Condition category
Circulatory System
Date applied
21/09/2010
Date assigned
14/10/2010
Last edited
14/10/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Christophe Tzourio

ORCID ID

Contact details

Inserm U708
Hopital de la Salpetriere
Paris
75651
France
christophe.tzourio@upmc.fr

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

2010-A00701-38

Study information

Scientific title

A longitudinal, cluster randomised, study on the impact of home blood pressure measurement on blood pressure control in the elderly

Acronym

Study hypothesis

That self measurement of blood pressure at home by elderly individuals may help to improve blood pressure control

Ethics approval

The Regional Ethics Committee (Comité de Protection des Personnes [CPP] Ile-de-France 7) approved on the 10th of June 1999 for the main cohort and on the 7th of July 2010 for the present study (ref: SC10-004)

Study design

Observational cluster randomised study

Primary study design

Observational

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Prevention

Patient information sheet

Not available in web format, please use contact details below to request a patient information sheet

Condition

Hypertension

Intervention

Patients to the clinic will be randomised by week, those visiting on even weeks will be assigned to:
1. Regular (every 3 months) self-measurement of blood pressure at home with an automatic device
Those visiting on odd weeks will be assigned to:
2. No regular self-measurement
The total duration of the intervention will be one year.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Difference of office mean values of systolic and diastolic blood pressure among hypertensives between both groups at the end of the intervention period (1 year)

Secondary outcome measures

1. Difference of home mean values of systolic and diastolic blood pressure among hypertensives between both groups
2. Difference of percentage of participants with hypertension between both groups
3. Difference of use of antihypertensive drugs between both groups
4. Frequency of masked and white coat hypertension and difference between both groups
5. Feasibility
All outcomes will be measured at the end of the intervention period (1 year)

Overall trial start date

01/02/2010

Overall trial end date

01/02/2011

Reason abandoned

Eligibility

Participant inclusion criteria

Volunteers of an ongoing observational cohort study:
1. ≥ 65 year of age
2. Written informed consent

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

600 in each arm (total of 1200)

Participant exclusion criteria

Does not match inclusion criteria

Recruitment start date

01/02/2010

Recruitment end date

01/02/2011

Locations

Countries of recruitment

France

Trial participating centre

Inserm U708
Paris
75651
France

Sponsor information

Organisation

National Institute of Health and Medical Research (Institut National de la Santé et de la Recherche Médicale [INSERM]) (France)

Sponsor details

INSERM U708
Hopital de la Salpetriere
Paris
75651
France

Sponsor type

Research organisation

Website

Funders

Funder type

Government

Funder name

Ministry of Health (France):

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

National Institute for Prevention and Health Education (Institut National de Prévention et d'Éducation pour la Santé [INPES])

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

High Authority of Health (Haute Autorité de Santé [HAS])

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes