Feasibility of an Extended Test Battery and Influencing Factors for Detecting Frailty

Frailty Syndrome Clinical Trial

Official title:

Feasibility of an Extended Test Battery and Influencing Factors for Detecting Frailty

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04190329
• Other study ID #: Frailty-Testing
• Status: Completed
• Start date: December 18, 2019
• Est. completion date: July 20, 2020

Study information

• Verified date: October 2020
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The aim of the prospective study is to assess the feasibility of a screening and baseline measurement protocol that is planned for a main study (PRÄP-GO) in a collective of 30 patients ageing 70+ scheduled for elective surgery. Comprehensive geriatric assessment scores and modified Fried frailty phenotype component evaluation are performed in all patients at baseline before elective surgery. The assessment of cognitive tests is conducted with a battery of neuropsychological tests, computer-based tests from the Cambridge Neuropsychological Test Automated Battery [CANTAB®] and non-computer based tests. Frailty scores from 0 to 5 (i.e., 1 point for each component; 0 = best to 5 = worst) represent robust (0), pre-frail (1-2), and frail (3-5) health status. 10 patients without Frailty, 10 patients with Pre-Frailty and 10 patients with Frailty should be analyzed in this study and receive further comprehensive geriatric assessment testing up to seven days after surgery/discharge (before 7 postoperative days).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: July 20, 2020
• Est. primary completion date: July 16, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years and older

Eligibility

Inclusion criteria:

• Age = 70 years

• Male and female patients

• Patient eligible for inclusion: by the patient, preoperatively

• elective surgery

• Expected anesthesia duration> 60min

Exclusion criteria:

• Severe cardiological or pulmonary disease (NYHA IV, Gold IV)

• Intracranial interventions

• Moribund patients (palliative situation)

• Not enough language skills

• Non-consenting patients

• Participation in another prospective intervention study for study inclusion or throughout the study period.

Related Conditions & MeSH terms

• Frailty
• Frailty Syndrome

Locations

Country	Name	City	State
Germany	Department of Anesthesiology and Operative Intensive Care Medicine (CCM/CVK), Charité - Universitätsmedizin Berlin	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Cognitive Status	Neuropsychological testing	1 day (Once only at screening)
Other	Depression	The assessment of Depression is measured with the - Patient Health Questionnaire (PHQ-8)	1 day (Once only at screening)
Other	Frailty	Frailty is operationalized using modified Fried frailty criteria. Frailty scores from 0 to 5 (i.e., 1 point for each component; 0 = best to 5 = worst) represent robust (0), pre-frail (1-2), and frail (3-5) health status.	1 day (Once only at screening)
Primary	Duration to run the test battery	The duration of the screening test battery is measured with a stopwatch.	1 day (Once only at screening)
Secondary	Acceptance of test battery	The study patient´s acceptance of the screening test battery is measured with a questionnaire.	1 day (Once only at screening)
Secondary	Problems to conduct the test battery	Problems while performing the test battery are categorized according to a standardized protocol.	1 day (Once only at screening)
Secondary	Change in pain	Pain is measured with a pain score, a higher score indicates more pain.	Baseline, day 3 after surgery and discharge or day 7 after surgery
Secondary	Intelligibility of the patient Diary 1	Number of completed items	Up to day 7 after surgery
Secondary	Intelligibility of the patient Diary 2	Number of completed days	Up to day 7 after surgery
Secondary	Intelligibility of the patient Diary 3	Coherence of the diary with clinical patient record	Up to day 7 after surgery
Secondary	Implementation rate of the patient Diary 3		Up to day 7 after surgery
Secondary	Handgrip strength	Handgrip strength measured using a Dynamometer.	Baseline, day 3 after surgery and discharge or day 7 after surgery
Secondary	Mobility	Mobility is measured using the Charité Mobilitäts-Index (CHARMI®).	Baseline, day 3 after the operation and discharge or day 7 after surgery
Secondary	Nutritional status 1	Nutritional status 1 is measured using serum albumin.	Baseline and discharge or day 7 after surgery
Secondary	Nutritional status 2	Nutritional status 2 is measured using arm circumference.	Baseline and discharge or day 7 after surgery
Secondary	Nutritional status 3	Nutritional status 3 is measured using calf circumference.	Baseline and discharge or day 7 after surgery
Secondary	Nutritional status 4	Nutritional status 4 is measured using the Mini Nutritional Assessment - Short Form (MNA®-SF).	Baseline and discharge or day 7 after surgery
Secondary	Intra- and postoperative organ complications		Up to 7 days after surgery
Secondary	Length of intensive care unit stay		Participants will be followed for the duration of hospital stay, an expected average of 1 day.
Secondary	Length of stay		Participants will be followed for the duration of hospital stay, an expected average of 7 days.