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Comparison of Hand Feeding Techniques for Persons With Dementia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01780402
First Posted: January 31, 2013
Last Update Posted: October 6, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
The John A. Hartford Foundation
Information provided by (Responsible Party):
Duke University
January 29, 2013
January 31, 2013
October 6, 2016
March 2012
September 2014   (Final data collection date for primary outcome measure)
  • Change in frequency of aversive feeding behaviors [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Day 6 ]
    Changes in meal intake for a person with dementia being assisted with 3 meals daily over 6 days
Same as current
Complete list of historical versions of study NCT01780402 on ClinicalTrials.gov Archive Site
  • Functional ability and feeding behaviors exhibited by person with dementia [ Time Frame: Day 6 ]
    Coding of video recorded meals from Outcomes 1-3
  • Characterize feeding assistant responses to functional ability and feeding behaviors [ Time Frame: 6 days ]
    Coding of video recorded meals from Outcomes 1-3
  • Develop decision-making algorithm of adaptive approaches used by feeding assistant [ Time Frame: 6 days ]
    Coding of video recorded meals from Outcomes 1-3
Not Provided
Not Provided
Not Provided
 
Comparison of Hand Feeding Techniques for Persons With Dementia
Comparison of Hand Feeding Techniques for Persons With Dementia Living in the Nursing Home
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.

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.

Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Supportive Care
Dementia
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.

Other Name: Direct hand feeding, hand over hand feeding, and hand under hand feeding.
Experimental: Hand feeding intervention delivery
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.
Intervention: Behavioral: Hand feeding techniques
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
October 2014
September 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
60 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01780402
Pro00035130
Yes
Not Provided
Plan to Share IPD: Undecided
Duke University
Duke University
The John A. Hartford Foundation
Principal Investigator: Melissa B Aselage, PhD,RN,FNP Duke University School of Nursing
Study Chair: Ruth Anderson, PhD,RN,FAAN Duke University School of Nursing
Study Chair: Elaine J Amella, PhD,RN,FAAN Medical University of South Carolina
Duke University
October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP