Clinical Trial: Two Interventions for Early Stage Dementia: A Comparative Efficacy Trial

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Two Interventions for Early Stage Dementia: A Comparative Efficacy Trial

Brief Summary: 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 improv

Detailed Summary:
Sponsor: University of Washington

Current Primary Outcome:

  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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 (Q

    Original Primary Outcome: Same as current

    Current Secondary Outcome:

    • 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.
    • 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.
    • 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.
    • 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.
    • 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.
    • 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.


    Original Secondary Outcome: Same as current

    Information By: University of Washington

    Dates:
    Date Received: March 5, 2012
    Date Started: February 2012
    Date Completion:
    Last Updated: June 8, 2015
    Last Verified: June 2015