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Octabaix Intervention Study

F

Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

Status and phase

Unknown
Phase 3
Phase 2

Conditions

Malnutrition
Falls

Treatments

Behavioral: nutritional and a rehabilitation plan.

Study type

Interventional

Funder types

Other

Identifiers

NCT01141166
AFF2191

Details and patient eligibility

About

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

Full 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.

Enrollment

328 estimated patients

Sex

All

Ages

85 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

  • Institutionalized

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

328 participants in 1 patient group

nutritional and physical rehabilitation plan
Experimental group
Treatment:
Behavioral: nutritional and a rehabilitation plan.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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