ClinicalTrials.gg
RecruitingNCT06395558ENFORCERUpdated Mar 30, 2026

intErnet-based iNterventions FOR Cardiac arrEst suRvivors

An interventional study of Lifestyle intervention in Cognitive Impairment, Depression, Anxiety and Cardiac Arrest, sponsored by Azienda Usl di Bologna. Recruiting at 2 sites in Italy. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-03-30.

Sponsored by Azienda Usl di Bologna · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Started Aug 2024; still recruiting 2 years 3 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
106
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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

02

Conditions studied

  • Cognitive Impairment
  • Depression, Anxiety
  • Cardiac Arrest
  • Quality of Life
  • Social Functioning
  • Sexual Dysfunction
03

In context

Cognitive Dysfunction

3,872 studies on the registry are indexed under Cognitive Dysfunction; 1,119 are open to participants now.

This study's planned enrollment of 106 is above the median of 64 across 2,794 interventional studies indexed under Cognitive Dysfunction.

Browse Cognitive Dysfunction studies →

Lead sponsor

Azienda Usl di Bologna is the lead sponsor of 43 studies on the registry; 13 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Hospital discharge after out-of-hospital cardiac arrest with Cerebral Performance Category 1 or 2
  • 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

Exclusion Criteria:

  • Previous cognitive dysfunction
  • Previous psychiatric disease
  • Previous episode of out-of-hospital cardiac arrest
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
106 participants (estimated)

Study arms

  • Experimental
    Lifestyle intervention

    Behavioral: Lifestyle intervention

  • No intervention
    Control

Interventions

  • BehavioralLifestyle 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

06

What researchers measure

Primary outcomes

  1. Health Related Quality of Life

    SF-12 Health Survey

    Time frame: 12 months

Secondary outcomes

  1. HADS (Hospital Anxiety and Depression Scale) value

    Depression and anxiety symptoms

    Time frame: 12 months

  2. TICS (Telephone Interview for Cognitive Status)

    Cognitive symptoms

    Time frame: 12 months

  3. SF-12 (Short Form Health Survey 36)

    Health Related Quality of Life

    Time frame: 12 months

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

    Behavioural symptoms

    Time frame: 12 months

  5. NRS (Neurobehavioural rating scale)

    Behavioural symptoms

    Time frame: 12 months

  6. Pittsburgh Sleep Quality Index (PSQI)

    Sleep Quality

    Time frame: 12 months

  7. Sexual Interest and Satisfaction Scale (SISS)

    Sexual Interest and Satisfaction

    Time frame: 12 months

  8. Zarit Burden Inventory (ZBI)

    Caregiver Burden

    Time frame: 12 months

  9. PCRS (Patient Competency Rating Scale)

    Behavioural symptoms

    Time frame: 12 months

  10. HADS (Hospital Anxiety and Depression Scale) - Caregiver

    Caregiver's depression and anxiety symptoms

    Time frame: 12 months

  11. PSQI (Pittsburgh Sleep Quality Index) - Caregiver

    Caregiver's sleep quality

    Time frame: 12 months

  12. SF-12 (Short Form Health Survey 36) - Caregiver

    Caregiver's Health Related Quality of Life

    Time frame: 12 months

07

Study locations

2 of 2 sites recruiting
08

References and documents

Publications

  • 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. PubMed 39328897 ↗

Individual participant data

Plan to share: Yes — Fully anonymized patient data will be shared in an online repository

Supporting information: Study protocol

Time frame: After study publication, indefinitely.

Access criteria: No Access restrictions

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 30, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06395558
Lead sponsor
Azienda Usl di Bologna
Collaborators
Montecatone Rehabilitation Institute S.p.A.
Responsible party
Sponsor
First posted
May 2, 2024
Start date
Aug 5, 2024
Primary completion
Aug 5, 2027 (estimated)
Completion
Oct 1, 2027 (estimated)
Last update
Mar 30, 2026

Study contacts

Lorenzo Gamberini, MD
Contact
gamberini6@ausl.bologna.it
3403550540 ext. +39
Pamela Salucci, MD
Contact
pamela.salucci@montecatone.com
Lorenzo Gamberini, MD
principal investigator · Azienda USL Bologna

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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