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| Name | Class |
|---|---|
| Instituto de Salud Carlos III | OTHER_GOV |
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To assess the effect over the nutritional status in patients who are malnourished with chronic heart failure, of an educational intervention and the provision of nutritional supplements. Randomized clinical trial with blind assessors. Unicentric. Follow up: 12 months
Randomized clinical trial with blinded evaluators. (The evaluators will not know the group the patients are assigned. Blinded evaluators are no responsible for randomization and intervention once the patients have been randomized). Patients will be recruited from the cardiology inpatient unit of tertiary hospital, before discharge. Patients will be divided in two groups randomly:
In one arm will be held a double intervention:
In the other arm of the study was carried out regular interventions
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| educational intervention and supplements | Experimental | structured educational intervention and dietary supplements |
|
| usual interventions | Active Comparator | Usual treatment without nutritional supplements or structured assessment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hypercaloric beverages | Dietary Supplement | Nutritional supplement: Hypercaloric beverages |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change on nutritional status measured with Global Subjective Assesment | At inclusion , months 3 and 9 |
| Measure | Description | Time Frame |
|---|---|---|
| Change on quality of life of patients measured with Minnesota Living With Heart Failure Questionnaire, after an educational intervention and nutritional supplement | At inclusion , months 3 and 9 | |
| Change on meters walked in six minutes (functional capacity), after the intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Luis Guerra, Nurse | Hospital General Universitario Gregorio Maranon | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Servicio de NefrologÃa Hospital General universitario Gregorio Maranon | Madrid | Madrid | 28007 | Spain |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Oct 26, 2020 | |
| Reset | Nov 17, 2020 | |
| Release | Feb 14, 2021 | |
| Reset | Mar 4, 2021 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Oct 26, 2020 | Nov 17, 2020 | |||
| Feb 14, 2021 |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| standard treatment | Other | No other than standard treatment |
|
| educational structured counseling | Other | Nutritional counseling leaded to patient and caregivers |
|
| At inclusion , months 3 and 9 |
| Number of readmission. | at month 12 |
| Mar 4, 2021 |