Changing Talk to Reduce Resistiveness to Care
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|ClinicalTrials.gov Identifier: NCT01324219|
Recruitment Status : Completed
First Posted : March 28, 2011
Last Update Posted : February 13, 2017
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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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||202 participants|
|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|
|Active Comparator: 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.
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.
- 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.
- 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.
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.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
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,
- manic-depressive disorder,
- and mental retardation.
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
|United States, Kansas|
|University of Kansas Medical Center|
|Kansas City, Kansas, United States, 66160|
|Principal Investigator:||Kristine Williams, RN, PhD, APRN, FNP-BC||University of Kansas School of Nursing|
|Responsible Party:||University of Kansas Medical Center|
|Other Study ID Numbers:||
|First Posted:||March 28, 2011 Key Record Dates|
|Last Update Posted:||February 13, 2017|
|Last Verified:||February 2017|
Central Nervous System Diseases
Nervous System Diseases