ENFORCER, internet-based interventions for cardiac arrest survivors: A study protocol for a randomised, parallel-group, multicentre clinical trial.
Lorenzo Gamberini, Paola Rucci, Camilla Dolcini...
https://pubmed.ncbi.nlm.nih.gov/39328897/Actively Recruiting
Led by Azienda Usl di Bologna · Updated on 2026-03-30
106
Participants Needed
2
Research Sites
8 weeks
Total Duration
Researchers are evaluating an internet-based lifestyle intervention delivered through a web app to improve health-related quality of life in patients who survived an out-of-hospital cardiac arrest and experience symptoms such as cognitive impairment, depression, anxiety, social functioning difficulties, and sexual dysfunction. The trial is randomized and aims to assess how this approach may support survivors in managing these challenges. The intervention group receives a multimodal web-based program focusing on anxiety, depression, and cognitive impairment. This includes knowledge development sessions and practical or gaming activities targeting cognitive skills, social relationships, emotional health, physical activity, and nutrition. The study also includes a control group receiving no intervention. Participants are followed and assessed over 12 months. During the study, participants complete various assessments including the Hospital Anxiety and Depression Scale, Telephone Interview for Cognitive Status, Short Form Health Survey 36, Neurobehavioural Rating Scale, Patient Competency Rating Scale, Pittsburgh Sleep Quality Index, Sexual Interest and Satisfaction Scale, and Zarit Burden Inventory. Caregiver assessments are also included. Researchers monitor these outcomes to evaluate changes in quality of life and mental and cognitive health throughout the 12-month period.
CONDITIONS
intErnet-based iNterventions FOR Cardiac arrEst suRvivors
L
Lorenzo Gamberini, MD
P
Pamela Salucci, MD
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Azienda Usl di Bologna
Lead Sponsor
Montecatone Rehabilitation Institute S.p.A.
Collaborating Sponsor
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 months
Participants engage in a multimodal web-based lifestyle intervention focusing on anxiety, depression, cognitive competence, socio-relational skills, emotions, and physical activity-nutrition.
Regular online sessions with self-guided activities
Duration - Up to 12 months post-intervention
Participants are monitored to assess health-related quality of life, cognitive status, and psychological well-being after completing the intervention.
Periodic assessments via online or telephone interviews
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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Lorenzo Gamberini, Paola Rucci, Camilla Dolcini...
https://pubmed.ncbi.nlm.nih.gov/39328897/Azienda Usl di Bologna
Lead Sponsor
Montecatone Rehabilitation Institute S.p.A.
Collaborating Sponsor