Octabaix Intervention Study

Study 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.

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

Conditions
-----------------
Falls, Malnutrition

Intervention / Treatment
-----------------
* Behavioral: nutritional and a rehabilitation plan.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects born in 1924 of one of the 7 participating health centers and noninstitutionalized Exclusion Criteria: Institutionalized

Ages Eligible for Study
-----------------
Minimum Age: 85 Years
Maximum Age: 85 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: nutritional and physical rehabilitation plan<br> | Behavioral: nutritional and a rehabilitation plan.<br>* The intervention consisted of recommendations to the subject and their primary physician, and others providers, telephone calls of a nutritional and a rehabilitation plan.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of falls and rate of undernutrition risk as MNA < 23,5 | Nutritional risk was evaluated by the MNA questionnaire |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ELDERLY, NUTRITION