Optimizing Care for Patients With Dementia

March 12, 2024 updated by: Natalie Leland, University of Pittsburgh

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
53

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • University of Pittsburgh

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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).

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: transdisciplinary approach
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
Other: transdisciplinary approach
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;
Active Comparator: multidisciplinary approach
The multidisciplinary approach that is problem-based and draws on the expertise of individual healthcare providers (e.g., occupational therapy) to address care concerns.
Other: multidisciplinary approach
This is a problem-based approach that draws on the expertise of individual healthcare providers (e.g., occupational therapy) to address care concerns.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
6-month period (months 1-6)
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.
12-month period (months 7-12)
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.
18-month period (months 13-18)
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.
6-month period (months 1-6)
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.
12-month period (months 7-12)
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.
18-month period (months 13-18)
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.
6-month period (months 1-6)
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.
12-month period (months 7-12)
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.
18-month period (months 13-18)
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.
6-month period (months 1-6)
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.
12-month period (months 7-12)
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.
18-month period (months 13-18)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Unintended Weight Loss
Time Frame: 6-month period (months 1-6)
Percentage of nursing home residents with dementia who had unintended weight loss over Months 1-6 of Intervention.
6-month period (months 1-6)
Unintended Weight Loss
Time Frame: 12-month period (months 7-12)
Percentage of nursing home residents with dementia who had unintended weight loss over Months 7-12 of Intervention.
12-month period (months 7-12)
Unintended Weight Loss
Time Frame: 18-month period (months 13-18)
Percentage of nursing home residents with dementia who had unintended weight loss over Months 13-18 of Intervention.
18-month period (months 13-18)
Falls
Time Frame: 6-month period (months 1-6)
Percent of nursing home residents with dementia who had falls over Months 1-6 of Intervention.
6-month period (months 1-6)
Falls
Time Frame: 12-month period (months 7-12)
Percent of nursing home residents with dementia who had falls over Months 7-12 of Intervention.
12-month period (months 7-12)
Falls
Time Frame: 18-month period (months 13-18)
Percent of nursing home residents with dementia who had falls over Months 13-18 of Intervention.
18-month period (months 13-18)
Depressive Symptoms
Time Frame: 6-month period (months 1-6)
Percent of nursing home residents with dementia who had depressive symptoms over Months 1-6 of Intervention
6-month period (months 1-6)
Depressive Symptoms
Time Frame: 12-month period (months 7-12)
Percent of nursing home residents with dementia who had depressive symptoms over Months 7-12 of Intervention.
12-month period (months 7-12)
Depressive Symptoms
Time Frame: 18-month period (months 13-18)
Percent of nursing home residents with dementia who had depressive symptoms over Months 13-18 of Intervention.
18-month period (months 13-18)
Physical Restraints Use
Time Frame: 6-month period (months 1-6)
Percent of nursing home residents with dementia who had physical restraint use over Months 1-6 of Intervention.
6-month period (months 1-6)
Physical Restraints Use
Time Frame: 12-month period (months 7-12)
Percent of nursing home residents with dementia who had physical restraint use over Months 7-12 of Intervention.
12-month period (months 7-12)
Physical Restraints Use
Time Frame: 18-month period (months 13-18)
Percent of nursing home residents with dementia who had physical restraint use over Months 13-18 of Intervention.
18-month period (months 13-18)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Pittsburgh

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Patient-Centered Outcomes Research Institute

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Natalie E Leland, PhD, University of Pittsburgh

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 15, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 26, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 26, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 31, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 15, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 22, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 19, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 12, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STUDY19090117

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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