Octabaix Intervention Study
|ClinicalTrials.gov Identifier: NCT01141166|
Recruitment Status : Unknown
Verified June 2010 by Jordi Gol i Gurina Foundation.
Recruitment status was: Active, not recruiting
First Posted : June 10, 2010
Last Update Posted : June 10, 2010
|Condition or disease||Intervention/treatment||Phase|
|Falls Malnutrition||Behavioral: nutritional and a rehabilitation plan.||Phase 2 Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||328 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Care Provider)|
|Official Title:||A Randomised Controlled Trial on Falls and Malnutrition Prevention in the Community in 85 Year Old Subjects|
|Study Start Date :||January 2009|
|Estimated Primary Completion Date :||April 2011|
|Experimental: nutritional and physical rehabilitation plan||
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 < 23,5Nutritional risk was evaluated by the MNA questionnaire
- Different geriatrics characteristicsFunctional, 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01141166
|Assumpta Ferrer Feliu|
|sant Feliu de Llobregat, Barcelona, Spain, 08980|