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Completed

NCT Number: NCT04190329

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

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).

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Key information

Conditions

Frailty Syndrome Frailty Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

70 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Berlin, 13353, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Duration to run the test battery

    Time frame: 1 day (Once only at screening)

    The duration of the screening test battery is measured with a stopwatch.

Secondary outcomes

  1. Acceptance of test battery

    Time frame: 1 day (Once only at screening)

    The study patient´s acceptance of the screening test battery is measured with a questionnaire.

  2. Problems to conduct the test battery

    Time frame: 1 day (Once only at screening)

    Problems while performing the test battery are categorized according to a standardized protocol.

  3. Change in pain

    Time frame: 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.

  4. Intelligibility of the patient Diary 1

    Time frame: Up to day 7 after surgery

    Number of completed items

  5. Intelligibility of the patient Diary 2

    Time frame: Up to day 7 after surgery

    Number of completed days

  6. Intelligibility of the patient Diary 3

    Time frame: Up to day 7 after surgery

    Coherence of the diary with clinical patient record

  7. Implementation rate of the patient Diary 3

    Time frame: Up to day 7 after surgery

  8. Handgrip strength

    Time frame: Baseline, day 3 after surgery and discharge or day 7 after surgery

    Handgrip strength measured using a Dynamometer.

  9. Mobility

    Time frame: Baseline, day 3 after the operation and discharge or day 7 after surgery

    Mobility is measured using the Charité Mobilitäts-Index (CHARMI®).

  10. Nutritional status 1

    Time frame: Baseline and discharge or day 7 after surgery

    Nutritional status 1 is measured using serum albumin.

  11. Nutritional status 2

    Time frame: Baseline and discharge or day 7 after surgery

    Nutritional status 2 is measured using arm circumference.

  12. Nutritional status 3

    Time frame: Baseline and discharge or day 7 after surgery

    Nutritional status 3 is measured using calf circumference.

  13. Nutritional status 4

    Time frame: Baseline and discharge or day 7 after surgery

    Nutritional status 4 is measured using the Mini Nutritional Assessment - Short Form (MNA®-SF).

  14. Intra- and postoperative organ complications

    Time frame: Up to 7 days after surgery

  15. Length of intensive care unit stay

    Time frame: Participants will be followed for the duration of hospital stay, an expected average of 1 day.

  16. Length of stay

    Time frame: Participants will be followed for the duration of hospital stay, an expected average of 7 days.

Other outcomes

  1. Cognitive Status

    Time frame: 1 day (Once only at screening)

    Neuropsychological testing

  2. Depression

    Time frame: 1 day (Once only at screening)

    The assessment of Depression is measured with the - Patient Health Questionnaire (PHQ-8)

  3. Frailty

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Dec 9, 2019
Registry last updated
Oct 8, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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