of nursing home 6 weeks prior to intervention delivery
• 60+ years old
• Have a legally authorized representative to provide informed consent
• medical diagnosis of dementia
• required extensive assistance to total dependence for feeding
• Brief Interview for Mental Status (BIMS) score of 0-12

Exclusion Criteria

• Positive diagnosis of Human Immunodeficiency Virus (HIV), Parkinson's, and/or Traumatic Brain Injury
• Any swallowing disorder
• Presence of feeding tube that is sole source for meal delivery
• Significant auditory or visual impairment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Change in frequency of aversive feeding behaviors	Day 6	Changes in behaviors of person with dementia being assisted with 3 meals daily over 6 days
Changes in time spent providing feeding assistance	Day 6	Changes in time spent providing feeding assistance to a person with dementia being assisted with 3 meals daily over 6 days
Changes in meal intake	Day 6	Changes in meal intake for a person with dementia being assisted with 3 meals daily over 6 days

Secondary Outcome Measures

Name	Time	Method
Develop decision-making algorithm of adaptive approaches used by feeding assistant	6 days	Coding of video recorded meals from Outcomes 1-3
Functional ability and feeding behaviors exhibited by person with dementia	Day 6	Coding of video recorded meals from Outcomes 1-3
Characterize feeding assistant responses to functional ability and feeding behaviors	6 days	Coding of video recorded meals from Outcomes 1-3

Trial Locations

Locations (11)

Rex Apex; 🇺🇸 Apex, North Carolina, United States

Carolina Meadows; 🇺🇸 Chapel Hill, North Carolina, United States

Carver Living Center; 🇺🇸 Durham, North Carolina, United States

Croasdaile; 🇺🇸 Durham, North Carolina, United States

Hillcrest; 🇺🇸 Durham, North Carolina, United States

Pettigrew; 🇺🇸 Durham, North Carolina, United States

Treyburn; 🇺🇸 Durham, North Carolina, United States

Kindred Cypress Pointe; 🇺🇸 Wilmington, North Carolina, United States

Wilmington Health & Rehabilitation Center; 🇺🇸 Wilmington, North Carolina, United States

Liberty Commons Nursing Center; 🇺🇸 Wilmington, North Carolina, United States

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