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Clinical Trials/NCT01141166
NCT01141166
Unknown
Phase 2

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

Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina1 site in 1 country328 target enrollmentJanuary 2009

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Falls
Sponsor
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Enrollment
328
Locations
1
Primary Endpoint
Rate of falls and rate of undernutrition risk as MNA < 23,5
Last Updated
15 years ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
January 2009
End Date
April 2011
Last Updated
15 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

Eligibility Criteria

Inclusion Criteria

  • Subjects born in 1924 of one of the 7 participating health centers and noninstitutionalized

Exclusion Criteria

  • Institutionalized

Outcomes

Primary Outcomes

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

Nutritional risk was evaluated by the MNA questionnaire

Secondary Outcomes

  • Different geriatrics characteristics

Study Sites (1)

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