Compliance With Treatment For Patients With Hyperlipidemia (COLL)
This study has been completed.
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00828945
First received: January 23, 2009
Last updated: February 16, 2012
Last verified: February 2012
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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
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 May 16, 2013