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Changing Talk to Reduce Resistiveness to Care

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01324219
Recruitment Status : Completed
First Posted : March 28, 2011
Last Update Posted : February 13, 2017
Sponsor:
Information provided by (Responsible Party):
University of Kansas Medical Center

Study Description
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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.


Condition or disease Intervention/treatment Phase
Dementia Behavioral: Staff Behavioral: Resident Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 202 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Changing Talk to Reduce Resistiveness to Care
Study Start Date : March 2011
Actual Primary Completion Date : June 2014
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dementia

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Staff Behavioral: Staff
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.
Experimental: Resident Behavioral: Resident
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.


Outcome Measures
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Primary Outcome Measures :
  1. the effects of the nursing staff communication - change in frequency and duration of resident Resistiveness to Care behaviors. [ Time Frame: up to 6 months ]
    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 :
  1. Calculate the costs of nursing staff communication system [ Time Frame: up to 6 months ]
    Calculate the costs of CHAT using traditional methods and assess its cost-effectiveness with innovative Data Envelopment Analysis.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01324219


Locations
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United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Sponsors and Collaborators
University of Kansas Medical Center
Investigators
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Principal Investigator: Kristine Williams, RN, PhD, APRN, FNP-BC University of Kansas School of Nursing
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University of Kansas Medical Center
ClinicalTrials.gov Identifier: NCT01324219    
Other Study ID Numbers: 12146
First Posted: March 28, 2011    Key Record Dates
Last Update Posted: February 13, 2017
Last Verified: February 2017
Keywords provided by University of Kansas Medical Center:
nursing staff
residents
Additional relevant MeSH terms:
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Dementia
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Neurocognitive Disorders
Mental Disorders