Analysis of Frailty Syndrome Within the Framework of the Innovation Fund Project PRÄP-GO (ANA-PRÄP-GO)
Status
Conditions
Treatments
Details and patient eligibility
About
The patients included in PRÄP-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.
Amendment vote of 08/05/2024: Recruitment extension of Non-frail surgical control group (NFC cohort) until August 31, 2025.
Full description
As part of the innovation fund project PRÄP-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 PRÄP-GO.
The groups of participants in this accompanying program ANA-PRÄP-GO are:
- Randomized study patients with a frailty syndrome of the intervention study PRÄP-GO (PG cohort)
- Non-frail surgical control group (NFC cohort)
- Non-surgical comparison 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 surgical cohorts from studies carried out at the department of anesthesiology to describe domain-specific changes in the perioperative course
- Perspectives of different health professional groups regarding barriers and facilitators in the implementation of a prehabilitation program and necessary changes in skill, organizational and management, and communication in an interdisciplinary setting
- 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, dental status etc.)
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion criteria
PG cohort:
Inclusion criteria
- Consent given and inclusion in PRÄP-GO
- Patient capable of giving consent or existing legal guardian in the case of patients not capable of giving consent
Exclusion criteria
- None
NFC cohort:
Inclusion criteria
- Patient capable of giving consent or existing legal guardian in the case of patients not capable of giving consent
- Age ≥ 70 years
- Elective surgery planned
- Expected anesthesia duration> 60 min
- No frailty syndrome (0 positive out of 5 standardized parameters) according to the physical frailty phenotype (Fried et al., 2001)
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:
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 PRÄP-GO cohort
- Age ≥ 18 years
Exclusion criterion
- Language barrier
Trial design
693 participants in 4 patient groups
Trial contacts and locations
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Central trial contact
Claudia Spies, MD, Prof.
Data sourced from clinicaltrials.gov
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