BridgeMD
Tests treatment safety and results for Critical Illness
Official title Effectiveness of a Structured Multidimensional Tele-rehabilitation Intervention in Cardiac Patients With Post-Intensive Care Syndrome (CARDIO-PICS)
ClinicalTrials.gov ID: NCT07599306
What this study is testing
- What it's testing
- This two-arm, parallel-group randomized clinical trial investigates the effectiveness of an additional telerehabilitation program compared with standard care in patients with Post-Intensive Care Syndrome (PICS). The post-rehabilitation phase is crucial for consolidating recovery and ensuring continuity of care, with telerehabilitation offering a promising tool to enhance long-term adherence and outcomes.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 30 to 75
You may be able to join if
- Adults aged 30-75 years
- Previous ICU admission ≥48 hours
- Presence of Post-Intensive Care Syndrome (PICS), defined as at least one of the following objectively assessed impairments at baseline (T0):
- Neuromotor impairment, defined as Diagnosis of Critical Illness Myopathy (CIM) or Critical Illness Polyneuropathy (CIP), confirmed by...
- Cognitive impairment, defined as Montreal Cognitive Assessment (MoCA) score \< 26
You likely can't join if
- Prognostically unfavorable malnutrition defined as: CONUT score ≥5.
- Delirium present at the time of the enrollment, documented by a positive Confusion Assessment Method (CAM or CAM-ICU)
- Pre-existing severe cognitive impairment or dementia, defined as: documented diagnosis in the medical record prior to ICU admission \- Any clinical...
See the full eligibility criteria
- Adults aged 30-75 years
- Previous ICU admission ≥48 hours
- Presence of Post-Intensive Care Syndrome (PICS), defined as at least one of the following objectively assessed impairments at baseline (T0):
- Neuromotor impairment, defined as Diagnosis of Critical Illness Myopathy (CIM) or Critical Illness Polyneuropathy (CIP), confirmed by electromyography (EMG)
- Cognitive impairment, defined as Montreal Cognitive Assessment (MoCA) score \< 26
- Psychological impairment, defined as Patient Health Questionnaire-9 (PHQ-9) score ≥ 10
- Nutritional impairment, defined as the presence of malnutrion according to GLIM criteria, requiring at least one phenotypic criterion (non-volitional weight loss \>5% within 6 months or \>10% beyond 6 months; BMI \ 1...
- Metabolic or bone metabolism disorder, defined as altered bone metabolism markers (Bone Turnover Markers outside reference range) Ability to provide written informed consent
- Prognostically unfavorable malnutrition defined as: CONUT score ≥5.
- Delirium present at the time of the enrollment, documented by a positive Confusion Assessment Method (CAM or CAM-ICU)
- Pre-existing severe cognitive impairment or dementia, defined as: documented diagnosis in the medical record prior to ICU admission \- Any clinical condition limiting participation in the rehabilitation program...
The study team makes the final eligibility decision.
Where it's taking place
- Milan, Milano, Italy
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 30 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Milan, Milano, Italy. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.