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

7. oktober 2020 oppdatert 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).

Studieoversikt

Status

Fullført

Forhold

Studietype

Observasjonsmessig

Registrering (Faktiske)

30

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

70 år og eldre (Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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)

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Charite University, Berlin, Germany

Etterforskere

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

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

18. desember 2019

Primær fullføring (Faktiske)

16. juli 2020

Studiet fullført (Faktiske)

20. juli 2020

Datoer for studieregistrering

Først innsendt

28. november 2019

Først innsendt som oppfylte QC-kriteriene

4. desember 2019

Først lagt ut (Faktiske)

9. desember 2019

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

8. oktober 2020

Siste oppdatering sendt inn som oppfylte QC-kriteriene

7. oktober 2020

Sist bekreftet

1. oktober 2020

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • Frailty-Testing

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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