Two Interventions for Early Stage Dementia: A Comparative Efficacy Trial

NCT ID: NCT01550718

Last Updated: 2015-06-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 152 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-02-29
• Study Completion Date: 2015-02-28

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 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.

Conditions

Dementia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

ESML-EX (Physical Activity Program)

Intervention Type: 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)

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.

Group Type: ACTIVE_COMPARATOR

ESML-Social (Social Activity Program)

Intervention Type: 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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Washington

OTHER

Sponsor Role: lead

Responsible Party

Rebecca Logsdon

Research Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rebecca G Logsdon, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

UWashington

Seattle, Washington, United States

Countries

United States

Other Identifiers

41577-G

Identifier Type: -

Identifier Source: org_study_id