Clinical trial NCT02269956: Mealtime Symptoms in Dementia
Official title: Mealtime Symptoms in Dementia: Adaptive Leadership Approaches
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dementia
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2014-10-21
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Feeding Skills Knowledge Test
timeFrame: Baseline (before training program), Week 6 (after training program), and Week 12
measure: Change in Feeding Skills Self-Efficacy Test
timeFrame: Baseline (before training program), Week 6 (after training program), and Week 12
Secondary outcomes:
measure: Functional Rating Scale for Symptoms in Dementia
timeFrame: 12 weeks
measure: Brief Inventory of Mental Status
timeFrame: 12 weeks
measure: C3P Feeding Skills Checklist
timeFrame: 12 weeks
measure: Food Intake Record
timeFrame: Collected for 3 meals over 2 days at Baseline, Week 6 and Week 12
measure: Edinburgh Feeding in Dementia (EdFED) scale
timeFrame: Collected for 3 meals over 2 days at Baseline, Week 6 and Week 12
measure: Time Spent Feeding
timeFrame: Collected for 3 meals over 2 days at Baseline, Week 6 and Week 12
Other outcomes:
Locations:
Study officials:
affiliation: Duke University School of Nursing
name: Melissa Batchelor-Murphy, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.