Cardiac Arrest, Cognitive Impairment, Depression, Anxiety, Quality of Life, Sexual Dysfunction, Social Functioning
Conditions
Brief summary
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
Interventions
BEHAVIORALLifestyle intervention
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
Sponsors
Azienda Usl di Bologna
Montecatone Rehabilitation Institute S.p.A.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Masking description
The assessor will be unaware about the study arm allocation of the patient
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Hospital discharge after out-of-hospital cardiac arrest with Cerebral Performance Category 1 or 2 * Informed consent for participation in the study * Native Italian speaker or adequate understanding of the Italian language * Adequate ability to use the web to guarantee access to the contents
Exclusion criteria
* Previous cognitive dysfunction * Previous psychiatric disease * Previous episode of out-of-hospital cardiac arrest
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Health Related Quality of Life | 12 months | SF-12 Health Survey |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| HADS (Hospital Anxiety and Depression Scale) value | 12 months | Depression and anxiety symptoms |
| TICS (Telephone Interview for Cognitive Status) | 12 months | Cognitive symptoms |
| SF-12 (Short Form Health Survey 36) | 12 months | Health Related Quality of Life |
| NRS (Neurobehavioural rating scale), PCRS (Patient Competency Rating Scale) | 12 months | Behavioural symptoms |
| NRS (Neurobehavioural rating scale) | 12 months | Behavioural symptoms |
| Pittsburgh Sleep Quality Index (PSQI) | 12 months | Sleep Quality |
| Sexual Interest and Satisfaction Scale (SISS) | 12 months | Sexual Interest and Satisfaction |
| Zarit Burden Inventory (ZBI) | 12 months | Caregiver Burden |
| PCRS (Patient Competency Rating Scale) | 12 months | Behavioural symptoms |
| HADS (Hospital Anxiety and Depression Scale) - Caregiver | 12 months | Caregiver's depression and anxiety symptoms |
| PSQI (Pittsburgh Sleep Quality Index) - Caregiver | 12 months | Caregiver's sleep quality |
| SF-12 (Short Form Health Survey 36) - Caregiver | 12 months | Caregiver's Health Related Quality of Life |
Countries
Italy
Contacts
CONTACTLorenzo Gamberini, MD
CONTACTPamela Salucci, MD
PRINCIPAL_INVESTIGATORLorenzo Gamberini, MD
Azienda USL Bologna
Outcome results
None listed