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| Name | Class |
|---|---|
| Montecatone Rehabilitation Institute S.p.A. | OTHER |
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This randomized clinical trial will test whether an internet-based lifestyle intervention administered through a web app can foster Health Related Quality of Life in patients who survived an out-of-hospital cardiac arrest and suffer from these symptoms
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lifestyle intervention | Experimental |
| |
| Control | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lifestyle intervention | Behavioral | Multimodal web-based intervention programme on anxiety, depression and cognitive impairment consisting of knowledge development sessions and practical/gaming sessions focused on different domains: cognitive competence, socio-relational competence and emotions/affectivity, and physical activity-nutrition |
| Measure | Description | Time Frame |
|---|---|---|
| Health Related Quality of Life | SF-12 Health Survey | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| HADS (Hospital Anxiety and Depression Scale) value | Depression and anxiety symptoms | 12 months |
| TICS (Telephone Interview for Cognitive Status) | Cognitive symptoms |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lorenzo Gamberini, MD | Contact | 3403550540 | +39 | gamberini6@ausl.bologna.it |
| Pamela Salucci, MD | Contact | pamela.salucci@montecatone.com |
| Name | Affiliation | Role |
|---|---|---|
| Lorenzo Gamberini, MD | Azienda USL Bologna | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Azienda Unità Sanitaria Locale | Recruiting | Bologna | Bologna | 40100 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39328897 | Derived | Gamberini L, Rucci P, Dolcini C, Masi M, Simoncini L, Tartaglione M, Del Giudice D, Domina R, Fagiolini A, Salucci P; Collaborators. ENFORCER, internet-based interventions for cardiac arrest survivors: A study protocol for a randomised, parallel-group, multicentre clinical trial. Resusc Plus. 2024 Sep 18;20:100772. doi: 10.1016/j.resplu.2024.100772. eCollection 2024 Dec. |
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Fully anonymized patient data will be shared in an online repository
After study publication, indefinitely.
No Access restrictions
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| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| D003863 | Depression |
| D001008 | Anxiety Disorders |
| D006323 | Heart Arrest |
| D012917 | Social Adjustment |
| D012735 | Sexual Dysfunction, Physiological |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
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The assessor will be unaware about the study arm allocation of the patient
|
| 12 months |
| SF-12 (Short Form Health Survey 36) | Health Related Quality of Life | 12 months |
| NRS (Neurobehavioural rating scale), PCRS (Patient Competency Rating Scale) | Behavioural symptoms | 12 months |
| NRS (Neurobehavioural rating scale) | Behavioural symptoms | 12 months |
| Pittsburgh Sleep Quality Index (PSQI) | Sleep Quality | 12 months |
| Sexual Interest and Satisfaction Scale (SISS) | Sexual Interest and Satisfaction | 12 months |
| Zarit Burden Inventory (ZBI) | Caregiver Burden | 12 months |
| PCRS (Patient Competency Rating Scale) | Behavioural symptoms | 12 months |
| HADS (Hospital Anxiety and Depression Scale) - Caregiver | Caregiver's depression and anxiety symptoms | 12 months |
| PSQI (Pittsburgh Sleep Quality Index) - Caregiver | Caregiver's sleep quality | 12 months |
| SF-12 (Short Form Health Survey 36) - Caregiver | Caregiver's Health Related Quality of Life | 12 months |
| Montecatone Rehabilitation Institute | Recruiting | Imola | Bologna | 40026 | Italy |
|
| D001519 |
| Behavior |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D012919 | Social Behavior |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |