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Process Versus Outcomes Incentives for Lipid Management

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ClinicalTrials.gov Identifier: NCT02246959
Recruitment Status : Completed
First Posted : September 23, 2014
Last Update Posted : February 26, 2019
Sponsor:
Collaborators:
Rutgers University
University of California, San Francisco
Carnegie Mellon University
Lancaster General Hospital
Information provided by (Responsible Party):
University of Pennsylvania

Brief Summary:
In a 4-arm, randomized controlled trial, we will evaluate the relative effectiveness and cost-effectiveness of improving cholesterol levels among participants who are at high risk of CVD and who have elevated LDL cholesterol levels by testing process versus outcomes financial incentives. Participants will use electronic pill bottles that continuously monitor statin adherence. The primary outcome will be change in LDL cholesterol over 12 months.

Condition or disease Intervention/treatment Phase
Diabetes Cardiovascular Disease Behavioral: Process Incentive Behavioral: Outcome Incentive Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 764 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: In a 4-arm, randomized controlled trial, we propose to evaluate the relative effectiveness and cost-effectiveness of improving cholesterol levels among participants who are at high risk of CVD and who have elevated LDL cholesterol levels by testing process versus outcomes financial incentives. Participants will use electronic pill bottles that continuously monitor statin adherence.
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Comparative Effectiveness of Process and Outcomes Incentives for Lipid Management
Study Start Date : February 2015
Actual Primary Completion Date : May 2018
Actual Study Completion Date : October 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Control Arm
Arm 1 will be the Control arm, in which participants receive electronic pill bottles for their statin medication but are not enrolled in the sweepstakes.
Experimental: Process Arm
Arm 2 will be a Process incentive arm where participants receive electronic pill bottles for their statin medication. In addition, this group is enrolled in a sweepstakes, in which participants may win money if they remember to take their medication.
Behavioral: Process Incentive
Daily sweepstake conditional on daily medication adherence

Experimental: Outcome Arm
Arm 3 will be an Outcome incentive arm where participants receive electronic pill bottles for their statin medication. In addition, this group may receive incentives if they lower their LDL.
Behavioral: Outcome Incentive
Incentives conditional on LDL cholesterol reduction

Experimental: Process Plus Outcome Arm
Arm 4 will be a process plus outcome incentive arm where participants receive electronic pill bottles for their statin medication. In addition, this group is enrolled in a sweepstakes, in which participants may win money if they remember to take their medication and receive additional incentives for lowering their LDL cholesterol.
Behavioral: Process Incentive
Daily sweepstake conditional on daily medication adherence

Behavioral: Outcome Incentive
Incentives conditional on LDL cholesterol reduction




Primary Outcome Measures :
  1. Change in LDL cholesterol from baseline to 12 months [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Statin Adherence [ Time Frame: 18 months ]


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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Individuals at high risk of a cardiac event, specifically one of the following:
  • Individuals with clinical ASCVD (defined as diagnosis with myocardial infarction, stroke, or peripheral vascular disease) with an LDL greater than or equal to 100 mg/dl ;
  • Individuals with Diabetes (between the ages of 40-75) with an LDL greater than or equal to 100 mg/dl;
  • Individuals without clinical ASCVD or diabetes with LDLC with an LDL greater than or equal to 100 mg/dl and estimated 10-year ASCVD risk 7.5%;
  • Individuals without clinical ASCVD or diabetes with LDL cholesterol 190 mg/dl
  • A prescription filled for a statin medication within the last 12 months (derived from pharmacy records);
  • Low medication adherence on self-report completed during enrollment

Exclusion Criteria:

  • Under 18 years old
  • A contraindication to further statin use or have suffered statin side effects, such as myopathy
  • Will not or cannot give consent
  • A history of active or progressive liver disease
  • Participating in another clinical trial with related aims
  • Co-morbidities likely to lead to death within a short period (e.g. metastatic cancer)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02246959


Locations
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United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
Rutgers University
University of California, San Francisco
Carnegie Mellon University
Lancaster General Hospital
Investigators
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Principal Investigator: Kevin Volpp, MD, PhD University of Pennsylvania
Principal Investigator: Peter Reese, MD, MSCE University of Pennsylvania
Principal Investigator: Iwan Barankay, PhD University of Pennsylvania

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Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT02246959     History of Changes
Other Study ID Numbers: 1R01HL118195-01A1 ( U.S. NIH Grant/Contract )
First Posted: September 23, 2014    Key Record Dates
Last Update Posted: February 26, 2019
Last Verified: February 2019
Additional relevant MeSH terms:
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Cardiovascular Diseases