Octabaix Intervention Study
This trial is active, not recruiting.
|Treatment||nutritional and a rehabilitation plan.|
|Phase||phase 2/phase 3|
|Sponsor||Jordi Gol i Gurina Foundation|
|Collaborator||Preventive Services and Health Promotion Research Network|
|Start date||January 2009|
|End date||April 2011|
|Trial size||328 participants|
|Trial identifier||NCT01141166, AFF2191|
Objective: To determine the effectiveness of an individual multifactorial intervention on falls and undernutrition risk in very older people in the community.
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
|Masking||double blind (subject, caregiver)|
Rate of falls and rate of undernutrition risk as MNA < 23,5
Different geriatrics characteristics
Male or female participants from 85 years up to 85 years old.
Inclusion Criteria: - Subjects born in 1924 of one of the 7 participating health centers and noninstitutionalized Exclusion Criteria: - Institutionalized
|Official title||A Randomised Controlled Trial on Falls and Malnutrition Prevention in the Community in 85 Year Old Subjects|
|Description||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.|
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