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Octabaix Intervention Study

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2010 by Jordi Gol i Gurina Foundation.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01141166
First Posted: June 10, 2010
Last Update Posted: June 10, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Preventive Services and Health Promotion Research Network
Information provided by:
Jordi Gol i Gurina Foundation
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Prevention
Official Title: A Randomised Controlled Trial on Falls and Malnutrition Prevention in the Community in 85 Year Old Subjects

Resource links provided by NLM:


Further study details as provided by Jordi Gol i Gurina Foundation:

Primary Outcome Measures:
  • Rate of falls and rate of undernutrition risk as MNA < 23,5
    Nutritional risk was evaluated by the MNA questionnaire


Secondary Outcome Measures:
  • 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.


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

Information from the National Library of Medicine

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Ages Eligible for Study:   85 Years to 85 Years   (Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Institutionalized
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01141166


Locations
Spain
Assumpta Ferrer Feliu
sant Feliu de Llobregat, Barcelona, Spain, 08980
Sponsors and Collaborators
Jordi Gol i Gurina Foundation
Preventive Services and Health Promotion Research Network
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Cecíla Borau, Jordi Gol i Gurina Foundation
ClinicalTrials.gov Identifier: NCT01141166     History of Changes
Other Study ID Numbers: AFF2191
First Submitted: April 14, 2010
First Posted: June 10, 2010
Last Update Posted: June 10, 2010
Last Verified: June 2010

Keywords provided by Jordi Gol i Gurina Foundation:
ELDERLY
NUTRITION

Additional relevant MeSH terms:
Malnutrition
Nutrition Disorders