- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02269956
Mealtime Symptoms in Dementia
April 3, 2017 updated by: Duke University
Mealtime Symptoms in Dementia: Adaptive Leadership Approaches
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.
Study Overview
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.
Study Type
Interventional
Enrollment (Anticipated)
132
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
: 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
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Feeding Skills Knowledge Test
Time Frame: Baseline (before training program), Week 6 (after training program), and Week 12
|
10 item multiple choice test administered in paper/ pencil format to nursing staff assisting with feeding persons with dementia (Scores range from 0-10)
|
Baseline (before training program), Week 6 (after training program), and Week 12
|
Change in Feeding Skills Self-Efficacy Test
Time Frame: Baseline (before training program), Week 6 (after training program), and Week 12
|
10 items with likert scale response administered to nursing home staff
|
Baseline (before training program), Week 6 (after training program), and Week 12
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Functional Rating Scale for Symptoms in Dementia
Time Frame: 12 weeks
|
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
|
12 weeks
|
Brief Inventory of Mental Status
Time Frame: 12 weeks
|
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.
|
12 weeks
|
C3P Feeding Skills Checklist
Time Frame: 12 weeks
|
Multi-item checklist of feeding skill behaviors grouped around changing the person, place or people.
Each section is given numerical value.
|
12 weeks
|
Food Intake Record
Time Frame: Collected for 3 meals over 2 days at Baseline, Week 6 and Week 12
|
Meal intake documented by pre-post meal tray weight as well as documentation of hand feeding techniques used during the meal.
|
Collected for 3 meals over 2 days at Baseline, Week 6 and Week 12
|
Edinburgh Feeding in Dementia (EdFED) scale
Time Frame: Collected for 3 meals over 2 days at Baseline, Week 6 and Week 12
|
Scale measuring aversive feeding behaviors on a 0-20 scale of 10 items.
Higher scores equal more aversive feeding behaviors.
|
Collected for 3 meals over 2 days at Baseline, Week 6 and Week 12
|
Time Spent Feeding
Time Frame: Collected for 3 meals over 2 days at Baseline, Week 6 and Week 12
|
Time spent feeding was measured in hours and minutes via stopwatch.
|
Collected for 3 meals over 2 days at Baseline, Week 6 and Week 12
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Melissa Batchelor-Murphy, PhD, Duke University School of Nursing
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2014
Primary Completion (Actual)
September 1, 2016
Study Completion (Actual)
September 1, 2016
Study Registration Dates
First Submitted
October 14, 2014
First Submitted That Met QC Criteria
October 17, 2014
First Posted (Estimate)
October 21, 2014
Study Record Updates
Last Update Posted (Actual)
April 4, 2017
Last Update Submitted That Met QC Criteria
April 3, 2017
Last Verified
March 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pro00055958
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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