Compliance With Treatment For Patients With Hyperlipidemia (COLL)

A Non-Randomized, Non-Controlled, Open Study In Order To Document The Compliance With Treatment, According To Clinical Praxis And National Guidelines For Patients With Hyperlipidemia. COLL: Control Of Lipid Lowering

It is a prospective observational study.

Patients will be high risk patients (for developing cardiovascular events) that are treated with a statin. Patients will be enrolled at a normal clinic visit and provided with a small box containing info about the disease, a LDL self-test and two questionnaires. They will test themselves for LDL at home between normal clinic visits (normally 12 months interval) and note their value. In the end of the study all patients will fill out a questionnaire with questions if the tests and info have raised their awareness of the disease as well if their motivation to be compliant has increased.

We want to look at the possibility to put more responsibility for treatment and for reaching treatment goals on the patients since there's a big problem with compliance in this group of patients.

Study Overview

• Status: Completed
• Conditions: Hyperlipidemia
• Intervention / Treatment: Device: Lipid Self Test

Detailed Description

Consecutive patient sampling

• Study Type: Observational
• Enrollment (Actual): 259

Contacts and Locations

Study Locations

• Sweden
  • Akersberga, Sweden, 184 27
    • Pfizer Investigational Site
  • Forshaga, Sweden, 667 32
    • Pfizer Investigational Site
  • Goteborg, Sweden, 41665
    • Pfizer Investigational Site
  • Goteborg, Sweden, 405 30
    • Pfizer Investigational Site
  • Goteborg, Sweden, 415 10
    • Pfizer Investigational Site
  • Hoganas, Sweden, 263 36
    • Pfizer Investigational Site
  • Jonkoping, Sweden, 553 16
    • Pfizer Investigational Site
  • Lessebo, Sweden, 360 50
    • Pfizer Investigational Site
  • Lilla Edet, Sweden, 46330
    • Pfizer Investigational Site
  • Limhamn, Sweden, 216 43
    • Pfizer Investigational Site
  • Malmo, Sweden, 211 20
    • Pfizer Investigational Site
  • Oviken, Sweden, 830 24
    • Pfizer Investigational Site
  • Partille, Sweden, 433 34
    • Pfizer Investigational Site
  • Stockholm, Sweden, 111 35
    • Pfizer Investigational Site
  • Taby, Sweden, 183 30
    • Pfizer Investigational Site
  • Trollhattan, Sweden, 461 53
    • Pfizer Investigational Site
  • Vasteras, Sweden, 722 11
    • Pfizer Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Aged 18 years or older and able to understand and sign the informed consent form.

• Patients diagnosed with hyperlipidemia and a very high risk developing cardiovascular disease prescribed statin treatment according to clinical praxis and the recommendations set forth in the MPA national guideline for treatment of hyperlipidemia.

Description

Inclusion Criteria:

• Aged 18 years or older and able to understand and sign the informed consent form.

  • Patients diagnosed with hyperlipidemia and a very high risk developing cardiovascular disease prescribed statin treatment according to clinical praxis and the recommendations set forth in the MPA national guideline for treatment of hyperlipidemia.

Exclusion Criteria:

• Patients contraindicated for statin treatment according to market authorization for these drugs should be excluded from the study.
• Patients participating in other clinical trials or non-interventional studies.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Hyperlipidemic Patients	Device: Lipid Self Test; Self test for lipid levels, twice during study period

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Positive Response on Increased Motivation Using a Self-test at Month 12	Participants with "Yes" response to a question which stated "The self-test have increased my motivation for taking my medication for hyperlipidemia?". The self test done for assessment of LDL levels using CARE diagnostica LDL-cholesterol test.	Month 12
Percentage of Participants With Positive Response on Increased Motivation After Awareness at Month 12	Participants with "Yes" response to a question which stated "The awareness of my disease has increased my motivation for taking my medication for hyperlipidemia?".	Month 12
Percentage of Participants With Positive Response on Self-estimated Treatment Compliance at Week 8	Participants with "Yes" response to a question which stated "Have you been taking at least 90% of your medication for hyperlipidemia?".	Week 8
Percentage of Participants With Positive Response on Self-estimated Treatment Compliance at Month 6	Participants with "Yes" response to a question which stated "Have you been taking at least 90% of your medication for hyperlipidemia?".	Month 6
Percentage of Participants With Positive Response on Self-estimated Treatment Compliance at Month 12	Participants with "Yes" response to a question which stated "Have you been taking at least 90% of your medication for hyperlipidemia?".	Month 12
Percentage of Participants With LDL Lower Than 2.5 mmol/L at Week 8	LDL levels were self-assessed by participants using CARE diagnostica LDL-cholesterol test.	Week 8
Percentage of Participants With LDL Lower Than 2.5 mmol/L at Month 6	LDL levels were self-assessed by participants using CARE diagnostica LDL-cholesterol test.	Month 6
Percentage of Participants With LDL Lower Than 2.5 mmol/L at Month 12	LDL levels were self-assessed by participants using CARE diagnostica LDL-cholesterol test.	Month 12
Percentage of Participants With Response Achieving Targeted LDL-cholesterol Level at Week 8	Participants with "Yes" or "No" responses to a question which stated "Have you reached your target LDL-cholesterol level?". LDL levels were self-assessed by participants using CARE diagnostica LDL-cholesterol test.	Week 8
Percentage of Participants With Response Achieving Targeted LDL-cholesterol Level at Month 6	Participants with "Yes" or "No" responses to a question which stated "Have you reached your target LDL-cholesterol level?". LDL levels were self-assessed by participants using CARE diagnostica LDL-cholesterol test.	Month 6
Percentage of Participants With Response Achieving Targeted LDL-cholesterol Level at Month 12	Participants with "Yes" or "No" responses to a question which stated "Have you reached your target LDL-cholesterol level?". LDL levels were self-assessed by participants using CARE diagnostica LDL-cholesterol test.	Month 12

Collaborators and Investigators

• Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start: February 1, 2009
• Primary Completion (Actual): March 1, 2011
• Study Completion (Actual): March 1, 2011

Study Registration Dates

• First Submitted: January 23, 2009
• First Submitted That Met QC Criteria: January 23, 2009
• First Posted (Estimate): January 26, 2009

Study Record Updates

• Last Update Posted (Actual): February 21, 2021
• Last Update Submitted That Met QC Criteria: February 17, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Dyslipidemias; Hyperlipidemias; Hyperlipoproteinemias
• Other Study ID Numbers: A2581178