Frailty Syndrome
Conditions
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).
Interventions
None listed
Sponsors
Charite University, Berlin, Germany
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
70 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 |
| Intelligibility of the patient Diary 2 | Up to day 7 after surgery | Number of completed days |
| Intelligibility of the patient Diary 3 | Up to day 7 after surgery | Coherence of the diary with clinical patient record |
| Implementation rate of the patient Diary 3 | Up to day 7 after surgery | — |
| Handgrip strength | Baseline, day 3 after surgery and discharge or day 7 after surgery | Handgrip strength measured using a Dynamometer. |
| Mobility | Baseline, day 3 after the operation and discharge or day 7 after surgery | Mobility is measured using the Charité Mobilitäts-Index (CHARMI®). |
| Nutritional status 1 | Baseline and discharge or day 7 after surgery | Nutritional status 1 is measured using serum albumin. |
| Nutritional status 2 | Baseline and discharge or day 7 after surgery | Nutritional status 2 is measured using arm circumference. |
| Nutritional status 3 | Baseline and discharge or day 7 after surgery | Nutritional status 3 is measured using calf circumference. |
| 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). |
| 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. | — |
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Cognitive Status | 1 day (Once only at screening) | Neuropsychological testing |
| Depression | 1 day (Once only at screening) | The assessment of Depression is measured with the - Patient Health Questionnaire (PHQ-8) |
| Frailty | 1 day (Once only at screening) | 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. |
Countries
Germany
Outcome results
None listed