Compensation Training and Lifestyle Modifications to Promote Healthy Aging in Persons at Risk for Alzheimer's Disease: a Digital Application Supported Intervention (Brain Boosters 2)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Enrollment
- 263
- Locations
- 2
- Primary Endpoint
- Digit Span
Study Overview
Brief Summary
The purpose of this research is to determine if training in memory support aids and healthy lifestyle activities (physical exercise, mentally stimulating activities and stress management) can have a positive effect on memory, thinking, and activities that people do every day. Participation in this study will involve being placed into one of two groups: a Self-Guided Intervention Group or a Structured Intervention Group. Both groups will be asked to attend group sessions in which they will be provided education on memory support strategies and lifestyle changes. The Structured Intervention Group will also be provided with an iPad and a digital application (called EMMA) to track their activity. Study participation involves a 6-month intervention and completing outcome measures at 4 different time points for up to a year.
Detailed Description
Participants in this research will be asked to participate in group sessions about memory support strategies and healthy behaviors. They may also choose to have a partner participate in this study with them, but it is not required.
There will be weekly sessions for 10 weeks, followed by sessions 1 to 2 times per month for the next 4 months.
Participants will be asked to complete healthy lifestyle activities on their own. Before the intervention starts and at three time points after the intervention, we will collect cognitive assessments and questionnaires to measure the possible impact of the treatment. The post-intervention assessments will take place right after completion of the intervention, and then 6 and 12 months later.
Before the start of the study, participants will be required to get permission from their primary care provider to ensure that it is safe for them to complete physical aerobic exercise.
The Self-Guided and Structured Intervention Groups will be required to participate in the following study activities:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Outcomes Assessor)
Masking Description
The outcomes examiner will be blinded to participants' study arm assignment.
Eligibility Criteria
- Ages
- 65 Years to 90 Years (Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •The target population is cognitively normal older adults with Subjective Cognitive Concerns (SCC). SCC will be operationalized as
- •a positive complaint in response to the question: 'Have you experienced a decline in your memory or other aspect of thinking in the last 1-3 years that seems worse than others of your age'
- •normal cognition on the modified Telephone Interview of Cognitive Status (mTICS)
- •independent function in daily life.
- •Age 65 or older
- •English speaking
- •Lower level of engagement in healthy lifestyle behaviors and compensation use at study baseline (i.e., broadly defined as not a regular exerciser)
- •Approval from primary care (due to physical exercise component of the intervention)
- •Open to utilizing digital tools such as a digital calendar in daily life
Exclusion Criteria
- •Known diagnosis of dementia or cognitive impairment;
- •Other known neurological condition with potential to affect cognition (e.g., Parkinson's disease)
- •Reported history of severe psychiatric disorder (e.g., self-reported history of bipolar disorder or schizophrenia or other psychotic disorder)
- •Inability to complete the study protocols due to severe vision or hearing difficulties.
- •Has previously participated in a previous version of Brain Boosters, or another study utilizing the Digital Memory Notebook (DMN) application or EMMA.
Outcomes
Primary Outcomes
Digit Span
Time Frame: Change in assessment scores from baseline to 6-months, 12-months, and 18-months
A standardized assessment of attention and working memory by recalling short lists of numbers immediately in either forward or backwards order.
Everyday Function
Time Frame: Change in assessment scores from baseline to 6-months, 12-months, and 18-months
Evaluates participants everyday cognition through a variety of self-report questions about their daily functioning.
Verbal Fluency
Time Frame: Change in assessment scores from baseline to 6-months, 12-months, and 18-months
A standardized assessment of executive functioning by having participants list as many words they can that start with a specific letter.
Free and Cued Selective Reminding Test (FCRT)
Time Frame: Change in assessment scores from baseline to 6-months, 12-months, and 18-months
A standardized assessment of immediate and delayed memory by using cues or free recall
Digit Symbol
Time Frame: Change in assessment scores from baseline to 6-months, 12-months, and 18-months
A standardized assessment of executive functioning by having participants match symbols and letters.
Logical Memory
Time Frame: Change in assessment scores from baseline to 6-months, 12-months, and 18-months
A standardized assessment of narrative episodic memory.
Trail Making
Time Frame: Change in assessment scores from baseline to 6-months, 12-months, and 18-months
A standardized assessment of executive functioning by assessing following order but switching between letters and numbers.
Royal Prince Alfred Prospective Memory Test
Time Frame: Change in assessment scores from baseline to 6-months, 12-months, and 18-months
A standardized assessment of prospective memory by asking participants to remind the examiner of a task at different intervals throughout the session.
Secondary Outcomes
- Satisfaction with Life(Change in assessment scores from baseline to 6-months, 12-months, and 18-months)
- Coping Self efficacy (CSES)(Change in assessment scores from baseline to 6-months, 12-months, and 18-months)
- Purpose in Life(Change in assessment scores from baseline to 6-months, 12-months, and 18-months)
- Brief Resiliency Scale (BRS)(Change in assessment scores from baseline to 6-months, 12-months, and 18-months)
- Cooperative Study Activities of Daily Living (ADL) Prevention Instrument (ADCS-ADL-PI)(Change in assessment scores from baseline to 6-months, 12-months, and 18-months)
- Short Physical Performance Battery(Change in assessment scores from baseline to 6-months, 12-months, and 18-months)
- Mindfulness Inventory(Change in assessment scores from baseline to 6-months, 12-months, and 18-months)
- Perceived Stress Scale (PSS)(Change in assessment scores from baseline to 6-months, 12-months, and 18-months)
- Everyday Compensation (EComp)(Change in assessment scores from baseline to 6-months, 12-months, and 18-months)
- The Gratitude Questionnaire - Six Item Form(Change in assessment scores from baseline to 6-months, 12-months, and 18-months)
- Center for Epidemiologic Studies Depression Scale (CES-D)(Change in assessment scores from baseline to 6-months, 12-months, and 18-months)
- Patient Reported Outcomes Measurement Information System (PROMIS) General Health and Quality of Life Measure(Change in assessment scores from baseline to 6-months, 12-months, and 18-months)
- Positive Affect and Negative Affect Scale (PANAS)(Change in assessment scores from baseline to 6-months, 12-months, and 18-months)
- Community Healthy Activities Model Program for Seniors (CHAMPS)(Change in assessment scores from baseline to 6-months, 12-months, and 18-months)