DementiaNCT01550718
Two Interventions for Early Stage Dementia: A Comparative Efficacy Trial
A study testing ESML-EX (Physical Activity Program) and ESML-Social (Social Activity Program) in people with Dementia, run by University of Washington at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dementia
- What is being tested?
- ESML-EX (Physical Activity Program) and ESML-Social (Social Activity Program)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 152 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2012to Feb 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- ESML-EX (Physical Activity Program), ESML-Social (Social Activity Program)
- Keywords
- Aerobic Exercise, Alzheimer's Disease, Burden and Stress, Caregiving Issues, Quality of Life, Early Stage Memory Loss
- Medical subject headings
- Dementia, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ESML-EX (Physical Activity Program)Behavioural
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)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| ESML-Exercise (Physical Activity Program) | Active comparator | 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. Receives: Behavioral: ESML-EX (Physical Activity Program) |
| ESML-SOCIAL (Social Activity Program) | Active comparator | 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. Receives: Behavioral: ESML-Social (Social Activity Program) |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and 4 month follow-up
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and 4 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2012 (estimated)
- Study startFeb 2012
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DementiaStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 152 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rebecca Logsdon, University of Washington
- Investigators
- Rebecca G Logsdon, Ph.D., Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01550718
- Sponsor's protocol ID
- 41577-G
- Status last verified
- Jun 2015
- First submitted
- 5 Mar 2012
- Last updated
- 10 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Two Interventions for Early Stage Dementia: A Comparative Efficacy Trial
- ClinicalTrials.gov ID
- NCT01550718
- Acronym / sponsor ID
- 41577-G
- Conditions
- Dementia
- Keywords
- Aerobic Exercise, Alzheimer's Disease, Burden and Stress, Caregiving Issues, Quality of Life, Early Stage Memory Loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 152 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 12 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ESML-Exercise (Physical Activity Program) | Active comparator | Behavioral: ESML-EX (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. |
| ESML-SOCIAL (Social Activity Program) | Active comparator | 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. 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | ESML-Exercise (Physical Activity Program) |
| 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. | Behavioural | ESML-SOCIAL (Social Activity Program) |
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 (QOL-AD)scale will measure quality of life domains identified as important for cognitively impaired older adults.
6 secondary outcomes
Change from Baseline in Communication at post-treatment (1 month)
Time frame: Baseline and post treatment (1 month)
Change from Baseline in Physical Function at post-treatment (1 month)
Time frame: Baseline and post treatment (1 month)
Change from Baseline in Mood at post-treatment (1 month)
Time frame: Baseline and post-treatment (1 month)
Change from Baseline in Communication at post-treatment (1 month)
Time frame: Baseline and post-treatment (1 month)
Change from Baseline in Physical Functioning at post-treatment (1 month)
Time frame: Baseline and post-treatment (1 month)
Change from Baseline in Mood at 4 month follow-up.
Time frame: Baseline and 4 month follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2015.
Related trials for Dementia
RecruitingObservational study
Investigating Complex Neurodegenerative Disorders Related to Amyotrophic Lateral Sclerosis and Frontotemporal Dementia
Frontotemporal Dementia, Amyotrophic Lateral Sclerosis
RecruitingPhase 1
A First-In-Human Study of LY3954068 in Participants With Early Symptomatic Alzheimer's Disease
Alzheimer Disease
RecruitingPhase 2/3
Study to Evaluate the Pharmacodynamics, Safety and Efficacy of SKY-0515 in Participants With Huntington's Disease
Huntington Disease
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
RecruitingObservational study
Amyloid PET Imaging in the Baltimore Longitudinal Study of Aging
Aging
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rebecca G Logsdon, Ph.D. principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ESML-EX (Physical Activity Program) and ESML-Social (Social Activity Program) in people with Dementia, run by University of Washington at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Social Activity at post-treatment (1 month) (time frame: Baseline and post treatment (1 month)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2015.