Clinical trial NCT04190329: Feasibility of an Extended Test Battery and Influencing Factors for Detecting Frailty
Official title: Feasibility of an Extended Test Battery and Influencing Factors for Detecting Frailty
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Frailty Syndrome
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2019-12-09
Enrollment: 30
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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).


Eligibility criteria: 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.

Primary outcomes:
measure: Duration to run the test battery
timeFrame: 1 day (Once only at screening)
Secondary outcomes:
measure: Acceptance of test battery
timeFrame: 1 day (Once only at screening)
measure: Problems to conduct the test battery
timeFrame: 1 day (Once only at screening)
measure: Change in pain
timeFrame: Baseline, day 3 after surgery and discharge or day 7 after surgery
measure: Intelligibility of the patient Diary 1
timeFrame: Up to day 7 after surgery
measure: Intelligibility of the patient Diary 2
timeFrame: Up to day 7 after surgery
measure: Intelligibility of the patient Diary 3
timeFrame: Up to day 7 after surgery
measure: Implementation rate of the patient Diary 3
timeFrame: Up to day 7 after surgery
measure: Handgrip strength
timeFrame: Baseline, day 3 after surgery and discharge or day 7 after surgery
measure: Mobility
timeFrame: Baseline, day 3 after the operation and discharge or day 7 after surgery
measure: Nutritional status 1
timeFrame: Baseline and discharge or day 7 after surgery
measure: Nutritional status 2
timeFrame: Baseline and discharge or day 7 after surgery
measure: Nutritional status 3
timeFrame: Baseline and discharge or day 7 after surgery
measure: Nutritional status 4
timeFrame: Baseline and discharge or day 7 after surgery
measure: Intra- and postoperative organ complications
timeFrame: Up to 7 days after surgery
measure: Length of intensive care unit stay
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 1 day.
measure: Length of stay
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 7 days.
Other outcomes:
measure: Cognitive Status
timeFrame: 1 day (Once only at screening)
measure: Depression
timeFrame: 1 day (Once only at screening)
measure: Frailty
timeFrame: 1 day (Once only at screening)
Locations:
city: Berlin
country: Germany
facility: Department of Anesthesiology and Operative Intensive Care Medicine (CCM/CVK), Charité - Universitätsmedizin Berlin
Study officials:
affiliation: Department of Anesthesiology and Operative Intensive Care Medicine (CCM/CVK), Charité Univerisitätsmedizin Berlin
name: Claudia Spies, MD Prof.
role: STUDY_DIRECTOR
References: