Feasibility of an Extended Test Battery and Influencing Factors for Detecting Frailty
7 oktober 2020 uppdaterad av: Claudia Spies, Charite University, Berlin, Germany
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).
Studieöversikt
Status
Avslutad
Betingelser
Studietyp
Observationell
Inskrivning (Faktisk)
30
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
-
Berlin, Tyskland, 13353
- Department of Anesthesiology and Operative Intensive Care Medicine (CCM/CVK), Charité - Universitätsmedizin Berlin
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
70 år och äldre (Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Testmetod
Icke-sannolikhetsprov
Studera befolkning
Patients undergoing elective surgery aged ≥70 years, including 10 patients without Frailty, 10 patients with Pre-Frailty and 10 patients with Frailty.
Beskrivning
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.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
|---|
|
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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Duration to run the test battery
Tidsram: 1 day (Once only at screening)
|
The duration of the screening test battery is measured with a stopwatch.
|
1 day (Once only at screening)
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Acceptance of test battery
Tidsram: 1 day (Once only at screening)
|
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
Tidsram: 1 day (Once only at screening)
|
Problems while performing the test battery are categorized according to a standardized protocol.
|
1 day (Once only at screening)
|
|
Change in pain
Tidsram: 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.
|
Baseline, day 3 after surgery and discharge or day 7 after surgery
|
|
Intelligibility of the patient Diary 1
Tidsram: Up to day 7 after surgery
|
Number of completed items
|
Up to day 7 after surgery
|
|
Intelligibility of the patient Diary 2
Tidsram: Up to day 7 after surgery
|
Number of completed days
|
Up to day 7 after surgery
|
|
Intelligibility of the patient Diary 3
Tidsram: Up to day 7 after surgery
|
Coherence of the diary with clinical patient record
|
Up to day 7 after surgery
|
|
Implementation rate of the patient Diary 3
Tidsram: Up to day 7 after surgery
|
Up to day 7 after surgery
|
|
|
Handgrip strength
Tidsram: Baseline, day 3 after surgery and discharge or day 7 after surgery
|
Handgrip strength measured using a Dynamometer.
|
Baseline, day 3 after surgery and discharge or day 7 after surgery
|
|
Mobility
Tidsram: Baseline, day 3 after the operation and discharge or day 7 after surgery
|
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
Tidsram: Baseline and discharge or day 7 after surgery
|
Nutritional status 1 is measured using serum albumin.
|
Baseline and discharge or day 7 after surgery
|
|
Nutritional status 2
Tidsram: Baseline and discharge or day 7 after surgery
|
Nutritional status 2 is measured using arm circumference.
|
Baseline and discharge or day 7 after surgery
|
|
Nutritional status 3
Tidsram: Baseline and discharge or day 7 after surgery
|
Nutritional status 3 is measured using calf circumference.
|
Baseline and discharge or day 7 after surgery
|
|
Nutritional status 4
Tidsram: Baseline and discharge or day 7 after surgery
|
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
Tidsram: Up to 7 days after surgery
|
Up to 7 days after surgery
|
|
|
Length of intensive care unit stay
Tidsram: Participants will be followed for the duration of hospital stay, an expected average of 1 day.
|
Participants will be followed for the duration of hospital stay, an expected average of 1 day.
|
|
|
Length of stay
Tidsram: Participants will be followed for the duration of hospital stay, an expected average of 7 days.
|
Participants will be followed for the duration of hospital stay, an expected average of 7 days.
|
Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Cognitive Status
Tidsram: 1 day (Once only at screening)
|
Neuropsychological testing
|
1 day (Once only at screening)
|
|
Depression
Tidsram: 1 day (Once only at screening)
|
The assessment of Depression is measured with the - Patient Health Questionnaire (PHQ-8)
|
1 day (Once only at screening)
|
|
Frailty
Tidsram: 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.
|
1 day (Once only at screening)
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Utredare
- Studierektor: Claudia Spies, MD Prof., Department of Anesthesiology and Operative Intensive Care Medicine (CCM/CVK), Charité Univerisitätsmedizin Berlin
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
18 december 2019
Primärt slutförande (Faktisk)
16 juli 2020
Avslutad studie (Faktisk)
20 juli 2020
Studieregistreringsdatum
Först inskickad
28 november 2019
Först inskickad som uppfyllde QC-kriterierna
4 december 2019
Första postat (Faktisk)
9 december 2019
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
8 oktober 2020
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
7 oktober 2020
Senast verifierad
1 oktober 2020
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- Frailty-Testing
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .