Clinical Intervention in Frail Older People (FRAILCLINIC) (FRAILCLINIC)

September 8, 2023 updated by: Hospital Universitario Getafe

Feasibility and Effectiveness of Frailty Screening and Management Programs Implemented in Different Clinical Settings (FRAILCLINIC)

Frailty is the main risk factor for the development of incident disability in older people and one of the most important for other adverse outcomes (death, hospitalisation, falls, and permanent institutionalisation).

Although frailty is a frequent condition in older adults who attend hospitals, little is known about its true prevalence in different settings of care. Better knowledge of this issue will inform the rational design of more effective strategies aimed at providing fitted care for these patients. Thus, the current study will potentially have impact on the quality of care for frail patients by revealing the prevalence of frailty in different settings of care, the difficulties in detection and management of frailty in these settings and the best instruments to detect frailty.

The investigators proposal brings together 6 partners in the European Union (EU) from three countries, with the common aim of studying the feasibility of a program to detect frail older patients in high risk clinical settings.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Quality assurance plan:

  • To perform regular monitoring according to the International Conference on Harmonisation (ICH) and Good Clinical Practice (GCP): The data will be evaluated according to the protocol and source documents.
  • To give training to the centres involved in the study.
  • To check the electronic Case Report Form (eCRF)

Data checks to compare data entered into the registry:

The eCRF has been designed to capture all data required in the protocol. A unique eCRF will be completed for subject, taking into account the protection law in each country of the study.Subjects will be identified by a unique subject number (with key held by the relevant partner), so none id card number will not be recorded on the eCRF or the database. The monitor will guarantee that the eCRF is fully and correctly fill up according to the source documents. The researcher will assure that all data recorded in the eCRF coincide with the information recorded in the source documents.

Plan for missing data to address situations where variables are reported as missing:

The investigators will check the missing data in each eCRF and source documents.

Statistical analysis:

Data will be analyzed using STATA®. Descriptive statistics will be reported and histograms will assess the distribution of frailty scores in each scale. Each analysis will be categorised according to frail, prefrail or robust patients.The prevalence of frailty will be calculated for each scale based on the score thresholds and relationships between frailty and age and other variables will be evaluated. Agreement among scales will be examined using the Cohen kappa statistic. Receiver operator characteristic (ROC) curves will be constructed to compare the area under the ROC curve (AUC) for each scale for available outcomes.

Sample Size: A minimum of 50 patients will be studied in each clinical setting, providing a database of 900 patients.

Study Type

Interventional

Enrollment (Actual)

821

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
    • Madrid
      • Getafe, Madrid, Spain, 28905
        • Hopsital Universitario de Getafe

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

71 years and older (Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Frailty patients older than 75 years old attended in the settings of care.
  2. Willing and able to provide informed consent

Exclusion Criteria:

  1. Lack of capacity to give informed consent.
  2. Those unable or unwilling to cooperate with any of the assessments

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Geriatric Program
A comprehensive management plan of the frail patients, covering both in-hospital and postdischarge time, according to the treating physicians (s) surgeon and the performance of a geriatrician . This management will consist of the therapeutic plan, access to geriatric levels of care, coordination with primary and social care, rehabilitation, and discharge plan.
Other: Intervention Geriatric Program
The investigators will implemented programs to detected and manage care for older patients in four settings: Emergency room, oncology department, surgery departments making major surgery and Cardiology. The core intervention will consist of the following elements: comprehensive geriatric assessment, coordination with primary ans social care, integrated and continued care, access to rehabilitation facilities, management of drug treatment avoiding polypharmacy and stressing adherence.
No Intervention: Usual clinical practice
A comprehensive management plan of the frail patients, covering both in-hospital and postdischarge time, agreed with the treating physicians (s) surgeon.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional Status assessed using the Barthel index for Basic Activities of Daily Living
Time Frame: 36 months
will be assessed using the Barthel index for Basic Activities of Daily Living
36 months
Functional Status assessed using the Lawton index for Instrumental Activities of Daily Living
Time Frame: 36 months
will be assessed using the Lawton index for Instrumental Activities of Daily Living
36 months
Institutionalization (defined as the number of patients newly addressed to nursing)
Time Frame: 36 months
defined as the number of patients newly addressed to nursing
36 months
Mortality
Time Frame: 36 months
number of deaths occurred either during hospitalization or at follow-up
36 months

Collaborators and Investigators

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

Sponsor

Hospital Universitario Getafe

Investigators

  • Principal Investigator: Leocadio Rodriguez Mañas, IP, Hospital Universitario de Getafe

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 (Actual)

February 1, 2014

Primary Completion (Actual)

March 1, 2021

Study Completion (Actual)

March 1, 2021

Study Registration Dates

First Submitted

March 26, 2015

First Submitted That Met QC Criteria

December 29, 2015

First Posted (Estimated)

December 30, 2015

Study Record Updates

Last Update Posted (Actual)

September 13, 2023

Last Update Submitted That Met QC Criteria

September 8, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20131208

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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