DementiaNCT02269956
Mealtime Symptoms in Dementia
A study testing 12 week feasibility study in people with Dementia, run by Duke University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dementia
- What is being tested?
- 12 week feasibility study
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- No sites listed yet
- Study dates
- Oct 2014to 1 Sep 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
Show all 13Show fewer
- 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.
Who cannot join
- 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.
About this study
Official title: 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.
Read the 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.
- Conditions
- Dementia
- Being tested
- 12 week feasibility study
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
12 week feasibility studyBehavioural
: 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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Measured: Baseline (before training program), Week 6 (after training program), and Week 12
Secondary outcomes (6)
Functional Rating Scale for Symptoms in Dementia
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
Measured: 12 weeks
Brief Inventory of Mental Status
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.
Measured: 12 weeks
C3P Feeding Skills Checklist
Multi-item checklist of feeding skill behaviors grouped around changing the person, place or people. Each section is given numerical value.
Measured: 12 weeks
Food Intake Record
Meal intake documented by pre-post meal tray weight as well as documentation of hand feeding techniques used during the meal.
Measured: Collected for 3 meals over 2 days at Baseline, Week 6 and Week 12
Edinburgh Feeding in Dementia (EdFED) scale
Scale measuring aversive feeding behaviors on a 0-20 scale of 10 items. Higher scores equal more aversive feeding behaviors.
Measured: Collected for 3 meals over 2 days at Baseline, Week 6 and Week 12
Time Spent Feeding
Time spent feeding was measured in hours and minutes via stopwatch.
Measured: Collected for 3 meals over 2 days at Baseline, Week 6 and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2014 (estimated)
- Study startOct 2014
- Primary completion1 Sep 2016
- Study completion1 Sep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for DementiaStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Melissa Batchelor-Murphy, PhD, Principal investigator, Duke University School of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02269956
- Sponsor's protocol ID
- Pro00055958
- Status last verified
- Mar 2017
- First submitted
- 14 Oct 2014
- Last updated
- 4 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 32726447Liu 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.
PubMed 32680448
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mealtime Symptoms in Dementia: Adaptive Leadership Approaches
- ClinicalTrials.gov ID
- NCT02269956
- Acronym / sponsor ID
- Pro00055958
- Conditions
- Dementia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- 1 Sep 2016 (actual)
- Study completion
- 1 Sep 2016 (actual)
- First posted
- 21 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Active comparator | Behavioral: 12 week feasibility studyThe 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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.
- a resident (> 6 wks) of NH,
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Behavioural | Intervention |
Primary outcome
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
6 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2017.
- Derived from this study: PubMed 32726447Liu 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.
- Derived from this study: PubMed 32680448Liu 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Melissa Batchelor-Murphy, PhD principal investigator
Duke University School of Nursing
Questions about this trial
What is this clinical trial studying?
A study testing 12 week feasibility study in people with Dementia, run by Duke University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Feeding Skills Knowledge Test (time frame: Baseline (before training program), Week 6 (after training program), and Week 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02269956, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2017.