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CompletedNCT02269956Updated Apr 4, 2017

Mealtime Symptoms in Dementia

An interventional study of 12 week feasibility study in Dementia, sponsored by Duke University. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-04-04.

Sponsored by Duke University · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
132
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Dementia

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03

In context

Dementia

2,172 studies on the registry are indexed under Dementia; 540 are open to participants now.

This study's planned enrollment of 132 is above the median of 83 across 1,629 interventional studies indexed under Dementia.

Browse Dementia studies →

Lead sponsor

Duke University is the lead sponsor of 2,025 studies on the registry; 275 are open to participants now.

Of its 194 completed or terminated interventional studies of FDA-regulated products, 159 (82%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
132 participants (estimated)

Study arms

  • Active comparator
    Intervention

    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.

    Behavioral: 12 week feasibility study

  • No intervention
    Focus Groups

    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.

Interventions

  • Behavioral12 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 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

06

What researchers measure

Primary outcomes

  1. 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)

    Time frame: Baseline (before training program), Week 6 (after training program), and Week 12

  2. Change in Feeding Skills Self-Efficacy Test

    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 outcomes

  1. 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

    Time frame: 12 weeks

  2. 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.

    Time frame: 12 weeks

  3. 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.

    Time frame: 12 weeks

  4. Food Intake Record

    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

  5. 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 frame: Collected for 3 meals over 2 days at Baseline, Week 6 and Week 12

  6. Time Spent Feeding

    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

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • 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. PubMed 32726447 ↗
  • 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. PubMed 32680448 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 4, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02269956
Lead sponsor
Duke University
Responsible party
Sponsor
First posted
Oct 21, 2014
Start date
Oct 2014
Primary completion
Sep 1, 2016
Completion
Sep 1, 2016
Last update
Apr 4, 2017

Study contacts

Melissa Batchelor-Murphy, PhD
principal investigator · Duke University School of Nursing

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.

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