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Mental AcuityPhase 2/3NCT01126021

Using Technology to Promote Mental Acuity

A Phase 2/3 study testing Financial incentives and No incentives in people with Mental Acuity, run by University of Pennsylvania at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The study plans to test the effectiveness of behavioral economics based incentives to promote the daily use of computer programs designed to improve memory and mental acuity. Subjects will be recruited from the Pittsburgh metropolitan area. Read more about this study

Who is it for?
Ages 55 to 80 years
Conditions the study is for
Mental Acuity
What is being tested?
Financial incentives and No incentives
Could I receive a placebo?
No, everyone receives an active treatment
How many people
600 participants
Where
2 sitesUnited States
Study dates
May 2010to Mar 2012
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 55 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 55-80 years old

Who cannot join

  • Unable to read or understand the informed consent form

Trial locations and contacts

2 sites in 1 country.

United States2 sites
  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Carnegie Mellon University

    Pittsburgh, Pennsylvania, 15213

Other trials in United States

About this study

The study plans to test the effectiveness of behavioral economics based incentives to promote the daily use of computer programs designed to improve memory and mental acuity. Subjects will be recruited from the Pittsburgh metropolitan area. The primary objective is to determine the impact of structured financial incentives on the number of computer-based cognitive exercises completed during a 3 month intervention period.

Conditions
Mental Acuity
Being tested
Financial incentives, No incentives
Keywords
Senior citizens, mental acuity, memory

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Financial incentivesBehavioural

    Participants are eligible for incentives if they participate in at least 30 games per day.

  • No incentivesBehavioural

    Participants will be given training and access to the software to participate in mental exercises but will not be given financial incentives for participation.

Study groups in NCT01126021
Study groupRoleWhat they receive
ControlActive comparatorGiven access to mental exercises but receives no rewards for use.
Receives: Behavioral: No incentives
AtomisticExperimentalEach individual is awarded for his or her individual participation
Receives: Behavioral: Financial incentives
AltruisticExperimentalParticipants are paired and rewarded according to the other individual's participation.
Receives: Behavioral: Financial incentives
Team-basedExperimentalTeams compete against each other and receive rewards according to relative participation.
Receives: Behavioral: Financial incentives

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of activities completed

    The number of memory and cognition enhancement activities played per day using the study provided software will be measured.

    Measured: 6 weeks

  2. Performance on activities completed

    Performance is measured by a scoring algorithm designed to estimate levels of memory, attention, cognitive control and processing speed.

    Measured: 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 May 2010 (estimated)
  2. Study startMay 2010
  3. Primary completionSep 2011
  4. Study completionMar 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
600 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01126021
Sponsor's protocol ID
HS09-634
Status last verified
Dec 2016
First submitted
17 May 2010
Last updated
2 Dec 2016
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Financial incentives and No incentives in people with Mental Acuity, run by University of Pennsylvania at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of activities completed (time frame: 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2016; AzTrials last refreshed its copy on 27 Oct 2026.

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