Update on the Detection of Frailty in the Older Adult

Depression Clinical Trial

Official title:

Update on the Detection of Frailty in the Older Adult: a Big Data-based Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06218121
• Other study ID #: Detection of Frailty
• Status: Recruiting
• Start date: April 20, 2024
• Est. completion date: June 15, 2025

Study information

• Verified date: February 2024
• Source: Universidad Europea de Madrid
• Contact: Eleuterio A. Sánchez Romero, PhD
• Phone: +34 617 123 563
• Email: eleuterio.sanchez[@]universidadeuropea.es
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The main objective is to update the diagnostic assessment of frailty by correlating several variables with the ultrasound image of the frail elderly patient.

Secondarily, the investigators intend to collect and analyze data on functional capacity and quality of life variables on the evolution of musculoskeletal symptoms, as well as on pain and psychological variables. Similarly, it is intended to make a record of different profiles and subtypes of frail older adult patients to be stored in Big Data in order to establish therapeutic intervention plans that allow both the evaluation and treatment of patients.

Description:

The present cohort study will be conducted in 500 older adults diagnosed with frailty.

The correlation of the demographic variables, physical functionality tests and psychoemotional constructs that will be analyzed in this study with the ultrasound image obtained from the patients will improve the ultrasound diagnosis of frailty, providing new information that will facilitate the work of healthcare personnel in the diagnosis and management of frailty.

Similarly, the use of Big Data will allow institutions to extract data on different patient profiles, signs and symptoms of frailty and the different risk factors that affect frailty patients, which will improve treatments and favor the development of educational programs tailored to the patient's needs.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: June 15, 2025
• Est. primary completion date: April 15, 2025
• Gender: All
• Age group: 62 Years and older

Eligibility

Inclusion Criteria:

A diagnosis of signs and symptoms of frailty by a geriatric physician in the research group will be used as the primary inclusion criterion. Frailty will be assessed and diagnosed using the frailty phenotype and the Clinical Frailty Scale.

Exclusion Criteria:

• Acute myocardial infarction in the last 3 months and/or unstable angina pectoris

• Uncontrolled arrhythmia, recent thromboembolism and terminal illness.

• Patients undergoing MMII unloading or MMSS/MMII fractures in the last three months.

• Patients with a functional gait index of 1 (Inability to walk)

• Severe pain (7/10 VAS)

• Previous neuromuscular pathology presenting with weakness

• Medication that does not allow the patient's actual muscle reaction to be assessed

• Severe cognitive impairment that would prevent collaboration and understanding of the tests to be performed.

• Cardiovascularly unstable patients and uncontrolled arterial hypertension.

Related Conditions & MeSH terms

• Anxiety
• Depression
• Frailty
• Functional Independence
• Functionality
• Kinesiophobia
• Pain
• Quality of Life
• Sarcopenia
• Strength

Intervention

Diagnostic Test:
• Instrumental and Functional Tests that Assess Functional Capacity
The correlation between all functional, ultrasound, nutritional, and psychological variables will be analyzed. Through GLIM diagnosis, anthropometric data (weight, height, BMI) as well as analytical data including inflammation information (CRP and albumin) will be used to reach a diagnosis that allows comparison/correlation with the rest of the variable parameters.

Locations

Country	Name	City	State
Spain	Hospital Puerta de Hierro de Majadahonda	Madrid	Outside Of The US

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Europea de Madrid

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Manual Grip Strength	The grip strength in both hands will be measured by measuring the maximum grip strength. A bulb dynamometer will be used for this measurement.	Baseline
Primary	Quality of Life (EQ-5D-5L)	It will be evaluated by means of the the EuroQol 5-dimensions 5-levels (EQ-5D-5L), which is a generic instrument for measuring health-related quality of life. The patient himself assesses his state of health, in levels of severity by dimensions The first allows the respondent to define the state of health according to the EQ-5D multi-attribute classification system, composed of 5 dimensions (mobility, self-care, activities of daily living, pain/discomfort and anxiety/depression), and in each of them there are 3 levels of severity (1, 2 or 3).	Baseline
Primary	Basic Activities in Daily Life	The Barthel Index evaluated one's ability to care for him/herself through ten activitiesof daily living like feeding, bathing, grooming, dressing, bowel and bladder control,toileting, chair transfer, ambulation, and stair climbing; the maximum score is 100 pointsand the higher the score, the greater the functional independence of the patient. Thefollowing baseline data regarding age, sex, and admission diagnosis were also collected .	Baseline
Primary	Balance	The Trunk Control Test (TCT) evaluated four aspects of trunk movement, swinging to both sides, sitting balance, and rising from the floor; individual items are scored from 0 (incapable) to 12 (ability to perform the movement but with an unusual style) and 25 (ability to perform the movement correctly).	Baseline
Primary	Visual Analog Scale (VAS)	To evaluate the pain that the patient has, we use the VAS. This is a 100 mm line that measures pain intensity. The left end of the line represents the absence of pain, while the right end represents the worst pain imaginable. The numerical pain intensity scale adds a numerical graduation where 1 is no pain and 10 is the worst pain imaginable. The confidence and reliability of this scale has been approved and validated in different studies.	Baseline
Primary	Strength	The Medical Research Council Sum Score (MRCSS) strength assessment scale evaluated muscle strength in the upper and lower limbs. The different movements evaluated arescored from 0 to 5 and a maximum score of 60 can be obtained.	Baseline
Primary	Anxiety	Anxiety was measured with Spanish version of State-trait Anxiety Inventory (STAI). Scores of 20-37 indicate no or low anxiety; 38-44 moderate anxiety; 45-80 high anxiety.	Baseline
Primary	Kinesiophobia	Kinesiophobia was measured with Spanish version of Tampa Scale of Kinesiophobia. Higher scores denotes greater fear of experiencing pain while moving.	Baseline
Primary	Depression	Depressive symptoms were measured with Spanish version of Beck Inventory II. 0-13 normal scores; 14-19 mild; 20-28 moderate; 29-63 severe depression.	Baseline
Primary	Risk of Falls	Assessment of fall risk according to the Vivifrail protocol: cumulative number of falls in the past year, cumulative number of falls with physician care, suffer at least 1 fall in the past year, Timed Up and Go test (TUG) and existence of dementia to establish the existence of fall risk (+ or -); the TUG assesses the time it takes to get out of the chair, walk three meters, back to the chair, and to sit down.	Baseline