A Phase 2/3 interventional study of nutritional and a rehabilitation plan. in Falls and Malnutrition, sponsored by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina. Status unknown at 1 site in Spain. Open to participants aged 85 Years to 85 Years. Per ClinicalTrials.gov, last updated 2010-06-10.
Sponsored by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina · Phase 2/3, Interventional, and Prevention
Objective: To determine the effectiveness of an individual multifactorial intervention on falls and undernutrition risk in very older people in the community.
Design: Randomized, controlled trial.
Method: Three hundred and twenty eight people born in 1924, after recruitment will be followed for a three year period. Subjects received two in-home visits from a trained nurse or physicians who assessed falls and nutritional risk factors using an algorithm.
The intervention consisted of recommendations to the subject and their primary physician, and other providers, telephone calls, and exercise and nutritional plan. Control subjects received a general primary care assessment.
Measurements: the primary outcome were rate of falls and rate of undernourished risk. Secondary outcomes included different geriatrics characteristics.The outcomes of this study will provide important new information to reduce the incidence of falls and the risk of undernutrition of this population by intervention. Significant differences are not expected according to social-demographics sex and other factors, but they are expected by other obtained factors and indices that could allow to detection of octogenarian people with great risk of deterioration in just a short time.
1,587 studies on the registry are indexed under Malnutrition; 237 are open to participants now.
This study's planned enrollment of 328 is above the median of 90 across 1,134 interventional studies indexed under Malnutrition.
Browse Malnutrition studies →Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina is the lead sponsor of 158 studies on the registry; 20 are open to participants now.
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Exclusion Criteria:
Behavioral: nutritional and a rehabilitation plan.
The intervention consisted of recommendations to the subject and their primary physician, and others providers, telephone calls of a nutritional and a rehabilitation plan.
Rate of falls and rate of undernutrition risk as MNA < 23,5
Nutritional risk was evaluated by the MNA questionnaire
Different geriatrics characteristics
Functional, cognitive and nutritional status and social risk were assessed by instruments currently used in geriatric practice. Functional status was measured using the BI (Mahoney and Barthel, 1965) for the basic ADL, and the Lawton index (LI) (Lawton and Brody, 1969). Cognitive function was measured by the Spanish version (MEC) (Lobo et al., 1999) of the MMSE. Comorbidity by the Charlson comorbidity index (CCI)and the others.
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Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina