Skip to main content
OpenTrials
Completed

NCT Number: NCT02643069

Clinical Intervention in Frail Older People (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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Frailty Syndrome Frailty Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

75 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hopsital Universitario de Getafe

Getafe, Madrid, 28905, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Intervention Geriatric Program

Other

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.

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. Mortality

    Time frame: 36 months

    number of deaths occurred either during hospitalization or at follow-up

Sponsors and collaborators

Lead sponsor

Hospital Universitario Getafe

Other

Registry information

Official study title

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

Acronym: FRAILCLINIC

Important dates

Study start
2014
Primary completion
2021
Study completion
2021
First posted
Dec 30, 2015
Registry last updated
Sep 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.