Changing Talk to Reduce Resistiveness to Care

February 10, 2017 updated by: University of Kansas Medical Center

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

202

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
up to 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
up to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Kansas Medical Center

Investigators

  • Principal Investigator: Kristine Williams, RN, PhD, APRN, FNP-BC, University of Kansas School of Nursing

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2011

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

June 1, 2016

Study Registration Dates

First Submitted

March 16, 2011

First Submitted That Met QC Criteria

March 25, 2011

First Posted (Estimate)

March 28, 2011

Study Record Updates

Last Update Posted (Actual)

February 13, 2017

Last Update Submitted That Met QC Criteria

February 10, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12146

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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