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Completed

NCT Number: NCT01780402

Comparison of Hand Feeding Techniques for Persons With Dementia

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.

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Key information

Conditions

Dementia Brain Diseases Central Nervous System Diseases Mental Disorders Nervous System Diseases Neurocognitive Disorders

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rex Apex, Apex, North Carolina, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hand feeding techniques

Behavioral

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.

Primary outcomes

  1. 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

  2. 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

  3. 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

Secondary outcomes

  1. Functional ability and feeding behaviors exhibited by person with dementia

    Time frame: Day 6

    Coding of video recorded meals from Outcomes 1-3

  2. Characterize feeding assistant responses to functional ability and feeding behaviors

    Time frame: 6 days

    Coding of video recorded meals from Outcomes 1-3

  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

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • The John A. Hartford Foundation

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Jan 31, 2013
Registry last updated
Oct 6, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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