Changing Talk to Reduce Resistiveness to Care

Dementia Clinical Trial

Official title:

Changing Talk to Reduce Resistiveness to Care

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01324219
• Other study ID #: 12146
• Status: Completed
• Phase: N/A
• First received: March 16, 2011
• Last updated: February 10, 2017
• Start date: March 2011
• Est. completion date: June 2016

Study information

• Verified date: February 2017
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 202
• Est. completion date: June 2016
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dementia

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of Kansas Medical Center	Kansas City	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
University of Kansas Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	up to 6 months
Secondary	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.	up to 6 months