DementiaPhase 2/3NCT00255866
Improving Mood and Behavior in Assisted Living Residents Through Skills Training for Their Caregivers
A Phase 2/3 study testing Skills training for the care of dementia patients in people with Dementia and Alzheimer Disease, run by University of Washington at 2 sites in United States.
Trial summary
This study will develop a treatment program to reduce mood and behavior problems in assisted living residents who have dementia. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dementia, Alzheimer Disease
- What is being tested?
- Skills training for the care of dementia patients
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 90 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2004to Dec 2006
- Phase
- Phase 2/3
- 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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Work in the assisted living residence for at least 6 months prior to study entry
- Work in the assisted living residence at least 5 days a week, for at least 4 hours a day on day or afternoon-evening shifts
- Provide direct care for at least 1 assisted living resident
- Agree to attend all training sessions and complete assessment forms
- Able to speak, read, and understand English at a 6th grade level
- Diagnosis of dementia
Show all 9Show fewer
- Identified by caregiving staff as having mood or behavioral problems
- Have lived at the assisted living residence for at least 3 months prior to study entry
- Have a family member with power of attorney
Who cannot join
- Plan to receive medication for affective or behavioral problems during the study
- History of alcohol or drug abuse
- Have attempted suicide within 1 year prior to study entry
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Rush University School of Nursing
Chicago, Illinois, 60612
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
About this study
Official title: Improving Affect and Behavior in Assisted Living Residents
This study will develop a treatment program to reduce mood and behavior problems in assisted living residents who have dementia.
Read the detailed description
Assisted living is rapidly becoming one of the most common methods of caring for older adults with dementia in long-term care. Over half of assisted living residents have dementia and many exhibit affective and behavioral problems related to the condition; residents' care and quality of life may suffer as a result of these problems. Despite the seriousness of this condition, interventions to teach direct care staff how to care for these residents are limited. This study will develop a program for teaching assisted living staff how to deal with the issues of patients with dementia and reduce mood and behavioral problems among this population.
Caregivers will be randomly assigned to attend skills training sessions as two 4-hour workshops, four 30 minute individual training sessions, or two 30 minute in-services. Training will focus on dementia, depression and anxiety, the incidence of behavior problems, and skills and techniques for alleviating care challenges associated with behavior problems. Caregivers will complete self-report scales and questionnaires at the beginning and at the end of the study; these measures will assess job satisfaction, reactions to resident behavioral problems, and job skills. Residents will also be recruited for this study; they will complete questionnaires about their depressive episodes, anxiety, behavioral problems, and quality of life at the beginning and at the end of the study.
- Conditions
- Dementia, Alzheimer Disease
- Being tested
- Skills training for the care of dementia patients
- Keywords
- Assisted Living Facilities, Aged, Elderly, Caregivers
- Medical subject headings
- Dementia, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skills training for the care of dementia patientsBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Skills to effectively deal with resident behavioral problems
Secondary outcomes (1)
Resident depression, anxiety, behavioral problems, and quality of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2005 (estimated)
- Study startJan 2004
- Primary completionDec 2006
- Study completionDec 2006
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 WashingtonThe 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 2/3
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Linda Teri, University of Washington
- Investigators
- Linda Teri, PhD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00255866
- Sponsor's protocol ID
- 26082-ED
- Other IDs
- R21MH069651, DSIR 82-SEDR
- Status last verified
- Dec 2013
- First submitted
- 16 Nov 2005
- Last updated
- 2 Dec 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Affect and Behavior in Assisted Living Residents
- ClinicalTrials.gov ID
- NCT00255866
- Acronym / sponsor ID
- 26082-ED
- Conditions
- Dementia, Alzheimer Disease
- Keywords
- Assisted Living Facilities, Aged, Elderly, Caregivers
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Jan 2004
- Primary completion
- Dec 2006 (actual)
- Study completion
- Dec 2006 (actual)
- First posted
- 21 Nov 2005 (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.
This study will develop a treatment program to reduce mood and behavior problems in assisted living residents who have dementia.
Detailed description
Assisted living is rapidly becoming one of the most common methods of caring for older adults with dementia in long-term care. Over half of assisted living residents have dementia and many exhibit affective and behavioral problems related to the condition; residents' care and quality of life may suffer as a result of these problems. Despite the seriousness of this condition, interventions to teach direct care staff how to care for these residents are limited. This study will develop a program for teaching assisted living staff how to deal with the issues of patients with dementia and reduce mood and behavioral problems among this population.
Caregivers will be randomly assigned to attend skills training sessions as two 4-hour workshops, four 30 minute individual training sessions, or two 30 minute in-services. Training will focus on dementia, depression and anxiety, the incidence of behavior problems, and skills and techniques for alleviating care challenges associated with behavior problems. Caregivers will complete self-report scales and questionnaires at the beginning and at the end of the study; these measures will assess job satisfaction, reactions to resident behavioral problems, and job skills. Residents will also be recruited for this study; they will complete questionnaires about their depressive episodes, anxiety, behavioral problems, and quality of life at the beginning and at the end of the study.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Work in the assisted living residence for at least 6 months prior to study entry
- Work in the assisted living residence at least 5 days a week, for at least 4 hours a day on day or afternoon-evening shifts
- Provide direct care for at least 1 assisted living resident
- Agree to attend all training sessions and complete assessment forms
- Able to speak, read, and understand English at a 6th grade level
Key exclusion criteria (3 listed)
- Plan to receive medication for affective or behavioral problems during the study
- History of alcohol or drug abuse
- Have attempted suicide within 1 year prior to study entry
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 |
|---|---|---|
| Skills training for the care of dementia patients | Behavioural | – |
Primary outcome
Skills to effectively deal with resident behavioral problems
1 secondary outcome
Resident depression, anxiety, behavioral problems, and quality of life
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 2 Dec 2015.
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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.
Linda Teri, PhD principal investigator
University of Washington
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Skills training for the care of dementia patients in people with Dementia and Alzheimer Disease, run by University of Washington at 2 sites 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 9 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: finished, as of the sponsor's last update on 2 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Skills to effectively deal with resident behavioral problems. 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 Dec 2015.