Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT00828945
Previous Study | Return to List | Next Study

Compliance With Treatment For Patients With Hyperlipidemia (COLL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00828945
Recruitment Status : Completed
First Posted : January 26, 2009
Results First Posted : March 22, 2012
Last Update Posted : March 22, 2012
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date January 23, 2009
First Posted Date January 26, 2009
Results First Submitted Date February 16, 2012
Results First Posted Date March 22, 2012
Last Update Posted Date March 22, 2012
Study Start Date February 2009
Actual Primary Completion Date March 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 16, 2012)
  • 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.
  • 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?".
  • 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?".
  • 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?".
  • 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?".
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Primary Outcome Measures
 (submitted: January 23, 2009)
  • Proportion answering "Yes" on, "The self-test have increased my motivation for taking my medication for hyperlipidemia?" [ Time Frame: 1 year ]
  • Proportion answering "Yes" on, "The awareness of my disease have increased my motivation for taking my medication for hyperlipidemia?" [ Time Frame: 1 year ]
  • Proportion answering, "Yes" on, "Have you been taking at least 90% of your medication for hyperlipidemia?" [ Time Frame: 1 year ]
  • Proportion patients with LDL < 2,5 mmol/L [ Time Frame: 1 year ]
  • Proportion answering, "Yes" ,or "No" on, "Have you reached your target LDL-cholesterol level?" [ Time Frame: 1 year ]
Change History Complete list of historical versions of study NCT00828945 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures
 (submitted: January 23, 2009)
There are no secondary outcome measures.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.

Condition Hyperlipidemia
Intervention Device: Lipid Self Test
Self test for lipid levels, twice during study period
Study Groups/Cohorts Hyperlipidemic Patients
Intervention: Device: Lipid Self Test
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: July 28, 2011)
259
Original Estimated Enrollment
 (submitted: January 23, 2009)
300
Actual Study Completion Date March 2011
Actual Primary Completion Date March 2011   (Final data collection date for primary outcome measure)
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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Sweden
Removed Location Countries  
 
Administrative Information
NCT Number NCT00828945
Other Study ID Numbers A2581178
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date February 2012