NCT01141166

Octabaix Intervention Study

A Randomised Controlled Trial on Falls and Malnutrition Prevention in the Community in 85 Year Old Subjects

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 328 (estimated)
• Sponsor: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina · Academic / Other
• Sex: All
• Age: 85 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

Objective: To determine the effectiveness of an individual multifactorial intervention on falls and undernutrition risk in very older people in the community.

Detailed 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.

Conditions

• Falls
• Malnutrition

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2009-01-01
• Primary completion: 2011-04-01
• First posted: 2010-06-10
• Last updated: 2010-06-10

Locations

1 site across 1 country: Spain