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Comparison of Hand Feeding Techniques for Persons With Dementia

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Duke University
Sponsor:
Collaborator:
The John A. Hartford Foundation
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT01780402
First received: January 29, 2013
Last updated: July 18, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention
Feeding and Eating Difficulties
Dementia
Behavioral: Hand feeding techniques

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Supportive Care
Official Title: Comparison of Hand Feeding Techniques for Persons With Dementia Living in the Nursing Home

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • Change in frequency of aversive feeding behaviors [ Time Frame: Day 6 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Changes in meal intake for a person with dementia being assisted with 3 meals daily over 6 days


Estimated Enrollment: 30
Study Start Date: March 2012
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.

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

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01780402

Locations
United States, North Carolina
Rex Apex Recruiting
Apex, North Carolina, United States, 27502
Contact: Melissa Aselage    910-471-7477    melissa.aselage@duke.edu   
Carolina Meadows Recruiting
Chapel Hill, North Carolina, United States, 27517
Contact: Melissa Aselage    910-471-7477    melissa.aselage@duke.edu   
Croasdaile Recruiting
Durham, North Carolina, United States, 27705
Contact: Melissa Aselage    919-471-7477    melissa.aselage@duke.edu   
Hillcrest Recruiting
Durham, North Carolina, United States, 27705
Contact: Melissa Aselage    910-471-7477    melissa.aselage@duke.edu   
Pettigrew Recruiting
Durham, North Carolina, United States, 27705
Contact: Melissa Aselage    910-471-7477    melissa.aselage@duke.edu   
Treyburn Recruiting
Durham, North Carolina, United States, 27712
Contact: Melissa Aselage    910-471-7477    melissa.aselage@duke.edu   
Carver Living Center Recruiting
Durham, North Carolina, United States, 27704
Contact: Melissa Aselage    910-471-7477    melissa.aselage@duke.edu   
Wilmington Health & Rehabilitation Center Recruiting
Wilmington, North Carolina, United States, 28401
Contact: Melissa Aselage    910-471-7477    melissa.aselage@duke.edu   
Davis Health Care Center Recruiting
Wilmington, North Carolina, United States, 28411
Contact: Melissa Aselage    910-471-7477    melissa.aselage@duke.edu   
Kindred Cypress Pointe Recruiting
Wilmington, North Carolina, United States, 28401
Contact: Melissa Aselage    910-471-7477    melissa.aselage@duke.edu   
Liberty Commons Nursing Center Recruiting
Wilmington, North Carolina, United States, 28403
Contact: Melissa Aselage    910-471-7477    melissa.aselage@duke.edu   
Sponsors and Collaborators
Duke University
The John A. Hartford Foundation
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
  More Information

No publications provided

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01780402     History of Changes
Other Study ID Numbers: Pro00035130
Study First Received: January 29, 2013
Last Updated: July 18, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Duke University:
feeding difficulty
eating difficulty
dementia
nursing home
careful hand feeding

Additional relevant MeSH terms:
Dementia
Brain Diseases
Central Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on November 27, 2014