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

NCT04190329 | Completed

• 1 other identifier: Frailty-Testing
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Frailty Syndrome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (16)

• Acceptance of test battery

  1 day (Once only at screening)

• Problems to conduct the test battery

  1 day (Once only at screening)

• Change in pain

  Baseline, day 3 after surgery and discharge or day 7 after surgery

• Intelligibility of the patient Diary 1

  Up to day 7 after surgery

• Intelligibility of the patient Diary 2

  Up to day 7 after surgery

Other Outcomes (3)

• Cognitive Status

  1 day (Once only at screening)

• Depression

  1 day (Once only at screening)

• Frailty

  1 day (Once only at screening)

Study Arms (3)

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.

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• 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.

You may qualify if:

• Age ≥ 70 years
• Male and female patients
• elective surgery
• Expected anesthesia duration\> 60min

You may not qualify if:

• Severe cardiological or pulmonary disease (NYHA IV, Gold IV)
• Intracranial interventions
• Moribund patients (palliative situation)
• Not enough language skills
• Non-consenting patients

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead

Study Sites (1)

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

Berlin, 13353, Germany

Location

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Claudia Spies, MD Prof.

  Department of Anesthesiology and Operative Intensive Care Medicine (CCM/CVK), Charité Univerisitätsmedizin Berlin

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the Department of Anesthesiology and Operative Intensive Care Medicine (CCM/CVK), Charité - Universitätsmedizin Berlin

Study Record Dates

• First Submitted: November 28, 2019
• First Posted: December 9, 2019
• Study Start: December 18, 2019
• Primary Completion: July 16, 2020
• Study Completion: July 20, 2020
• Last Updated: October 8, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)