Two Interventions for Early Stage Dementia: A Comparative Efficacy Trial

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by University of Washington
Sponsor:
Information provided by (Responsible Party):
Rebecca Logsdon, University of Washington
ClinicalTrials.gov Identifier:
NCT01550718
First received: March 5, 2012
Last updated: May 29, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention
Dementia
Behavioral: ESML-EX (Physical Activity Program)
Behavioral: ESML-Social (Social Activity Program)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Two Interventions for Early Stage Dementia: A Comparative Efficacy Trial

Resource links provided by NLM:


Further study details as provided by University of Washington:

Primary Outcome Measures:
  • Change from Baseline in Social Activity at post-treatment (1 month) [ Time Frame: Baseline and post treatment (1 month) ] [ Designated as safety issue: No ]
    The Pleasant Events Schedule-AD, long version, will be used to evaluate social participation and activity.

  • Change from Baseline in Physical Activity at post-treatment (1 month) [ Time Frame: Baseline and post-treatment (1 month) ] [ Designated as safety issue: No ]
    The Physical Activity Scale for the Elderly (PASE) will be used to assess level of physical activity of participants and care partners.

  • Change from Baseline in Quality of Life at post-treatment (1 month) [ Time Frame: Baseline and post treatment (1 month) ] [ Designated as safety issue: No ]
    The Quality of Life-AD (QOL-AD)scale will measure quality of life domains identified as important for cognitively impaired older adults.

  • Change from Baseline in Social Activity at 4 month follow-up [ Time Frame: Baseline and 4 month follow-up ] [ Designated as safety issue: No ]
    The Pleasant Events Schedule-AD, long version, will be used to evaluate social participation and activity.

  • Change from Baseline in Physical Activity at 4 month follow-up [ Time Frame: Baseline and 4 month follow-up ] [ Designated as safety issue: No ]
    The Physical Activity Scale for the Elderly (PASE) will be used to assess level of physical activity of participants and care partners.

  • Change from Baseline in Quality of Life at 4 month follow-up [ Time Frame: Baseline and 4 month follow-up ] [ Designated as safety issue: No ]
    The Quality of Life-AD (QOL-AD)scale will measure quality of life domains identified as important for cognitively impaired older adults.


Secondary Outcome Measures:
  • Change from Baseline in Communication at post-treatment (1 month) [ Time Frame: Baseline and post treatment (1 month) ] [ Designated as safety issue: No ]
    The Communication, Affective Expression, and Involvement subscales of the Family Assessment Measure will measure the quality of caregiver-patient communication.

  • Change from Baseline in Physical Function at post-treatment (1 month) [ Time Frame: Baseline and post treatment (1 month) ] [ Designated as safety issue: No ]
    The Physical Functioning Scale rates the performance of everyday tasks such as walking around the residence and getting in and out of bed.

  • Change from Baseline in Mood at post-treatment (1 month) [ Time Frame: Baseline and post-treatment (1 month) ] [ Designated as safety issue: No ]
    The Geriatric Depression Scale will assess the mood of the participant and their caregiver.

  • Change from Baseline in Communication at post-treatment (1 month) [ Time Frame: Baseline and post-treatment (1 month) ] [ Designated as safety issue: No ]
    The Communication, Affective Expression, and Involvement subscales of the Family Assessment Measure will measure the quality of caregiver-patient communication.

  • Change from Baseline in Physical Functioning at post-treatment (1 month) [ Time Frame: Baseline and post-treatment (1 month) ] [ Designated as safety issue: No ]
    The Physical Functioning Scale rates the performance of everyday tasks such as walking around the residence and getting in and out of bed.

  • Change from Baseline in Mood at 4 month follow-up. [ Time Frame: Baseline and 4 month follow-up ] [ Designated as safety issue: No ]
    The Geriatric Depression Scale will assess the mood of the participant and their caregiver.


Estimated Enrollment: 240
Study Start Date: February 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01550718

Contacts
Contact: Amy Moore, M.S. 206-616-5550 amoore@u.washington.edu

Locations
United States, Washington
UWashington Recruiting
Seattle, Washington, United States, 98195
Sponsors and Collaborators
University of Washington
Investigators
Principal Investigator: Rebecca G Logsdon, Ph.D. University of Washington
  More Information

No publications provided

Responsible Party: Rebecca Logsdon, Research Professor, University of Washington
ClinicalTrials.gov Identifier: NCT01550718     History of Changes
Other Study ID Numbers: 41577-G
Study First Received: March 5, 2012
Last Updated: May 29, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Washington:
Aerobic Exercise
Alzheimer's Disease
Burden and Stress
Caregiving Issues
Quality of Life
Early Stage Memory Loss

Additional relevant MeSH terms:
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 18, 2014