Octabaix Intervention Study

Phase 2

• Conditions: Falls; Malnutrition
• Interventions: Behavioral: nutritional and a rehabilitation plan.

• Registration Number: NCT01141166
• Lead Sponsor: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

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.

Study Timeline

• Study Start: 2009-01
• Study First Submitted: 2010-04-14
• Status Verified: 2010-06
• Study First Submitted QC: 2010-06-09
• Last Update Submitted: 2010-06-09
• Study First Posted: 2010-06-10
• Last Update Posted: 2010-06-10
• Primary Completion: 2011-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 328

Inclusion Criteria

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

Exclusion Criteria

• Institutionalized

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
nutritional and physical rehabilitation plan	nutritional and a rehabilitation plan.	-

Primary Outcome Measures

Name	Time	Method
Rate of falls and rate of undernutrition risk as MNA < 23,5		Nutritional risk was evaluated by the MNA questionnaire

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Assumpta Ferrer Feliu; 🇪🇸 sant Feliu de Llobregat, Barcelona, Spain