NCT04880824CompletedNot Applicable
Analysis of the Pathophysiology of Frailty Syndrome and Clinical Development of Frailty Within the Framework of the Innovation Fund Project PRÄP-GO (ANA-PRÄP-GO)
Charite University, Berlin, Germany27 sites in 1 country693 target enrollmentStarted: May 19, 2021Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 693
- Locations
- 27
- Primary Endpoint
- Frailty
Study Overview
Brief Summary
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.
Detailed 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:
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 70 Years to — (Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Frailty
Time Frame: Up to 1 year
Frequency of frailty is measured by modified Fried criteria (category 1 +2 = pre-frail, category 3 -5 = frail)
Neuro-cognitive disorder (NCD)
Time Frame: Up to 1 year
Frequency of neuro-cognitive disorder (mild / major NCD)
Secondary Outcomes
- Number of Participants with Delirium as Determined by Chart Review(During the hospital stay, an expected average of 1 week)
- Confusion Assessment Method for the Intensive Care Unit (CAM-ICU)(During the hospital stay, an expected average of 1 week)
- Confusion Assessment Method Severity-Score (CAM-S Long Form) in English(During the hospital stay, an expected average of 1 week)
- Ethical aspects(Up to 1 year)
- Findings of Memory consultation(Up to 1 year)
- Neuroimaging(Up to 1 year)
- Demand of health services(Up to 1 year)
- Sarcopenia(Up to 1 year)
- Quality of life(Up to 1 year)
- Cholinesterases 1(Up to 1 year)
- Delirium Rating Scale Revised 98 in English (DRS-R-98)(During the hospital stay, an expected average of 1 week)
- Delirium Severity Scale (CAM-ICU-7) in English(During the hospital stay, an expected average of 1 week)
- Cardiovascular function 2(Up to 1 year)
- Incidence of delirium(During the hospital stay, an expected average of 1 week)
- Nursing Delirium Screening Scale (Nu-DESC)(During the hospital stay, an expected average of 1 week)
- Cardiovascular function 1(Up to 1 year)
- Patient-related outcome measures (PROMS)(Up to 1 year)
- Incidence of cognitive impairment(Up to 1 year)
- Severity of delirium(During the hospital stay, an expected average of 1 week)
- Confusion Assessment Method (CAM)(During the hospital stay, an expected average of 1 week)
- Intensive Care Delirium Screening Checklist (ICDSC)(During the hospital stay, an expected average of 1 week)
- Patient-related experience measures (PREMS)(Up to 1 year)
- Incidence of dementia(Up to 1 year)
- Calf circumference(Up to 1 year)
- Arm circumference(Up to 1 year)
- Number of participants with changes in laboratory values 2(Up to 1 year)
- APOE polymorphisms(Up to 1 year)
- Total interleukin-8(Up to 1 year)
- Delirium days(During the hospital stay, an expected average of 1 week)
- COVID-19(Up to 1 year)
- Patient satisfaction(Up to 1 year)
- Insomnia(Up to 1 year)
- Dental status(Up to 1 year)
- Stress(Up to 1 year)
- Anxiety 1(Up to 1 year)
- Anxiety 2(Up to 1 year)
- Nutritional Status(Up to 1 year)
- Number of participants with changes in laboratory values 1(Up to 1 year)
- Autophagy of platelets(Up to 1 year)
- Biomarker panel(Up to 1 year)
- Vitamin D (cholecalciferol)(Up to 1 year)
- Analysis of urine(Up to 1 year)
- Hip Osteoarthritis Outcome(Up to 1 year)
- Skill management(Up to 1 year)
- Electroencephalography band power(During the hospital stay, an expected average of 1 week)
- Adverse events(Up to 1 year)
- Adherence to Mediterranean diet (MD)(Up to 1 year)
- Psychometric properties of the Meta Memory questionnaire(During the hospital stay, at the beginning of the investigation, an average of two hours.)
- Postoperative complications(Up to 30 days)
- HbA1c(Up to 1 year)
- Cholinesterases 2(Up to 1 year)
- Intracellular pH(Up to 1 year)
- Multiplex gene expression analyzes (neuroinflammation and micro RNA panels)(Up to 1 year)
- Autoantibodies(Up to 1 year)
- Trypotophan metabolites and short-chain fatty acids(Up to 1 year)
- Peripheral Blood Mononuclear Cell(Up to 1 year)
- Protein panel(Up to 1 year)
- Serum albumin(Up to 1 year)
- Sciatica Bothersomeness Index(Up to 1 year)
- Depth of anesthesia(During surgery, an expected average of 2 hours)
- Cytokines(Up to 1 year)
- Chemokines(Up to 1 year)
- Markers immune-brain axis and gut-brain axis(Up to 1 year)
- Analysis of microbiome(Up to 1 year)
- Gait analysis 1(Up to 1 year)
- Gait analysis 2(Up to 1 year)
- Clinical investigation(Up to 1 year)
- Oswestry disability index (ODI)(Up to 1 year)
- Microbiome 1(Up to 1 year)
- Microbiome 2(Up to 1 year)
- Dementia markers(Up to 1 year)
- Biobanks samples(Up to 1 year)
- Range of Motion of the hip/knee(Up to 1 year)
- Hip abduction force (for total hip arthroplasty patients)(Up to 1 year)
- Disabilities of the Arm, Shoulder and Hand Questionnaire (DASH)(Up to 1 year)
- Knee Osteoarthritis Outcome(Up to 1 year)
- Knee extension and flexion force measurement (for total knee arthroplasty patients)(Up to 1 year)
- Back pain(Up to 1 year)
- Modified Japanese orthopaedic association scale(Up to 1 year)
- ASIA Impairment Scale (AIS)(Up to 1 year)
- Leg pain(Up to 1 year)
- Acceptance of participatory decision-making(Up to 1 year)
- Electroencephalography spectral analysis(During the hospital stay, at the beginning of the investigation, an average of one hour.)
- Effect of analgesics(During the hospital stay, an expected average of 1 week)
Investigators
Claudia Spies
Head of the Department of Anesthesiology and Operative Intensive Care Medicine (CCM/CVK)
Charite University, Berlin, Germany
Study Sites (27)
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