Cognitive FunctionNCT00805259
Promoting Mental Acuity in Elderly Populations Through Incentive for Technology Use
A study testing Financial incentives in people with Cognitive Function, run by Carnegie Mellon University at 1 site in United States.
Trial summary
In this between-subject randomized controlled trial the investigators will test the impact of three novel structured financial incentives: atomistic, altruistic and team-based. These incentive schemes will be used to motivate one month of daily use of software designed to improve cognitive function (including memory… Read more about this study
- Who is it for?
- Ages 55 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Function
- What is being tested?
- Financial incentives
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 312 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2010to May 2011
- Phase
- Interventional
- 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 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age between 55 and 85
- Resident in participating retirement community
Who cannot join
- Unstable medical conditions that would likely prevent the subject from completing the study
- Severe depression
- Inability to read or severe cognitive deficits that would preclude ability to read consent form or fill out surveys
Trial locations and contacts
1 site in 1 country.
United States1 site
Retirement communities near Pittsburgh Pennsylvania
Pittsburgh, Pennsylvania
About this study
In this between-subject randomized controlled trial the investigators will test the impact of three novel structured financial incentives: atomistic, altruistic and team-based. These incentive schemes will be used to motivate one month of daily use of software designed to improve cognitive function (including memory, reaction times, attention and executive function) among the elderly. The 400 participants will be members of retirement communities in Pennsylvania. Three outcomes will be monitored and analyzed: activities completed using the software (primary), performance on the activities, and changes in cognitive functioning. This study is designed to be a pilot study. The investigators will have 90% power to find a mean daily difference of 4 activities completed in the control group versus 7 activities completed in the incentive groups assuming a standard deviation of 3.5 and an alpha of 0.017 (the bonferroni corrected significance level to account for multiple comparisons). In addition during a three month "follow-up period" all participants will have continued access to the software, however, no incentives will be provided for use. This period will be used to assess the impact of the initial incentives on long run use after financial incentives have ceased.
Read the detailed description
The proposed study, a 4-arm randomized control trial, tests three novel incentive systems intended to promote the daily use of computer programs designed to improve memory and mental acuity among residents of retirement communities. Three outcome measures will be used to assess the effectiveness of the incentive programs: number of activities completed using the software (primary outcome of interest), performance on the activities, and differences between pre and post measures of mental acuity (using a standardized test of mental functions). Incentives to use the software will be offered to individuals in the experimental conditions for the first month of the 4 month study. After the initial month of incentives, all individuals will have continued access to the software, however, no incentives will be provided for use.
Incentives: Three incentive structures will be tested against one control group:
- Control: Access to software programs, but no rewards for use.
- Atomistic: Each individual is rewarded for his or her individual participation
- Altruistic: Participants will be paired with an individual at a different retirement community and will be rewarded according to the other individual's participation
- Combination cooperative/competitive: Individuals will be paired in teams which will compete against each other. Each team will be rewarded according to relative participation, but members within a team will receive the same amount.
Pairs will be matched on gender, age, and education, and then pairs will be randomly assigned to the different incentive conditions. Rewards in all incentive conditions will range to a maximum of $5 per day, and will be awarded differently depending on the incentive condition. Although participants will be informed of their winnings each day (to give frequent positive reinforcement), they will be paid cumulated amounts once a month (to reduce transactions costs and to ensure that actual payments are substantial). The number of activities completed using the software (up to 10 daily, or approximately 30 minutes of use) will be the basis for daily incentive payments to reward effort and avoid discouraging those who are not highly skilled. Cognitive testing will be done with the NueroTrax Mindstreams cognitive testing software.
Subjects: Roughly 400 participants will be recruited from local retirement communities which offer computing services to their residents. Subjects will be between the ages of 55 and 85 and will be required to sign informed consent forms before they are admitted to the study. Due to our focus on a population facing cognitive declines, extra care will be taken to ensure that all participants understand the information provided in the informed consent document. We will not enroll potential participants who are not able to verbalize understanding of the contents of the consent form. Participants will be trained in basic computer use and operation of the software using the Carnegie Mellon University mobile research van (see http://www.cmu.edu/news/archive/2007/June/june20_datatruck.shtml).
This pilot study will serve as the basis for a larger-scale study of financial incentives for elderly individuals to engage in mentally challenging tasks that help them improve cognitive function. In addition, this research will help us determine the relative effectiveness of different types of incentive designs that could be used in further studies of the use of financial incentives to encourage the elderly to engage in a variety of other healthy behaviors.
- Conditions
- Cognitive Function
- Being tested
- Financial incentives
- Keywords
- cognitive function, elderly, technology, financial incentives, General maintenance of cognitive function
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Financial incentivesBehavioural
Financial incentives based on use of software designed to promote cognitive function
| Study group | Role | What they receive |
|---|---|---|
| 1. Atomistic | Active comparator | payment for own work Receives: Behavioral: Financial incentives |
| 2. Altruistic | Active comparator | payment for partner's work Receives: Behavioral: Financial incentives |
| 3. Team-based | Active comparator | payment for relative performance of combined effort of each team Receives: Behavioral: Financial incentives |
| 4. Control | No intervention | access to software but no financial incentives |
What is being measured
The primary outcome is the main question the study is designed to answer.
Daily activities completed
Measured: 4 months
Secondary outcomes (1)
Performance on completed activities
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2008 (estimated)
- Study startAug 2010
- Primary completionMay 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive FunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 312 participants (actual)
Sponsor and investigators
- Lead sponsor
- Carnegie Mellon University
- Sponsor type
- University, hospital or other
- Collaborators
- Pennsylvania Department of Health, National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Heather Schofield, Harvard University
- Investigators
- George Loewenstein, PhD., Principal investigator, Carngie Mellon UniversityKevin Volpp, MD PhD, Principal investigator, Univeristy of Pennsylvania and Philadelphia Bereans Administration Medical CenterHeather Schofield, Principal investigator, Harvard University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00805259
- Sponsor's protocol ID
- CMU HS08-605
- Status last verified
- Dec 2013
- First submitted
- 5 Dec 2008
- Last updated
- 19 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting Mental Acuity in Elderly Populations Through Incentive for Technology Use
- ClinicalTrials.gov ID
- NCT00805259
- Acronym / sponsor ID
- CMU HS08-605
- Conditions
- Cognitive Function
- Keywords
- cognitive function, elderly, technology, financial incentives, General maintenance of cognitive function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 312 participants (actual)
- Lead sponsor
- Carnegie Mellon UniversityUniversity, hospital or other
- Collaborators
- Pennsylvania Department of Health, National Institute on Aging (NIA)
- Study start
- Aug 2010
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 9 Dec 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this between-subject randomized controlled trial the investigators will test the impact of three novel structured financial incentives: atomistic, altruistic and team-based. These incentive schemes will be used to motivate one month of daily use of software designed to improve cognitive function (including memory, reaction times, attention and executive function) among the elderly. The 400 participants will be members of retirement communities in Pennsylvania. Three outcomes will be monitored and analyzed: activities completed using the software (primary), performance on the activities, and changes in cognitive functioning. This study is designed to be a pilot study. The investigators will have 90% power to find a mean daily difference of 4 activities completed in the control group versus 7 activities completed in the incentive groups assuming a standard deviation of 3.5 and an alpha of 0.017 (the bonferroni corrected significance level to account for multiple comparisons). In addition during a three month "follow-up period" all participants will have continued access to the software, however, no incentives will be provided for use. This period will be used to assess the impact of the initial incentives on long run use after financial incentives have ceased.
Detailed description
The proposed study, a 4-arm randomized control trial, tests three novel incentive systems intended to promote the daily use of computer programs designed to improve memory and mental acuity among residents of retirement communities. Three outcome measures will be used to assess the effectiveness of the incentive programs: number of activities completed using the software (primary outcome of interest), performance on the activities, and differences between pre and post measures of mental acuity (using a standardized test of mental functions). Incentives to use the software will be offered to individuals in the experimental conditions for the first month of the 4 month study. After the initial month of incentives, all individuals will have continued access to the software, however, no incentives will be provided for use.
Incentives: Three incentive structures will be tested against one control group:
- Control: Access to software programs, but no rewards for use.
- Atomistic: Each individual is rewarded for his or her individual participation
- Altruistic: Participants will be paired with an individual at a different retirement community and will be rewarded according to the other individual's participation
- Combination cooperative/competitive: Individuals will be paired in teams which will compete against each other. Each team will be rewarded according to relative participation, but members within a team will receive the same amount.
Pairs will be matched on gender, age, and education, and then pairs will be randomly assigned to the different incentive conditions. Rewards in all incentive conditions will range to a maximum of $5 per day, and will be awarded differently depending on the incentive condition. Although participants will be informed of their winnings each day (to give frequent positive reinforcement), they will be paid cumulated amounts once a month (to reduce transactions costs and to ensure that actual payments are substantial). The number of activities completed using the software (up to 10 daily, or approximately 30 minutes of use) will be the basis for daily incentive payments to reward effort and avoid discouraging those who are not highly skilled. Cognitive testing will be done with the NueroTrax Mindstreams cognitive testing software.
Subjects: Roughly 400 participants will be recruited from local retirement communities which offer computing services to their residents. Subjects will be between the ages of 55 and 85 and will be required to sign informed consent forms before they are admitted to the study. Due to our focus on a population facing cognitive declines, extra care will be taken to ensure that all participants understand the information provided in the informed consent document. We will not enroll potential participants who are not able to verbalize understanding of the contents of the consent form. Participants will be trained in basic computer use and operation of the software using the Carnegie Mellon University mobile research van (see http://www.cmu.edu/news/archive/2007/June/june20_datatruck.shtml).
This pilot study will serve as the basis for a larger-scale study of financial incentives for elderly individuals to engage in mentally challenging tasks that help them improve cognitive function. In addition, this research will help us determine the relative effectiveness of different types of incentive designs that could be used in further studies of the use of financial incentives to encourage the elderly to engage in a variety of other healthy behaviors.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1. Atomistic | Active comparator | Behavioral: Financial incentivespayment for own work |
| 2. Altruistic | Active comparator | Behavioral: Financial incentivespayment for partner's work |
| 3. Team-based | Active comparator | Behavioral: Financial incentivespayment for relative performance of combined effort of each team |
| 4. Control | No intervention | –access to software but no financial incentives |
Who may qualify
- Ages
- 55 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age between 55 and 85
- Resident in participating retirement community
Key exclusion criteria (3 listed)
- Unstable medical conditions that would likely prevent the subject from completing the study
- Severe depression
- Inability to read or severe cognitive deficits that would preclude ability to read consent form or fill out surveys
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Financial incentivesFinancial incentives based on use of software designed to promote cognitive function | Behavioural | 1. Atomistic, 2. Altruistic, 3. Team-based |
Primary outcome
Daily activities completed
Time frame: 4 months
1 secondary outcome
Performance on completed activities
Time frame: 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2013.
Related trials for Cognitive Function
Enrolling by invitationPhase 2
Tau PET Outcomes With Anti-amyloid Immunotherapies
Cognitive Impairment, Mild, Dementia, Mild
Active, not recruiting
Primary Care Detection of Cognitive Impairment Leveraging Health & Consumer Technologies in Underserved Communities: The MyCog Trial
Dementia, Cognitive Impairment
Not yet recruitingObservational study
Ecological Momentary Assessment of State-Dependent Decision-Making and Metacognition Across a Psychopathology Continuum
Depression, Anxiety
Not yet recruitingObservational study
Correlation Between Forward Head Posture and Executive Functions in Cervical Radiculopathy
Cervical Radiculopathy, Forward Head Posture
RecruitingPhase 1
PET Imaging of Phosphodiesterase-4 (PDE4) in Volunteers With Alzheimer Disease (AD) or Mild Cognitive Impairment (MCI)
Alzheimer s Disease, Mild Cognitive Impairment
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
George Loewenstein, PhD. principal investigator
Carngie Mellon University
Kevin Volpp, MD PhD principal investigator
Univeristy of Pennsylvania and Philadelphia Bereans Administration Medical Center
Heather Schofield principal investigator
Harvard University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Financial incentives in people with Cognitive Function, run by Carnegie Mellon University at 1 site 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 2 inclusion and 3 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 19 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
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?
Daily activities completed (time frame: 4 months). 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 19 Dec 2013.