Clinical trial NCT05027789: Brain Boosters 2 in Persons at Risk for Alzheimer's Disease: a Digital Application Supported Intervention
Official title: 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)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Memory Disorders
Cognitive Impairment
Lead sponsor: University of California, Davis
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2021-08-30
Enrollment: 263
Sex: ALL
Minimum age (years): 65
Maximum age (years): 90
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This project will utilize a randomized controlled trial (RCT) design with single blinding (outcomes examiner) comparing the structured intervention (combined structured training in compensation and lifestyle modification, assisted by the EMMA) to the self-guided intervention group, which focuses on providing education and allowing participants to choose how to implement the information was chosen to account for the impact of two general factors: 1) the provision of information, and 2) the social support and stimulation provided by attending a group-based intervention.
Primary purpose: PREVENTION

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:

Intervention Training Sessions:

Participants will be asked to attend 15 information sessions that include:

1. training on ways to help support memory like remembering appointments or taking medication and
2. training on increasing interest in three health behaviors known to reduce risk of memory declines (physical exercise, mental stimulation, stress management).

These sessions will be in a group of up to 15 people and will last about 2 hours each. For 10 weeks, there will be sessions every week, and then for the next 4 months there will be 1-2 session each month.

There are two different versions of the intervention we are evaluating. Participants will be randomly assigned into one of the two groups. Both groups provide similar information about memory support strategies and lifestyle modifications to promote cognitive health.

Self-Guided Group

Participants in the self-guided group will:

* Receive education on memory support strategies and healthy lifestyles.
* Decide how they want to implement this information into their daily life.
* Receive information on various commercially available digital and other tools that might help them implement healthy changes in their life.
* The chance that participants will be in this group is random, like flipping a coin. One in every three participants will be enrolled in this group.

Structured Group

Participants in this group will:

* Receive specific recommended behavior targets (e.g., like how much exercise they should engage in each week).
* Receive an iPad to use throughout the study and follow up period with the digital application installed.
* Be asked to use the digital application to record their activity and to get reminders to complete this information.

Two in every three participants will receive the iPad and digital application.

Participants in this group will receive training on how to use the digital application.

Participants with their own iPad and/or smartphone can install the digital application on their personal iPad or smartphone if they prefer.

Both the Self-Guided and Structured groups will complete the following assessments:

Physical Assessment:

Cardiovascular health - This questionnaire will ask about age, sex, education, blood pressure, total cholesterol level, body-mass index and complete a short test of physical activity.

Cholesterol Test:

A blood test at the University of California Davis Pathology laboratory will be performed for any participant who has not had this test in the past year. Participants must fast overnight and have nothing but water for 12 hours before the blood test. Approximately 4 milliliters (or about 1 teaspoon) of blood will be drawn for this test.

Memory and Behavior Questionnaires:

Tests of memory and thinking and questionnaires about health and behaviors will be completed at the beginning of the study and three additional times (every 6 months). Study partners will also be asked to complete some questionnaires about the participant.

Participants who are randomized to the Structured Intervention Group will also be asked to complete these additional assessments:

* Week-Long Assessment:

  o Structured Intervention Group participants will be asked to complete daily assessments for one week at four different times during participation. This will include questions about the experience with EMMA and some short memory and thinking assessments.
* Digital application (EMMA) Experiences Interview:

  * A subset of participants in the Structured Intervention Group will be asked to complete an interview about their experience with using EMMA. This interview will occur over the telephone or video conferencing (such as Zoom) and will be recorded for scoring and quality assurances. The researchers will keep these recordings until the study is complete (about 5 years). This is completely voluntary, and participants can choose not to complete the interview.

Eligibility criteria: Inclusion Criteria:

* The target population is cognitively normal older adults with Subjective Cognitive Concerns (SCC). SCC will be operationalized as

  1. 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'
  2. normal cognition on the modified Telephone Interview of Cognitive Status (mTICS)
  3. 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.

Primary outcomes:
measure: Logical Memory
timeFrame: Change in assessment scores from baseline to 6-months, 12-months, and 18-months
measure: Free and Cued Selective Reminding Test (FCRT)
timeFrame: Change in assessment scores from baseline to 6-months, 12-months, and 18-months
measure: Digit Span
timeFrame: Change in assessment scores from baseline to 6-months, 12-months, and 18-months
measure: Trail Making
timeFrame: Change in assessment scores from baseline to 6-months, 12-months, and 18-months
measure: Digit Symbol
timeFrame: Change in assessment scores from baseline to 6-months, 12-months, and 18-months
measure: Verbal Fluency
timeFrame: Change in assessment scores from baseline to 6-months, 12-months, and 18-months
measure: Royal Prince Alfred Prospective Memory Test
timeFrame: Change in assessment scores from baseline to 6-months, 12-months, and 18-months
measure: Everyday Function
timeFrame: Change in assessment scores from baseline to 6-months, 12-months, and 18-months
Secondary outcomes:
measure: Coping Self efficacy (CSES)
timeFrame: Change in assessment scores from baseline to 6-months, 12-months, and 18-months
measure: Center for Epidemiologic Studies Depression Scale (CES-D)
timeFrame: Change in assessment scores from baseline to 6-months, 12-months, and 18-months
measure: Perceived Stress Scale (PSS)
timeFrame: Change in assessment scores from baseline to 6-months, 12-months, and 18-months
measure: Satisfaction with Life
timeFrame: Change in assessment scores from baseline to 6-months, 12-months, and 18-months
measure: Purpose in Life
timeFrame: Change in assessment scores from baseline to 6-months, 12-months, and 18-months
measure: Short Physical Performance Battery
timeFrame: Change in assessment scores from baseline to 6-months, 12-months, and 18-months
measure: Brief Resiliency Scale (BRS)
timeFrame: Change in assessment scores from baseline to 6-months, 12-months, and 18-months
measure: Patient Reported Outcomes Measurement Information System (PROMIS) General Health and Quality of Life Measure
timeFrame: Change in assessment scores from baseline to 6-months, 12-months, and 18-months
measure: Cooperative Study Activities of Daily Living (ADL) Prevention Instrument (ADCS-ADL-PI)
timeFrame: Change in assessment scores from baseline to 6-months, 12-months, and 18-months
measure: Everyday Compensation (EComp)
timeFrame: Change in assessment scores from baseline to 6-months, 12-months, and 18-months
measure: Community Healthy Activities Model Program for Seniors (CHAMPS)
timeFrame: Change in assessment scores from baseline to 6-months, 12-months, and 18-months
measure: Positive Affect and Negative Affect Scale (PANAS)
timeFrame: Change in assessment scores from baseline to 6-months, 12-months, and 18-months
measure: The Gratitude Questionnaire - Six Item Form
timeFrame: Change in assessment scores from baseline to 6-months, 12-months, and 18-months
measure: Mindfulness Inventory
timeFrame: Change in assessment scores from baseline to 6-months, 12-months, and 18-months
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: University of California, Davis Alzheimer's Disease Center
state: California
Study officials:
affiliation: University of California, Davis
name: Sarah Farias, PhD
role: PRINCIPAL_INVESTIGATOR
References: