L89 K59
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Residents of Vivantes Hauptstadtpflege Haus Leonore: age = 65 years
Exclusion criteria
Exclusion criteria: Absolute non-compliance likely (e.g., due to severe dementia syndrome, Korsakow's syndrome, etc.) = non-compliance with the Instructions of the nursing staff - In temporary care/preventive care only. - Nutritional therapy has already been initiated Acute situations, such as acute severe inflammatory event (e.g. pancreas) or acute organ insufficiency - Contraindication for nutritional support exists, such as condition in the terminal phase of death - Cardiac pacemaker is inserted (as these persons must be excluded from a BIA measurement). must be excluded)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint of this study is the recurrence of an adverse clinical event within clinical event within 10 weeks (y/n). This is a composite endpoint, consisting of various geriatric Comorbidities that potentially increase the burden of care: Recurrence Wound area/decubitus or visible enlargement Wound area/decubitus or New onset Falls or new onset Hospitalizations or new onset Constipation or 10% decrease in Barthel index of the Barthel Index, which measures the ability to perform daily tasks of self-care. Once at least one of these events occurs, it is clinical outcome (ACO=yes), if none of these events is new, the patient is If none of these events occurs, then by definition there is no new adverse clinical outcome (ACO=no). This composite endpoint is dichotomous, it is is formed following Schuetz et al [5]. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints of this study are all comorbidities summarized in the composite endpoint Comorbidities summarized, each considered individually: New onset or Worsening Wound area/decubiti, new occurrence Falls, new occurrence Hospitalizations, new onset of constipation/cases of constipation, new onset or worsening diarrhea, new-onset aspiration, and the Barthel index. Because nutritional status has been shown in previous studies to be closely associated with multimorbidity, a further secondary endpoint will be body weight and risk of body weight and the risk of malnutrition and sarcopenia, measured by Mini Nutritional Risk Screenings (Long Form), and the SARC-F Questionnaire. | — |
Countries
Germany
Contacts
Vivantes Humboldt Klinikum