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

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).

Study Overview

• Status: Completed
• Conditions: Frailty Syndrome

• Study Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 13353
    • Department of Anesthesiology and Operative Intensive Care Medicine (CCM/CVK), Charité - Universitätsmedizin Berlin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 70 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing elective surgery aged ≥70 years, including 10 patients without Frailty, 10 patients with Pre-Frailty and 10 patients with Frailty.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
10 non-frail (robust) study patients; Patients fulfill 0 criteria according to modified Fried frailty score.
10 pre-frail study patients; Patients fulfill 1-2 criteria criteria according to modified Fried frailty score.
10 frail study patients; Patients fulfill 3, 4 or 5 criteria according to modified Fried frailty score.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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
Intelligibility of the patient Diary 1	Number of completed items	Up to day 7 after surgery
Intelligibility of the patient Diary 2	Number of completed days	Up to day 7 after surgery
Intelligibility of the patient Diary 3	Coherence of the diary with clinical patient record	Up to day 7 after surgery
Implementation rate of the patient Diary 3		Up to day 7 after surgery
Handgrip strength	Handgrip strength measured using a Dynamometer.	Baseline, day 3 after surgery and discharge or day 7 after surgery
Mobility	Mobility is measured using the Charité Mobilitäts-Index (CHARMI®).	Baseline, day 3 after the operation and discharge or day 7 after surgery
Nutritional status 1	Nutritional status 1 is measured using serum albumin.	Baseline and discharge or day 7 after surgery
Nutritional status 2	Nutritional status 2 is measured using arm circumference.	Baseline and discharge or day 7 after surgery
Nutritional status 3	Nutritional status 3 is measured using calf circumference.	Baseline and discharge or day 7 after surgery
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
Intra- and postoperative organ complications		Up to 7 days after surgery
Length of intensive care unit stay		Participants will be followed for the duration of hospital stay, an expected average of 1 day.
Length of stay		Participants will be followed for the duration of hospital stay, an expected average of 7 days.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cognitive Status	Neuropsychological testing	1 day (Once only at screening)
Depression	The assessment of Depression is measured with the - Patient Health Questionnaire (PHQ-8)	1 day (Once only at screening)
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)

Collaborators and Investigators

• Sponsor: Charite University, Berlin, Germany
• Investigators: Study Director: Claudia Spies, MD Prof., Department of Anesthesiology and Operative Intensive Care Medicine (CCM/CVK), Charité Univerisitätsmedizin Berlin

Study record dates

Study Major Dates

• Study Start (Actual): December 18, 2019
• Primary Completion (Actual): July 16, 2020
• Study Completion (Actual): July 20, 2020

Study Registration Dates

• First Submitted: November 28, 2019
• First Submitted That Met QC Criteria: December 4, 2019
• First Posted (Actual): December 9, 2019

Study Record Updates

• Last Update Posted (Actual): October 8, 2020
• Last Update Submitted That Met QC Criteria: October 7, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Frailty
• Other Study ID Numbers: Frailty-Testing

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No