An interventional study of assessment of drug compliance in Uncontrolled Hypertension, sponsored by Hospices Civils de Lyon. Terminated at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-06-23.
Sponsored by Hospices Civils de Lyon · Not applicable, Interventional, and Other
Therapeutic compliance is defined as the degree of coincidence between a person's behavior and prescribing advice given by his or her physician. According to the World Health Organization (WHO), "insufficient adherence is the main reason why patients do not get all the benefits they could expect from their medicines. It causes medical and psychosocial complications, diminishes the quality of life of patients, increases the likelihood of drug resistance, and waste of resources. " In the case of certain conditions such as high blood pressure (hypertension), poor adherence increases the risk of stroke, acute coronary syndrome, and heart failure.
In patients with uncontrolled hypertension under treatment, the issue of therapeutic non-compliance should always be considered before considering the dose (supplemental drug) of antihypertensive therapy.
For each patient participating in the study, medication adherence (for one of the antihypertensive treatments) will be assessed for 2 months using an electronic pill. The antihypertensive treatments considered for the study belong to the following classes: diuretics, beta-blockers, calcium-blockers, ACE (angiotensin-converting enzyme) inhibitors, sartans.
Main objective: care objective: to provide physicians and patients with assistance in case of ineffectiveness or therapeutic escape in a chronic disease such as hypertension, by assessing the compliance profile of each patient.
Secondary objectives: to carry out a quantitative typology of drug adherence in patients with unbalanced HTA under treatment.
Exclusion Criteria:
Other: assessment of drug compliance
assessment of drug compliance using electronic monitoring devices (2 months duration)
individual pattern of drug compliance
compliance measurement using electronic monitoring devices
Time frame: 2 months of follow-up
Percentage of Prescribed Dosing Days with Correct Intake
The percentage of days with accurate dose intake is defined according to the reference: Vrijens B, Goetghebeur E. Comparing compliance patterns between randomized treatments. Control Clin Trials. 1997 Jun;18(3):187-203.
Time frame: 2 months of follow-up
Percentage of Prescribed Dose Taken
This measure, though often close to the previous one, focuses on the dose actually received and is defined according to the reference: Vrijens B, Goetghebeur E. Comparing compliance patterns between randomized treatments. Control Clin Trials. 1997 Jun;18(3):187-203.
Time frame: 2 months of follow-up
Percentage of Drug Holidays
We define a "drug holiday" as a period of one or more days without drug intake (that is, without MEMS (Medication Event Monitoring System) opening). The statistic counts the number of gaps among the prescribed days, ignoring the length of each individual gap, according to the reference: Vrijens B, Goetghebeur E. Comparing compliance patterns between randomized treatments. Control Clin Trials. 1997 Jun;18(3):187-203.
Time frame: 2 months of follow-up
Time Variability in Drug Intake
summary measures consider only the number of medication events each day, according to the reference: Vrijens B, Goetghebeur E. Comparing compliance patterns between randomized treatments. Control Clin Trials. 1997 Jun;18(3):187-203.
Time frame: 2 months of follow-up
Plan to share: No
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This study is terminated, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.
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Hospices Civils de Lyon