intErnet-based iNterventions FOR Cardiac arrEst suRvivors

Not Applicable

Recruiting

• Conditions: Depression, Anxiety; Quality of Life; Sexual Dysfunction; Social Functioning; Cognitive Impairment; Cardiac Arrest
• Interventions: Behavioral: Lifestyle intervention

• Registration Number: NCT06395558
• Lead Sponsor: Azienda Usl di Bologna

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-04-24
• Study First Submitted QC: 2024-04-30
• Study First Posted: 2024-05-02
• Status Verified: 2024-08
• Study Start: 2024-08-05
• Last Update Submitted: 2024-08-23
• Last Update Posted: 2024-08-26
• Primary Completion: 2026-08-05
• Study Completion: 2026-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 137

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

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Exclusion Criteria

• Previous cognitive dysfunction
• Previous psychiatric disease
• Previous episode of out-of-hospital cardiac arrest

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lifestyle intervention	Lifestyle intervention	-

Primary Outcome Measures

Name	Time	Method
Composite outcome	12 months	HADS (Hospital Anxiety and Depression Scale) score \< 8 for depression or anxiety and TICS (Telephone Interview for Cognitive Status) \> 31

Secondary Outcome Measures

Name	Time	Method
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
Zarit Burden Inventory (ZBI)	12 months	Caregiver Burden
TICS (Telephone Interview for Cognitive Status)	12 months	Cognitive symptoms
HADS (Hospital Anxiety and Depression Scale) - Caregiver	12 months	Caregiver's depression and anxiety symptoms
SF-12 (Short Form Health Survey 36) - Caregiver	12 months	Caregiver's Health Related Quality of Life
NRS (Neurobehavioural rating scale)	12 months	Behavioural symptoms
PCRS (Patient Competency Rating Scale)	12 months	Behavioural symptoms
Sexual Interest and Satisfaction Scale (SISS)	12 months	Sexual Interest and Satisfaction
PSQI (Pittsburgh Sleep Quality Index) - Caregiver	12 months	Caregiver's sleep quality
HADS (Hospital Anxiety and Depression Scale) value	12 months	Depression and anxiety symptoms
Pittsburgh Sleep Quality Index (PSQI)	12 months	Sleep Quality

Trial Locations

Locations (2)

Montecatone Rehabilitation Institute; 🇮🇹 Imola, Bologna, Italy

Azienda Unità Sanitaria Locale; 🇮🇹 Bologna, Italy