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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02643069
Recruitment Status : Recruiting
First Posted : December 30, 2015
Last Update Posted : August 24, 2016
Information provided by (Responsible Party):
Hospital Universitario Getafe

Brief Summary:

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.

Condition or disease Intervention/treatment
Frailty Syndrome Other: Intervention Geriatric Program

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  (Clinical Trial)
Estimated Enrollment : 1300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Feasibility and Effectiveness of Frailty Screening and Management Programs Implemented in Different Clinical Settings (FRAILCLINIC)
Study Start Date : February 2014
Estimated Primary Completion Date : October 2016
Estimated Study Completion Date : December 2017

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.

Primary Outcome Measures :
  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

Information from the National Library of Medicine

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Ages Eligible for Study:   75 Years and older   (Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02643069

Contact: Leocadio Rodriguez Mañas, IP +34 916839360 ext 2689
Contact: Marta Checa, MD +34 916839360 ext 2760

Hopsital Universitario de Getafe Recruiting
Getafe, Madrid, Spain, 28905
Contact: LEOCADIO RODRIGUEZ MAÑAS, MD, PhD    +34 916839360 ext 2760   
Principal Investigator: LEOCADIO RODRIGUEZ MAÑAS, MD, PhD         
Sponsors and Collaborators
Hospital Universitario Getafe
Principal Investigator: Leocadio Rodriguez Mañas, IP Hospital Universitario de Getafe

Publications of Results:
Other Publications:
Responsible Party: Hospital Universitario Getafe Identifier: NCT02643069     History of Changes
Other Study ID Numbers: 20131208
First Posted: December 30, 2015    Key Record Dates
Last Update Posted: August 24, 2016
Last Verified: August 2016

Keywords provided by Hospital Universitario Getafe:
Frailty tools
Clinical settings
Quality of life
Functional Autonomy