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Trial record 1 of 1 for:    NCT03849937
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Changing Talk Online (CHATO) Study

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ClinicalTrials.gov Identifier: NCT03849937
Recruitment Status : Enrolling by invitation
First Posted : February 21, 2019
Last Update Posted : June 17, 2020
Sponsor:
Collaborator:
University of Iowa
Information provided by (Responsible Party):
University of Kansas Medical Center

Brief Summary:

Objectives AIM 1. Establish acceptability and preliminary efficacy of online CHATO modules through pilot testing with NH staff.

AIM 2. Develop and pilot test the data collection tool with consultant and advisory panel input. Interviews of NH administrators and staff who participate in the pilot testing of CHATO and a process evaluation will be used to identify and develop supports for implementation and sustainability in preparation for future CHATO testing.

Design and Outcomes The R61 will prepare for the R01 pragmatic trial by establishing feasibility of online modules and preliminary efficacy of CHATO with NH staff. The research design is a randomized clinical trial. One NH will provide initial feasibility testing. Any modifications to the modules will be made. Then six nursing homes (estimated N=150 staff) will be randomly assigned to intervention or wait-list control groups. The primary outcome will be knowledge gain for staff completing CHATO training. Additional outcomes include resident quality measures related to behavioral and psychological symptoms of dementia (BPSD) on both resident and facility levels and facility level data related to inappropriate use of psychotropic medications to control BPSD. Implementation strategies will be assessed by survey and leadership interviews completed by an external evaluator.

Interventions and Duration Changing Talk Online (CHATO) training is a course is to increase awareness of the importance of effective communication with older adults and to use evidence-based person-centered communication during interactions with older adults in nursing homes and other health care settings. The total program is approximately 3 hours, split into 3 modules. Each module is approximately an hour, depending on the individual user. Each NH will work with the research team for three months to plan, implement, and collect data.

Sample Size and Population This course is designed for staff in nursing homes, independent and assisted living, and health care settings in the community that include registered nurses, nursing assistants, nursing home dieticians, direct care professionals, other administrations and support employees. All the employees at all seven nursing homes will be asked to participate. Assignment of NHs to intervention and wait-list control groups will be at random. A sample of 150 training participants are estimated.


Condition or disease Intervention/treatment Phase
Staff Attitude Dementia Behavioral: Changing Talk Online (CHATO) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: The research design is a randomized clinical trial. An initial nursing home will be used to test feasibility. Six nursing homes (estimated N=150 staff) will be randomly assigned to intervention or wait-list control groups.
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Changing Talk Online (CHATO): A Pragmatic Trial to Reduce Behavioral Symptoms in Dementia Care
Actual Study Start Date : September 30, 2018
Actual Primary Completion Date : May 31, 2020
Estimated Study Completion Date : August 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention
Three nursing homes will receive the training and three control nursing homes will complete assessments, but not receive the training.
Behavioral: Changing Talk Online (CHATO)
Three, one-hour online training modules highlighting barriers and ineffective communication behaviors with older adults while teaching and modeling alternative, effective communication strategies.

Active Comparator: Waitlist Control
After the intervention group takes the training, the waitlist control group will crossover and take the training.
Behavioral: Changing Talk Online (CHATO)
Three, one-hour online training modules highlighting barriers and ineffective communication behaviors with older adults while teaching and modeling alternative, effective communication strategies.




Primary Outcome Measures :
  1. Knowledge gain will be compared between the intervention and wait-list control groups and within nursing homes before and after the CHATO training. [ Time Frame: Three Months for each group ]
    CHATO Knowledge Pre-Test/Post-Test Two forms (Forms A and B) measures knowledge gained from training.

  2. Communication Rating data will be compared between the intervention and wait-list control groups and within nursing homes before and after the CHATO training. [ Time Frame: Three Months for each group ]
    Communication Rating Sheet Pre-Test/Post-Test Participant watches a video and answers questions testing their ability to visually and audibly identify effective vs ineffective communication strategies and recognize elderspeak vs. person-centered care.

  3. BPSD reports for the one-month period before baseline data collection and one month after will be compared between the intervention and wait-list control groups and within nursing homes before and after the CHATO training. [ Time Frame: Three Months for each group ]
    NH Level Deidentified Resident data from nursing homes

  4. Psychotropic medication reports for the one-month period before baseline data collection and one month after will be compared between the intervention and wait-list control groups and within nursing homes before and after the CHATO training. [ Time Frame: Three Months for each group ]
    NH Level Deidentified Resident data from nursing homes


Secondary Outcome Measures :
  1. Nursing home implementation strategies assessed by survey and will be described, categorized, and correlated with participation rates. [ Time Frame: Three months for each group ]
    A descriptive implementation survey created by the investigators will identify the approach types (Implementation Teams, Champions, Stakeholders, Location of training, NH Communication Plan, Discussion Types, and Incentives), motivation to participate in research, and NH level evaluation.

  2. Nursing home practices, environment, and staffing as assessed by the Artifacts of Culture Change and correlated with participation rates. [ Time Frame: Three months for each group ]
    The Artifacts of Culture Change Tool measures NH care environment and practices, leadership and workplace practices, staffing outcomes, and occupancy.

  3. Nursing home implementation strategies assessed by interviews will be described, categorized, and correlated with participation rates. [ Time Frame: Three months for each group ]
    Leadership Phone Interviews measures qualitative data regarding implementation strategies, lessons learned, and overall evaluation of the CHATO pilot from the NH leadership perspective.

  4. The cost associated with hypothesized BPSD reductions after the CHATO training will be calculated using primary outcomes and wage data. [ Time Frame: Three months for each group ]
    Staff Wage Data measures wages per hour by NH role and will be used in a simple cost-effectiveness analysis (CEA).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria

  • Nursing Homes that serve people with dementia.
  • Nursing Homes that have internet available for staff to complete the CHATO training.
  • Nursing Homes that are willing to complete leadership interviews and surveys.
  • CNAs and nurses who are permanent employees and who provide direct care at least 8 hours weekly will be invited to complete the CHATO training, available by URL link.
  • Other personnel, such as housekeeping, dietary, and administrators may also participate. Participation by as many staff as possible is desired to achieve facility-wide communication change.
  • Aggregate, deidentified data for residents with Alzheimer's disease or non-Alzheimer's dementia documented on the MDS Active Diagnoses list.

Exclusion Criteria

  • Assisted Living facilities or other types of facilities are excluded due to lack of MDS data as well as NHs that previously participated in the CHAT study.

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): NCT03849937


Locations
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United States, Iowa
University of Iowa School of Nursing
Iowa City, Iowa, United States, 52242
United States, Kansas
University of Kansas School of Nursing
Kansas City, Kansas, United States, 66160
Sponsors and Collaborators
University of Kansas Medical Center
University of Iowa
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Responsible Party: University of Kansas Medical Center
ClinicalTrials.gov Identifier: NCT03849937    
Other Study ID Numbers: 1R61AG061881-01 ( U.S. NIH Grant/Contract )
First Posted: February 21, 2019    Key Record Dates
Last Update Posted: June 17, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Kansas Medical Center:
Behavioral and Psychological Symptoms of Dementia
Psychotropic Medication
Elderspeak
Staff Training
Staff Communication
Nonpharmacological treatment for Dementia
Additional relevant MeSH terms:
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Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders