NCT01998022

Brief Summary

Numerous studies highlight the insufficiency of blood pressure control in treated hypertensive population \[1\]. As shown in the MONICA study, increased cardiovascular mortality is found in Alsace compared to other french regions. The incidence and prevalence of diabetes and obesity are likely explanatory factors leading to this excess mortality \[2\]. Furthermore, the incidence and prevalence of alsacian patients with end-stage renal failure (ESRD) is also higher than the national average. The high prevalence of diabetes, hypertension and obesity in this population is also probably responsible for the high prevalence of ESRD \[3\]. Opportunities to prevent the progression of kidney disease involve an optimal control of treatable evolutionary factors. Beyond control of diabetes and obesity, optimization of blood pressure control are an important factor to consider, as national and international guidelines recommend lower blood pressure targets in this population \[4\]. Knowledge of the disease and treatment goals are a key component of hypertensive patient management. Studies have shown that the knowledge of hypertensive disease and therapeutic targets were correlated with treatment compliance and with the rate of blood pressure control \[5\]. Patient education and participation of non-medical actors (nurses, pharmacists, …) are likely to improve the management and treatment compliance of these patients \[6\]. To our knowledge, no investigation has been performed in our region to determine the epidemiological characteristics, the knowledge level and blood pressure control in the population of hypertensive patients. The main objectives of this observational study are to evaluate, in a treated hypertensive population: the knowledge level of the blood pressure treatment goals, the impact of patient knowledge on this blood pressure control, the potential impact of the patient's comorbidities on his blood pressure control. Such a study should provide the basis for the feasibility of a large survey.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
383

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2013

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2013

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

October 24, 2013

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 28, 2013

Completed
3 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
Last Updated

October 3, 2014

Status Verified

October 1, 2014

Enrollment Period

8 months

First QC Date

October 24, 2013

Last Update Submit

October 2, 2014

Conditions

Keywords

hypertensionknowledgeblood pressure control

Outcome Measures

Primary Outcomes (1)

  • percentage of patients knowing the blood pressure target

    Patients are included for the time of form completion, an expected average of 15 minutes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Treated hypertensive population

You may qualify if:

  • Hypertensive patients moving spontaneously to their pharmacy to get their usual medications, including at least one drug in the class of anti-hypertensive

You may not qualify if:

  • Refusal or inability of the patient to respond to the questionnaire.
  • Antihypertensive therapy changed in the month preceding the survey.
  • Antihypertensive therapy initiated within three months preceding the survey.
  • Age \<18 years.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHMulhouse

Mulhouse, 68100, France

Location

Related Publications (6)

  • Mancia G, Sega R, Milesi C, Cesana G, Zanchetti A. Blood-pressure control in the hypertensive population. Lancet. 1997 Feb 15;349(9050):454-7. doi: 10.1016/s0140-6736(96)07099-7.

    PMID: 9040574BACKGROUND
  • Berard E, Bongard V, Arveiler D, Amouyel P, Wagner A, Dallongeville J, Haas B, Cottel D, Ruidavets JB, Ferrieres J. Ten-year risk of all-cause mortality: assessment of a risk prediction algorithm in a French general population. Eur J Epidemiol. 2011 May;26(5):359-68. doi: 10.1007/s10654-010-9541-6. Epub 2010 Dec 28.

    PMID: 21188478BACKGROUND
  • Registre REIN Rapport annuel 2010

    BACKGROUND
  • Mancia G, Laurent S, Agabiti-Rosei E, Ambrosioni E, Burnier M, Caulfield MJ, Cifkova R, Clement D, Coca A, Dominiczak A, Erdine S, Fagard R, Farsang C, Grassi G, Haller H, Heagerty A, Kjeldsen SE, Kiowski W, Mallion JM, Manolis A, Narkiewicz K, Nilsson P, Olsen MH, Rahn KH, Redon J, Rodicio J, Ruilope L, Schmieder RE, Struijker-Boudier HA, Van Zwieten PA, Viigimaa M, Zanchetti A. Reappraisal of European guidelines on hypertension management: a European Society of Hypertension Task Force document. Blood Press. 2009;18(6):308-47. doi: 10.3109/08037050903450468. No abstract available.

    PMID: 20001654BACKGROUND
  • Atallah A, Papouin G, Mimran C, Braunstein C, Ganty J, Larifla L, Djaballah K, Inamo J. [Knowledge of hypertension among hypertensive patients in general practice, and its relation to achieving therapeutic goals: The Co-HACT study, French West Indies]. Ann Cardiol Angeiol (Paris). 2011 Feb;60(1):21-6. doi: 10.1016/j.ancard.2010.06.001. Epub 2010 Jul 16. French.

    PMID: 20800218BACKGROUND
  • M Ashok Kumar. Improving medication adherence and clinical outcomes of hypertensive patients through patient counseling. Research Journal of Pharmaceutical, Biological and Chemical Sciences 2011; 2: 232-241

    BACKGROUND

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 24, 2013

First Posted

November 28, 2013

Study Start

April 1, 2013

Primary Completion

December 1, 2013

Study Completion

January 1, 2014

Last Updated

October 3, 2014

Record last verified: 2014-10

Locations