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Octabaix Intervention Study

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

Status
UNKNOWN
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01141166
Enrollment
328
Registered
2010-06-10
Start date
2009-01-31
Completion date
Unknown
Last updated
2010-06-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Falls, Malnutrition

Keywords

ELDERLY, NUTRITION

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.

Interventions

BEHAVIORALnutritional 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.

Sponsors

Preventive Services and Health Promotion Research Network
CollaboratorOTHER
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender
ALL
Age
85 Years to 85 Years
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* Institutionalized

Design outcomes

Primary

MeasureTime frameDescription
Rate of falls and rate of undernutrition risk as MNA < 23,5Nutritional risk was evaluated by the MNA questionnaire

Secondary

MeasureTime frameDescription
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.

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 5, 2026