Comparison of Hand Feeding Techniques for Persons With Dementia
Primary Purpose
Dementia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Hand feeding techniques
Sponsored by
About this trial
This is an interventional supportive care trial for Dementia focused on measuring feeding difficulty, eating difficulty, dementia, nursing home, careful hand feeding
Eligibility 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
Sites / Locations
- Rex Apex
- Carolina Meadows
- Carver Living Center
- Croasdaile
- Hillcrest
- Pettigrew
- Treyburn
- Kindred Cypress Pointe
- Wilmington Health & Rehabilitation Center
- Liberty Commons Nursing Center
- Davis Health Care Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Hand feeding intervention delivery
Arm Description
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.
Outcomes
Primary Outcome Measures
Change in frequency of aversive feeding behaviors
Changes in behaviors of person with dementia being assisted with 3 meals daily over 6 days
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
Changes in meal intake
Changes in meal intake for a person with dementia being assisted with 3 meals daily over 6 days
Secondary Outcome Measures
Functional ability and feeding behaviors exhibited by person with dementia
Coding of video recorded meals from Outcomes 1-3
Characterize feeding assistant responses to functional ability and feeding behaviors
Coding of video recorded meals from Outcomes 1-3
Develop decision-making algorithm of adaptive approaches used by feeding assistant
Coding of video recorded meals from Outcomes 1-3
Full Information
NCT ID
NCT01780402
First Posted
January 29, 2013
Last Updated
October 5, 2016
Sponsor
Duke University
Collaborators
The John A. Hartford Foundation
1. Study Identification
Unique Protocol Identification Number
NCT01780402
Brief Title
Comparison of Hand Feeding Techniques for Persons With Dementia
Official Title
Comparison of Hand Feeding Techniques for Persons With Dementia Living in the Nursing Home
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
October 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
Collaborators
The John A. Hartford Foundation
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia
Keywords
feeding difficulty, eating difficulty, dementia, nursing home, careful hand feeding
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare Provider
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Hand feeding intervention delivery
Arm Type
Experimental
Arm Description
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 Type
Behavioral
Intervention Name(s)
Hand feeding techniques
Other Intervention Name(s)
Direct hand feeding, hand over hand feeding, and hand under hand feeding.
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in frequency of aversive feeding behaviors
Description
Changes in behaviors of person with dementia being assisted with 3 meals daily over 6 days
Time Frame
Day 6
Title
Changes in time spent providing feeding assistance
Description
Changes in time spent providing feeding assistance to a person with dementia being assisted with 3 meals daily over 6 days
Time Frame
Day 6
Title
Changes in meal intake
Description
Changes in meal intake for a person with dementia being assisted with 3 meals daily over 6 days
Time Frame
Day 6
Secondary Outcome Measure Information:
Title
Functional ability and feeding behaviors exhibited by person with dementia
Description
Coding of video recorded meals from Outcomes 1-3
Time Frame
Day 6
Title
Characterize feeding assistant responses to functional ability and feeding behaviors
Description
Coding of video recorded meals from Outcomes 1-3
Time Frame
6 days
Title
Develop decision-making algorithm of adaptive approaches used by feeding assistant
Description
Coding of video recorded meals from Outcomes 1-3
Time Frame
6 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Melissa B Aselage, PhD,RN,FNP
Organizational Affiliation
Duke University School of Nursing
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ruth Anderson, PhD,RN,FAAN
Organizational Affiliation
Duke University School of Nursing
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Elaine J Amella, PhD,RN,FAAN
Organizational Affiliation
Medical University of South Carolina
Official's Role
Study Chair
Facility Information:
Facility Name
Rex Apex
City
Apex
State/Province
North Carolina
ZIP/Postal Code
27502
Country
United States
Facility Name
Carolina Meadows
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27517
Country
United States
Facility Name
Carver Living Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27704
Country
United States
Facility Name
Croasdaile
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Facility Name
Hillcrest
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Facility Name
Pettigrew
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Facility Name
Treyburn
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27712
Country
United States
Facility Name
Kindred Cypress Pointe
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
Country
United States
Facility Name
Wilmington Health & Rehabilitation Center
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
Country
United States
Facility Name
Liberty Commons Nursing Center
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28403
Country
United States
Facility Name
Davis Health Care Center
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28411
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Comparison of Hand Feeding Techniques for Persons With Dementia
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