Mealtime Symptoms in Dementia

NCT02269956 | Completed DMC

• 1 other identifier: Pro00055958
• Study Type: interventional
• Target: 132
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Dementia

Outcome Measures

Primary Outcomes (2)

• 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)

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

• Change in Feeding Skills Self-Efficacy Test

  10 items with likert scale response administered to nursing home staff

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

Secondary Outcomes (6)

• Functional Rating Scale for Symptoms in Dementia

  12 weeks

• Brief Inventory of Mental Status

  12 weeks

• C3P Feeding Skills Checklist

  12 weeks

• Food Intake Record

  Collected for 3 meals over 2 days at Baseline, Week 6 and Week 12

• Edinburgh Feeding in Dementia (EdFED) scale

  Collected for 3 meals over 2 days at Baseline, Week 6 and Week 12

Study Arms (2)

Intervention

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.

Behavioral: 12 week feasibility study

Focus Groups

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.

Interventions

12 week feasibility study BEHAVIORAL

: 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

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Nursing Home staff participants must be:
• 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,
• + 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Duke University: lead

Related Publications (2)

• 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.

  PMID: 32726447 DERIVED

• 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.

  PMID: 32680448 DERIVED

MeSH Terms

Conditions

Dementia

Interventions

Feasibility Studies

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Epidemiologic Study Characteristics; Epidemiologic Methods; Investigative Techniques; Evaluation Studies as Topic; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Melissa Batchelor-Murphy, PhD

  Duke University School of Nursing

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2014
• First Posted: October 21, 2014
• Study Start: October 1, 2014
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: April 4, 2017

Record last verified: 2017-03