Effectiveness of a Multifactorial Intervention on Frailty
NCT ID: NCT01969526
Last Updated: 2017-11-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
352 participants
INTERVENTIONAL
2013-01-31
2017-09-30
Brief Summary
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Methods: randomized clinical trial with a control group, of one year and a half of follow-up, conducted in eight primary care teams in Barcelona. Individuals to be included are 65 years or older with positive frailty screening, timed get-up-and-go between 10 to 30 seconds, and cognitive Lobo test greater than or equal to 18. 165 patients will be selected in each group (difference to be detected on physical performance (Short physical performance battery (SPPB)): 0.5 units; common Standard Deviation : 1.42, 20% lost to follow-up).
Intervention: consists in three different actions on frailty dimensions, applied to each subject in the intervention group, in groups of 15 participants: rehabilitative therapy plus intake of hyperproteic shakes, memory workshop and review of the medication.
Evaluations will be blinded and conducted at 0, 3 and 18 months. Analysis of variance for repeated measures to adjust for differences attributable to intervention effect and for potential confounders such as comorbidity, sensory limitations, social risk, other medical or social interventions, among others.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Multifactorial Intervention
Intervention consists in three different actions on frailty dimensions, applied to each subject in the intervention group, in groups of 15 participants: rehabilitative therapy plus intake of hyperproteic shakes, memory workshop and review of the medication.
Multifactorial intervention
Intervention consists in three different actions on frailty dimensions, applied to each subject in the intervention group, in groups of 15 participants: rehabilitative therapy and physical exercise plus intake of hyperproteic shakes, memory workshop and review of the medication.
No intervention
Usual care
No interventions assigned to this group
Interventions
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Multifactorial intervention
Intervention consists in three different actions on frailty dimensions, applied to each subject in the intervention group, in groups of 15 participants: rehabilitative therapy and physical exercise plus intake of hyperproteic shakes, memory workshop and review of the medication.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Timed get-up-and-go 10 to 20 seconds
* cognitive Lobo test greater than or equal to 18
Exclusion Criteria
* Institutionalization
* Conditions not allowing physical exercise
65 Years
ALL
No
Sponsors
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Carlos III Health Institute
OTHER_GOV
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
OTHER
Responsible Party
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Principal Investigators
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Josep Maria segura, MD, Phd
Role: PRINCIPAL_INVESTIGATOR
Jordi Gol Foundation
Locations
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Institut Català de la Salut
Barcelona, , Spain
Countries
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References
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Romera L, Orfila F, Segura JM, Ramirez A, Moller M, Fabra ML, Lancho S, Bastida N, Foz G, Fabregat MA, Marti N, Cullell M, Martinez D, Gine M, Bistuer A, Cendros P, Perez E. Effectiveness of a primary care based multifactorial intervention to improve frailty parameters in the elderly: a randomised clinical trial: rationale and study design. BMC Geriatr. 2014 Nov 27;14:125. doi: 10.1186/1471-2318-14-125.
Other Identifiers
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PI12/01503
Identifier Type: -
Identifier Source: org_study_id