Octabaix Intervention Study
Recruitment status was Active, not recruiting
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Purpose
Objective: To determine the effectiveness of an individual multifactorial intervention on falls and undernutrition risk in very older people in the community.
| Condition | Intervention | Phase |
|---|---|---|
|
Falls Malnutrition |
Behavioral: nutritional and a rehabilitation plan. |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver) Primary Purpose: Prevention |
| Official Title: | A Randomised Controlled Trial on Falls and Malnutrition Prevention in the Community in 85 Year Old Subjects |
- Rate of falls and rate of undernutrition risk as MNA < 23,5Nutritional risk was evaluated by the MNA questionnaire
- Different geriatrics characteristicsFunctional, 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.
| Estimated Enrollment: | 328 |
| Study Start Date: | January 2009 |
| Estimated Primary Completion Date: | April 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: nutritional and physical rehabilitation plan |
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.
|
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.
Eligibility| Ages Eligible for Study: | 85 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Subjects born in 1924 of one of the 7 participating health centers and noninstitutionalized
Exclusion Criteria:
- Institutionalized
Contacts and Locations More Information
No publications provided
| Responsible Party: | Cecíla Borau, Jordi Gol i Gurina Foundation |
| ClinicalTrials.gov Identifier: | NCT01141166 History of Changes |
| Other Study ID Numbers: | AFF2191 |
| Study First Received: | April 14, 2010 |
| Last Updated: | June 9, 2010 |
| Health Authority: | Spain: Ethics Committee |
Keywords provided by Jordi Gol i Gurina Foundation:
|
ELDERLY NUTRITION |
Additional relevant MeSH terms:
|
Malnutrition Nutrition Disorders |
ClinicalTrials.gov processed this record on May 16, 2013