Compliance With Treatment For Patients With Hyperlipidemia

Study Overview
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Brief Summary
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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.

Detailed Description
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Consecutive patient sampling

Official Title
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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

Conditions
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Hyperlipidemia

Intervention / Treatment
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* Device: Lipid Self Test


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Hyperlipidemic Patients<br> | Device: Lipid Self Test<br>* Self test for lipid levels, twice during study period<br>|

What is the study measuring?
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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 |