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NCT06395558 Clinical Trial

intErnet-based iNterventions FOR Cardiac arrEst suRvivors

Quality of Life Clinical Trial

— ENFORCER  

Official title:
Internet-Based Interventions for Cardiac Arrest Survivors

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06395558
Other study ID # ENFORCER
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date July 1, 2024
Est. completion date October 1, 2026

Study information
Verified date April 2024
Source Azienda Usl di Bologna
Contact Lorenzo Gamberini, MD
Phone 3403550540
Email gamberini6@ausl.bologna.it
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 137
Est. completion date October 1, 2026
Est. primary completion date July 1, 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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 Exclusion Criteria: - Previous cognitive dysfunction - Previous psychiatric disease - Previous episode of out-of-hospital cardiac arrest

Study Design

Related Conditions & MeSH terms

Intervention

Behavioral:
• Lifestyle 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

Locations
Country Name City State
Italy Azienda Unità Sanitaria Locale Bologna
Italy Montecatone Rehabilitation Institute Imola Bologna

Sponsors (2)
Lead Sponsor Collaborator
Azienda Usl di Bologna Montecatone Rehabilitation Institute S.p.A.

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary Composite outcome HADS (Hospital Anxiety and Depression Scale) score < 8 for depression or anxiety and TICS (Telephone Interview for Cognitive Status) > 31 12 months
Secondary HADS (Hospital Anxiety and Depression Scale) value Depression and anxiety symptoms 12 months
Secondary TICS (Telephone Interview for Cognitive Status) Cognitive symptoms 12 months
Secondary SF-12 (Short Form Health Survey 36) Health Related Quality of Life 12 months
Secondary NRS (Neurobehavioural rating scale), PCRS (Patient Competency Rating Scale) Behavioural symptoms 12 months
Secondary NRS (Neurobehavioural rating scale) Behavioural symptoms 12 months
Secondary Pittsburgh Sleep Quality Index (PSQI) Sleep Quality 12 months
Secondary Sexual Interest and Satisfaction Scale (SISS) Sexual Interest and Satisfaction 12 months
Secondary Zarit Burden Inventory (ZBI) Caregiver Burden 12 months
Secondary PCRS (Patient Competency Rating Scale) Behavioural symptoms 12 months
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