intErnet-based iNterventions FOR Cardiac arrEst suRvivors (ENFORCER)

April 30, 2024 updated by: Azienda Usl di Bologna

Internet-Based Interventions for Cardiac Arrest Survivors

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

137

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
      • Bologna, Italy, 40100
        • Azienda Unità Sanitaria Locale
    • Bologna

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Experimental: Lifestyle 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azienda Usl di Bologna

Collaborators

Montecatone Rehabilitation Institute S.p.A.

Investigators

  • Principal Investigator: Lorenzo Gamberini, MD, Azienda USL Bologna

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2024

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

October 1, 2026

Study Registration Dates

First Submitted

April 24, 2024

First Submitted That Met QC Criteria

April 30, 2024

First Posted (Actual)

May 2, 2024

Study Record Updates

Last Update Posted (Actual)

May 2, 2024

Last Update Submitted That Met QC Criteria

April 30, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ENFORCER

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Fully anonymized patient data will be shared in an online repository

IPD Sharing Time Frame

After study publication, indefinitely.

IPD Sharing Access Criteria

No Access restrictions

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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