Clinical and Economic Assessment of a Pre-frail Screening Program

Not Applicable

Completed

• Conditions: Elderly; Pre-frail
• Interventions: Other: Multidisciplinary intervention

• Registration Number: NCT02138968
• Lead Sponsor: Consorci Sanitari del Maresme

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2013-09
• Study First Submitted: 2014-05-12
• Study First Submitted QC: 2014-05-14
• Study First Posted: 2014-05-15
• Status Verified: 2015-08
• Primary Completion: 2015-08
• Last Update Submitted: 2015-08-31
• Last Update Posted: 2015-09-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 170

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Multidimensional intervention	Multidisciplinary intervention	Multidimensional intervention based on: good control of baseline diseases, review of medication adequacy, exercise program, nutritional assessment and control, social assessment and control.

Primary Outcome Measures

Name	Time	Method
Frailty according to L.Fried criteria (questionnaire).	One year	L.Fried frailty criteria: (Robust: 0 criteria; Pre-frail: 1-2 criteria; Frail: \>=3 criteria); 1. Weight loss; 2. Fatigue; 3. Poor physical activity; 4. Low walking speed; 5. Low muscle strength Reference of L.Fried: J Gerontol A Biol Sci Med Sci. 2001 Mar; 56(3):M146-56. PMID: 11253156.
Functional capacity according to Barthel score and Timed up and go test.	One year	Barthel score and Timed up and go test.

Secondary Outcome Measures

Name	Time	Method
Health resource consumption (composite measure)	One year	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.
Quality of live according to EuroQoL.	One year	EuroQoL.
Mortality	One year
Nutritional status according to MNA-sf.	One year	Mini Nutritional Assessment short form (MNA-sf).

Trial Locations

Locations (1)

Consorci Sanitari del Maresme; 🇪🇸 Mataró, Barcelona, Spain