DementiaNCT01324219
Changing Talk to Reduce Resistiveness to Care
A study testing Staff and Resident in people with Dementia, run by University of Kansas Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dementia
- What is being tested?
- Staff and Resident
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 202 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2011to Jun 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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,
Show all 9Show fewer
- manic-depressive disorder,
- deafness,
- and mental retardation.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kansas Medical Center
Kansas City, Kansas, 66160
About this study
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.
- Conditions
- Dementia
- Being tested
- Staff, Resident
- Keywords
- nursing staff, residents
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
StaffBehavioural
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.
ResidentBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Staff | Active comparator | Not described Receives: Behavioral: Staff |
| Resident | Experimental | Not described Receives: Behavioral: Resident |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 6 months
Secondary outcomes (1)
Calculate the costs of nursing staff communication system
Calculate the costs of CHAT using traditional methods and assess its cost-effectiveness with innovative Data Envelopment Analysis.
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2011 (estimated)
- Study startMar 2011
- Primary completionJun 2014
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 202 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kristine Williams, RN, PhD, APRN, FNP-BC, Principal investigator, University of Kansas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01324219
- Sponsor's protocol ID
- 12146
- Status last verified
- Feb 2017
- First submitted
- 16 Mar 2011
- Last updated
- 13 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 35131660Liu 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.
PubMed 32726447Jao 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.
PubMed 31241031Williams 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.
PubMed 27048705
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changing Talk to Reduce Resistiveness to Care
- ClinicalTrials.gov ID
- NCT01324219
- Acronym / sponsor ID
- 12146
- Conditions
- Dementia
- Keywords
- nursing staff, residents
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 202 participants (actual)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 28 Mar 2011 (estimated)
- 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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Staff | Active comparator | Behavioral: Staff |
| Resident | Experimental | Behavioral: Resident |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (9 listed)
- 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,
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 |
|---|---|---|
| StaffYour 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. | Behavioural | Staff |
| ResidentYour 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. | Behavioural | Resident |
Primary outcome
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.
1 secondary outcome
Calculate the costs of nursing staff communication system
Time frame: up to 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2017.
- Derived from this study: PubMed 35131660Liu 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.
- Derived from this study: PubMed 32726447Liu 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.
- Derived from this study: PubMed 31241031Jao 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.
- Derived from this study: PubMed 27048705Williams 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.
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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. This study is not recruiting at the moment.
Kristine Williams, RN, PhD, APRN, FNP-BC principal investigator
University of Kansas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Staff and Resident in people with Dementia, run by University of Kansas Medical Center at 1 site in United States.
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 0 inclusion and 9 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: finished, as of the sponsor's last update on 13 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the effects of the nursing staff communication - change in frequency and duration of resident Resistiveness to Care behaviors. (time frame: up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01324219, which also lists 4 linked publications.
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 13 Feb 2017.