Ignite Creation Date:
2025-12-25 @ 4:05 AM
Ignite Modification Date:
2025-12-27 @ 10:07 PM
Study NCT ID:
NCT01780402
Status:
COMPLETED
Last Update Posted:
2016-10-06
First Post:
2013-01-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Hand Feeding Techniques for Persons With Dementia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003704', 'term': 'Dementia'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-10-05', 'studyFirstSubmitDate': '2013-01-29', 'studyFirstSubmitQcDate': '2013-01-29', 'lastUpdatePostDateStruct': {'date': '2016-10-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-01-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in frequency of aversive feeding behaviors', 'timeFrame': 'Day 6', 'description': 'Changes in behaviors of person with dementia being assisted with 3 meals daily over 6 days'}, {'measure': 'Changes in time spent providing feeding assistance', 'timeFrame': 'Day 6', 'description': 'Changes in time spent providing feeding assistance to a person with dementia being assisted with 3 meals daily over 6 days'}, {'measure': 'Changes in meal intake', 'timeFrame': 'Day 6', 'description': 'Changes in meal intake for a person with dementia being assisted with 3 meals daily over 6 days'}], 'secondaryOutcomes': [{'measure': 'Functional ability and feeding behaviors exhibited by person with dementia', 'timeFrame': 'Day 6', 'description': 'Coding of video recorded meals from Outcomes 1-3'}, {'measure': 'Characterize feeding assistant responses to functional ability and feeding behaviors', 'timeFrame': '6 days', 'description': 'Coding of video recorded meals from Outcomes 1-3'}, {'measure': 'Develop decision-making algorithm of adaptive approaches used by feeding assistant', 'timeFrame': '6 days', 'description': 'Coding of video recorded meals from Outcomes 1-3'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['feeding difficulty', 'eating difficulty', 'dementia', 'nursing home', 'careful hand feeding'], 'conditions': ['Dementia']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nProposed Aim 2: Evaluate implementation of the hand feeding intervention for larger randomized study of feeding techniques.\n\nAim 2a: Conduct a process evaluation for method of recruiting, screening, and obtaining informed consent of legally authorized representatives (LARs)/ assent of PWD.\n\nAim 2b: Establish fidelity to treatment for all three hand feeding interventions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Resident of nursing home 6 weeks prior to intervention delivery\n* 60+ years old\n* Have a legally authorized representative to provide informed consent\n* medical diagnosis of dementia\n* required extensive assistance to total dependence for feeding\n* Brief Interview for Mental Status (BIMS) score of 0-12\n\nExclusion Criteria:\n\n* Positive diagnosis of Human Immunodeficiency Virus (HIV), Parkinson's, and/or Traumatic Brain Injury\n* Any swallowing disorder\n* Presence of feeding tube that is sole source for meal delivery\n* Significant auditory or visual impairment"}, 'identificationModule': {'nctId': 'NCT01780402', 'briefTitle': 'Comparison of Hand Feeding Techniques for Persons With Dementia', 'organization': {'class': 'OTHER', 'fullName': 'Duke University'}, 'officialTitle': 'Comparison of Hand Feeding Techniques for Persons With Dementia Living in the Nursing Home', 'orgStudyIdInfo': {'id': 'Pro00035130'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Hand feeding intervention delivery', '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.', 'interventionNames': ['Behavioral: Hand feeding techniques']}], 'interventions': [{'name': 'Hand feeding techniques', 'type': 'BEHAVIORAL', 'otherNames': ['Direct hand feeding, hand over hand feeding, and hand under hand feeding.'], '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.\n\nHand-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.\n\nHand-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.', 'armGroupLabels': ['Hand feeding intervention delivery']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27502', 'city': 'Apex', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Rex Apex', 'geoPoint': {'lat': 35.73265, 'lon': -78.85029}}, {'zip': '27517', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Carolina Meadows', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}, {'zip': '27704', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Carver Living Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '27705', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Croasdaile', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '27705', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Hillcrest', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '27705', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Pettigrew', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '27712', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Treyburn', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '28401', 'city': 'Wilmington', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Kindred Cypress Pointe', 'geoPoint': {'lat': 34.23556, 'lon': -77.94604}}, {'zip': '28401', 'city': 'Wilmington', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Wilmington Health & Rehabilitation Center', 'geoPoint': {'lat': 34.23556, 'lon': -77.94604}}, {'zip': '28403', 'city': 'Wilmington', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Liberty Commons Nursing Center', 'geoPoint': {'lat': 34.23556, 'lon': -77.94604}}, {'zip': '28411', 'city': 'Wilmington', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Davis Health Care Center', 'geoPoint': {'lat': 34.23556, 'lon': -77.94604}}], 'overallOfficials': [{'name': 'Melissa B Aselage, PhD,RN,FNP', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke University School of Nursing'}, {'name': 'Ruth Anderson, PhD,RN,FAAN', 'role': 'STUDY_CHAIR', 'affiliation': 'Duke University School of Nursing'}, {'name': 'Elaine J Amella, PhD,RN,FAAN', 'role': 'STUDY_CHAIR', 'affiliation': 'Medical University of South Carolina'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duke University', 'class': 'OTHER'}, 'collaborators': [{'name': 'The John A. Hartford Foundation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}