Clinical and Economic Assessment of a Pre-frail Screening Program

Elderly Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02138968
• Other study ID #: 17/13
• Secondary ID: CEIC 17/13
• Status: Completed
• Phase: N/A
• First received: May 12, 2014
• Last updated: August 31, 2015
• Start date: September 2013

Study information

• Verified date: August 2015
• Source: Consorci Sanitari del Maresme
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 170
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 70 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Elderly
• Pre-frail

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Spain	Consorci Sanitari del Maresme	Mataró	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Consorci Sanitari del Maresme

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Pain according Visual Analog Scale.		One year	No
Primary	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	No
Primary	Functional capacity according to Barthel score and Timed up and go test.	Barthel score and Timed up and go test.	One year	No
Secondary	Nutritional status according to MNA-sf.	Mini Nutritional Assessment short form (MNA-sf).	One year	No
Secondary	Quality of live according to EuroQoL.	EuroQoL.	One year	No
Secondary	Mortality		One year	No
Secondary	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	No