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
Scientific
Inserm U708
Hopital de la Salpetriere
Paris
75651
France
| 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
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 |
