N/A
N=257
Compliance With Treatment For Patients With Hyperlipidemia
Hyperlipidemia
Bottom Line
View on ClinicalTrials.gov: NCT00828945 ↗Enrolled (actual)
257
Serious AEs
2.7%
Results posted
Mar 2012
Primary outcome: Primary: Percentage of Participants With Positive Response on Increased Motivation Using a Self-test at Month 12 — 36.2 Percentage of participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Lipid Self Test (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Primary completion
- Mar 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Positive Response on Increased Motivation Using a Self-test at Month 12 |
36.2 | — |
| PRIMARY Percentage of Participants With Positive Response on Increased Motivation After Awareness at Month 12 |
54.9 | — |
| PRIMARY Percentage of Participants With Positive Response on Self-estimated Treatment Compliance at Week 8 |
74.3 | — |
| PRIMARY Percentage of Participants With Positive Response on Self-estimated Treatment Compliance at Month 6 |
61.1 | — |
| PRIMARY Percentage of Participants With Positive Response on Self-estimated Treatment Compliance at Month 12 |
75.9 | — |
| PRIMARY Percentage of Participants With LDL Lower Than 2.5 mmol/L at Week 8 |
9.3 | — |
| PRIMARY Percentage of Participants With LDL Lower Than 2.5 mmol/L at Month 6 |
8.2 | — |
| PRIMARY Percentage of Participants With LDL Lower Than 2.5 mmol/L at Month 12 |
51.4 | — |
| PRIMARY Percentage of Participants With Response Achieving Targeted LDL-cholesterol Level at Week 8 |
14.8; 18.3 | — |
| PRIMARY Percentage of Participants With Response Achieving Targeted LDL-cholesterol Level at Month 6 |
14.0; 10.1 | — |
| PRIMARY Percentage of Participants With Response Achieving Targeted LDL-cholesterol Level at Month 12 |
31.9; 13.6 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT00828945). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.