DementiaNCT01780402
Comparison of Hand Feeding Techniques for Persons With Dementia
A study testing Hand feeding techniques in people with Dementia, run by Duke University at 11 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Dementia
- What is being tested?
- Hand feeding techniques
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 11 sitesUnited States
- Study dates
- Mar 2012to Oct 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Rex Apex
Apex, North Carolina, 27502
Carolina Meadows
Chapel Hill, North Carolina, 27517
Carver Living Center
Durham, North Carolina, 27704
Croasdaile
Durham, North Carolina, 27705
Hillcrest
Durham, North Carolina, 27705
Pettigrew
Durham, North Carolina, 27705
Treyburn
Durham, North Carolina, 27712
Kindred Cypress Pointe
Wilmington, North Carolina, 28401
Wilmington Health & Rehabilitation Center
Wilmington, North Carolina, 28401
Liberty Commons Nursing Center
Wilmington, North Carolina, 28403
Davis Health Care Center
Wilmington, North Carolina, 28411
About this study
Official title: Comparison of Hand Feeding Techniques for Persons With Dementia Living in the Nursing Home
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.
Read the 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.
- Conditions
- Dementia
- Being tested
- Hand feeding techniques
- Keywords
- feeding difficulty, eating difficulty, dementia, nursing home, careful hand feeding
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hand feeding techniquesBehavioural
Also called Direct hand feeding, hand over hand feeding, and hand under hand feeding.
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.
| Study group | Role | What they receive |
|---|---|---|
| Hand feeding intervention delivery | Experimental | 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. Receives: Behavioral: Hand feeding techniques |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in frequency of aversive feeding behaviors
Changes in behaviors of person with dementia being assisted with 3 meals daily over 6 days
Measured: 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
Measured: Day 6
Changes in meal intake
Changes in meal intake for a person with dementia being assisted with 3 meals daily over 6 days
Measured: Day 6
Secondary outcomes (3)
Functional ability and feeding behaviors exhibited by person with dementia
Coding of video recorded meals from Outcomes 1-3
Measured: Day 6
Characterize feeding assistant responses to functional ability and feeding behaviors
Coding of video recorded meals from Outcomes 1-3
Measured: 6 days
Develop decision-making algorithm of adaptive approaches used by feeding assistant
Coding of video recorded meals from Outcomes 1-3
Measured: 6 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2013 (estimated)
- Study startMar 2012
- Primary completionSep 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DementiaStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- The John A. Hartford Foundation
- Responsible party
- Sponsor
- Investigators
- Melissa B Aselage, PhD,RN,FNP, Principal investigator, Duke University School of NursingRuth Anderson, PhD,RN,FAAN, Study chair, Duke University School of NursingElaine J Amella, PhD,RN,FAAN, Study chair, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01780402
- Sponsor's protocol ID
- Pro00035130
- Status last verified
- Oct 2016
- First submitted
- 29 Jan 2013
- Last updated
- 6 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Hand Feeding Techniques for Persons With Dementia Living in the Nursing Home
- ClinicalTrials.gov ID
- NCT01780402
- Acronym / sponsor ID
- Pro00035130
- Conditions
- Dementia
- Keywords
- feeding difficulty, eating difficulty, dementia, nursing home, careful hand feeding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- The John A. Hartford Foundation
- Study start
- Mar 2012
- Primary completion
- Sep 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 31 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Double blind (participant, care provider)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hand feeding intervention delivery | Experimental | Behavioral: Hand feeding techniquesTrained 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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hand feeding techniquesAlso: Direct hand feeding, hand over hand feeding, and hand under hand feeding.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. | Behavioural | Hand feeding intervention delivery |
Primary outcome
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
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
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
3 secondary outcomes
Functional ability and feeding behaviors exhibited by person with dementia
Time frame: Day 6
Characterize feeding assistant responses to functional ability and feeding behaviors
Time frame: 6 days
Develop decision-making algorithm of adaptive approaches used by feeding assistant
Time frame: 6 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2016.
- Individual participant dataSharing planned: Undecided
Related trials for Dementia
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
Not yet recruiting
Acupressure as Long-term Intervention to Slow the Progression of Early/Mild Alzheimer's Disease
Alzheimer's Disease
RecruitingObservational study
Effectiveness and Safety of Disease-Modifying Therapy for Alzheimer's Disease: A Multicenter Retrospective Study
Alzheimer's Disease (AD)
Not yet recruitingPhase 2
Lisdexamfetamine For the Treatment of Conduct Disorder in Children
Conduct Disorder
RecruitingPhase 3
A Phase 3 Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease (ADAGIO-1)
Alzheimer Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Melissa B Aselage, PhD,RN,FNP principal investigator
Duke University School of Nursing
Ruth Anderson, PhD,RN,FAAN study chair
Duke University School of Nursing
Elaine J Amella, PhD,RN,FAAN study chair
Medical University of South Carolina
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hand feeding techniques in people with Dementia, run by Duke University at 11 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in frequency of aversive feeding behaviors (time frame: Day 6). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2016.