Two Interventions for Early Stage Dementia: A Comparative Efficacy Trial

Study Overview
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Brief Summary
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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.

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

Conditions
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Dementia

Intervention / Treatment
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* Behavioral: ESML-EX (Physical Activity Program)
* Behavioral: ESML-Social (Social Activity Program)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ESML-Exercise (Physical Activity Program)<br>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)<br>* ESML-EX consists of four weekly 90-minute classes. Each class includes exercises and a brief discussion of a specific health topic.<br>|
| Active Comparator: ESML-SOCIAL (Social Activity Program)<br>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)<br>* 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.<br>|
| No Intervention: No Intervention<br>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?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in Social Activity at 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) | 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) | 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 | 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 | 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 | 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in Communication at 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) | 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) | 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) | 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) | 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. | The Geriatric Depression Scale will assess the mood of the participant and their caregiver. | Baseline and 4 month follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Aerobic Exercise, Alzheimer's Disease, Burden and Stress, Caregiving Issues, Quality of Life, Early Stage Memory Loss