intErnet-based iNterventions FOR Cardiac arrEst suRvivors

NCT06395558 | Recruiting DMC

• 1 other identifier: ENFORCER
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 2

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

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Health Related Quality of Life

  SF-12 Health Survey

  12 months

Secondary Outcomes (12)

• HADS (Hospital Anxiety and Depression Scale) value

  12 months

• TICS (Telephone Interview for Cognitive Status)

  12 months

• SF-12 (Short Form Health Survey 36)

  12 months

• NRS (Neurobehavioural rating scale), PCRS (Patient Competency Rating Scale)

  12 months

• NRS (Neurobehavioural rating scale)

  12 months

Study Arms (2)

Lifestyle intervention

EXPERIMENTAL

Behavioral: Lifestyle intervention

Control

NO INTERVENTION

Interventions

Lifestyle intervention BEHAVIORAL

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

Lifestyle intervention

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Azienda Usl di Bologna: lead
• Montecatone Rehabilitation Institute S.p.A.: collaborator

Study Sites (2)

Azienda Unità Sanitaria Locale

Bologna, Bologna, 40100, Italy

RECRUITING

Montecatone Rehabilitation Institute

Imola, Bologna, 40026, Italy

RECRUITING

Related Publications (1)

• Gamberini L, Rucci P, Dolcini C, Masi M, Simoncini L, Tartaglione M, Del Giudice D, Domina R, Fagiolini A, Salucci P; Collaborators. ENFORCER, internet-based interventions for cardiac arrest survivors: A study protocol for a randomised, parallel-group, multicentre clinical trial. Resusc Plus. 2024 Sep 18;20:100772. doi: 10.1016/j.resplu.2024.100772. eCollection 2024 Dec.

  PMID: 39328897 DERIVED

MeSH Terms

Conditions

Cognitive Dysfunction; Depression; Anxiety Disorders; Heart Arrest; Social Adjustment; Sexual Dysfunction, Physiological

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Behavioral Symptoms; Behavior; Heart Diseases; Cardiovascular Diseases; Social Behavior; Genital Diseases; Urogenital Diseases

Study Officials

• Lorenzo Gamberini, MD

  Azienda USL Bologna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lorenzo Gamberini, MD

CONTACT

3403550540; gamberini6@ausl.bologna.it

Pamela Salucci, MD

CONTACT

pamela.salucci@montecatone.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The assessor will be unaware about the study arm allocation of the patient
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2024
• First Posted: May 2, 2024
• Study Start: August 5, 2024
• Primary Completion (Estimated): August 5, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: March 30, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After study publication, indefinitely.
• Access Criteria: No Access restrictions

Locations

IT (2)