Overview

This trial is active, not recruiting.

Condition dementia
Treatment 12 week feasibility study
Sponsor Duke University
Start date October 2014
End date December 2017
Trial size 132 participants
Trial identifier NCT02269956, Pro00055958

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose supportive care
Arm
(Active Comparator)
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.
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)
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.

Primary Outcomes

Measure
Change in Feeding Skills Knowledge Test
time frame: 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

Secondary Outcomes

Measure
Functional Rating Scale for Symptoms in Dementia
time frame: 12 weeks
Brief Inventory of Mental Status
time frame: 12 weeks
C3P Feeding Skills Checklist
time frame: 12 weeks
Food Intake Record
time frame: 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
Time Spent Feeding
time frame: Collected for 3 meals over 2 days at Baseline, Week 6 and Week 12

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title Mealtime Symptoms in Dementia: Adaptive Leadership Approaches
Principal investigator Melissa Batchelor-Murphy, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Duke University.