Comparison of Hand Feeding Techniques for Persons With Dementia

October 5, 2016 updated by: Duke University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • North Carolina
      • Apex, North Carolina, United States, 27502
        • Rex Apex
      • Chapel Hill, North Carolina, United States, 27517
        • Carolina Meadows
      • Durham, North Carolina, United States, 27704
        • Carver Living Center
      • Durham, North Carolina, United States, 27705
        • Croasdaile
      • Durham, North Carolina, United States, 27705
        • Hillcrest
      • Durham, North Carolina, United States, 27705
        • Pettigrew
      • Durham, North Carolina, United States, 27712
        • Treyburn
      • Wilmington, North Carolina, United States, 28401
        • Kindred Cypress Pointe
      • Wilmington, North Carolina, United States, 28401
        • Wilmington Health & Rehabilitation Center
      • Wilmington, North Carolina, United States, 28403
        • Liberty Commons Nursing Center
      • Wilmington, North Carolina, United States, 28411
        • Davis Health Care Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

58 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

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 Names:
  • Direct hand feeding, hand over hand feeding, and hand under hand feeding.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Day 6
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
Day 6
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
Day 6

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (Actual)

September 1, 2014

Study Completion (Actual)

October 1, 2014

Study Registration Dates

First Submitted

January 29, 2013

First Submitted That Met QC Criteria

January 29, 2013

First Posted (Estimate)

January 31, 2013

Study Record Updates

Last Update Posted (Estimate)

October 6, 2016

Last Update Submitted That Met QC Criteria

October 5, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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