Clinical and Economic Assessment of a Pre-frail Screening Program

August 31, 2015 updated by: Consorci Sanitari del Maresme

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

170

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Barcelona
      • Mataró, Barcelona, Spain, 08304
        • Consorci Sanitari Del Maresme

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

70 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Usual care
Experimental: Multidimensional intervention
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
Multidimensional intervention based on: good control of baseline diseases, review of medication adequacy, exercise program, nutritional assessment and control, social assessment and control.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frailty according to L.Fried criteria (questionnaire).
Time Frame: 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.
One year
Functional capacity according to Barthel score and Timed up and go test.
Time Frame: One year
Barthel score and Timed up and go test.
One year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality
Time Frame: One year
One year
Nutritional status according to MNA-sf.
Time Frame: One year
Mini Nutritional Assessment short form (MNA-sf).
One year
Quality of live according to EuroQoL.
Time Frame: One year
EuroQoL.
One year
Health resource consumption (composite measure)
Time Frame: 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.
One year

Other Outcome Measures

Outcome Measure
Time Frame
Pain according Visual Analog Scale.
Time Frame: One year
One year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Consorci Sanitari del Maresme

Investigators

  • Principal Investigator: Mateu Serra-Prat, PhD, Fundació Salut del Consorci Sanitari del Maresme

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (Actual)

August 1, 2015

Study Registration Dates

First Submitted

May 12, 2014

First Submitted That Met QC Criteria

May 14, 2014

First Posted (Estimate)

May 15, 2014

Study Record Updates

Last Update Posted (Estimate)

September 1, 2015

Last Update Submitted That Met QC Criteria

August 31, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 17/13
  • CEIC 17/13 (Other Identifier: CEIC)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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