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Octabaix Intervention Study

Primary Purpose

Falls, Malnutrition

Status
Unknown status
Phase
Phase 2
Locations
Spain
Study Type
Interventional
Intervention
nutritional and a rehabilitation plan.
Sponsored by
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Falls focused on measuring ELDERLY, NUTRITION

Eligibility Criteria

85 Years - 85 Years (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • Institutionalized

Sites / Locations

  • Assumpta Ferrer Feliu

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

nutritional and physical rehabilitation plan

Arm Description

Outcomes

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.

Full Information

First Posted
April 14, 2010
Last Updated
June 9, 2010
Sponsor
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Collaborators
Preventive Services and Health Promotion Research Network
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1. Study Identification

Unique Protocol Identification Number
NCT01141166
Brief Title
Octabaix Intervention Study
Official Title
A Randomised Controlled Trial on Falls and Malnutrition Prevention in the Community in 85 Year Old Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
June 2010
Overall Recruitment Status
Unknown status
Study Start Date
January 2009 (undefined)
Primary Completion Date
April 2011 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Collaborators
Preventive Services and Health Promotion Research Network

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Falls, Malnutrition
Keywords
ELDERLY, NUTRITION

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
328 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
nutritional and physical rehabilitation plan
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
nutritional and a rehabilitation plan.
Intervention Description
The intervention consisted of recommendations to the subject and their primary physician, and others providers, telephone calls of a nutritional and a rehabilitation plan.
Primary Outcome Measure Information:
Title
Rate of falls and rate of undernutrition risk as MNA < 23,5
Description
Nutritional risk was evaluated by the MNA questionnaire
Secondary Outcome Measure Information:
Title
Different geriatrics characteristics
Description
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
85 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects born in 1924 of one of the 7 participating health centers and noninstitutionalized Exclusion Criteria: Institutionalized
Facility Information:
Facility Name
Assumpta Ferrer Feliu
City
sant Feliu de Llobregat
State/Province
Barcelona
ZIP/Postal Code
08980
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
25887312
Citation
Badia T, Formiga F, Ferrer A, Sanz H, Hurtos L, Pujol R. Multifactorial assessment and targeted intervention in nutritional status among the older adults: a randomized controlled trial: the Octabaix study. BMC Geriatr. 2015 Apr 11;15:45. doi: 10.1186/s12877-015-0033-0.
Results Reference
derived
PubMed Identifier
24596458
Citation
Ferrer A, Formiga F, Sanz H, de Vries OJ, Badia T, Pujol R; OCTABAIX Study Group. Multifactorial assessment and targeted intervention to reduce falls among the oldest-old: a randomized controlled trial. Clin Interv Aging. 2014 Feb 25;9:383-93. doi: 10.2147/CIA.S57580. eCollection 2014.
Results Reference
derived

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Octabaix Intervention Study

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