Clinical trial NCT00828945: Compliance With Treatment For Patients With Hyperlipidemia
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hyperlipidemia
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-01-26
Enrollment: 259
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

Brief 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.

Detailed description: Consecutive patient sampling

Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Participants With Positive Response on Increased Motivation Using a Self-test at Month 12
timeFrame: Month 12
measure: Percentage of Participants With Positive Response on Increased Motivation After Awareness at Month 12
timeFrame: Month 12
measure: Percentage of Participants With Positive Response on Self-estimated Treatment Compliance at Week 8
timeFrame: Week 8
measure: Percentage of Participants With Positive Response on Self-estimated Treatment Compliance at Month 6
timeFrame: Month 6
measure: Percentage of Participants With Positive Response on Self-estimated Treatment Compliance at Month 12
timeFrame: Month 12
measure: Percentage of Participants With LDL Lower Than 2.5 mmol/L at Week 8
timeFrame: Week 8
measure: Percentage of Participants With LDL Lower Than 2.5 mmol/L at Month 6
timeFrame: Month 6
measure: Percentage of Participants With LDL Lower Than 2.5 mmol/L at Month 12
timeFrame: Month 12
measure: Percentage of Participants With Response Achieving Targeted LDL-cholesterol Level at Week 8
timeFrame: Week 8
measure: Percentage of Participants With Response Achieving Targeted LDL-cholesterol Level at Month 6
timeFrame: Month 6
measure: Percentage of Participants With Response Achieving Targeted LDL-cholesterol Level at Month 12
timeFrame: Month 12
Secondary outcomes:
Other outcomes:
Locations:
city: Akersberga
country: Sweden
facility: Pfizer Investigational Site
city: Forshaga
country: Sweden
facility: Pfizer Investigational Site
city: Goteborg
country: Sweden
facility: Pfizer Investigational Site
city: Goteborg
country: Sweden
facility: Pfizer Investigational Site
city: Goteborg
country: Sweden
facility: Pfizer Investigational Site
city: Hoganas
country: Sweden
facility: Pfizer Investigational Site
city: Jonkoping
country: Sweden
facility: Pfizer Investigational Site
city: Lessebo
country: Sweden
facility: Pfizer Investigational Site
city: Lilla Edet
country: Sweden
facility: Pfizer Investigational Site
city: Limhamn
country: Sweden
facility: Pfizer Investigational Site
city: Malmo
country: Sweden
facility: Pfizer Investigational Site
city: Oviken
country: Sweden
facility: Pfizer Investigational Site
city: Partille
country: Sweden
facility: Pfizer Investigational Site
city: Stockholm
country: Sweden
facility: Pfizer Investigational Site
city: Taby
country: Sweden
facility: Pfizer Investigational Site
city: Trollhattan
country: Sweden
facility: Pfizer Investigational Site
city: Vasteras
country: Sweden
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: