NCT03348878

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 16, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 21, 2017

Completed
2.1 years until next milestone

Study Start

First participant enrolled

December 16, 2019

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 23, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 23, 2022

Completed
Last Updated

June 23, 2022

Status Verified

June 1, 2022

Enrollment Period

2.3 years

First QC Date

November 16, 2017

Last Update Submit

June 17, 2022

Conditions

Uncontrolled Hypertension

Keywords

drug compliancehypertensionanti-hypertensive agents

Outcome Measures

Primary Outcomes (1)

  • individual pattern of drug compliance

    compliance measurement using electronic monitoring devices

    2 months of follow-up

Secondary Outcomes (4)

  • Percentage of Prescribed Dosing Days with Correct Intake

    2 months of follow-up

  • Percentage of Prescribed Dose Taken

    2 months of follow-up

  • Percentage of Drug Holidays

    2 months of follow-up

  • Time Variability in Drug Intake

    2 months of follow-up

Study Arms (1)

cohort of uncontrolled hypertensive patients

OTHER
Other: assessment of drug compliance

Interventions

assessment of drug complianceOTHER

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

cohort of uncontrolled hypertensive patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Louis Pradel

Bron, France

Location

MeSH Terms

Conditions

Medication AdherenceHypertension

Condition Hierarchy (Ancestors)

Patient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehaviorVascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 16, 2017

First Posted

November 21, 2017

Study Start

December 16, 2019

Primary Completion

March 23, 2022

Study Completion

March 23, 2022

Last Updated

June 23, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)