Compliance With Treatment For Patients With Hyperlipidemia (COLL)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00828945
First received: January 23, 2009
Last updated: February 16, 2012
Last verified: February 2012
  Purpose

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.


Condition Intervention
Hyperlipidemia
Device: Lipid Self Test

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Percentage of Participants With Positive Response on Increased Motivation Using a Self-test at Month 12 [ Time Frame: Month 12 ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants With Positive Response on Increased Motivation After Awareness at Month 12 [ Time Frame: Month 12 ] [ Designated as safety issue: No ]
    Participants with "Yes" response to a question which stated "The awareness of my disease has increased my motivation for taking my medication for hyperlipidemia?".

  • Percentage of Participants With Positive Response on Self-estimated Treatment Compliance at Week 8 [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
    Participants with "Yes" response to a question which stated "Have you been taking at least 90% of your medication for hyperlipidemia?".

  • Percentage of Participants With Positive Response on Self-estimated Treatment Compliance at Month 6 [ Time Frame: Month 6 ] [ Designated as safety issue: No ]
    Participants with "Yes" response to a question which stated "Have you been taking at least 90% of your medication for hyperlipidemia?".

  • Percentage of Participants With Positive Response on Self-estimated Treatment Compliance at Month 12 [ Time Frame: Month 12 ] [ Designated as safety issue: No ]
    Participants with "Yes" response to a question which stated "Have you been taking at least 90% of your medication for hyperlipidemia?".

  • Percentage of Participants With LDL Lower Than 2.5 mmol/L at Week 8 [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
    LDL levels were self-assessed by participants using CARE diagnostica LDL-cholesterol test.

  • Percentage of Participants With LDL Lower Than 2.5 mmol/L at Month 6 [ Time Frame: Month 6 ] [ Designated as safety issue: No ]
    LDL levels were self-assessed by participants using CARE diagnostica LDL-cholesterol test.

  • Percentage of Participants With LDL Lower Than 2.5 mmol/L at Month 12 [ Time Frame: Month 12 ] [ Designated as safety issue: No ]
    LDL levels were self-assessed by participants using CARE diagnostica LDL-cholesterol test.

  • Percentage of Participants With Response Achieving Targeted LDL-cholesterol Level at Week 8 [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants With Response Achieving Targeted LDL-cholesterol Level at Month 6 [ Time Frame: Month 6 ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants With Response Achieving Targeted LDL-cholesterol Level at Month 12 [ Time Frame: Month 12 ] [ Designated as safety issue: No ]
    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.


Enrollment: 259
Study Start Date: February 2009
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Hyperlipidemic Patients Device: Lipid Self Test
Self test for lipid levels, twice during study period

Detailed Description:

Consecutive patient sampling

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00828945

Locations
Sweden
Pfizer Investigational Site
Akersberga, Sweden, 184 27
Pfizer Investigational Site
Forshaga, Sweden, 667 32
Pfizer Investigational Site
Goteborg, Sweden, 405 30
Pfizer Investigational Site
Goteborg, Sweden, 415 10
Pfizer Investigational Site
Goteborg, Sweden, 41665
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
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00828945     History of Changes
Other Study ID Numbers: A2581178
Study First Received: January 23, 2009
Results First Received: February 16, 2012
Last Updated: February 16, 2012
Health Authority: Sweden: Swedish Research Council

Additional relevant MeSH terms:
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on September 18, 2014