THERMO-HTA: Descriptive Study of Drug Compliance in Uncontrolled Hypertensive Patients

Sponsor

Hospices Civils de Lyon (Other)

Overall Status

Terminated

CT.gov ID

NCT03348878

Collaborator

(none)

Enrollment

Location

Arm

27.2

Actual Duration (Months)

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Uncontrolled Hypertension	Other: assessment of drug compliance	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

4 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

Drug Compliance of Patients With Uncontrolled Hypertension Under Treatment: a Pilot Study (Descriptive, Prospective, Monocentric Cohort)

Actual Study Start Date :

Dec 16, 2019

Actual Primary Completion Date :

Mar 23, 2022

Actual Study Completion Date :

Mar 23, 2022

Arms and Interventions

Arm	Intervention/Treatment
Other: cohort of uncontrolled hypertensive patients	Other: assessment of drug compliance assessment of drug compliance using electronic monitoring devices (2 months duration)

Arm

Intervention/Treatment

Other: cohort of uncontrolled hypertensive patients

Other: assessment of drug compliance

assessment of drug compliance using electronic monitoring devices (2 months duration)

Outcome Measures

Primary Outcome Measures

individual pattern of drug compliance [2 months of follow-up]
compliance measurement using electronic monitoring devices

Secondary Outcome Measures

Percentage of Prescribed Dosing Days with Correct Intake [2 months of follow-up]
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.
Percentage of Prescribed Dose Taken [2 months of follow-up]
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.
Percentage of Drug Holidays [2 months of follow-up]
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 Variability in Drug Intake [2 months of follow-up]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

patient treated with diuretics and / or beta-blockers and / or calcium-blockers and / or ACE inhibitors and / or sartans
Holter blood pressure total average of 24h greater than 135/85 mmHg or a daytime average greater than 140/90 mmHg or a nighttime average greater than 125/75 mmHg.
informed consent given

Exclusion Criteria:

Adults with severe hypertension (BP ≥ 180/110 mmHg) with or without organ failure requiring therapeutic adaptation
Adults unable to comply with study procedures
Patients who do not wish to receive generic drugs.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hôpital Louis Pradel	Bron		France

Sponsors and Collaborators

Hospices Civils de Lyon

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hospices Civils de Lyon

ClinicalTrials.gov Identifier:

NCT03348878

Other Study ID Numbers:

69HCL17_0325

First Posted:

Nov 21, 2017

Last Update Posted:

Jun 23, 2022

Last Verified:

Jun 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Hospices Civils de Lyon

drug compliance

hypertension

anti-hypertensive agents

Additional relevant MeSH terms:

Hypertension

Study Results

No Results Posted as of Jun 23, 2022