Compliance With Treatment For Patients With Hyperlipidemia

Hyperlipidemia Clinical Trial

— COLL  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00828945
• Other study ID #: A2581178
• Status: Completed
• Start date: February 2009
• Est. completion date: March 2011

Study information

• Verified date: February 2021
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

Consecutive patient sampling

Recruitment information / eligibility

• Status: Completed
• Enrollment: 259
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hyperlipidemia
• Hyperlipidemias
• Hyperlipoproteinemias

Intervention

Device:
• Lipid Self Test
Self test for lipid levels, twice during study period

Locations

Country	Name	City	State
Sweden	Pfizer Investigational Site	Akersberga
Sweden	Pfizer Investigational Site	Forshaga
Sweden	Pfizer Investigational Site	Goteborg
Sweden	Pfizer Investigational Site	Goteborg
Sweden	Pfizer Investigational Site	Goteborg
Sweden	Pfizer Investigational Site	Hoganas
Sweden	Pfizer Investigational Site	Jonkoping
Sweden	Pfizer Investigational Site	Lessebo
Sweden	Pfizer Investigational Site	Lilla Edet
Sweden	Pfizer Investigational Site	Limhamn
Sweden	Pfizer Investigational Site	Malmo
Sweden	Pfizer Investigational Site	Oviken
Sweden	Pfizer Investigational Site	Partille
Sweden	Pfizer Investigational Site	Stockholm
Sweden	Pfizer Investigational Site	Taby
Sweden	Pfizer Investigational Site	Trollhattan
Sweden	Pfizer Investigational Site	Vasteras

Sponsors (1)

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

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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

External Links

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