Octabaix Intervention Study

Malnutrition Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01141166
• Other study ID #: AFF2191
• Status: Active, not recruiting
• Phase: Phase 2/Phase 3
• First received: April 14, 2010
• Last updated: June 9, 2010
• Start date: January 2009

Study information

• Verified date: June 2010
• Source: Jordi Gol i Gurina Foundation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 328
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 85 Years to 85 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Institutionalized

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Falls
• Malnutrition

Intervention

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.

Locations

Country	Name	City	State
Spain	Assumpta Ferrer Feliu	sant Feliu de Llobregat	Barcelona

Sponsors (2)

Lead Sponsor	Collaborator
Jordi Gol i Gurina Foundation	Preventive Services and Health Promotion Research Network

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of falls and rate of undernutrition risk as MNA < 23,5	Nutritional risk was evaluated by the MNA questionnaire
Secondary	Different geriatrics characteristics	Functional, 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.