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Clinical Trials/NCT06395558
NCT06395558RecruitingNot Applicable

Internet-Based Interventions for Cardiac Arrest Survivors

Azienda Usl di Bologna2 sites in 1 country106 target enrollmentStarted: August 5, 2024Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
106
Locations
2
Primary Endpoint
Health Related Quality of Life
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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

Study Design

Study Type
Interventional
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 Criteria

Ages
18 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts 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

Arms & Interventions

Lifestyle intervention

Experimental

Intervention: Lifestyle intervention (Behavioral)

Control

No Intervention

Outcomes

Primary Outcomes

Health Related Quality of Life

Time Frame: 12 months

SF-12 Health Survey

Secondary Outcomes

  • HADS (Hospital Anxiety and Depression Scale) - Caregiver(12 months)
  • 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)
  • 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)

Investigators

Sponsor Class
Other Gov
Responsible Party
Sponsor

Study Sites (2)

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