Clinical trial NCT04964544: Technology-Assisted Cholesterol Trial in Consumers (TACTiC)
Official title: A Phase III, 6-Month Self-selection and Actual Use Study for Rx-to-OTC Switch of Rosuvastatin 5 mg Once-daily in Combination With a Web App
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: High Cholesterol
Keywords: Cholesterol, Web App
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: Concentrics Research
name: Idea Evolver
name: The Cleveland Clinic
First posted: 2021-07-16
Enrollment: 1196
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is a 6-month, single-arm, uncontrolled technology-assisted Self-Selection and Actual Use Study to evaluate the use of nonprescription rosuvastatin 5 mg in combination with a Web App. It is an open-label study where participants qualify for treatment based on the medical history, laboratory and blood pressure data they enter into the Web App, accessed on their own device on the internet.
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criteria:

1. Males, 20-75 years of age
2. Females, 20-75 years of age (This inclusion criterion will be applied until 50 females under the age of 50 years complete the initial TASS assessment in the Web App). After this quota of 50 females under the age of 50 years old is met, the inclusion criterion will be revised to females 50-75 years old).
3. Respond to advertising regarding a concern about high cholesterol or heart health
4. Able to read speak and understand English

Additional Criteria for Inclusion for Actual Use (at Virtual Visit 1)

1. Participant reads and signs the Informed Consent form

Exclusion Criteria:

1. The participant or anyone in their household is currently employed by any of the following:

   * A pharmacy or pharmaceutical company
   * A consumer healthcare company
   * A manufacturer of medicines
   * A managed care or health insurance company
   * A healthcare practice
   * An employee of AstraZeneca or Concentrics Research
2. The participant has ever been trained or employed as a healthcare professional (physician, nurse, nurse practitioner, physician assistant, pharmacist).
3. 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
4. The participant is not willing to provide contact information.
5. Previous enrollment in the present study.
6. The participant has a mailing address in Alaska or their mailing address is a Post Office (PO) Box.
7. The participant is not willing to complete an eDiary
8. 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.
9. The participant does not have access to the internet.
10. The participant does not have an email address or the ability to receive emails.
11. The participant responds to the Single Item Literacy Screener 2 (SILS2) 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 Rapid Estimate of Adult Literacy in Medicine \[REALM\] testing at Virtual Visit 1 will not be excluded from entry into the treatment phase of the study.)
12. 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:

1. 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).
2. That the participant is breastfeeding.
3. That the participant has an allergy to rosuvastatin.

Primary outcomes:
measure: Overall Correct Initial TASS Outcome, Worst Case Imputation, First Co-Primary Endpoint (Self-Selection Population)
timeFrame: Study day -30 to -1, at initial TASS assessment
measure: Overall Correct Final Use Outcome With Mitigation, Second Co-primary Endpoint (Per Protocol Population)
timeFrame: From enrollment to end of the home use period at 180 days, at final TASS Assessment
measure: Percent Change From Baseline in Verified LDL-C Regardless of Final Use Outcome (AUS ITT Population)
timeFrame: From enrollment to end of the home use period at 180 days, at final assessment
Secondary outcomes:
measure: Participants Eligble for Continuous Treatment Who Self-Tested With a Verified LDL-C Retest During Study, Overall and by Subgroups (Per Protocol Population)
timeFrame: From enrollment to end of the home use period at 180 days
measure: Participants Who Self-Identify a Stop Use Warning Also Identified by the CMOG, and Stop Medication (Per Protocol Population)
timeFrame: From enrollment to end of the home use period at 180 days
measure: Participants Who Self-Identify a Do Not Use Warning Also Identified by the CMOG at Final Use Assessment(Per Protocol Population, Participants Who Had a do Not Use Warning Identified by the CMOG at Final Use Visit)
timeFrame: From enrollment to end of the home use period at 180 days
measure: Participants Who Self-Identify an Ask a Doctor Before Use Warning Also Identified by the CMOG at Final Use Assessment (Per Protocol Population, Participants Who Had a do Not Use Warning Identified by the CMOG at Final Use Visit)
timeFrame: From enrollment to end of the home use period at 180 days
measure: Participants With Overall Compliance Between 50% and 120%
timeFrame: From enrollment to end of the home use period at 180 days
measure: Participants Who Were Longitudinally Compliant (Per Protocol Population)
timeFrame: From enrollment to end of the home use period at 180 days
measure: Participants Who Were Persistent (Per Protocol Population)
timeFrame: From enrollment to end of the home use period at 180 days
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Research Site
state: Indiana
Study officials:
affiliation: Concentrics Central Medical Operations Group
name: William C. Miller, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: Grundy SM, Stone NJ, Bailey AL, Beam C, Birtcher KK, Blumenthal RS, Braun LT, de Ferranti S, Faiella-Tommasino J, Forman DE, Goldberg R, Heidenreich PA, Hlatky MA, Jones DW, Lloyd-Jones D, Lopez-Pajares N, Ndumele CE, Orringer CE, Peralta CA, Saseen JJ, Smith SC Jr, Sperling L, Virani SS, Yeboah J. 2018 AHA/ACC/AACVPR/AAPA/ABC/ACPM/ADA/AGS/APhA/ASPC/NLA/PCNA Guideline on the Management of Blood Cholesterol: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Circulation. 2019 Jun 18;139(25):e1082-e1143. doi: 10.1161/CIR.0000000000000625. Epub 2018 Nov 10.