Comparison of Hand Feeding Techniques for Persons With Dementia
1 other identifier
interventional
30
1 country
11
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2012
Typical duration for not_applicable
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2012
CompletedFirst Submitted
Initial submission to the registry
January 29, 2013
CompletedFirst Posted
Study publicly available on registry
January 31, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2014
CompletedOctober 6, 2016
October 1, 2016
2.5 years
January 29, 2013
October 5, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Change in frequency of aversive feeding behaviors
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
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
Changes in meal intake for a person with dementia being assisted with 3 meals daily over 6 days
Day 6
Secondary Outcomes (3)
Functional ability and feeding behaviors exhibited by person with dementia
Day 6
Characterize feeding assistant responses to functional ability and feeding behaviors
6 days
Develop decision-making algorithm of adaptive approaches used by feeding assistant
6 days
Study Arms (1)
Hand feeding intervention delivery
EXPERIMENTALTrained 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Resident of nursing home 6 weeks prior to intervention delivery
- + 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Duke Universitylead
- The John A. Hartford Foundationcollaborator
Study Sites (11)
Rex Apex
Apex, North Carolina, 27502, United States
Carolina Meadows
Chapel Hill, North Carolina, 27517, United States
Carver Living Center
Durham, North Carolina, 27704, United States
Croasdaile
Durham, North Carolina, 27705, United States
Hillcrest
Durham, North Carolina, 27705, United States
Pettigrew
Durham, North Carolina, 27705, United States
Treyburn
Durham, North Carolina, 27712, United States
Kindred Cypress Pointe
Wilmington, North Carolina, 28401, United States
Wilmington Health & Rehabilitation Center
Wilmington, North Carolina, 28401, United States
Liberty Commons Nursing Center
Wilmington, North Carolina, 28403, United States
Davis Health Care Center
Wilmington, North Carolina, 28411, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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 Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 29, 2013
First Posted
January 31, 2013
Study Start
March 1, 2012
Primary Completion
September 1, 2014
Study Completion
October 1, 2014
Last Updated
October 6, 2016
Record last verified: 2016-10