NCT01324219

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
202

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

March 16, 2011

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 28, 2011

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

February 13, 2017

Status Verified

February 1, 2017

Enrollment Period

3.3 years

First QC Date

March 16, 2011

Last Update Submit

February 10, 2017

Conditions

Keywords

nursing staffresidents

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Calculate the costs of nursing staff communication system

    up to 6 months

Study Arms (2)

Staff

ACTIVE COMPARATOR
Behavioral: Staff

Resident

EXPERIMENTAL
Behavioral: Resident

Interventions

StaffBEHAVIORAL

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.

Staff
ResidentBEHAVIORAL

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.

Resident

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • 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).

You may not qualify if:

  • 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.
  • diagnosis with Huntington's disease,
  • alcohol-related dementias,
  • schizophrenia,
  • manic-depressive disorder,
  • deafness,
  • and mental retardation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Related Publications (4)

  • 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.

  • 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.

  • 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.

  • 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.

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Kristine Williams, RN, PhD, APRN, FNP-BC

    University of Kansas

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 16, 2011

First Posted

March 28, 2011

Study Start

March 1, 2011

Primary Completion

June 1, 2014

Study Completion

June 1, 2016

Last Updated

February 13, 2017

Record last verified: 2017-02

Locations