The impact of home blood pressure measurement on blood pressure control in the elderly

ISRCTN	ISRCTN97164929
DOI	https://doi.org/10.1186/ISRCTN97164929
Protocol serial number	2010-A00701-38
Sponsor	National Institute of Health and Medical Research (Institut National de la Santé et de la Recherche Médicale [INSERM]) (France)
Funders	Ministry of Health (France):, National Institute for Prevention and Health Education (Institut National de Prévention et d'Éducation pour la Santé [INPES]), High Authority of Health (Haute Autorité de Santé [HAS])

Submission date: 21/09/2010
Registration date: 14/10/2010
Last edited: 14/10/2010

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Christophe Tzourio
Scientific

Inserm U708
Hopital de la Salpetriere
Paris
75651
France

Email	christophe.tzourio@upmc.fr

Study information

Primary study design	Observational
Study design	Observational cluster randomised study
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	A longitudinal, cluster randomised, study on the impact of home blood pressure measurement on blood pressure control in the elderly
Study objectives	That self measurement of blood pressure at home by elderly individuals may help to improve blood pressure control
Ethics approval(s)	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)
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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)
Key secondary outcome measure(s)	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)
Completion date	01/02/2011

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	1200
Key inclusion criteria	Volunteers of an ongoing observational cohort study: 1. ≥ 65 year of age 2. Written informed consent
Key exclusion criteria	Does not match inclusion criteria
Date of first enrolment	01/02/2010
Date of final enrolment	01/02/2011

Locations

Countries of recruitment

France

Study participating centre

Inserm U708

Paris
75651
France

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes