DementiaNCT06636214
Adapting Changing Talk: Online (CHATO) to CHATO-Inclusive
A study testing CHATO-I in people with Dementia, run by University of Kansas Medical Center.
Trial summary
This study will adapt and test online interactive training for nursing home staff that improves staff communication and reduces behavioral symptoms of persons with dementia that they care for. This research will adapt and test communication training to meet the needs of nursing homes to improve dementia care. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dementia
- What is being tested?
- CHATO-I
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,200 participants
- Where
- No sites listed yet
- Study dates
- Jan 2027to 31 Aug 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Medicare certified NHs (N=40) caring for residents diagnosed with AD/ADRD.
- CNAs, nurses, and other direct care staff who are permanent employees of participating NHs and who provide direct care at least 8 hours weekly will complete the CHATO-I training, available by URL link.
- All staff will be encouraged to participate as high staff participation is desired to achieve facility-wide communication change. NHs will provide the number of eligible staff participants.
- Data for residents in participating NHs with AD/ADRD documented on the MDS Active Diagnoses list will be included in the analyses as well as MDS data for: age, sex, race and ethnicity, frailty (MDS-CHESS scale), and level of cognitive function (MDS Cognitive Performance Scale).
Who cannot join
- NHs serving 25% of residents admitted prior to age 65 will be excluded (screening out NHs serving primarily younger persons with serious mental illnesses).
- CNAs, nurses, and other direct care staff who do not meet the inclusion criteria.
- Resident data excluded from MDS includes active psychiatric diagnoses (bipolar disorder, major depressive episode, schizophrenia or schizoaffective disorder, mood disorder with psychotic features, psychotic symptoms, hallucinations, or delusions); terminal illness (on hospice); and lack of response to staff (MDS section B).
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Adapting the CHATO Communication Intervention for Diverse Nursing Home Communities
This study will adapt and test online interactive training for nursing home staff that improves staff communication and reduces behavioral symptoms of persons with dementia that they care for. This research will adapt and test communication training to meet the needs of nursing homes to improve dementia care.
Read the detailed description
A person is diagnosed with Alzheimer's disease or related dementia (AD/ADRD) every 65 seconds, and most persons living with dementia (PLWD) experience nursing home (NH) care at some stage. NH staff shortages and lack of dementia care skills limit care quality, especially in NHs with low income and resources. Care is complicated by the behavioral and psychological symptoms of dementia (BPSD) of PLWD who cannot express their unmet physical and psychosocial needs. BPSD increase staff stress and time to complete care and contribute to staff turnover, injury, and inappropriate psychotropic medication use.
The PI and other researchers have empirically verified that BPSD occur when staff use elderspeak (speech like 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 PLWD who react with withdrawal or BPSD. The investigators R03 study first established that elderspeak use more than doubled the occurrences of resident responses of BPSD (measured by timed sequential behavioral analyses of BPSD in relation to type of staff communication in video data). The investigators R01 trial (NR011455) confirmed that the three-session Changing Talk(CHAT) staff education intervention reduced staff elderspeak use that significantly reduced resident BPSD.The evidence-based CHAT intervention was transitioned to online modules (CHATO), maintaining content, active engagement, and application activities, with equal knowledge gain (mechanism of action) and improved participation and completion rates. The investigators are currently testing CHATO in a pragmatic national trial in 128 NHs (R01AG069171). However, NHs serving high minority-resident populations with fewer resources and staff and more frequent and serious care deficiencies, including high antipsychotic medication use rates, have been less likely to respond to recruitment and study participation. Research has established that tailoring interventions and intensification of recruitment and implementation approaches are frequently necessary to reach and achieve intervention success to overcome health care disparities in diverse care settings.
This study will first engage NH staff in completing the current CHATO training and providing in depth focus groups feedback. We will then integrate focus group findings with findings from our CHATO study and expert stakeholder panel advise to streamline content, improve format and user interface, and expand implementation support to create CHATO-I, designed to increase appropriateness and uptake across NH communities. The investigators will then conduct a cluster randomized trial in NHs (N=40). NHs will be randomized to intervention or waitlist control groups and one of two waves for staff completion of the CHATO-I intervention with high intensity implementation support. The investigators will test feasibility and acceptability and use hierarchical mixed modeling analyses to evaluate preliminary effects of the intervention on BPSD and psychoactive medication use by residents with dementia in a pragmatic evaluation of Electronic Medical Record (EMR) data.
Aim 1 (years 1 and 2): Tailor recruitment, implementation support, and intervention content and format appropriate for all NHs. Administrators, directors of nursing, and care staff including certified nursing assistants (CNAs) from six NHs (N=24) will complete current CHATO and participate in focus groups. Thematic analyses of transcribed recordings will identify tailoring modifications to support uptake across all varieties of NH communities. The ADAPT framework will guide CHATO to CHATO-I adaptation with support from expert consultants and stakeholders.
Aim 2 (years 3 to 5): Test feasibility, acceptability, and preliminary effects of CHATO-I in 40 NHs in a cluster-randomized waitlist-controlled trial. Enrollment and completion rates will be used to evaluate feasibility and acceptability (Aim 2a). Mixed modeling will evaluate change in resident BPSD and psychoactive medication use from eight quarters of Minimum Data Set (MDS) and Nursing Home Quality Measure (NHQM) data (Aim 2b). We hypothesize that CHATO-I will reduce resident BPSD and psychoactive medication use.
Aim 3 (years 3 to 5): Validate the mechanism of action of CHATO-I. Additional modeling analyses will evaluate the effects of CHATO-I on learning outcomes (gains in knowledge, confidence, recognition) and intention to use learned skills on resident BPSD and psychoactive medication use. We hypothesize that greater staff knowledge gain and intention to use new skills will be associated with greater outcome reductions.
This Stage 1B research will adapt and test the evidence-based CHATO intervention across NHs, increasing dissemination and improving care (reduced BPSD and psychotropic medication use). This research addresses the National Plan to Address Alzheimer's disease goals, NIA's milestones for nonpharmacological interventions, and the National Academy National Imperative for interventions to improve NH care quality.
- Conditions
- Dementia
- Being tested
- CHATO-I
- Keywords
- ADRD, Nursing Home Staff Communication, Elderspeak
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CHATO-IBehavioural
Online communication education program
| Study group | Role | What they receive |
|---|---|---|
| CHATO Inclusive Intervention | Experimental | Not described Receives: Behavioral: CHATO-I |
| Waitlist Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Test CHATO's effects on Behavioral and Psychological Symptoms of Dementia (BPSD) - Change in MDS E0200 pre/post intervention
Center for Medicare and Medicaid Services (CMS) Minimum Data Set (MDS) Quarterly data - E0200 Presence and Frequency of Behavioral Symptoms in the last 7 days; The steps for assessment are to review the medical record, observe the resident in a variety of situations, and interview staff, across all shifts and disciplines. Coding Instruction: Code 0, behavior not exhibited, Code 1, behavior of this type occurred 1-3 days, Code 2, behavior of this type occurred 4-6 days, but less than daily, or Code 3, behavior of this type occurred daily.
Measured: pre (3 months) / post (3 months) post intervention
Test CHATO's effects on Behavioral and Psychological Symptoms of Dementia (BPSD) - Change in MDS E0800 pre/post intervention
CMS MDS Quarterly data - E0800 Rejection of Care - Presence and Frequency over past 7 days; The steps for assessment are to review the medical record, observe the resident in a variety of situations, and interview staff, across all shifts and disciplines. If the resident exhibits behavior that appears to communicate a rejection of care (and that rejection behavior has not been previously determined to be consistent with the resident's values or goals), ask him or her directly whether the behavior is meant to decline or refuse care. Coding Instruction: Code 0, behavior not exhibited, Code 1, behavior of this type occurred 1-3 days, Code 2, behavior of this type occurred 4-6 days, but less than daily, or Code 3, behavior of this type occurred daily.
Measured: pre (3 months) / post (3 months) post intervention
Test CHATO's effects on Behavioral and Psychological Symptoms of Dementia (BPSD) - Change in MDS E1100 pre/post intervention
CMS MDS Quarterly data - E1100 Change in Behavioral or Other Symptoms: The steps for assessment are review responses provided to items E0100-E1000 on the current MDS assessment, compare with responses provided on prior MDS assessment, and then taking all of these MDS items into consideration, make a global assessment of the change in behavior from the most recent to the current MDS. Rate the overall behavior as same, improved, or worse.
Coding Instructions: Code 0, same: if overall behavior is the same (unchanged), Code 1, improved: if overall behavior is improved, Code 2, worse: if overall behavior is worse, or Code 3, N/A: if there was no prior MDS assessment of this resident.
Measured: pre (3 months) / post (3 months) post intervention
Test CHATO's effects on psychotropic medication - Change in MDS N0410 pre/post intervention
CMS MDS Quarterly data - N0410 Medications Received: The steps for assessment are review the resident's medical record for documentation that any of these medications were received by the resident during the 7-day look-back period (or since admission/entry or reentry if less than 7 days) and review documentation from other health care settings where the resident may have received any of these medications while a resident of the nursing home (e.g., valium given in the emergency room). Coding Instructions: N0410A, Antipsychotic,N0410B, Antianxiety, N0410C, Antidepressant, N0410D, Hypnotic, N0410E, Anticoagulant, N0410F, Antibiotic, N0410G, Diuretic
Measured: pre (3 months) / post (3 months) post intervention
Test CHATO's effects on psychotropic medication - Change in NHQM Prescribed Antipsychotic pre/post intervention
CMS Quarterly Nursing Home Quality Measure: Prescribed Antipsychotic (Long-stay quality measure 419) The percentage of long-stay residents who are receiving antipsychotic drugs in a 7-day look-back period. Exclusions: Residents with a diagnosis of schizophrenia, Tourette's syndrome, or Huntington's disease. Reported by nursing homes quarterly and gathered from Nursing Home Compare.
Measured: pre (3 months) / post (3 months) post intervention
Test CHATO's effects on psychotropic medication - Change in Survey 757 and 758 Noncompliance
Survey 757 and 758 (prior 319), Noncompliance due to unnecessary medications and level of deficiency - Noncompliance due to unnecessary medications and level of deficiency (immediate jeopardy, actual harm, no actual harm \& isolated, pattern and occurrence).
Measured: pre (3 months) / post (3 months) post intervention
Secondary outcomes (3)
Analyze NH strategies to engage staff and maximize CHATO effects _ Change in Knowledge at post intervention
CHAT Scale - 13 questions, measures knowledge gained from training. Scale would be 0-13, Higher scores indicate more knowledge gained and better outcomes. During Aim 1 of the grant, we will determine a new time frame for the intervention.
Measured: post intervention
Analyze NH strategies to engage staff and maximize CHATO effects _ Change in Communication Ratings
Communication Rating Sheet - 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. During Aim 1 of the grant, we will determine a new time frame for the intervention.
Measured: post intervention
Analyze NH strategies to engage staff and maximize CHATO effects _ Implementation Strategies utilized during the training phase
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.During Aim 1 of the grant, we will determine a new time frame for the intervention.
Measured: post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2024
- Study startJan 2027 (estimated)
- Primary completion31 Aug 2029 (estimated)
- Study completion31 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DementiaStudies of the same condition, open and under way.
- More trials run by University of Kansas Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oklahoma, University of Iowa
- Responsible party
- Sponsor
- Investigators
- Kristine Williams, RN, PhD, Principal investigator, University of Kansas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06636214
- Sponsor's protocol ID
- R01AG085177
- Status last verified
- May 2026
- First submitted
- 23 Sep 2024
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adapting the CHATO Communication Intervention for Diverse Nursing Home Communities
- ClinicalTrials.gov ID
- NCT06636214
- Acronym / sponsor ID
- R01AG085177
- Conditions
- Dementia
- Keywords
- ADRD, Nursing Home Staff Communication, Elderspeak
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Collaborators
- University of Oklahoma, University of Iowa
- Study start
- Jan 2027 (estimated)
- Primary completion
- 31 Aug 2029 (estimated)
- Study completion
- 31 Aug 2029 (estimated)
- First posted
- 10 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will adapt and test online interactive training for nursing home staff that improves staff communication and reduces behavioral symptoms of persons with dementia that they care for. This research will adapt and test communication training to meet the needs of nursing homes to improve dementia care.
Detailed description
A person is diagnosed with Alzheimer's disease or related dementia (AD/ADRD) every 65 seconds, and most persons living with dementia (PLWD) experience nursing home (NH) care at some stage. NH staff shortages and lack of dementia care skills limit care quality, especially in NHs with low income and resources. Care is complicated by the behavioral and psychological symptoms of dementia (BPSD) of PLWD who cannot express their unmet physical and psychosocial needs. BPSD increase staff stress and time to complete care and contribute to staff turnover, injury, and inappropriate psychotropic medication use.
The PI and other researchers have empirically verified that BPSD occur when staff use elderspeak (speech like 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 PLWD who react with withdrawal or BPSD. The investigators R03 study first established that elderspeak use more than doubled the occurrences of resident responses of BPSD (measured by timed sequential behavioral analyses of BPSD in relation to type of staff communication in video data). The investigators R01 trial (NR011455) confirmed that the three-session Changing Talk(CHAT) staff education intervention reduced staff elderspeak use that significantly reduced resident BPSD.The evidence-based CHAT intervention was transitioned to online modules (CHATO), maintaining content, active engagement, and application activities, with equal knowledge gain (mechanism of action) and improved participation and completion rates. The investigators are currently testing CHATO in a pragmatic national trial in 128 NHs (R01AG069171). However, NHs serving high minority-resident populations with fewer resources and staff and more frequent and serious care deficiencies, including high antipsychotic medication use rates, have been less likely to respond to recruitment and study participation. Research has established that tailoring interventions and intensification of recruitment and implementation approaches are frequently necessary to reach and achieve intervention success to overcome health care disparities in diverse care settings.
This study will first engage NH staff in completing the current CHATO training and providing in depth focus groups feedback. We will then integrate focus group findings with findings from our CHATO study and expert stakeholder panel advise to streamline content, improve format and user interface, and expand implementation support to create CHATO-I, designed to increase appropriateness and uptake across NH communities. The investigators will then conduct a cluster randomized trial in NHs (N=40). NHs will be randomized to intervention or waitlist control groups and one of two waves for staff completion of the CHATO-I intervention with high intensity implementation support. The investigators will test feasibility and acceptability and use hierarchical mixed modeling analyses to evaluate preliminary effects of the intervention on BPSD and psychoactive medication use by residents with dementia in a pragmatic evaluation of Electronic Medical Record (EMR) data.
Aim 1 (years 1 and 2): Tailor recruitment, implementation support, and intervention content and format appropriate for all NHs. Administrators, directors of nursing, and care staff including certified nursing assistants (CNAs) from six NHs (N=24) will complete current CHATO and participate in focus groups. Thematic analyses of transcribed recordings will identify tailoring modifications to support uptake across all varieties of NH communities. The ADAPT framework will guide CHATO to CHATO-I adaptation with support from expert consultants and stakeholders.
Aim 2 (years 3 to 5): Test feasibility, acceptability, and preliminary effects of CHATO-I in 40 NHs in a cluster-randomized waitlist-controlled trial. Enrollment and completion rates will be used to evaluate feasibility and acceptability (Aim 2a). Mixed modeling will evaluate change in resident BPSD and psychoactive medication use from eight quarters of Minimum Data Set (MDS) and Nursing Home Quality Measure (NHQM) data (Aim 2b). We hypothesize that CHATO-I will reduce resident BPSD and psychoactive medication use.
Aim 3 (years 3 to 5): Validate the mechanism of action of CHATO-I. Additional modeling analyses will evaluate the effects of CHATO-I on learning outcomes (gains in knowledge, confidence, recognition) and intention to use learned skills on resident BPSD and psychoactive medication use. We hypothesize that greater staff knowledge gain and intention to use new skills will be associated with greater outcome reductions.
This Stage 1B research will adapt and test the evidence-based CHATO intervention across NHs, increasing dissemination and improving care (reduced BPSD and psychotropic medication use). This research addresses the National Plan to Address Alzheimer's disease goals, NIA's milestones for nonpharmacological interventions, and the National Academy National Imperative for interventions to improve NH care quality.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CHATO Inclusive Intervention | Experimental | Behavioral: CHATO-I |
| Waitlist Control | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Medicare certified NHs (N=40) caring for residents diagnosed with AD/ADRD.
- CNAs, nurses, and other direct care staff who are permanent employees of participating NHs and who provide direct care at least 8 hours weekly will complete the CHATO-I training, available by URL link.
- All staff will be encouraged to participate as high staff participation is desired to achieve facility-wide communication change. NHs will provide the number of eligible staff participants.
- Data for residents in participating NHs with AD/ADRD documented on the MDS Active Diagnoses list will be included in the analyses as well as MDS data for: age, sex, race and ethnicity, frailty (MDS-CHESS scale), and level of cognitive function (MDS Cognitive Performance Scale).
Key exclusion criteria (3 listed)
- NHs serving 25% of residents admitted prior to age 65 will be excluded (screening out NHs serving primarily younger persons with serious mental illnesses).
- CNAs, nurses, and other direct care staff who do not meet the inclusion criteria.
- Resident data excluded from MDS includes active psychiatric diagnoses (bipolar disorder, major depressive episode, schizophrenia or schizoaffective disorder, mood disorder with psychotic features, psychotic symptoms, hallucinations, or delusions); terminal illness (on hospice); and lack of response to staff (MDS section B).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CHATO-IOnline communication education program | Behavioural | CHATO Inclusive Intervention |
Primary outcome
Test CHATO's effects on Behavioral and Psychological Symptoms of Dementia (BPSD) - Change in MDS E0200 pre/post intervention
Time frame: pre (3 months) / post (3 months) post intervention
Center for Medicare and Medicaid Services (CMS) Minimum Data Set (MDS) Quarterly data - E0200 Presence and Frequency of Behavioral Symptoms in the last 7 days; The steps for assessment are to review the medical record, observe the resident in a variety of situations, and interview staff, across all shifts and disciplines. Coding Instruction: Code 0, behavior not exhibited, Code 1, behavior of this type occurred 1-3 days, Code 2, behavior of this type occurred 4-6 days, but less than daily, or Code 3, behavior of this type occurred daily.
Test CHATO's effects on Behavioral and Psychological Symptoms of Dementia (BPSD) - Change in MDS E0800 pre/post intervention
Time frame: pre (3 months) / post (3 months) post intervention
CMS MDS Quarterly data - E0800 Rejection of Care - Presence and Frequency over past 7 days; The steps for assessment are to review the medical record, observe the resident in a variety of situations, and interview staff, across all shifts and disciplines. If the resident exhibits behavior that appears to communicate a rejection of care (and that rejection behavior has not been previously determined to be consistent with the resident's values or goals), ask him or her directly whether the behavior is meant to decline or refuse care. Coding Instruction: Code 0, behavior not exhibited, Code 1, behavior of this type occurred 1-3 days, Code 2, behavior of this type occurred 4-6 days, but less than daily, or Code 3, behavior of this type occurred daily.
Test CHATO's effects on Behavioral and Psychological Symptoms of Dementia (BPSD) - Change in MDS E1100 pre/post intervention
Time frame: pre (3 months) / post (3 months) post intervention
CMS MDS Quarterly data - E1100 Change in Behavioral or Other Symptoms: The steps for assessment are review responses provided to items E0100-E1000 on the current MDS assessment, compare with responses provided on prior MDS assessment, and then taking all of these MDS items into consideration, make a global assessment of the change in behavior from the most recent to the current MDS. Rate the overall behavior as same, improved, or worse. Coding Instructions: Code 0, same: if overall behavior is the same (unchanged), Code 1, improved: if overall behavior is improved, Code 2, worse: if overall behavior is worse, or Code 3, N/A: if there was no prior MDS assessment of this resident.
Test CHATO's effects on psychotropic medication - Change in MDS N0410 pre/post intervention
Time frame: pre (3 months) / post (3 months) post intervention
CMS MDS Quarterly data - N0410 Medications Received: The steps for assessment are review the resident's medical record for documentation that any of these medications were received by the resident during the 7-day look-back period (or since admission/entry or reentry if less than 7 days) and review documentation from other health care settings where the resident may have received any of these medications while a resident of the nursing home (e.g., valium given in the emergency room). Coding Instructions: N0410A, Antipsychotic,N0410B, Antianxiety, N0410C, Antidepressant, N0410D, Hypnotic, N0410E, Anticoagulant, N0410F, Antibiotic, N0410G, Diuretic
Test CHATO's effects on psychotropic medication - Change in NHQM Prescribed Antipsychotic pre/post intervention
Time frame: pre (3 months) / post (3 months) post intervention
CMS Quarterly Nursing Home Quality Measure: Prescribed Antipsychotic (Long-stay quality measure 419) The percentage of long-stay residents who are receiving antipsychotic drugs in a 7-day look-back period. Exclusions: Residents with a diagnosis of schizophrenia, Tourette's syndrome, or Huntington's disease. Reported by nursing homes quarterly and gathered from Nursing Home Compare.
Test CHATO's effects on psychotropic medication - Change in Survey 757 and 758 Noncompliance
Time frame: pre (3 months) / post (3 months) post intervention
Survey 757 and 758 (prior 319), Noncompliance due to unnecessary medications and level of deficiency - Noncompliance due to unnecessary medications and level of deficiency (immediate jeopardy, actual harm, no actual harm \& isolated, pattern and occurrence).
3 secondary outcomes
Analyze NH strategies to engage staff and maximize CHATO effects _ Change in Knowledge at post intervention
Time frame: post intervention
Analyze NH strategies to engage staff and maximize CHATO effects _ Change in Communication Ratings
Time frame: post intervention
Analyze NH strategies to engage staff and maximize CHATO effects _ Implementation Strategies utilized during the training phase
Time frame: post intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kristine Williams, RN, PhD principal investigator
University of Kansas
Questions about this trial
What is this clinical trial studying?
A study testing CHATO-I in people with Dementia, run by University of Kansas Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kristine Williams, RN, PhD (785-979-7879, kwilliams1@kumc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Test CHATO's effects on Behavioral and Psychological Symptoms of Dementia (BPSD) - Change in MDS E0200 pre/post intervention (time frame: pre (3 months) / post (3 months) post intervention). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2026.