intErnet-based iNterventions FOR Cardiac arrEst suRvivors

Azienda Usl di Bologna137 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Enrollment

137

Conditions

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

Interventions

Lifestyle interventionBEHAVIORAL

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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 * 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

Locations (2)

Montecatone Rehabilitation Institute

Imola, Bologna, Italy

RECRUITING

Azienda Unità Sanitaria Locale

Bologna, Italy

RECRUITING

Outcomes

Primary Outcomes

Composite outcome

HADS (Hospital Anxiety and Depression Scale) score \< 8 for depression or anxiety and TICS (Telephone Interview for Cognitive Status) \> 31

Time frame: 12 months

Secondary Outcomes

HADS (Hospital Anxiety and Depression Scale) value

Depression and anxiety symptoms

Time frame: 12 months

TICS (Telephone Interview for Cognitive Status)

Cognitive symptoms

Time frame: 12 months

SF-12 (Short Form Health Survey 36)

Health Related Quality of Life

Time frame: 12 months

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

Behavioural symptoms

Time frame: 12 months

NRS (Neurobehavioural rating scale)

Behavioural symptoms

Time frame: 12 months

Pittsburgh Sleep Quality Index (PSQI)

Sleep Quality

Time frame: 12 months

Sexual Interest and Satisfaction Scale (SISS)

Sexual Interest and Satisfaction

Time frame: 12 months

Zarit Burden Inventory (ZBI)

Caregiver Burden

Time frame: 12 months

PCRS (Patient Competency Rating Scale)

Behavioural symptoms

Time frame: 12 months

HADS (Hospital Anxiety and Depression Scale) - Caregiver

Caregiver's depression and anxiety symptoms

Time frame: 12 months

PSQI (Pittsburgh Sleep Quality Index) - Caregiver

Caregiver's sleep quality

Time frame: 12 months

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

Caregiver's Health Related Quality of Life

Time frame: 12 months

Central Contacts

Lorenzo Gamberini, MD

CONTACT

3403550540 gamberini6@ausl.bologna.it

Pamela Salucci, MD

CONTACT

pamela.salucci@montecatone.com

Data from ClinicalTrials.gov

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