BID WM Digital Intervention in Aging
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Coherence, Worder.
- Who it may be relevant to
- Registry conditions: Working Memory, Inhibitory Control, Mild Cognitive Impairment (MCI), Aging. Basic parameters: 60 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Behavioral Intervention Development Core - Working Memory Digital Intervention in Aging
Overview
The goal of this clinical trial is to learn if engaging with an digital intervention may improve cognitive function. The main questions it aims to answer are: 1. Does engagement in with a digital intervention improve working memory? 2. Does engagement in with a digital intervention improve inhibitory control? Researchers will compare two different digital interventions to assess whether they may be helpful in improving cognitive function. Participants will conduct study activities remotely (e.g., at-home): 1. Baseline Assessment. Complete a series of cognitive assessments and surveys. 2. Intervention. Engage in a digital intervention for up to 8 weeks. 3. Post Intervention Assessment. Complete the same cognitive assessments and surveys as the Baseline Assessment. 4. Follow-Up Assessment. Six months after the intervention ends, participants will complete the same cognitive assessments and surveys as the Baseline Assessment.
Detailed description
During the Baseline Assessment, participants will complete web-based cognitive assessments and surveys. The assessments will address various cognitive functions including working memory, long-term memory, inhibitory control, and sustained attention. Surveys will include a characterization of expectancy for the intervention, ratings of stress, and background health information. The Baseline Assessment will take up to 120 minutes and can be completed across more than one session.
During the Intervention, participants will be provided an iPad tablet to engage with the assigned intervention app. Participants will be randomly assigned to one of two intervention apps. Regardless of the assigned intervention, participants will engage with the app for 25-45 minutes of training per day, 5 days a week for up to 8 weeks for a total of 1000 minutes of training.
After the intervention, participants will complete a Post Intervention Assessment and 6 month later, a Follow-Up Assessment. Both of these assessment periods will consist of the same cognitive assessments and surveys as conducted during the Baseline Assessment.
Upon completion of all study activities, participants will be able to keep the iPad as a gift for their voluntary participation.
Interventions
- Behavioral Coherence
Coherence is a music-based rhythm training app. - Behavioral Worder
Worder is a word search app.
Primary outcome measures
- Working Memory [Time frame: Immediately before the intervention, Immediately after the intervention, 6 months after the intervention]
Secondary outcome measures (2)
- Inhibitory Control [Time frame: Immediately before the intervention, Immediately after the intervention, 6 months after the intervention]
- Inhibitory Control [Time frame: Immediately before the intervention, Immediately after the intervention, 6 months after the intervention]
Eligibility criteria
Inclusion criteria
- Minimum of 12 years of education
- English fluency
- Normal or corrected-to-normal vision
- Normal or corrected-to-normal vision
- Medically healthy older adults including those with below-average cognitive performance or mild cognitive impairment patients without dementia
Exclusion criteria
- Under the age of 60
- Clinical diagnosis of neurological or psychiatric disorder
- Visually or hearing impaired without correction to normal
- Clinical diagnosis of dementia or AD8 score of >3
- Regularly (one or more times per week) practicing an instrument within the last year
- 10 or more years of formal musical instrument training
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- University of California, San Francisco — San Francisco
Identifiers
NCT: NCT06918704 · 24-42925 · P30AG086635