Cardiac Rehabilitation in Patients Acutely Managed for Cardiogenic Shock (ENIGMA)
- Conditions
- Cardiogenic Shock
- Interventions
- Other: Cardiac Rehabilitation intervention
- Registration Number
- NCT06572826
- Lead Sponsor
- Fondazione Don Carlo Gnocchi Onlus
- Brief Summary
This is a prospective and retrospective multicentre study conducted under the scientific coordination of the IRCCS Fondazione Don Gnocchi and funded by the Italian Ministry of Health (PNRR-MCNT2-2023-12377767). Using the Altshock registry, the largest multicentre Cardiogenic Shock (CS) registry in Italy, which currently has registered more than 1,000 CS patients across Italy, we will recruit patients to: (1) provide a granular assessment of post-acute phase programmes, patients' functional disability, return to work and quality of life, including specific reference to gender; (2) implement specific pathways of care in the post-acute phase; (3) provide a multidimensional assessment, thus validating an innovative model in comparison with the traditional pathway, defining the potential benefits to and impact on economic efficiency and the general sustainability of this therapeutic trajectory.
- Detailed Description
Study Population: The study will include all consecutive Cardiogenic Shock (CS) patients from the Altshock registry. The primary outcome is all-cause death and readmission-free survival at 6 months and 1 year post-ICU discharge. Secondary outcomes include functional recovery measured by illness severity (using the Medical Research Council Scale and electromyography if needed), disease-specific PROM (Kansas City Cardiomyopathy Questionnaire), and a chronic condition PROM (Long-Term Conditions Questionnaire) at 6 months.
Sample Size: An estimated cohort of 2000 CS patients, with around 1240 survivors, will be studied. This sample allows us to detect a 10% difference in death and readmission-free survival rates between those receiving post-acute care services and those who do not, with 80% power and a 5% significance level.
Validation and Assessment: A mixed-method approach will validate the innovative care model, incorporating clinical data, health economics, and professional perceptions. Key performance indicators and a RACI matrix will guide the implementation, with a focus on short- and long-term organizational impacts, economic benefits, and healthcare professional perceptions.
Data Analysis: Quantitative variables will be analyzed using standard statistical methods, and survival analysis will compare groups using Kaplan-Meier curves and log-rank tests. Multivariable Cox models will assess the impact of post-acute care services on outcomes. Economic analyses will involve cost-effectiveness and budget impact assessments.
Rehabilitation Intervention: Post-acute care, including cardiac and neuromotor rehabilitation, is critical for CS patients to prevent complications and rehospitalization. The rehabilitation program will include respiratory physiotherapy, muscle strengthening, endurance training, cardiovascular exercises, and secondary prevention strategies. Neuromotor rehabilitation will address sarcopenia and polyneuropathies with targeted exercises and advanced technologies like robotics and FES.
Expected Outcomes: The ENIGMA project aims to improve CS patient outcomes by transforming post-acute care, reducing mortality, enhancing quality of life, and proving the cost-effectiveness and sustainability of innovative care pathways.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 2000
• All consecutive patients with a clinical diagnosis of Cardiogenic Shock.
• Refusal to give informed consent.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Cardiogenic Shock Cardiac Rehabilitation intervention Study population: All consecutive patients with a clinical diagnosis of Cardiogenic Shock enrolled in the Altshock registry will be included.
- Primary Outcome Measures
Name Time Method Readmission in hospital for any cause 1 Year Incidence of readmission
All-cause of death 1 Year Incidence of all-cause death
- Secondary Outcome Measures
Name Time Method Disease-specific PROM 6-Months The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a specialized tool designed to assess the health-related quality of life in patients with heart failure. It measures the physical, social, and emotional impacts of heart failure, providing insights into the effectiveness of treatments and guiding clinical decisions.
PREMS: patient's opinion regarding their clinical service. 6-months Patients will be questioned about the clinical service received. The items explored will be coordination and integration of care; information, communication, and education; physical comfort; emotional support; welcoming and involvement of family and friends; transition and continuity; and access to care. Patients will define every item in terms of low quality, moderate quality and high quality.
Severity of critical illness polyneuropathy 6-months Assessment using clinical evaluation (using the Medical Research Council Scale for Muscle Strength), with electromyography and nerve conduction if required
Chronic-condition PROM 6-months standardized by the Food and Drug Administration and the Oxford Patient-Reported Outcomes Group's Long-Term Conditions Questionnaire
Trial Locations
- Locations (1)
Fondazione Don Gnocchi
🇮🇹Milan, Italy