DiabetesNCT01977495
Take Charge of Your Diabetes
A study testing Financial Incentive: Fixed Lottery in people with Diabetes and Hypertension, run by University of Pennsylvania at 1 site in United States.
Trial summary
The investigator plans to assess enrollment rates among two different enrollment methods, while providing a behavioral economic intervention to enhance the uptake of home-health monitoring devices to lower hemoglobin A1C among patients with uncontrolled diabetes. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabetes, Hypertension
- What is being tested?
- Financial Incentive: Fixed Lottery
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2013to Aug 2014
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults between 18 and 80 years of age
- Primary care patients at the Division of General Internal Medicine clinics at the University of Pennsylvania
- Hemoglobin A1c measured within the last 8 weeks greater than 8.0% OR no measured Hemoglobin A1C measured in the last two years
- A confirmed diabetes diagnosis
- Planning to stay in area for study duration (6 months)
- Can understand and communicate fluently in English
Who cannot join
- Unable to read and give consent
- Suffer from an uncontrolled psychiatric disease
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: Testing Enrollment Methods on Participation in Behavioral Economic Interventions for Diabetes Care: A Randomized Controlled Pilot Study
The investigator plans to assess enrollment rates among two different enrollment methods, while providing a behavioral economic intervention to enhance the uptake of home-health monitoring devices to lower hemoglobin A1C among patients with uncontrolled diabetes. The study is focusing on enrollment methods since the standard randomized control trial only reaches 15% of the population. The study is seeking to understand the effectiveness of a behavioral intervention, when rolled out in a larger population.
- Conditions
- Diabetes, Hypertension
- Being tested
- Financial Incentive: Fixed Lottery
- Keywords
- Diabetes, Enrollment methods, Behavioral Economic Intervention, Opt-in Enrollment, Opt-out Enrollment, lottery, financial incentives
- Medical subject headings
- Diabetes Mellitus, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Financial Incentive: Fixed LotteryBehavioural
Every day of the 91 day intervention period participants will be asked to use each of their biometric devices. A daily lottery will be conducted automatically by the study website. Participants must use each of their two devices daily to be eligible for the lottery the following day. Winning lottery numbers will be identified by a fixed-position match between the automatically generated winning number and a participant ID number, which each participant will pick at enrollment.
| Study group | Role | What they receive |
|---|---|---|
| Opt-in Enrollment | Active comparator | Opt-in enrollment: patient will be sent a recruitment letter, in which they must call the study team to take part in the study. During that call, the study team will schedule the participant for an intake visit. Receives: Behavioral: Financial Incentive: Fixed Lottery |
| Opt-out enrollment | Active comparator | Opt-out enrollment: patient will be sent a letter communicating to them that they have been enrolled into a research program at their doctor's office. After 10 days, the study team will contact the opt-out participants to schedule an intake visit. Receives: Behavioral: Financial Incentive: Fixed Lottery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Enrollment and participation rates
The primary objective is to obtain preliminary evidence regarding whether or not patients opt-into a research study, as opposed to enrolling by default, will affect participation in the program and the effectiveness of the intervention, among high-risk patients. The primary outcome is to measure enrollment rates. The investigators will also measure participation in the program through device usage.
Measured: End of study- 6 months after enrollment
Secondary outcomes (1)
Uptake of Device Usage
Assess the effect of financial incentives on the use of home health monitoring devices among high-risk patients
Measured: End of study- 6 months after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2013 (estimated)
- Study startDec 2013
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Jaya Aysola, University of Pennsylvania
- Investigators
- Jaya Aysola, MD, MPH, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01977495
- Sponsor's protocol ID
- 818810
- Status last verified
- Dec 2015
- First submitted
- 24 Oct 2013
- Last updated
- 9 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing Enrollment Methods on Participation in Behavioral Economic Interventions for Diabetes Care: A Randomized Controlled Pilot Study
- ClinicalTrials.gov ID
- NCT01977495
- Acronym / sponsor ID
- 818810
- Conditions
- Diabetes, Hypertension
- Keywords
- Diabetes, Enrollment methods, Behavioral Economic Intervention, Opt-in Enrollment, Opt-out Enrollment, lottery, financial incentives
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- Dec 2013
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 6 Nov 2013 (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.
The investigator plans to assess enrollment rates among two different enrollment methods, while providing a behavioral economic intervention to enhance the uptake of home-health monitoring devices to lower hemoglobin A1C among patients with uncontrolled diabetes. The study is focusing on enrollment methods since the standard randomized control trial only reaches 15% of the population. The study is seeking to understand the effectiveness of a behavioral intervention, when rolled out in a larger population.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Opt-in Enrollment | Active comparator | Behavioral: Financial Incentive: Fixed LotteryOpt-in enrollment: patient will be sent a recruitment letter, in which they must call the study team to take part in the study. During that call, the study team will schedule the participant for an intake visit. |
| Opt-out enrollment | Active comparator | Behavioral: Financial Incentive: Fixed LotteryOpt-out enrollment: patient will be sent a letter communicating to them that they have been enrolled into a research program at their doctor's office. After 10 days, the study team will contact the opt-out participants to schedule an intake visit. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adults between 18 and 80 years of age
- Primary care patients at the Division of General Internal Medicine clinics at the University of Pennsylvania
- Hemoglobin A1c measured within the last 8 weeks greater than 8.0% OR no measured Hemoglobin A1C measured in the last two years
- A confirmed diabetes diagnosis
- Planning to stay in area for study duration (6 months)
Key exclusion criteria (2 listed)
- Unable to read and give consent
- Suffer from an uncontrolled psychiatric disease
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 Incentive: Fixed LotteryEvery day of the 91 day intervention period participants will be asked to use each of their biometric devices. A daily lottery will be conducted automatically by the study website. Participants must use each of their two devices daily to be eligible for the lottery the following day. Winning lottery numbers will be identified by a fixed-position match between the automatically generated winning number and a participant ID number, which each participant will pick at enrollment. | Behavioural | Opt-in Enrollment, Opt-out enrollment |
Primary outcome
Enrollment and participation rates
Time frame: End of study- 6 months after enrollment
The primary objective is to obtain preliminary evidence regarding whether or not patients opt-into a research study, as opposed to enrolling by default, will affect participation in the program and the effectiveness of the intervention, among high-risk patients. The primary outcome is to measure enrollment rates. The investigators will also measure participation in the program through device usage.
1 secondary outcome
Uptake of Device Usage
Time frame: End of study- 6 months after enrollment
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 9 Dec 2015.
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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.
Jaya Aysola, MD, MPH principal investigator
University of Pennsylvania
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 Incentive: Fixed Lottery in people with Diabetes and Hypertension, run by University of Pennsylvania 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 6 inclusion and 2 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 9 Dec 2015. 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?
Enrollment and participation rates (time frame: End of study- 6 months after enrollment). 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 9 Dec 2015.