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OpenTrials
Completed

NCT Number: NCT02246959

Process Versus Outcomes Incentives for Lipid Management

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.

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Key information

Conditions

Diabetes Cardiovascular Disease Cardiovascular Diseases Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Process Incentive

Behavioral

Daily sweepstake conditional on daily medication adherence

Outcome Incentive

Behavioral

Incentives conditional on LDL cholesterol reduction

Primary outcomes

  1. Change in LDL cholesterol from baseline to 12 months

    Time frame: 12 months

Secondary outcomes

  1. Statin Adherence

    Time frame: 18 months

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Collaborators

  • Carnegie Mellon University
  • Lancaster General Hospital
  • Rutgers University
  • University of California, San Francisco

Registry information

Official study title

Comparative Effectiveness of Process and Outcomes Incentives for Lipid Management

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Sep 23, 2014
Registry last updated
Feb 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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