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NCT Number: NCT06395558

intErnet-based iNterventions FOR Cardiac arrEst suRvivors

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

Recruiting

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Key information

Conditions

Cognitive Impairment Anxiety Disorders Behavior Behavioral Symptoms Cardiac Arrest Cardiovascular Diseases Cognition Disorders Cognitive Dysfunction Depression Depression, Anxiety Genital Diseases Heart Arrest Heart Diseases Mental Disorders Neurocognitive Disorders Quality of Life Sexual Dysfunction Sexual Dysfunction, Physiological Social Adjustment Social Behavior Social Functioning Urogenital Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Azienda Unità Sanitaria Locale, Bologna, Italy

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Health Related Quality of Life

    Time frame: 12 months

    SF-12 Health Survey

Secondary outcomes

  1. HADS (Hospital Anxiety and Depression Scale) value

    Time frame: 12 months

    Depression and anxiety symptoms

  2. TICS (Telephone Interview for Cognitive Status)

    Time frame: 12 months

    Cognitive symptoms

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

    Time frame: 12 months

    Health Related Quality of Life

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

    Time frame: 12 months

    Behavioural symptoms

  5. NRS (Neurobehavioural rating scale)

    Time frame: 12 months

    Behavioural symptoms

  6. Pittsburgh Sleep Quality Index (PSQI)

    Time frame: 12 months

    Sleep Quality

  7. Sexual Interest and Satisfaction Scale (SISS)

    Time frame: 12 months

    Sexual Interest and Satisfaction

  8. Zarit Burden Inventory (ZBI)

    Time frame: 12 months

    Caregiver Burden

  9. PCRS (Patient Competency Rating Scale)

    Time frame: 12 months

    Behavioural symptoms

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

    Time frame: 12 months

    Caregiver's depression and anxiety symptoms

  11. PSQI (Pittsburgh Sleep Quality Index) - Caregiver

    Time frame: 12 months

    Caregiver's sleep quality

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

    Time frame: 12 months

    Caregiver's Health Related Quality of Life

Study contacts

Contact information is provided by the study sponsor or research team.

Lorenzo Gamberini, MD

CONTACT

[email protected]

3403550540 ext. +39

Pamela Salucci, MD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Azienda Usl di Bologna

Other Gov

Collaborators

  • Montecatone Rehabilitation Institute S.p.A.

Registry information

Acronym: ENFORCER

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
May 2, 2024
Registry last updated
Mar 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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