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

7. oktober 2020 opdateret af: 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).

Studieoversigt

Status

Afsluttet

Betingelser

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

30

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Tyskland
      • Berlin, Tyskland, 13353
        • Department of Anesthesiology and Operative Intensive Care Medicine (CCM/CVK), Charité - Universitätsmedizin Berlin

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

70 år og ældre (Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Patients undergoing elective surgery aged ≥70 years, including 10 patients without Frailty, 10 patients with Pre-Frailty and 10 patients with Frailty.

Beskrivelse

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Duration to run the test battery
Tidsramme: 1 day (Once only at screening)
The duration of the screening test battery is measured with a stopwatch.
1 day (Once only at screening)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Acceptance of test battery
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: Up to day 7 after surgery
Number of completed items
Up to day 7 after surgery
Intelligibility of the patient Diary 2
Tidsramme: Up to day 7 after surgery
Number of completed days
Up to day 7 after surgery
Intelligibility of the patient Diary 3
Tidsramme: 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
Tidsramme: Up to day 7 after surgery
Up to day 7 after surgery
Handgrip strength
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: Up to 7 days after surgery
Up to 7 days after surgery
Length of intensive care unit stay
Tidsramme: 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
Tidsramme: 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.

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Cognitive Status
Tidsramme: 1 day (Once only at screening)
Neuropsychological testing
1 day (Once only at screening)
Depression
Tidsramme: 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
Tidsramme: 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)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Charite University, Berlin, Germany

Efterforskere

  • Studieleder: Claudia Spies, MD Prof., Department of Anesthesiology and Operative Intensive Care Medicine (CCM/CVK), Charité Univerisitätsmedizin Berlin

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

18. december 2019

Primær færdiggørelse (Faktiske)

16. juli 2020

Studieafslutning (Faktiske)

20. juli 2020

Datoer for studieregistrering

Først indsendt

28. november 2019

Først indsendt, der opfyldte QC-kriterier

4. december 2019

Først opslået (Faktiske)

9. december 2019

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

8. oktober 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

7. oktober 2020

Sidst verificeret

1. oktober 2020

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • Frailty-Testing

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

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