Back to resultsChanging Talk to Reduce Resistiveness to Care
Primary Purpose
Dementia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Staff
Resident
Sponsored by
About this trial
This is an interventional supportive care trial for Dementia focused on measuring nursing staff, residents
Eligibility Criteria
Staff:Inclusion criteria for CNAs are:
- age 18 years old or greater (age of legal consent in Kansas and Missouri), signed informed consent,
- permanent employment in the NH,
- primary assignment to a specified unit,
- and English speaking
- Staff must have been assigned to care for the resident at least twice weekly in the past month (documented in NH staffing records). This will assure that staff-resident dyads have established relationships and will control effects of variability in contact between dyads during days when data are not being collected.
Resident inclusion criteria are:
- a diagnosis of Alzheimer's disease or related dementia documented in their medical records,
- documentation of daily RTC over the past week,
- and ability to hear staff communication (from the most recent MDS).
Exclusion criteria for CNAs include:
- non-English speaking,
- temporary employment, -and age under 18 years.
- If more than one CNA volunteers as a partner for a participating resident, a random selection will be made to determine which CNA will participate. Small variations in contact between staff and residents in dyads are anticipated due to PMMA policies for consistent CNA assignment to neighborhoods. Therefore dyads will have repeated contacts.
Exclusion criteria for residents include:
- diagnosis with Huntington's disease,
- alcohol-related dementias,
- schizophrenia,
- manic-depressive disorder,
- deafness,
- and mental retardation.
Sites / Locations
- University of Kansas Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Staff
Resident
Arm Description
Outcomes
Primary Outcome Measures
the effects of the nursing staff communication - change in frequency and duration of resident Resistiveness to Care behaviors.
Test the effects of the CHAnging Talk (CHAT) nursing staff communication intervention on reducing the frequency and duration of resident Resistiveness to Care (RTC) behaviors.
Secondary Outcome Measures
Calculate the costs of nursing staff communication system
Calculate the costs of CHAT using traditional methods and assess its cost-effectiveness with innovative Data Envelopment Analysis.
Full Information
NCT ID
NCT01324219
First Posted
March 16, 2011
Last Updated
February 10, 2017
Sponsor
University of Kansas Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT01324219
Brief Title
Changing Talk to Reduce Resistiveness to Care
Official Title
Changing Talk to Reduce Resistiveness to Care
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
June 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Kansas Medical Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The investigators are interested in reducing problem behaviors of nursing home residents with dementia that make providing care difficult. The investigators call these behaviors resistiveness to care. Previous research has found that resistiveness to care occurs more frequently when staff use certain types of communication. An inservice program will be provided to all nursing staff in your nursing home to teach staff about communication practices to reduce resistiveness to care. The research study will see whether changing communication will reduce resident resistiveness to care. If effective, the communication training may then be used to improve care in other facilities.
By doing this study, researchers hope to learn if changing communication practices will reduce resistiveness to care in nursing home residents with dementia.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia
Keywords
nursing staff, residents
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
202 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Staff
Arm Type
Active Comparator
Arm Title
Resident
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Staff
Intervention Description
Your participation will involve participating in video recordings of nursing care for a participating resident for 2-hour periods on 8 to 10 days. Communication training will be provided to staff in participating nursing homes during paid work hours regardless of their participation in the video recordings. The nursing home you work in may be randomly selected to receive the communication training at the start of the study or after a 3-month delay.
Intervention Type
Behavioral
Intervention Name(s)
Resident
Intervention Description
Your participation will involve participating in video recordings of nursing care for 2-hour periods on 8 to 10. Communication training will be provided to staff in participating facilities during paid work hours regardless of their participation in the video recordings. Your nursing home may be randomly selected to receive the communication training at the start of the study or after a 3-month delay.
Primary Outcome Measure Information:
Title
the effects of the nursing staff communication - change in frequency and duration of resident Resistiveness to Care behaviors.
Description
Test the effects of the CHAnging Talk (CHAT) nursing staff communication intervention on reducing the frequency and duration of resident Resistiveness to Care (RTC) behaviors.
Time Frame
up to 6 months
Secondary Outcome Measure Information:
Title
Calculate the costs of nursing staff communication system
Description
Calculate the costs of CHAT using traditional methods and assess its cost-effectiveness with innovative Data Envelopment Analysis.
Time Frame
up to 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Staff:Inclusion criteria for CNAs are:
age 18 years old or greater (age of legal consent in Kansas and Missouri), signed informed consent,
permanent employment in the NH,
primary assignment to a specified unit,
and English speaking
Staff must have been assigned to care for the resident at least twice weekly in the past month (documented in NH staffing records). This will assure that staff-resident dyads have established relationships and will control effects of variability in contact between dyads during days when data are not being collected.
Resident inclusion criteria are:
a diagnosis of Alzheimer's disease or related dementia documented in their medical records,
documentation of daily RTC over the past week,
and ability to hear staff communication (from the most recent MDS).
Exclusion criteria for CNAs include:
non-English speaking,
temporary employment, -and age under 18 years.
If more than one CNA volunteers as a partner for a participating resident, a random selection will be made to determine which CNA will participate. Small variations in contact between staff and residents in dyads are anticipated due to PMMA policies for consistent CNA assignment to neighborhoods. Therefore dyads will have repeated contacts.
Exclusion criteria for residents include:
diagnosis with Huntington's disease,
alcohol-related dementias,
schizophrenia,
manic-depressive disorder,
deafness,
and mental retardation.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kristine Williams, RN, PhD, APRN, FNP-BC
Organizational Affiliation
University of Kansas School of Nursing
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
35131660
Citation
Liu W, Perkhounkova Y, Williams K, Batchelor M, Hein M. Mealtime nonverbal behaviors in nursing home staff and residents with dementia: Behavioral analyses of videotaped observations. Geriatr Nurs. 2022 Mar-Apr;44:112-124. doi: 10.1016/j.gerinurse.2022.01.009. Epub 2022 Feb 4.
Results Reference
derived
PubMed Identifier
32726447
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.
Results Reference
derived
PubMed Identifier
31241031
Citation
Jao YL, Liu W, Williams K, Chaudhury H, Parajuli J. Association between environmental stimulation and apathy in nursing home residents with dementia. Int Psychogeriatr. 2019 Aug;31(8):1109-1120. doi: 10.1017/S1041610219000589.
Results Reference
derived
PubMed Identifier
27048705
Citation
Williams KN, Perkhounkova Y, Herman R, Bossen A. A Communication Intervention to Reduce Resistiveness in Dementia Care: A Cluster Randomized Controlled Trial. Gerontologist. 2017 Aug 1;57(4):707-718. doi: 10.1093/geront/gnw047.
Results Reference
derived
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Changing Talk to Reduce Resistiveness to Care
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