Two Interventions for Early Stage Dementia: A Comparative Efficacy Trial

June 8, 2015 updated by: Rebecca Logsdon, University of Washington
Alzheimer's disease (AD) is increasing exponentially, with a projected quadrupling of cases by the mid 21st century. Individuals with AD are at increased risk for a host of medical and psychiatric conditions, and evidence is accumulating supporting the efficacy and effectiveness of psychosocial interventions for improving their mood, function, health, and quality of life. Such interventions are likely to be most effective when they are implemented during the early stages of dementia, when individuals and their family members are coping with the initial diagnosis and associated changes in abilities and activities. Recent randomized clinical trials by the Principal Investigator and colleagues have developed two non-pharmacologic interventions to reduce the social, psychological, physical, and behavioral impact of dementia. This investigation is focused on facilitating their translation into ongoing community-based programs, such as those provided by Alzheimer's Association chapters, senior centers, retirement homes, and other health care providers. The core content of each intervention has been retained in order to maintain or improve their efficacy, and each has been modified to a 4-week group format to increase efficiency of delivery. These modified interventions (ESML-Social and ESML-Ex) will be compared to each other and to a usual care (UC) control group. Outcomes will be assessed at baseline, 1-month post treatment, and 4 month follow-up. Primary outcomes at the 1-month assessment include: social activity participation, family communication, physical activity participation, and physical function. Primary outcomes at 4-month follow up include overall quality of life and depression. It is hypothesized that ESML-Ex and ESML-Social both will have greater improvements than UC. It is hypothesized that ESML-Social will have greater improvements in social participation and family communication than ESML-Ex and UC. It is hypothesized that ESML-Ex will have greater improvements in physical activity participation and physical functioning than ESML-Social and UC. If successful, these 4-week programs may be developed into "modules" that can be incorporated into programming for individuals with early stage dementia in a variety of community settings.

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.
152

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
    • Washington
      • Seattle, Washington, United States, 98195
        • UWashington

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Dementia diagnosis
  • Clinical Dementia Rating Scale score
  • Care Partner agrees to participate with care recipient
  • Care recipient lives in the community or a retirement home
  • Both care partner and recipient speak English

Exclusion Criteria:

  • Significant physical or psychiatric illness in either care partner or care recipient that would prevent participant in a exercise program
  • Planning to move out of study area during the 4 month follow-up period

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

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: ESML-Exercise (Physical Activity Program)
ESML-Exercise consists of four weekly 90-minute classes. Each class includes exercises and a brief discussion of a specific health topic. Classes are carried out in small groups of five to six participant/care partner dyads (10-12 people total), to ensure everyone in the class gets individual attention and that all exercises are done safely using proper form.
Behavioral: ESML-EX (Physical Activity Program)
ESML-EX consists of four weekly 90-minute classes. Each class includes exercises and a brief discussion of a specific health topic.
Active Comparator: ESML-SOCIAL (Social Activity Program)
ESML-SOCIAL consists of four weekly 90-minute seminars. Each seminar includes discussion of a specific topic, open time for socializing, and a "homework" assignment to be completed prior to the next session. Seminars are carried out in small groups of five to six participant/care partner dyads (10-12 people total), to ensure everyone in the seminar gets individual attention and that everyone has a chance to bring up any concerns.
Behavioral: ESML-Social (Social Activity Program)
ESML-SOCIAL consists of four weekly 90-minute seminars. Each seminar includes discussion of a specific topic, open time for socializing, and a "homework" assignment to be completed prior to the next session.
No Intervention: No Intervention
This arm will receive no intervention during the active treatment period. After the 4 month assessment participants can choose to attend a support group.

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
Change from Baseline in Social Activity at post-treatment (1 month)
Time Frame: Baseline and post treatment (1 month)
The Pleasant Events Schedule-AD, long version, will be used to evaluate social participation and activity.
Baseline and post treatment (1 month)
Change from Baseline in Physical Activity at post-treatment (1 month)
Time Frame: Baseline and post-treatment (1 month)
The Physical Activity Scale for the Elderly (PASE) will be used to assess level of physical activity of participants and care partners.
Baseline and post-treatment (1 month)
Change from Baseline in Quality of Life at post-treatment (1 month)
Time Frame: Baseline and post treatment (1 month)
The Quality of Life-AD (QOL-AD)scale will measure quality of life domains identified as important for cognitively impaired older adults.
Baseline and post treatment (1 month)
Change from Baseline in Social Activity at 4 month follow-up
Time Frame: Baseline and 4 month follow-up
The Pleasant Events Schedule-AD, long version, will be used to evaluate social participation and activity.
Baseline and 4 month follow-up
Change from Baseline in Physical Activity at 4 month follow-up
Time Frame: Baseline and 4 month follow-up
The Physical Activity Scale for the Elderly (PASE) will be used to assess level of physical activity of participants and care partners.
Baseline and 4 month follow-up
Change from Baseline in Quality of Life at 4 month follow-up
Time Frame: Baseline and 4 month follow-up
The Quality of Life-AD (QOL-AD)scale will measure quality of life domains identified as important for cognitively impaired older adults.
Baseline and 4 month follow-up

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
Change from Baseline in Communication at post-treatment (1 month)
Time Frame: Baseline and post treatment (1 month)
The Communication, Affective Expression, and Involvement subscales of the Family Assessment Measure will measure the quality of caregiver-patient communication.
Baseline and post treatment (1 month)
Change from Baseline in Physical Function at post-treatment (1 month)
Time Frame: Baseline and post treatment (1 month)
The Physical Functioning Scale rates the performance of everyday tasks such as walking around the residence and getting in and out of bed.
Baseline and post treatment (1 month)
Change from Baseline in Mood at post-treatment (1 month)
Time Frame: Baseline and post-treatment (1 month)
The Geriatric Depression Scale will assess the mood of the participant and their caregiver.
Baseline and post-treatment (1 month)
Change from Baseline in Communication at post-treatment (1 month)
Time Frame: Baseline and post-treatment (1 month)
The Communication, Affective Expression, and Involvement subscales of the Family Assessment Measure will measure the quality of caregiver-patient communication.
Baseline and post-treatment (1 month)
Change from Baseline in Physical Functioning at post-treatment (1 month)
Time Frame: Baseline and post-treatment (1 month)
The Physical Functioning Scale rates the performance of everyday tasks such as walking around the residence and getting in and out of bed.
Baseline and post-treatment (1 month)
Change from Baseline in Mood at 4 month follow-up.
Time Frame: Baseline and 4 month follow-up
The Geriatric Depression Scale will assess the mood of the participant and their caregiver.
Baseline and 4 month follow-up

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 Washington

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: Rebecca G Logsdon, Ph.D., University of Washington

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

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.
February 1, 2012

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.
February 1, 2015

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.
February 1, 2015

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).
March 5, 2012

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.
March 7, 2012

First Posted (Estimate)

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.
March 12, 2012

Study Record Updates

Last Update Posted (Estimate)

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.
June 10, 2015

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.
June 8, 2015

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.
June 1, 2015

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.
  • 41577-G

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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