This trial is active, not recruiting.

Conditions falls, malnutrition
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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver)
Primary purpose prevention
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.

Primary Outcomes

Rate of falls and rate of undernutrition risk as MNA < 23,5
time frame:

Secondary Outcomes

Different geriatrics characteristics
time frame:

Eligibility Criteria

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

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2010.
Information provided to ClinicalTrials.gov by Jordi Gol i Gurina Foundation.