Comparison of Hand Feeding Techniques for Persons With Dementia

Not Applicable

Completed

• Conditions: Dementia
• Interventions: Behavioral: Hand feeding techniques

• 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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Hand feeding intervention delivery	Hand feeding techniques	Trained Research Feeding Assistants (TRFA), blind to the study outcomes, will assist enrolled PWDs with all three meals for two days using a pre-specified hand feeding technique. Videotaping will occur for two enrolled PWD during the six day time frame to promote efficiency. Coding of the video will be done by a trained Data Technician after meals have been recorded to determine frequency of aversive feeding behaviors, calculate meal intake, and time spent assisting with the meal.

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 meal intake	Day 6	Changes in meal intake for a 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

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

Pettigrew; 🇺🇸 Durham, North Carolina, United States

Hillcrest; 🇺🇸 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

Davis Health Care Center; 🇺🇸 Wilmington, North Carolina, United States

Croasdaile; 🇺🇸 Durham, North Carolina, United States