Comparison of Hand Feeding Techniques for Persons With Dementia

Dementia Clinical Trial

Official title:

Comparison of Hand Feeding Techniques for Persons With Dementia Living in the Nursing Home

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01780402
• Other study ID #: Pro00035130
• Status: Completed
• Phase: N/A
• First received: January 29, 2013
• Last updated: October 5, 2016
• Start date: March 2012
• Est. completion date: October 2014

Study information

• Verified date: October 2016
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years and older

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Dementia

Intervention

Behavioral:
• Hand feeding techniques
Direct hand feeding technique: When the feeding assistant holds the object (e.g., fork, spoon, cup) intended to provide food or fluids to the PWD without any active involvement on the part of the PWD. Hand-over-hand feeding technique: Occurs when the PWD is holding the object (e.g., fork, spoon, cup) in an attempt to feed/ drink for themselves. If the PWD has trouble with this activity, the feeding assistant puts his or her hand over the hand of the PWD, in an effort to guide/ support/ assist the PWD with the activity. Hand-under-hand feeding technique: Occurs when the feeding assistant holds the object (e.g., fork, spoon, cup) and places the PWD hand over the top of their hand; therefore, the feeding assistants hand is under the hand of the PWD in a more supportive position.

Locations

Country	Name	City	State
United States	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	Davis Health Care Center	Wilmington	North Carolina
United States	Kindred Cypress Pointe	Wilmington	North Carolina
United States	Liberty Commons Nursing Center	Wilmington	North Carolina
United States	Wilmington Health & Rehabilitation Center	Wilmington	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	The John A. Hartford Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in frequency of aversive feeding behaviors	Changes in behaviors of person with dementia being assisted with 3 meals daily over 6 days	Day 6	No
Primary	Changes in time spent providing feeding assistance	Changes in time spent providing feeding assistance to a person with dementia being assisted with 3 meals daily over 6 days	Day 6	No
Primary	Changes in meal intake	Changes in meal intake for a person with dementia being assisted with 3 meals daily over 6 days	Day 6	No
Secondary	Functional ability and feeding behaviors exhibited by person with dementia	Coding of video recorded meals from Outcomes 1-3	Day 6	No
Secondary	Characterize feeding assistant responses to functional ability and feeding behaviors	Coding of video recorded meals from Outcomes 1-3	6 days	No
Secondary	Develop decision-making algorithm of adaptive approaches used by feeding assistant	Coding of video recorded meals from Outcomes 1-3	6 days	No