An Observational Study of Lumosity in Seniors

Healthy Volunteers Clinical Trial

Official title:

An Observational Study of Lumosity in Seniors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02614755
• Other study ID #: LL004
• Status: Completed
• Phase: N/A
• First received: November 18, 2015
• Last updated: May 23, 2017
• Start date: November 2015
• Est. completion date: May 23, 2017

Study information

• Verified date: May 2017
• Source: Lumos Labs, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: May 23, 2017
• Est. primary completion date: May 23, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 55 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Healthy Volunteers

Locations

Country	Name	City	State
United States	Lumos Labs, Inc.	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
Lumos Labs, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Usability - as measured by self-report feedback surveys	Using self-report surveys administered to participants at baseline, 3 months and 6 months, investigators will calculate a usability score of Lumosity.	Change from Baseline - collected at baseline, 3 months and 6 months
Secondary	User Engagement - as measured by number of unique days played	Calculating the number of unique days played will allow us to estimate the engagement level of study participants.	6 months
Secondary	Change from baseline on the Lumosity Performance Index (LPI)	To evaluate the Lumosity Performance Index (LPI) results in a group of seniors	Change from Baseline - collected at baseline and 6 months
Secondary	Change from baseline on the Brain Performance Test (BPT)	To evaluate the Brain Performance Test (BPT) results in a group of seniors	Change from Baseline - collected at baseline, 3 months and 6 months