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REPRESS is an open label, pragmatic, multicenter, randomized controlled phase III trial with blinded endpoint with 1:1 (intervention to control arm) allocation ratio.
The REPRESS trial is aimed to determine the efficacy of an educational intervention aimed at reducing dietary salt intake in elderly people (60+) with moderate hypertension and exposed to polypharmacy (3+ drugs) in improving systolic BP control compared to an attention arm.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Patients randomized to intervention arm during the 12 weeks after randomization will receive on their smartphone and/or via e-mail, information materials such as videos, images and recipes for reminders specifically designed to make patients aware on the importance of reducing dietary salt intake and suggestions on how to do it. The educational interventions will be delivered once a week. The main objective of the educational interventions is to spread knowledge about the health risks of excessive salt intake, the actual amount of salt in food, measures to reduce salt intake (e.g. use spices, eat fresh fruits and vegetables, check food labels, gradually reduce the salt in favorite recipes, avoid putting salt and salty sauces on the table, etc.). The interventions, conceived with nutritionists, will be delivered once a week to the participants and to their caregivers and/or the closest family member, involved in the food shopping and the preparation of meals. |
|
| Control | No Intervention | Patients randomized to Control Group will only receive short tips on controlling blood pressure. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| educational intervention | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in systolic BP | The primary outcome will be the change in systolic BP defined as the difference from baseline to 12 weeks follow-up in the two study groups. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in 24-hour urinary sodium excretion | The change in the level of 24-hour urinary sodium excretion as the difference from baseline to 12 weeks follow-up (short follow-up), or 6 and 12 months (long follow-up) in the two study arms | 6 and 12 months |
| Change in adherence to the mediterranean diet |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Carlotta Franchi | Contact | +39 02 39014580 | carlotta.franchi@marionegri.it |
| Name | Affiliation | Role |
|---|---|---|
| Carlotta Franchi | Istituto Di Ricerche Farmacologiche Mario Negri | Principal Investigator |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D018479 | Early Intervention, Educational |
| ID | Term |
|---|---|
| D002662 | Child Health Services |
| D003153 | Community Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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|
The change in dietary habits of elderly patients during the 12 months follow-up in the two study groups measured by the adherence to Meditteranean Diet evaluated through the PREDIMED score (higher values correspond to better quality diet) |
| 6 and 12 months |
| Incidence of cardio- and cerebro-vascular events | The difference in the incidence of cardio- and cerebro-vascular events during 12-months follow-up between the intervention and the control arm | 12 months |
| D011314 | Preventive Health Services |