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Completed

NCT Number: NCT01550718

Two Interventions for Early Stage Dementia: A Comparative Efficacy Trial

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.

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Key information

Conditions

Dementia Alzheimer Disease Brain Diseases Central Nervous System Diseases Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UWashington

Seattle, Washington, 98195, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ESML-EX (Physical Activity Program)

Behavioral

ESML-EX consists of four weekly 90-minute classes. Each class includes exercises and a brief discussion of a specific health topic.

ESML-Social (Social Activity Program)

Behavioral

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Registry information

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Mar 12, 2012
Registry last updated
Jun 10, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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