Alzheimer DiseaseNCT03442322
Optimizing Care for Patients With Dementia
A study testing transdisciplinary approach and multidisciplinary approach in people with Alzheimer Disease, run by University of Pittsburgh at 1 site in United States.
Trial summary
Of the 1.4 million nursing home (NH) residents in long term care facilities, more than half have Alzheimer's disease or dementia. Due to changes in their familiar daily routines, difficulty expressing their thoughts or asking for what they need, and overstimulation (such as noise) or under stimulation (such as lack of… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- transdisciplinary approach and multidisciplinary approach
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Mar 2018to 26 Jul 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Eligible nursing home facilities will
- lack any existing dementia program targeting reduction of off-label psychotropic medication use
- each serve >60 long-term care residents with Alzheimer's or dementia
- meet Center for Medicare \& Medicaid Services' minimum requirements for NHs (e.g., meeting the mandated number of hours of staff training on dementia care, performing regularly scheduled resident assessments).
Who cannot join
- Facilities will be excluded if they have
- less than 60 long-stay residents
- an existing formal dementia care program in place
- an off-label psychotropic medication reduction program
- is located in a state that requires more than the Center for Medicare \& Medicaid Services' minimum for staff training requirements on the topic of dementia care
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
About this study
Official title: Optimizing Care for Patients With Dementia: A Comparison of Two Non-pharmacological Treatment Approaches
Of the 1.4 million nursing home (NH) residents in long term care facilities, more than half have Alzheimer's disease or dementia. Due to changes in their familiar daily routines, difficulty expressing their thoughts or asking for what they need, and overstimulation (such as noise) or under stimulation (such as lack of activity), individuals with dementia often display disruptive behaviors like resisting help or continually repeating the same phrases. Medications are often prescribed to reduce agitation and aggressive behavior; however, these medications may not be effective and can have a negative impact on the individual. Therefore, families and other stakeholders strongly advocate the use of other types of approaches that focus on minimizing the cause of the behavior. Two facility-based methodologies include the transdisciplinary approach for integrated dementia care, which combines the expertise of all NH staff, who work together to build a common language and approach for each resident, and the multidisciplinary approach for problem-based dementia care, in which each staff member conducts individual assessments and makes discipline-specific recommendations. While prior research suggests that both of these facility-based approaches are useful, the circumstances under which each approach is most effective are not clear. This project will prospectively randomize 80 nursing homes to one of the two treatment arms to compare the effect of the transdisciplinary approach versus the multidisciplinary approach.
This study will examine the difference between the two comparators with respect to facility rates of medications dispensed to residents with dementia, leading to enhanced quality of life for the resident.
This project is important because it will address a key clinical dilemma NH staff face as they strive to optimize the use of alternative approaches to reduce disruptive behaviors in residents with dementia. Transforming the quality of dementia care in NHs and enhancing the quality of life of residents with dementia are high priorities for families and other advocates.
- Conditions
- Alzheimer Disease
- Being tested
- transdisciplinary approach, multidisciplinary approach
- Keywords
- long term care residents, nursing home care
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transdisciplinary approachOther
This approach is integrated across disciplines and provides core training for all providers, staff members, and stakeholders, using a common language to address care concerns and support continuity and sustainability;
multidisciplinary approachOther
This is a problem-based approach that draws on the expertise of individual healthcare providers (e.g., occupational therapy) to address care concerns.
| Study group | Role | What they receive |
|---|---|---|
| transdisciplinary approach | Active comparator | The transdisciplinary approach that is integrated across disciplines and provides core training for all providers, staff members, and stakeholders, using a common language to address care concerns and support continuity and sustainability Receives: Other: transdisciplinary approach |
| multidisciplinary approach | Active comparator | The multidisciplinary approach that is problem-based and draws on the expertise of individual healthcare providers (e.g., occupational therapy) to address care concerns. Receives: Other: multidisciplinary approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dispensing of Psychotropic Medications
Percentage of nursing home residents with dementia who received one or more antipsychotic medication over Months 1-6 of Intervention.
Measured: 6-month period (months 1-6)
Dispensing of Psychotropic Medications
Percentage of nursing home residents with dementia who received one or more antipsychotic medication over Months 7-12 of Intervention.
Measured: 12-month period (months 7-12)
Dispensing of Psychotropic Medications
Percentage of nursing home residents with dementia who received one or more antipsychotic medication over Months 13-18 of Intervention.
Measured: 18-month period (months 13-18)
Behavioral Symptoms
Percentage of nursing home residents with dementia who had behavioral symptoms over Months 1-6 of Intervention.
Measured: 6-month period (months 1-6)
Behavioral Symptoms
Percentage of nursing home residents with dementia who had behavioral symptoms over Months 7-12 of Intervention.
Measured: 12-month period (months 7-12)
Behavioral Symptoms
Percentage of nursing home residents with dementia who had behavioral symptoms over Months 13-18 of Intervention.
Measured: 18-month period (months 13-18)
Wandering
Percentage of nursing home residents with dementia who had wandering over Months 1-6 of Intervention.
Measured: 6-month period (months 1-6)
Wandering
Percentage of nursing home residents with dementia who had wandering over Months 7-12 of Intervention.
Measured: 12-month period (months 7-12)
Wandering
Percentage of nursing home residents with dementia who had wandering over Months 13-18 of Intervention.
Measured: 18-month period (months 13-18)
Rejection of Care
Percentage of nursing home residents with dementia who had rejection of care over Months 1-6 of Intervention.
Measured: 6-month period (months 1-6)
Rejection of Care
Percentage of nursing home residents with dementia who had rejection of care over Months 7-12 of Intervention.
Measured: 12-month period (months 7-12)
Rejection of Care
Percentage of nursing home residents with dementia who had rejection of care over Months 13-18 of Intervention.
Measured: 18-month period (months 13-18)
Secondary outcomes (12)
Unintended Weight Loss
Percentage of nursing home residents with dementia who had unintended weight loss over Months 1-6 of Intervention.
Measured: 6-month period (months 1-6)
Unintended Weight Loss
Percentage of nursing home residents with dementia who had unintended weight loss over Months 7-12 of Intervention.
Measured: 12-month period (months 7-12)
Unintended Weight Loss
Percentage of nursing home residents with dementia who had unintended weight loss over Months 13-18 of Intervention.
Measured: 18-month period (months 13-18)
Falls
Percent of nursing home residents with dementia who had falls over Months 1-6 of Intervention.
Measured: 6-month period (months 1-6)
Falls
Percent of nursing home residents with dementia who had falls over Months 7-12 of Intervention.
Measured: 12-month period (months 7-12)
Falls
Percent of nursing home residents with dementia who had falls over Months 13-18 of Intervention.
Measured: 18-month period (months 13-18)
Depressive Symptoms
Percent of nursing home residents with dementia who had depressive symptoms over Months 1-6 of Intervention
Measured: 6-month period (months 1-6)
Depressive Symptoms
Percent of nursing home residents with dementia who had depressive symptoms over Months 7-12 of Intervention.
Measured: 12-month period (months 7-12)
Depressive Symptoms
Percent of nursing home residents with dementia who had depressive symptoms over Months 13-18 of Intervention.
Measured: 18-month period (months 13-18)
Physical Restraints Use
Percent of nursing home residents with dementia who had physical restraint use over Months 1-6 of Intervention.
Measured: 6-month period (months 1-6)
Physical Restraints Use
Percent of nursing home residents with dementia who had physical restraint use over Months 7-12 of Intervention.
Measured: 12-month period (months 7-12)
Physical Restraints Use
Percent of nursing home residents with dementia who had physical restraint use over Months 13-18 of Intervention.
Measured: 18-month period (months 13-18)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2018
- Study start15 Mar 2018
- Primary completion26 Jul 2022
- Study completion26 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This cluster pragmatic trial randomized eligible nursing homes to one of the two intervention arms according to the predetermined protocol to evaluate the effect of the facility-level intervention on resident (i.e. long term care residents living with Alzheimer's Disease or Related Dementia) and staff outcomes.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Responsible party
- Principal investigator, Natalie Leland, University of Pittsburgh
- Investigators
- Natalie E Leland, PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03442322
- Sponsor's protocol ID
- STUDY19090117
- Status last verified
- Mar 2024
- First submitted
- 31 Jan 2018
- Last updated
- 19 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Piersol CV, Martinez J, Chew F, Perry B, Leland NE. Understanding the Experiences of Family Caregivers of Nursing Home Residents With Dementia: A Grounded Theory Study. Gerontologist. 2024 Apr 1;64(4):gnad102. doi: 10.1093/geront/gnad102.
PubMed 37501632
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Care for Patients With Dementia: A Comparison of Two Non-pharmacological Treatment Approaches
- ClinicalTrials.gov ID
- NCT03442322
- Acronym / sponsor ID
- STUDY19090117
- Conditions
- Alzheimer Disease
- Keywords
- long term care residents, nursing home care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Study start
- 15 Mar 2018 (actual)
- Primary completion
- 26 Jul 2022 (actual)
- Study completion
- 26 Jul 2022 (actual)
- First posted
- 22 Feb 2018 (actual)
- Results
- Posted 19 Aug 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Of the 1.4 million nursing home (NH) residents in long term care facilities, more than half have Alzheimer's disease or dementia. Due to changes in their familiar daily routines, difficulty expressing their thoughts or asking for what they need, and overstimulation (such as noise) or under stimulation (such as lack of activity), individuals with dementia often display disruptive behaviors like resisting help or continually repeating the same phrases. Medications are often prescribed to reduce agitation and aggressive behavior; however, these medications may not be effective and can have a negative impact on the individual. Therefore, families and other stakeholders strongly advocate the use of other types of approaches that focus on minimizing the cause of the behavior. Two facility-based methodologies include the transdisciplinary approach for integrated dementia care, which combines the expertise of all NH staff, who work together to build a common language and approach for each resident, and the multidisciplinary approach for problem-based dementia care, in which each staff member conducts individual assessments and makes discipline-specific recommendations. While prior research suggests that both of these facility-based approaches are useful, the circumstances under which each approach is most effective are not clear. This project will prospectively randomize 80 nursing homes to one of the two treatment arms to compare the effect of the transdisciplinary approach versus the multidisciplinary approach.
This study will examine the difference between the two comparators with respect to facility rates of medications dispensed to residents with dementia, leading to enhanced quality of life for the resident.
This project is important because it will address a key clinical dilemma NH staff face as they strive to optimize the use of alternative approaches to reduce disruptive behaviors in residents with dementia. Transforming the quality of dementia care in NHs and enhancing the quality of life of residents with dementia are high priorities for families and other advocates.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This cluster pragmatic trial randomized eligible nursing homes to one of the two intervention arms according to the predetermined protocol to evaluate the effect of the facility-level intervention on resident (i.e. long term care residents living with Alzheimer's Disease or Related Dementia) and staff outcomes.
| Arm | Type | Receives |
|---|---|---|
| transdisciplinary approach | Active comparator | Other: transdisciplinary approachThe transdisciplinary approach that is integrated across disciplines and provides core training for all providers, staff members, and stakeholders, using a common language to address care concerns and support continuity and sustainability |
| multidisciplinary approach | Active comparator | Other: multidisciplinary approachThe multidisciplinary approach that is problem-based and draws on the expertise of individual healthcare providers (e.g., occupational therapy) to address care concerns. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Eligible nursing home facilities will
- lack any existing dementia program targeting reduction of off-label psychotropic medication use
- each serve >60 long-term care residents with Alzheimer's or dementia
- meet Center for Medicare \& Medicaid Services' minimum requirements for NHs (e.g., meeting the mandated number of hours of staff training on dementia care, performing regularly scheduled resident assessments).
Key exclusion criteria (5 listed)
- Facilities will be excluded if they have
- less than 60 long-stay residents
- an existing formal dementia care program in place
- an off-label psychotropic medication reduction program
- is located in a state that requires more than the Center for Medicare \& Medicaid Services' minimum for staff training requirements on the topic of dementia care
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 |
|---|---|---|
| transdisciplinary approachThis approach is integrated across disciplines and provides core training for all providers, staff members, and stakeholders, using a common language to address care concerns and support continuity and sustainability; | Other | transdisciplinary approach |
| multidisciplinary approachThis is a problem-based approach that draws on the expertise of individual healthcare providers (e.g., occupational therapy) to address care concerns. | Other | multidisciplinary approach |
Primary outcome
Dispensing of Psychotropic Medications
Time frame: 6-month period (months 1-6)
Percentage of nursing home residents with dementia who received one or more antipsychotic medication over Months 1-6 of Intervention.
Dispensing of Psychotropic Medications
Time frame: 12-month period (months 7-12)
Percentage of nursing home residents with dementia who received one or more antipsychotic medication over Months 7-12 of Intervention.
Dispensing of Psychotropic Medications
Time frame: 18-month period (months 13-18)
Percentage of nursing home residents with dementia who received one or more antipsychotic medication over Months 13-18 of Intervention.
Behavioral Symptoms
Time frame: 6-month period (months 1-6)
Percentage of nursing home residents with dementia who had behavioral symptoms over Months 1-6 of Intervention.
Behavioral Symptoms
Time frame: 12-month period (months 7-12)
Percentage of nursing home residents with dementia who had behavioral symptoms over Months 7-12 of Intervention.
Behavioral Symptoms
Time frame: 18-month period (months 13-18)
Percentage of nursing home residents with dementia who had behavioral symptoms over Months 13-18 of Intervention.
Wandering
Time frame: 6-month period (months 1-6)
Percentage of nursing home residents with dementia who had wandering over Months 1-6 of Intervention.
Wandering
Time frame: 12-month period (months 7-12)
Percentage of nursing home residents with dementia who had wandering over Months 7-12 of Intervention.
Wandering
Time frame: 18-month period (months 13-18)
Percentage of nursing home residents with dementia who had wandering over Months 13-18 of Intervention.
Rejection of Care
Time frame: 6-month period (months 1-6)
Percentage of nursing home residents with dementia who had rejection of care over Months 1-6 of Intervention.
Rejection of Care
Time frame: 12-month period (months 7-12)
Percentage of nursing home residents with dementia who had rejection of care over Months 7-12 of Intervention.
Rejection of Care
Time frame: 18-month period (months 13-18)
Percentage of nursing home residents with dementia who had rejection of care over Months 13-18 of Intervention.
12 secondary outcomes
Unintended Weight Loss
Time frame: 6-month period (months 1-6)
Unintended Weight Loss
Time frame: 12-month period (months 7-12)
Unintended Weight Loss
Time frame: 18-month period (months 13-18)
Falls
Time frame: 6-month period (months 1-6)
Falls
Time frame: 12-month period (months 7-12)
Falls
Time frame: 18-month period (months 13-18)
Depressive Symptoms
Time frame: 6-month period (months 1-6)
Depressive Symptoms
Time frame: 12-month period (months 7-12)
Depressive Symptoms
Time frame: 18-month period (months 13-18)
Physical Restraints Use
Time frame: 6-month period (months 1-6)
Physical Restraints Use
Time frame: 12-month period (months 7-12)
Physical Restraints Use
Time frame: 18-month period (months 13-18)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37501632Piersol CV, Martinez J, Chew F, Perry B, Leland NE. Understanding the Experiences of Family Caregivers of Nursing Home Residents With Dementia: A Grounded Theory Study. Gerontologist. 2024 Apr 1;64(4):gnad102. doi: 10.1093/geront/gnad102.
- Individual participant dataSharing planned: No
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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.
Natalie E Leland, PhD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transdisciplinary approach and multidisciplinary approach in people with Alzheimer Disease, run by University of Pittsburgh 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 4 inclusion and 5 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 19 Aug 2024. 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?
Yes. Results are posted in the registry (first posted 19 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Dispensing of Psychotropic Medications (time frame: 6-month period (months 1-6)). The study lists 12 primary outcomes in all. 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 NCT03442322, which also lists 1 linked publication.
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 19 Aug 2024.