- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01780402
Comparison of Hand Feeding Techniques for Persons With Dementia
Comparison of Hand Feeding Techniques for Persons With Dementia Living in the Nursing Home
Study Overview
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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North Carolina
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Apex, North Carolina, United States, 27502
- Rex Apex
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Chapel Hill, North Carolina, United States, 27517
- Carolina Meadows
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Durham, North Carolina, United States, 27704
- Carver Living Center
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Durham, North Carolina, United States, 27705
- Croasdaile
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Durham, North Carolina, United States, 27705
- Hillcrest
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Durham, North Carolina, United States, 27705
- Pettigrew
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Durham, North Carolina, United States, 27712
- Treyburn
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Wilmington, North Carolina, United States, 28401
- Kindred Cypress Pointe
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Wilmington, North Carolina, United States, 28401
- Wilmington Health & Rehabilitation Center
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Wilmington, North Carolina, United States, 28403
- Liberty Commons Nursing Center
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Wilmington, North Carolina, United States, 28411
- Davis Health Care Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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.
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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:
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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
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Changes in behaviors of person with dementia being assisted with 3 meals daily over 6 days
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Day 6
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Changes in time spent providing feeding assistance
Time Frame: Day 6
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Changes in time spent providing feeding assistance to a person with dementia being assisted with 3 meals daily over 6 days
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Day 6
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Changes in meal intake
Time Frame: Day 6
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Changes in meal intake for a person with dementia being assisted with 3 meals daily over 6 days
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Day 6
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Functional ability and feeding behaviors exhibited by person with dementia
Time Frame: Day 6
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Coding of video recorded meals from Outcomes 1-3
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Day 6
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Characterize feeding assistant responses to functional ability and feeding behaviors
Time Frame: 6 days
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Coding of video recorded meals from Outcomes 1-3
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6 days
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Develop decision-making algorithm of adaptive approaches used by feeding assistant
Time Frame: 6 days
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Coding of video recorded meals from Outcomes 1-3
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6 days
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Collaborators and Investigators
Sponsor
Collaborators
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
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pro00035130
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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