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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

693 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-05-19

Study Completion Date

2025-03-21

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Comparison of Preoperative Frailty Assessment Tools

NCT06889545

Frailty Frailty in Older Adults Frailty/Sarcopenia

NOT_YET_RECRUITING

Hand Grip Strength as a Marker of Frailty in Surgical Patients

NCT02966470

Frailty

TERMINATED

Frailty Assessment in Vascular Hot Clinic Setting - Feasibility and Prognostic Value

NCT06040658

Frailty Frail Elderly Syndrome Surgery

UNKNOWN

Frailty Screening in the Swedish Emergency Department Setting

NCT04877028

Frailty Frailty Syndrome Emergency Department +2 more

COMPLETED

Preoperative Frailty Assessment With Ultrasound in Elderly Patients

NCT05438628

Frailty

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.)

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Frailty Syndrome

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

PG cohort

800 randomized surgical study patients with a frailty syndrome (Pre-frail and frail) of the intervention study PRÄP-GO (PG cohort). 400 study patients receive the intervention and 400 study patients receive standard of care.

Prehabilitation- new form of care

Intervention Type BEHAVIORAL

The participants in the intervention group take part in a shared decision-making (SDM) conference to plan the intervention. The therapeutic content of the prehabilitation is defined individually for each patient in the SDM conference. Prehabilitation will be a structured and individually tailored 3-week program.

NFC cohort

400 non-frail surgical control group (NFC cohort)

No interventions assigned to this group

NO cohort

300 non-operative control group (NO cohort)

No interventions assigned to this group

GB cohort

Skill-Change-Management: a maximum of 30 coworkers and analysis of guiding principle: to a maximum of 35 patients, 30 relatives and 45 coworkers

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Prehabilitation- new form of care

The participants in the intervention group take part in a shared decision-making (SDM) conference to plan the intervention. The therapeutic content of the prehabilitation is defined individually for each patient in the SDM conference. Prehabilitation will be a structured and individually tailored 3-week program.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

* 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)

\- Age ≥ 70 years

* No elective surgery planned
* No surgery within 6 months prior to study enrollment

* Member of a patient in the PRÄP-GO cohort
* Age ≥ 18 years

Exclusion criterion

\- Language barrier

Exclusion Criteria

\- None

NFC cohort:

* 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:

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:

Minimum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes