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OpenTrials
Completed

NCT Number: NCT00828945

Compliance With Treatment For Patients With Hyperlipidemia

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.

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Key information

Conditions

Hyperlipidemia Dyslipidemias Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Pfizer Investigational Site, Forshaga, Sweden

Loading trial locations.

About this study

Consecutive patient sampling

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Lipid Self Test

Device

Self test for lipid levels, twice during study period

Primary outcomes

  1. Percentage of Participants With Positive Response on Increased Motivation Using a Self-test at Month 12

    Time frame: 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.

  2. Percentage of Participants With Positive Response on Increased Motivation After Awareness at Month 12

    Time frame: 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?".

  3. Percentage of Participants With Positive Response on Self-estimated Treatment Compliance at Week 8

    Time frame: Week 8

    Participants with "Yes" response to a question which stated "Have you been taking at least 90% of your medication for hyperlipidemia?".

  4. Percentage of Participants With Positive Response on Self-estimated Treatment Compliance at Month 6

    Time frame: Month 6

    Participants with "Yes" response to a question which stated "Have you been taking at least 90% of your medication for hyperlipidemia?".

  5. Percentage of Participants With Positive Response on Self-estimated Treatment Compliance at Month 12

    Time frame: Month 12

    Participants with "Yes" response to a question which stated "Have you been taking at least 90% of your medication for hyperlipidemia?".

  6. Percentage of Participants With LDL Lower Than 2.5 mmol/L at Week 8

    Time frame: Week 8

    LDL levels were self-assessed by participants using CARE diagnostica LDL-cholesterol test.

  7. Percentage of Participants With LDL Lower Than 2.5 mmol/L at Month 6

    Time frame: Month 6

    LDL levels were self-assessed by participants using CARE diagnostica LDL-cholesterol test.

  8. Percentage of Participants With LDL Lower Than 2.5 mmol/L at Month 12

    Time frame: Month 12

    LDL levels were self-assessed by participants using CARE diagnostica LDL-cholesterol test.

  9. Percentage of Participants With Response Achieving Targeted LDL-cholesterol Level at Week 8

    Time frame: 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.

  10. Percentage of Participants With Response Achieving Targeted LDL-cholesterol Level at Month 6

    Time frame: 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.

  11. Percentage of Participants With Response Achieving Targeted LDL-cholesterol Level at Month 12

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

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

Industry

Registry information

Official study title

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

Acronym: COLL

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Jan 26, 2009
Registry last updated
Feb 21, 2021

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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