Feasibility of an Extended Test Battery and Influencing Factors for Detecting Frailty
- Conditions
- Frailty Syndrome
- Registration Number
- NCT04190329
- Lead Sponsor
- Charite University, Berlin, Germany
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Duration to run the test battery 1 day (Once only at screening) The duration of the screening test battery is measured with a stopwatch.
- Secondary Outcome Measures
Name Time Method Problems to conduct the test battery 1 day (Once only at screening) Problems while performing the test battery are categorized according to a standardized protocol.
Acceptance of test battery 1 day (Once only at screening) The study patient´s acceptance of the screening test battery is measured with a questionnaire.
Intelligibility of the patient Diary 2 Up to day 7 after surgery Number of completed days
Implementation rate of the patient Diary 3 Up to day 7 after surgery Change in pain Baseline, day 3 after surgery and discharge or day 7 after surgery Pain is measured with a pain score, a higher score indicates more pain.
Intelligibility of the patient Diary 1 Up to day 7 after surgery Number of completed items
Nutritional status 1 Baseline and discharge or day 7 after surgery Nutritional status 1 is measured using serum albumin.
Nutritional status 4 Baseline and discharge or day 7 after surgery Nutritional status 4 is measured using the Mini Nutritional Assessment - Short Form (MNA®-SF).
Length of intensive care unit stay Participants will be followed for the duration of hospital stay, an expected average of 1 day. Nutritional status 2 Baseline and discharge or day 7 after surgery Nutritional status 2 is measured using arm circumference.
Intelligibility of the patient Diary 3 Up to day 7 after surgery Coherence of the diary with clinical patient record
Handgrip strength Baseline, day 3 after surgery and discharge or day 7 after surgery Handgrip strength measured using a Dynamometer.
Nutritional status 3 Baseline and discharge or day 7 after surgery Nutritional status 3 is measured using calf circumference.
Intra- and postoperative organ complications Up to 7 days after surgery Length of stay Participants will be followed for the duration of hospital stay, an expected average of 7 days. Mobility Baseline, day 3 after the operation and discharge or day 7 after surgery Mobility is measured using the Charité Mobilitäts-Index (CHARMI®).
Trial Locations
- Locations (1)
Department of Anesthesiology and Operative Intensive Care Medicine (CCM/CVK), Charité - Universitätsmedizin Berlin
🇩🇪Berlin, Germany