Internet-Based Interventions for Cardiac Arrest Survivors

Azienda Usl di Bologna2 sites in 1 country137 target enrollmentAugust 5, 2024

ConditionsCognitive Impairment Depression, Anxiety Cardiac Arrest Quality of Life Social Functioning Sexual Dysfunction

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Cognitive Impairment
Sponsor: Azienda Usl di Bologna
Enrollment: 137
Locations: 2
Primary Endpoint: Composite outcome
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

Anxiety, depression and cognitive impairment symptoms are common among cardiac arrest survivors. This randomized clinical trial will test whether an internet-based lifestyle intervention administered through a web app can foster anxiety and depression symptoms in patients who survived an out-of-hospital cardiac arrest and suffer from these symptoms

Registry

clinicaltrials.gov

Start Date

August 5, 2024

End Date

October 1, 2026

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Azienda Usl di Bologna

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Hospital discharge after out-of-hospital cardiac arrest with Cerebral Performance Category 1 or 2
•HADS anxiety or depression ≥ 8 and/or TICS ≤ 31
•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

Outcomes

Primary Outcomes

Composite outcome

Time Frame: 12 months

HADS (Hospital Anxiety and Depression Scale) score \< 8 for depression or anxiety and TICS (Telephone Interview for Cognitive Status) \> 31

Secondary Outcomes

SF-12 (Short Form Health Survey 36)(12 months)
NRS (Neurobehavioural rating scale), PCRS (Patient Competency Rating Scale)(12 months)
Zarit Burden Inventory (ZBI)(12 months)
TICS (Telephone Interview for Cognitive Status)(12 months)
HADS (Hospital Anxiety and Depression Scale) - Caregiver(12 months)
SF-12 (Short Form Health Survey 36) - Caregiver(12 months)
NRS (Neurobehavioural rating scale)(12 months)
PCRS (Patient Competency Rating Scale)(12 months)
Sexual Interest and Satisfaction Scale (SISS)(12 months)
PSQI (Pittsburgh Sleep Quality Index) - Caregiver(12 months)
HADS (Hospital Anxiety and Depression Scale) value(12 months)
Pittsburgh Sleep Quality Index (PSQI)(12 months)