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Mealtime Symptoms in Dementia

Primary Purpose

Dementia

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
12 week feasibility study
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Dementia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Nursing Home staff participants must be:

  1. 18 years of age or older,
  2. able to read and write English,
  3. willing to sign informed consent,
  4. employed as a Registered Nurse, Licensed Practical Nurse, Certified Nursing Assistant, part of the Nursing Home Administration team, or part of the therapy team.

Persons With Dementia participants must be:

  1. a resident (> 6 wks) of NH,
  2. 60+ years of age,
  3. able to speak English in order to give assent,
  4. have a positive Minimum Data Set 3.0 for: Active disease diagnosis of Alzheimer's Disease or dementia,
  5. require extensive assistance to total dependence for eating,
  6. have a Brief Interview for Mental Status (BIMS) score ranging from 0-12 (lower score indicates greater cognitive impairment)37, and
  7. have a legally authorized representative (LAR) able to read English in order to provide informed consent for the PWD.

Exclusion Criteria:

PWD:

  • Minimum Data Set 3.0 positive for: Human Immunodeficiency Virus (HIV) Infection, Parkinson's Disease, and/or Traumatic Brain Injury,
  • any swallowing disorder,
  • parental/ IV feedings, or presence of a feeding-tube;
  • any significant auditory or visual impairment that would prevent the PWD from hearing/seeing verbal/visual cues.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    No Intervention

    Arm Label

    Intervention

    Focus Groups

    Arm Description

    The 2 NH's not used in the focus groups will receive the intervention, a 12-week feasibility study. At baseline, weeks 6 and 12, dementia feeding skills knowledge and self-efficacy tests will be administered, meal observations of nursing staff assisting PWD with meals will be video recorded for 3 meals over 2 days at baseline and again at week 6 and 12, and a medical record review will be conducted. After baseline data is collected, the training program will be delivered in 5 weekly modules with group coaching sessions completed the same week.

    Year 1 focus groups will aim to identify how nursing staff feel about usual interventions for feeding behaviors of PWD and staff responses when a PWD displays difficult eating behaviors. Year 2 focus groups will evaluate the revised dementia feeding skills training program, the coaching interventions, and case scenarios, and indicate how realistic and compatible the intervention is with their work environment.

    Outcomes

    Primary Outcome Measures

    Change in Feeding Skills Knowledge Test
    10 item multiple choice test administered in paper/ pencil format to nursing staff assisting with feeding persons with dementia (Scores range from 0-10)
    Change in Feeding Skills Self-Efficacy Test
    10 items with likert scale response administered to nursing home staff

    Secondary Outcome Measures

    Functional Rating Scale for Symptoms in Dementia
    14 categories related to functional ability of PWD (e. g., eating and dressing ability, emotionality, memory). Each category scores 0-3. Totals range from 0-42; higher score indicative of greater impairment
    Brief Inventory of Mental Status
    Part of Minimum Data Set (MDS) 3.0. 5 sections of cognitive ability questions scored 0-2; scores of 0-12 considered moderate to severe cognitive impairment.
    C3P Feeding Skills Checklist
    Multi-item checklist of feeding skill behaviors grouped around changing the person, place or people. Each section is given numerical value.
    Food Intake Record
    Meal intake documented by pre-post meal tray weight as well as documentation of hand feeding techniques used during the meal.
    Edinburgh Feeding in Dementia (EdFED) scale
    Scale measuring aversive feeding behaviors on a 0-20 scale of 10 items. Higher scores equal more aversive feeding behaviors.
    Time Spent Feeding
    Time spent feeding was measured in hours and minutes via stopwatch.

    Full Information

    First Posted
    October 14, 2014
    Last Updated
    April 3, 2017
    Sponsor
    Duke University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02269956
    Brief Title
    Mealtime Symptoms in Dementia
    Official Title
    Mealtime Symptoms in Dementia: Adaptive Leadership Approaches
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2014 (undefined)
    Primary Completion Date
    September 1, 2016 (Actual)
    Study Completion Date
    September 1, 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Duke University

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The purpose of this study is to combine current evidence-based guidelines with adaptive leadership (AL) training to assist nursing staff to navigate the delicate balance of necessary technical and adaptive work to improve problematic dementia-related mealtime symptoms.
    Detailed Description
    Currently, basic training programs do not adequately teach nursing home (NH) staff to handle behavioral symptoms at mealtime that typically accompany dementia. When persons with dementia (PWD) exhibit mealtime symptoms (e.g. turning away of the head, pushing food away), these symptoms may be interpreted as lack of interest in eating, and feeding attempts ceased. This misinterpretation poses serious health risks to PWD including under-nutrition and increased risk for more aggressive medical treatment (e.g. feeding tube). The Aims of this study are to: 1) Identify the adaptive leadership challenges of NH staff for alleviating mealtime symptoms for PWD; 2) Determine NH staff evaluation of a dementia feeding skills training program that combines adaptive leadership approaches with technical approaches to mealtime symptoms; and 3) Conduct a 12-week feasibility study implementing this dementia feeding skills training program with NH staff, linking training to resident outcomes. Focus groups will be conducted in four NHs during which NH staff will describe adaptive challenges around: mealtime symptom recognition, communication patterns, typical responses to mealtime symptoms, and feelings when interventions are met with success or failure. Focus group interviews will be transcribed and content analysis conducted. Findings from the focus group interviews will be used to revise a dementia feeding skills program. The revised training program will be evaluated by NH staff to determine how NH staff perceives the coaching intervention, and if case scenarios are realistic and compatible with current workplace practices. The training program will be implemented in two skilled NHs over a five week period. NH staff outcomes include mealtime knowledge and self-efficacy. Through meal observations, NH staff will be assessed for time spent assisting with feeding and feeding skill behaviors; and PWD outcomes assessed by quantifying meal intake and aversive feeding behaviors. Findings from this study will describe adaptive leadership challenges for NH staff, revise and implement a training program teaching NH staff adaptive and technical interventions for alleviating mealtime symptoms for PWD in the NH setting.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Dementia

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    132 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention
    Arm Type
    Active Comparator
    Arm Description
    The 2 NH's not used in the focus groups will receive the intervention, a 12-week feasibility study. At baseline, weeks 6 and 12, dementia feeding skills knowledge and self-efficacy tests will be administered, meal observations of nursing staff assisting PWD with meals will be video recorded for 3 meals over 2 days at baseline and again at week 6 and 12, and a medical record review will be conducted. After baseline data is collected, the training program will be delivered in 5 weekly modules with group coaching sessions completed the same week.
    Arm Title
    Focus Groups
    Arm Type
    No Intervention
    Arm Description
    Year 1 focus groups will aim to identify how nursing staff feel about usual interventions for feeding behaviors of PWD and staff responses when a PWD displays difficult eating behaviors. Year 2 focus groups will evaluate the revised dementia feeding skills training program, the coaching interventions, and case scenarios, and indicate how realistic and compatible the intervention is with their work environment.
    Intervention Type
    Behavioral
    Intervention Name(s)
    12 week feasibility study
    Intervention Description
    : At baseline, weeks 6 and 12, dementia feeding skills knowledge and self-efficacy tests will be administered, meal observations of nursing staff assisting PWD with meals will be video recorded for three meals over two days, and a medical record review will be conducted to ascertain technical and adaptive interventions also in place for the PWD (e. g., high density protein supplements, appetite stimulant medications, weighing, diet texture modifications). After baseline data is collected, the training program will delivered in five weekly modules with group coaching sessions completed the same week
    Primary Outcome Measure Information:
    Title
    Change in Feeding Skills Knowledge Test
    Description
    10 item multiple choice test administered in paper/ pencil format to nursing staff assisting with feeding persons with dementia (Scores range from 0-10)
    Time Frame
    Baseline (before training program), Week 6 (after training program), and Week 12
    Title
    Change in Feeding Skills Self-Efficacy Test
    Description
    10 items with likert scale response administered to nursing home staff
    Time Frame
    Baseline (before training program), Week 6 (after training program), and Week 12
    Secondary Outcome Measure Information:
    Title
    Functional Rating Scale for Symptoms in Dementia
    Description
    14 categories related to functional ability of PWD (e. g., eating and dressing ability, emotionality, memory). Each category scores 0-3. Totals range from 0-42; higher score indicative of greater impairment
    Time Frame
    12 weeks
    Title
    Brief Inventory of Mental Status
    Description
    Part of Minimum Data Set (MDS) 3.0. 5 sections of cognitive ability questions scored 0-2; scores of 0-12 considered moderate to severe cognitive impairment.
    Time Frame
    12 weeks
    Title
    C3P Feeding Skills Checklist
    Description
    Multi-item checklist of feeding skill behaviors grouped around changing the person, place or people. Each section is given numerical value.
    Time Frame
    12 weeks
    Title
    Food Intake Record
    Description
    Meal intake documented by pre-post meal tray weight as well as documentation of hand feeding techniques used during the meal.
    Time Frame
    Collected for 3 meals over 2 days at Baseline, Week 6 and Week 12
    Title
    Edinburgh Feeding in Dementia (EdFED) scale
    Description
    Scale measuring aversive feeding behaviors on a 0-20 scale of 10 items. Higher scores equal more aversive feeding behaviors.
    Time Frame
    Collected for 3 meals over 2 days at Baseline, Week 6 and Week 12
    Title
    Time Spent Feeding
    Description
    Time spent feeding was measured in hours and minutes via stopwatch.
    Time Frame
    Collected for 3 meals over 2 days at Baseline, Week 6 and Week 12

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Nursing Home staff participants must be: 18 years of age or older, able to read and write English, willing to sign informed consent, employed as a Registered Nurse, Licensed Practical Nurse, Certified Nursing Assistant, part of the Nursing Home Administration team, or part of the therapy team. Persons With Dementia participants must be: a resident (> 6 wks) of NH, 60+ years of age, able to speak English in order to give assent, have a positive Minimum Data Set 3.0 for: Active disease diagnosis of Alzheimer's Disease or dementia, require extensive assistance to total dependence for eating, have a Brief Interview for Mental Status (BIMS) score ranging from 0-12 (lower score indicates greater cognitive impairment)37, and have a legally authorized representative (LAR) able to read English in order to provide informed consent for the PWD. Exclusion Criteria: PWD: Minimum Data Set 3.0 positive for: Human Immunodeficiency Virus (HIV) Infection, Parkinson's Disease, and/or Traumatic Brain Injury, any swallowing disorder, parental/ IV feedings, or presence of a feeding-tube; any significant auditory or visual impairment that would prevent the PWD from hearing/seeing verbal/visual cues.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Melissa Batchelor-Murphy, PhD
    Organizational Affiliation
    Duke University School of Nursing
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    32726447
    Citation
    Liu W, Batchelor M, Williams K. Development and Psychometric Testing of the Mealtime Engagement Scale in Direct Care Providers of Nursing Home Residents With Dementia. Gerontologist. 2021 Nov 15;61(8):e410-e420. doi: 10.1093/geront/gnaa097.
    Results Reference
    derived
    PubMed Identifier
    32680448
    Citation
    Liu W, Batchelor M. Mealtime Caregiving Engagement for Residents with Advanced Dementia: Item Response Theory Analysis. West J Nurs Res. 2021 Apr;43(4):374-380. doi: 10.1177/0193945920943898. Epub 2020 Jul 17.
    Results Reference
    derived

    Learn more about this trial

    Mealtime Symptoms in Dementia

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