Technology-Assisted Cholesterol Trial in Consumers (TACTiC)
Study Details
Study Description
Brief Summary
The purpose of this AUS is to evaluate the extent to which participants can safely and effectively self-select, purchase, and use Crestor OTC 5 mg for a 6-month period according to the label.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Detailed Description
This is a single-arm, interventional, phase III Self-Selection (SS) and Actual Use Study (AUS) using a technology assisted tool within a Web App. The open-label study will enroll approximately 1220 participants who qualify for treatment based on the data they enter into the Web App of which an estimated 1000 participants will ultimately proceed to the use phase.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: Open Label, Single Arm Technology-Assisted Cholesterol Trial Open Label Single Arm study in All-comers population who self-report having concern about high cholesterol or heart health |
Combination Product: 5 mg rosuvastatin calcium with a Web App (combination product)
The combination product will be a Drug (Rosuvastatin calcium 5 mg) and Software as a Medical Device (Web App that features a Technology-Assisted Self-Selection (TASS) tool). Rosuvastatin calcium 5 mg will be taken orally, 1 tablet daily to use for lowering cholesterol, a key risk factor that can lead to heart disease.
Other Names:
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Outcome Measures
Primary Outcome Measures
- Percentage of participants with an Overall Correct (correct + mitigated) Initial TASS Outcome at the initial self-selection [-30 to -1 days from Day 0 Drug Delivery]
Evaluate initial TASS outcome (for participants deemed "OK to Use" or those with an "Ask a Doctor" outcome who contact a doctor and are permitted to continue treatment) compared to the TASS outcome obtained using clinician-verified medical and laboratory data
- Percentage of participants with an Overall Correct (correct + mitigated) Final Use Outcome at the final use assessment [Through study completion, approximately 6 months]
Evaluate that participants are properly using non-prescription rosuvastatin during the use period as assessed by their ability to correctly enter their ongoing health status into the Web App to get the correct outcome or through the medical and medication history in those participants who fail to complete a final TASS use assessment
- Percent change from baseline in verified LDL-C to Visit 2 [Through study completion, approximately 6 months]
Effectiveness in lowering LDL-C in participants regardless of their final use outcome
Secondary Outcome Measures
- Cholesterol retest within 6 months of starting medication (that was verified at Visit 2, not including study mandated tests) by at least 60% of participants who are eligible for continuous treatment [Through study completion, approximately 6 months]
Compliance with cholesterol retesting within 6 months
- Percentage of participants who correctly self-identify as having a "Stop Use" warning and stop medication [Through study completion, approximately 6 months]
Compliance with "Stop Use" warnings
- Percentage of participants who correctly self-identify as having a "Do Not Use" warning at the final use assessment [Through study completion, approximately 6 months]
Compliance with "Do Not Use" warnings
- Percentage of participants who correctly self-identify as having an "Ask a Doctor Before Use" warning at the final use assessment [Through study completion, approximately 6 months]
Compliance with "Ask a Doctor Before Use" warnings
- Percentage of participants with overall compliance between 50% and 120% as determined by pill count [Through study completion, approximately 6 months]
Compliance with Continuous Dosing
- Percentage of participants with longitudinal compliance between 50% and 120% across all supply periods as determined using eDiary data [Through study completion, approximately 6 months]
Compliance with Continuous Dosing
- Percentage of participants who were persistent as determined by reorder data from the Web App [Through study completion, approximately 6 months]
Compliance with Continuous Dosing
Other Outcome Measures
- List of the number and percentage of incorrect entries and the reasons for incorrect TASS entries for initial TASS [-30 to -1 days from Day 0 Drug Delivery]
Evaluate the incorrect entries and the reasons for incorrect TASS entries for each question on the initial TASS assessment
- List of the number and percentage of incorrect entries and the reasons for incorrect TASS entries for final TASS [Through study completion, approximately 6 months]
Evaluate the incorrect entries and the reasons for incorrect TASS entries for each question on the final TASS assessment
- Percentage of participants who correctly self-identify as having a "Stop Use" warning and speak to a doctor [Through study completion, approximately 6 months]
Compliance with speak to a doctor component of the "Stop Use" warnings
- For participants who had a "Stop Use" warning and stopped the medication, the date from when participant self-identifies a "Stop Use" warning to the date the medication was stopped [Through study completion, approximately 6 months]
Timeframe for complying with "Stop Use" warnings
- For participants who had a "Stop Use" warning and talked to a doctor, the date from when a participant self-identifies a "Stop Use" warning to the date their doctor was contacted [Through study completion, approximately 6 months]
Timeframe for complying with "Stop Use" warnings
- For participants who correctly self-identify as having a "Do Not Use" warning at final use assessment, the date from when a participant self-identifies a "Do Not Use" warning to the date the medication was stopped [Through study completion, approximately 6 months]
Timeframe for complying with "Do Not Use" warnings
- Percentage of participants who correctly self-identify as having an "Ask a Doctor Before Use" warning and speak to a doctor [Through study completion, approximately 6 months]
Compliance with speak to a doctor component of the "Ask a Doctor Before Use" warnings
- For participants who correctly self-identify as having an "Ask a Doctor Before Use" warning at final use assessment, the date from participant receiving an "Ask a Doctor Before Use" warning to the date their doctor was contacted [Through study completion, approximately 6 months]
Timeframe for complying with "Ask a Doctor Before Use" warnings
- Difference in % change from baseline in LDL-C between participants who had a retest during the study with a verified source and those who did not retest but had a study mandated test completed based on participants eligible for continuous treatment at V2 [Through study completion, approximately 6 months]
Evaluate effectiveness in lowering LDL-C in different participant subgroups
- Percent change from baseline in verified LDL-C at Visit 2 stratified by level of overall compliance (<50%, 50-120% and >120%) and by 50-120% supply period compliance across all supply periods in participants eligible for continuous treatment [Through study completion, approximately 6 months]
Evaluate LDL-C lowering relative to level of dosing compliance
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Males, 20-75 years of age
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Females, 20-75 years of age (This inclusion will be applied until 50 females under the age of 50 years are enrolled in the study. After this quota of 50 females under the age of 50 years old are enrolled, the inclusion criteria will be revised to enroll only females 50-75 years old).
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Respond to advertising regarding a concern about high cholesterol or heart health
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Able to read speak and understand English
Additional Criteria for Inclusion for Actual Use (at Virtual Visit 1)
- Participant reads and signs the Informed Consent form
Exclusion Criteria:
- The participant or anyone in their household is currently employed by any of the following:
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A pharmacy or pharmaceutical company
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A consumer healthcare company
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A manufacturer of medicines
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A managed care or health insurance company
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A healthcare practice
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An employee of AstraZeneca or Concentrics Research
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The participant has ever been trained or employed as a healthcare professional (physician, nurse, nurse practitioner, physician assistant, pharmacist).
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The participant has, or cannot recall whether he/she has, received an investigational therapy as part of a clinical trial in the previous twelve (12) months
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The participant is not willing to provide contact information.
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Previous enrollment in the present study.
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The participant has a mailing address in Alaska or their mailing address is a Post Office (PO) Box.
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The participant is not willing to complete an eDiary
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The participant is a woman of childbearing potential and is not following contraception guidelines or is not willing to follow contraception guidelines including practicing abstinence or using at least 1 of the following acceptable methods of birth control for at least 1 month prior to entry into the study and for 1 month after study completion: hormonal -oral, implantable, injectable, or transdermal; mechanical - spermicide in conjunction with a barrier such as a condom or diaphragm; intrauterine device; or surgical sterilization of partner.
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The participant does not have access to the internet.
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The participant does not have an email address or the ability to receive emails.
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The participant responds to the Single Item Literacy Screener question (See References) with either 'extremely' or 'quite a bit.' (If the quota for normal literacy is met, but the limited literacy target is not met, the SILS2 exclusion will be used to help increase the percentage of limited literacy participants at Virtual Visit 1. Participants identified as normal literacy by REALM testing at Virtual Visit 1 will not be excluded from entry into the treatment phase of the study.)
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Inability to conduct interviews in a private location so that sensitive information about the participant or study would not be overheard by others not permitted to hear such information.
Additional Criteria for Exclusion from Actual Use (at Virtual Visit 1)
Confirmation by Concentrics Central Medical Operations Group (CMOG) clinician:
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That the participant is pregnant, as determined by an approved self-administered OTC urine pregnancy test (UPT) conducted for all female participants of childbearing potential (Female participants who are not post-menopausal or surgically sterile).
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That the participant is breast-feeding.
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That the participant has an allergy to rosuvastatin.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Research Site | Indianapolis | Indiana | United States | 46240 |
Sponsors and Collaborators
- AstraZeneca
- Concentrics Research LLC
- Concentrics Research - STATKING JV
- Idea Evolver
- The Cleveland Clinic
Investigators
- Principal Investigator: William C. Miller, M.D., Concentrics Central Medical Operations Group
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
- Chew LD, Griffin JM, Partin MR, Noorbaloochi S, Grill JP, Snyder A, Bradley KA, Nugent SM, Baines AD, Vanryn M. Validation of screening questions for limited health literacy in a large VA outpatient population. J Gen Intern Med. 2008 May;23(5):561-6. doi: 10.1007/s11606-008-0520-5. Epub 2008 Mar 12.
- Davis TC, Long SW, Jackson RH, Mayeaux EJ, George RB, Murphy PW, Crouch MA. Rapid estimate of adult literacy in medicine: a shortened screening instrument. Fam Med. 1993 Jun;25(6):391-5.
- Grundy, S.M., Stone, N.J., Bailey A.L., Beam, C., Birtcher, K.K., Blumenthal, R.S., Braun, L.T., de Ferranti, S., Faiella-Tommasino, J., Forman, D.E., Goldberg, R., Hedenreich, P.A., Hlatky, M.A., Jones, D.W., Lloyd-Jones, D., Lopez-Pajares, N., Ndumele, C.E., Orringer, C.E., Peralta, C.A., Saseen, J.J., Smith Jr, S.C., Sperling, L., Virani, S.S., Yeboah, J. (2018). 2018 AHA/ACC/AACVPR/AAPA/ABC/ACPM/ ADA/AGS/APhA/ASPC/NLA/PCNA guideline on the management of blood cholesterol: a report on the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Circulation, 139(25), e1082-e1143. https://doi.org/10.1161/CIR.0000000000000625.
- D356PL00015