Clinical trial NCT01780402: Comparison of Hand Feeding Techniques for Persons With Dementia
Official title: Comparison of Hand Feeding Techniques for Persons With Dementia Living in the Nursing Home
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dementia
Keywords: feeding difficulty
eating difficulty
dementia
nursing home
careful hand feeding
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: The John A. Hartford Foundation
First posted: 2013-01-31
Enrollment: 30
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in frequency of aversive feeding behaviors
timeFrame: Day 6
measure: Changes in time spent providing feeding assistance
timeFrame: Day 6
measure: Changes in meal intake
timeFrame: Day 6
Secondary outcomes:
measure: Functional ability and feeding behaviors exhibited by person with dementia
timeFrame: Day 6
measure: Characterize feeding assistant responses to functional ability and feeding behaviors
timeFrame: 6 days
measure: Develop decision-making algorithm of adaptive approaches used by feeding assistant
timeFrame: 6 days
Other outcomes:
Locations:
city: Apex
country: United States
facility: Rex Apex
state: North Carolina
city: Chapel Hill
country: United States
facility: Carolina Meadows
state: North Carolina
city: Durham
country: United States
facility: Carver Living Center
state: North Carolina
city: Durham
country: United States
facility: Croasdaile
state: North Carolina
city: Durham
country: United States
facility: Hillcrest
state: North Carolina
city: Durham
country: United States
facility: Pettigrew
state: North Carolina
city: Durham
country: United States
facility: Treyburn
state: North Carolina
city: Wilmington
country: United States
facility: Kindred Cypress Pointe
state: North Carolina
city: Wilmington
country: United States
facility: Wilmington Health & Rehabilitation Center
state: North Carolina
city: Wilmington
country: United States
facility: Liberty Commons Nursing Center
state: North Carolina
city: Wilmington
country: United States
facility: Davis Health Care Center
state: North Carolina
Study officials:
affiliation: Duke University School of Nursing
name: Melissa B Aselage, PhD,RN,FNP
role: PRINCIPAL_INVESTIGATOR
affiliation: Duke University School of Nursing
name: Ruth Anderson, PhD,RN,FAAN
role: STUDY_CHAIR
affiliation: Medical University of South Carolina
name: Elaine J Amella, PhD,RN,FAAN
role: STUDY_CHAIR
References: