Clinical and Economic Assessment of a Pre-frail Screening Program

Study Overview
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Brief Summary
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The study intervention improves functional capacity and delays frailty status in pre-frail elderly subjects.

Official Title
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Clinical and Economic Assessment of an Opportunistic Screening Program for Pre-frailty State in Elderly Population.

Conditions
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Pre-frail, Elderly

Intervention / Treatment
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* Other: Multidisciplinary intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: More than 70 years consulting in primary care Non institutionalized Pre-frailty according to L.Fried criteria (1 or 2 criteria) Signed informed consent Exclusion Criteria: Patient not able to stand by himself/herself Dementia Palliative care or life expectancy less than 6 months Blind patient unstable clinical situation Participation in other programs, studies or trials for elderly people

Ages Eligible for Study
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Minimum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Multidimensional intervention<br>Multidimensional intervention based on: good control of baseline diseases, review of medication adequacy, exercise program, nutritional assessment and control, social assessment and control. | Other: Multidisciplinary intervention<br>* Multidimensional intervention based on: good control of baseline diseases, review of medication adequacy, exercise program, nutritional assessment and control, social assessment and control.<br>|
| No Intervention: Usual care<br>Usual care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frailty according to L.Fried criteria (questionnaire). | L.Fried frailty criteria: (Robust: 0 criteria; Pre-frail: 1-2 criteria; Frail: >=3 criteria) Weight loss Fatigue Poor physical activity Low walking speed Low muscle strength Reference of L.Fried: J Gerontol A Biol Sci Med Sci. 2001 Mar; 56(3):M146-56. PMID: 11253156. | One year | 
| Functional capacity according to Barthel score and Timed up and go test. | Barthel score and Timed up and go test. | One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nutritional status according to MNA-sf. | Mini Nutritional Assessment short form (MNA-sf). | One year | 
| Quality of live according to EuroQoL. | EuroQoL. | One year | 
| Mortality |  | One year | 
| Health resource consumption (composite measure) | Number of visits to primary care center, number of visits to hospital emergency department, number of hospitalizations, days of hospital stay, institutionalization to nursing homes, visits to nutritionist and visits to social services. | One year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pre-frailty, Frail, Exercise, Nutritional assessment, Functional capacity