Analysis of Frailty Syndrome Within the Framework of the Innovation Fund Project PR P-GO (ANA-PR P-GO)

  • STATUS
    Recruiting
  • End date
    Nov 24, 2022
  • participants needed
    1640
  • sponsor
    Charite University, Berlin, Germany
Updated on 24 November 2021
Accepts healthy volunteers

Summary

The patients included in PRP-GO and the corresponding comparison cohorts will be offered to participate in this complementary study in order to be able to carry out a detailed characterization and phenotyping of the frailty complex.

Description

As part of the innovation fund project PRP-GO (EA1/225/19), a multimodal intervention is being conducted in patients with a frailty syndrome. However, the health care research project is limited to evaluating clinical issues only. In order to be able to research further pathophysiological, clinical, psychosocial and work-organizational connections, different groups of participants will be offered the participation in this scientific support program of PRP-GO.

The groups of participants in this accompanying program ANA-PRP-GO are:

  • Randomized study patients with a frailty syndrome of the intervention study PRP-GO (PG cohort)
  • Non-frail surgical control group (NFC cohort)
  • Non-operative control group (NO cohort)
  • Participants with health professions (GB cohort)

Additionally, relatives of the patients can be included.

Subprojects are included to reflect research questions of interest in sub groups:

  • Success of endoprosthetic implants (clinical outcome and gait pattern after total hip arthroplasty and total knee arthroplasty in frail patients)
  • Functional treatment outcome and health-related quality of life after elective spinal surgery in the PG cohort, in the NFC cohort, and in the NO cohort
  • Hemodynamic evaluation in patients of the PG and NFC cohort with preoperative abnormal cardiovascular function
  • Establishment of a German standard database for 14 CANTAB tests by CANTAB Connect technology
  • Aggregated evaluation of the cognitive data of different anesthesiological study cohorts to describe domain-specific changes in the perioperative course
  • Perspectives of different health professional groups regarding necessary changes in skill, organizational and management, and communication in interdisciplinary setting and with patients and significant others.
  • Perspectives of patients and significant others regarding the organizational pathway of the prehabilitation program
  • Frequency, pathophysiology and trajectory of muscle weakness as well as functional impairments of patients admitted to intensive care units of the PG and NFC cohort and their long-term outcomes.
  • The gut microbiome as a potential risk factor for perioperative neurocognitive disorders (PNDs) in the elderly
  • Evaluation of nutrition data in all cohorts (e.g. adherence to mediterranean diet, nutrition habits, nutritional status etc.)

Details
Condition Frailty Syndrome
Treatment Prehabilitation- new form of care
Clinical Study IdentifierNCT04880824
SponsorCharite University, Berlin, Germany
Last Modified on24 November 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Age 70 years
No elective surgery planned
No surgery within 6 months prior to study enrollment
Exclusion criteria - See NFC cohort
GB cohort
Inclusion criterion
Doctor, nurse or therapist from the cooperation partners of PRAEP-GO who were involved in the project
Exclusion criterion
Language barrier
Relatives
Inclusion criteria
Member of a patient in the PRP-GO cohort
Age 18 years
Exclusion criterion
Language barrier

Exclusion Criteria

Severe cardiac or pulmonary disease (NYHA IV, Gold IV)
Intracranial interventions
Moribund patients (palliative situation)
Patients with a neuropsychiatric clinical picture or severe hearing and / or visual acuity impairment (not compensated by visual or hearing aids), which limit the performance of the neurocognitive tests
Insufficient language skills
Participation in another interventional rehabilitation study or a study according to the German Drug Law or the medical Device Law that has not been approved by the study leader (Exception: parallel participation in adjuvant therapy study)
NO cohort
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