Clinical trial NCT02614755: An Observational Study of Lumosity in Seniors
Official title: An Observational Study of Lumosity in Seniors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy Volunteers
Keywords: Older Adults Volunteers
Seniors
Brain Performance Test
Lead sponsor: Lumos Labs, Inc.
Sponsor class: INDUSTRY
First posted: 2015-11-25
Enrollment: 68
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants must be cognitively stable older adult volunteers(over 55 years of age)

Brief summary: The primary objective of this observational study is to determine performance characteristics and usability of Lumosity and the Brain Performance Test in a group of older adult volunteers.

Detailed description: Approximately 200 prospective users currently will be provided free 6-month premium access Lumosity accounts. Participants will be provided with an account activation code and instructed on how to sign up for Lumosity with their email address. They will be subject to the Lumosity Terms of Service and follow the typical user experience. Upon creating an account, users would be asked to complete a short demographic survey that includes questions on gender, education, occupation, years since retirement, health, computer familiarity, and perceptions of brain training.

Those who sign up will have immediate access to the Lumosity training system and the entire suite of Lumosity games. In addition, they will be invited, via email, to take the Brain Performance Test one week after the initial sign-up and then again 12 weeks later. Approximately every 8 weeks, users will be asked to complete a short questionnaire about their experience with Lumosity. This questionnaire will be accessed via email. Participants will be asked to train 5 days a week for 20-30 minutes per day, but are free to play as much or a little as they choose. Community associates at the sites will be encouraged to host group training sessions, giving the seniors a chance to gather and complete their training together, share their experiences, and get any help they may need. In addition, sites will have the option of hosting 1-2 focus groups with participants and researchers from Lumos Labs. The focus groups will be an opportunity to give and receive direct feedback about Lumosity, and get any questions answered by the researchers.

Eligibility criteria: Inclusion Criteria:

Participants must meet the following criteria:

1. 55 years of age or older
2. English-speaker
3. Cognitively stable (i.e., without a known diagnosis that may affect cognitive abilities)
4. Regular access to and ability to use a computer or mobile device with Internet connectivity.

Exclusion Criteria:

1. Under 55 years of age
2. Have a current diagnosed cognitive or neuropsychological condition
3. Are taking medication that may impede cognitive functioning
4. Anticipate a dosage change in medication that may affect cognitive functioning during the course of the study (24 weeks)
5. Have other conditions or problems that may preclude regular computer usage

Primary outcomes:
measure: Usability - as measured by self-report feedback surveys
timeFrame: Change from Baseline - collected at baseline, 3 months and 6 months
Secondary outcomes:
measure: User Engagement - as measured by number of unique days played
timeFrame: 6 months
measure: Change from baseline on the Lumosity Performance Index (LPI)
timeFrame: Change from Baseline - collected at baseline and 6 months
measure: Change from baseline on the Brain Performance Test (BPT)
timeFrame: Change from Baseline - collected at baseline, 3 months and 6 months
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Lumos Labs, Inc.
state: California
Study officials:
affiliation: Lumos Labs
name: Glenn Morrison, PhD
role: PRINCIPAL_INVESTIGATOR
References: