Mealtime Symptoms in Dementia
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|ClinicalTrials.gov Identifier: NCT02269956|
Recruitment Status : Completed
First Posted : October 21, 2014
Last Update Posted : April 4, 2017
|Condition or disease||Intervention/treatment||Phase|
|Dementia||Behavioral: 12 week feasibility study||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||132 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Mealtime Symptoms in Dementia: Adaptive Leadership Approaches|
|Study Start Date :||October 2014|
|Actual Primary Completion Date :||September 1, 2016|
|Actual Study Completion Date :||September 1, 2016|
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
: 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.
- 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)
- 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
- 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
- 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.
- 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.
- 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.
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02269956
|Principal Investigator:||Melissa Batchelor-Murphy, PhD||Duke University School of Nursing|