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

Study Overview
=================
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).

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

Conditions
-----------------
Frailty Syndrome

Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 10 non-frail (robust) study patients<br>Patients fulfill 0 criteria according to modified Fried frailty score. | |
| 10 pre-frail study patients<br>Patients fulfill 1-2 criteria criteria according to modified Fried frailty score. | |
| 10 frail study patients<br>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. |