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Frailty SyndromeNCT04190329

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

An observational study of Frailty Syndrome, run by Charite University, Berlin, Germany at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 70 years and older
Conditions the study is for
Frailty Syndrome
How many people
30 participants
Where
1 siteGermany
Study dates
18 Dec 2019to 20 Jul 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 70 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

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

Who may be able to join

  • Age ≥ 70 years
  • Male and female patients
  • Patient eligible for inclusion: by the patient, preoperatively
  • elective surgery
  • Expected anesthesia duration> 60min

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Germany1 site

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

    Berlin, 13353

Other trials in Germany

About this study

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).

Medical subject headings
Frailty

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT04190329
Study groupRoleWhat they receive
10 non-frail (robust) study patientsPatients fulfill 0 criteria according to modified Fried frailty score.
10 pre-frail study patientsPatients fulfill 1-2 criteria criteria according to modified Fried frailty score.
10 frail study patientsPatients fulfill 3, 4 or 5 criteria according to modified Fried frailty score.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Duration to run the test battery

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

    Measured: 1 day (Once only at screening)

Secondary outcomes (16)

  1. Acceptance of test battery

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

    Measured: 1 day (Once only at screening)

  2. Problems to conduct the test battery

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

    Measured: 1 day (Once only at screening)

  3. Change in pain

    Pain is measured with a pain score, a higher score indicates more pain.

    Measured: Baseline, day 3 after surgery and discharge or day 7 after surgery

  4. Intelligibility of the patient Diary 1

    Number of completed items

    Measured: Up to day 7 after surgery

  5. Intelligibility of the patient Diary 2

    Number of completed days

    Measured: Up to day 7 after surgery

  6. Intelligibility of the patient Diary 3

    Coherence of the diary with clinical patient record

    Measured: Up to day 7 after surgery

  7. Implementation rate of the patient Diary 3

    Measured: Up to day 7 after surgery

  8. Handgrip strength

    Handgrip strength measured using a Dynamometer.

    Measured: Baseline, day 3 after surgery and discharge or day 7 after surgery

  9. Mobility

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

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

  10. Nutritional status 1

    Nutritional status 1 is measured using serum albumin.

    Measured: Baseline and discharge or day 7 after surgery

  11. Nutritional status 2

    Nutritional status 2 is measured using arm circumference.

    Measured: Baseline and discharge or day 7 after surgery

  12. Nutritional status 3

    Nutritional status 3 is measured using calf circumference.

    Measured: Baseline and discharge or day 7 after surgery

  13. Nutritional status 4

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

    Measured: Baseline and discharge or day 7 after surgery

  14. Intra- and postoperative organ complications

    Measured: Up to 7 days after surgery

  15. Length of intensive care unit stay

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

  16. Length of stay

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Dec 2019
  2. Study start18 Dec 2019
  3. Primary completion16 Jul 2020
  4. Study completion20 Jul 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04190329
Sponsor's protocol ID
Frailty-Testing
Status last verified
Oct 2020
First submitted
28 Nov 2019
Last updated
8 Oct 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Frailty Syndrome, run by Charite University, Berlin, Germany at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Duration to run the test battery (time frame: 1 day (Once only at screening)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04190329.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2020.

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