Clinical Trials Logo

Clinical Trial Summary

The National Plan to Address Alzheimer's disease has identified education of dementia care providers as a top priority to address the need for quality care for the population of persons with dementia that will triple in the next 30 years. This study will test new online interactive training for nursing home staff that improves staff communication and also reduces behavioral symptoms of persons with dementia that they care for. Innovative approaches to reach care providers are essential to achieve implementation of evidence-based practices to improve care.


Clinical Trial Description

A new person is diagnosed with Alzheimer's disease or other dementia every 65 seconds, and most persons living with dementia (PWD) spend the late stages of dementia in nursing homes (NHs) where shortages of staff and lack of dementia care skills limit quality of care. Care of PWD is complicated by behavioral and psychological symptoms of dementia (BPSD) such as aggression, vocal outbursts, wandering, and withdrawal that occur as PWD lose cognitive and communication abilities and cannot express their unmet physical and psychosocial needs. BPSD present to NH staff as resistiveness to care (RTC) that increases staff stress and costly time to complete care, often leading to staff turnover, injury, and inappropriate use of psychotropic medications to control BPSD. Although Center for Medicare and Medicaid Services (CMS) mandates and penalties have reduced NH antipsychotic medication use slightly, contraindicated use in NH residents remains a pervasive problem, causing harmful side effects and reducing the quality of life for PWD. The PI and other researchers have empirically verified that RTC occurs when NH staff use elderspeak (speech similar to baby talk) that features inappropriately intimate terms of endearment (diminutives such as "honey"), belittling pronoun substitutions that imply dependence ("we" need a bath), and harsh task-oriented commands ("sit down"). Elderspeak conveys a message of disrespect and incompetence to residents who react with withdrawal or BPSD. Our R03 study established that when staff use elderspeak instead of normal adult communication, residents with dementia are more than twice as likely to exhibit BPSD (measured by coding RTC behavior in videos). Our subsequent R01 clinical trial verified that staff reduced their use of elderspeak communication after attending the three-session Changing Talk (CHAT) program and that this reduced RTC. CHAT training is effective in changing staff communication practices and reducing RTC but requires an onsite trainer, limiting accessibility and feasibility for dissemination. Increasing access to this effective training, which improves communication and acts as a nonpharmacological intervention to reduce BPSD, is the next logical step. To facilitate dissemination, interactive online modules (CHATO) with the same CHAT content were developed and pilot-tested, establishing preliminary effects and increased participation by busy NH staff. We anticipate that this online training will increase access to training and the translation of evidence-based content and skill practice at reduced cost extending reach nationally to include small and rural NHs. Support for NH administrators will optimize staff engagement, implementation, and maintenance of CHATO skills in practice. This competitive renewal resubmission builds on R01 NR011455, "Changing Talk to Reduce Resistiveness to Dementia Care" demonstrating the 3-session CHAT intervention decreased staff elderspeak and reduced resident RTC.13 Online CHATO modules provide asynchronous, independent access for busy NH staff. Linear mixed modeling will be used to compare CHATO and CONTROL group change in BPSD and psychotropic medication use (from CMS and Nursing Home Compare data). CHATO is an innovative nonpharmacological intervention that reduces BPSD. Online delivery will increase cost effectiveness. SPECIFIC AIMS: 1. AIM 1. Test effects of CHATO on BPSD and psychotropic medication use in 120 NHs. Hypothesis: Reductions in BPSD and psychotropic medication use (extracted from CMS Minimum Data set and Nursing Home Compare Quality Measures) will occur for individual residents and within NH facilities in the CHATO vs CONTROL group. 2. AIM 2. Test strategies to engage staff and maximize CHATO effects. We will conduct a mixed-method process evaluation evaluating implementation strategies and supports to assist NHs in approach, motivation, and incentives to improve dissemination. NH characteristics and implementation strategies used will be analyzed in relation to participation rates, knowledge gain, and changes in primary outcomes. Interviews and focus groups will be conducted by our external evaluator. Hypothesis: Primary outcomes will vary by secondary outcomes; identifying most effective NH characteristics and strategies for implementation. 3. AIM 3. Evaluate cost and sustainability. Data envelopment analysis will identify CHATO costs in relation to BPSD reductions. NHs will complete a 1-year follow-up survey to report on their adoption and maintenance. Hypothesis: BPSD reductions will vary in cost; identifying the most efficient means of dissemination and NH sustainability will vary depending on adoption factors. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04610944
Study type Interventional
Source University of Kansas Medical Center
Contact Kristine N Williams, RN, PhD
Phone 9135881673
Email kwilliams1@kumc.edu
Status Recruiting
Phase N/A
Start date April 26, 2021
Completion date May 31, 2026

See also
  Status Clinical Trial Phase
Completed NCT04044495 - Sleep, Rhythms and Risk of Alzheimer's Disease N/A
Completed NCT04079803 - PTI-125 for Mild-to-moderate Alzheimer's Disease Patients Phase 2
Terminated NCT03052712 - Validation and Standardization of a Battery Evaluation of the Socio-emotional Functions in Various Neurological Pathologies N/A
Recruiting NCT04520698 - Utilizing Palliative Leaders In Facilities to Transform Care for Alzheimer's Disease N/A
Active, not recruiting NCT04606420 - Can Lifestyle Changes Reverse Early-Stage Alzheimer's Disease N/A
Recruiting NCT05820919 - Enhancing Sleep Quality for Nursing Home Residents With Dementia - R33 Phase N/A
Terminated NCT03672474 - REGEnLIFE RGn530 - Feasibility Pilot N/A
Completed NCT03430648 - Is Tau Protein Linked to Mobility Function?
Recruiting NCT04949750 - Efficacy of Paper-based Cognitive Training in Vietnamese Patients With Early Alzheimer's Disease N/A
Recruiting NCT05557409 - A Study to Assess the Efficacy and Safety of AXS-05 in Subjects With Alzheimer's Disease Agitation Phase 3
Recruiting NCT05288842 - Tanycytes in Alzheimer's Disease and Frontotemporal Dementia
Recruiting NCT04522739 - Spironolactone Safety in African Americans With Mild Cognitive Impairment and Early Alzheimer's Disease Phase 4
Completed NCT06194552 - A Multiple Dose Study of the Safety and Pharmacokinetics of NTRX-07 Phase 1
Completed NCT03239561 - Evaluation of Tau Protein in the Brain of Participants With Alzheimer's Disease Compared to Healthy Participants Early Phase 1
Completed NCT03184467 - Clinical Trial to Evaluate the Efficacy and Safety of GV1001 in Alzheimer Patients Phase 2
Active, not recruiting NCT03676881 - Longitudinal Validation of a Computerized Cognitive Battery (Cognigram) in the Diagnosis of Mild Cognitive Impairment and Alzheimer's Disease
Terminated NCT03487380 - Taxonomic and Functional Composition of the Intestinal Microbiome: a Predictor of Rapid Cognitive Decline in Patients With Alzheimer's Disease N/A
Completed NCT05538455 - Investigating ProCare4Life Impact on Quality of Life of Elderly Subjects With Neurodegenerative Diseases N/A
Recruiting NCT05328115 - A Study on the Safety, Tolerability and Immunogenicity of ALZ-101 in Participants With Early Alzheimer's Disease Phase 1
Completed NCT05562583 - SAGE-LEAF: Reducing Burden in Alzheimer's Disease Caregivers Through Positive Emotion Regulation and Virtual Support N/A