V-CARE (Virtual Care After REsuscitation)

NCT07498764 | Enrolling By Invitation DMC

• 1 other identifier: 23/WA/0342
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Out-of-hospital cardiac arrest (OHCA) survivors and their relatives may face challenges following hospital discharge, relating to mood, cognition, and returning to normal day-to-day activities. Identified research gaps include a lack of knowledge around what type of intervention is needed to best navigate recovery. In this study, the feasibility and patient acceptability of a new virtual psychoeducational group intervention for OHCA survivors and their relatives are evaluated and compared with those of a control group receiving a digital information booklet.

Conditions

Health-Related Quality-of-Life; Satisfaction With Care; Self-management Behaviors

Keywords

out-of-hospital cardiac arrest; psychoeducation; telemedicine; quality of life; family caregivers; survivors

Outcome Measures

Primary Outcomes (2)

• Feasibility of recruitment

  Proportion of eligible patients approached for participation who provide consent to enrol in the V-CARE study. Unit of Measure: Percentage of eligible patients approached who provide consent.

  At the point of recruitment

• Post-intervention assessment completion rate

  Proportion of randomized participants who complete the post-intervention assessment. Unit of Measure: Percentage of randomized participants completing the post-intervention assessment.

  At the end of intervention (approximately 6 weeks).

Secondary Outcomes (3)

• Satisfaction with care (Client Satisfaction Questionnaire-8) - OHCA Survivors

  At the end of treatment, around 6 weeks after enrolment

• Satisfaction with care (Client Satisfaction Questionnaire-8) - Key Supporters

  At the end of treatment, around 6 weeks after enrolment

• Self-management skills (Self-Management Assessment Scale)

  At the end of treatment, approximately 6 weeks after recruitment

Study Arms (2)

Virtual Care After Resuscitation remotely delivered group Arm

EXPERIMENTAL

V-CARE groups will be formed as soon as 3 to 6 patients have been recruited. Group size will usually be between 4 and 12 participants. The aim is for the V-CARE intervention to be delivered early to each group, starting around 2 and 3 months after hospital discharge

Other: Virtual Care After REsuscitation

Digital Information Leaflet intervention Arm

EXPERIMENTAL

In this group, patients will be sent a Digital Information Leaflet around 2 to 3 months after hospital discharge (content described in Digital Information Leaflet Arm intervention)

Other: Digital Information Leaflet

Interventions

Virtual Care After REsuscitation OTHER

The V-CARE programme involves 4 structured sessions, one a week, each lasting around one hour, supported by PowerPoint presentations. The content focuses on providing education on cardiac arrest and secondary prevention, addressing practical problems (for instance, returning to driving, travelling, living with an implantable cardioverter defibrillator (ICD), etc.) and understanding/coping with fatigue, cognitive changes, and psychological difficulties. Group size will usually be between 4 and 12 participants.

Virtual Care After Resuscitation remotely delivered group Arm

Digital Information Leaflet OTHER

This intervention, co-developed with a patient group, consists of an information booklet focused on providing information and coping strategies for fatigue, memory, low mood, anxiety, and cognitive problems after a cardiac arrest. Whereas the content is similar to that covered in the V-CARE arm, these patients are not included in a group and as such do not have access to peer support or to guided discussions and reflections as provided in the group setting. In this intervention arm, tolerability will be assessed by the proportion of participants who complete the post-intervention outcome measures; additionally, participants will be asked to self-report whether they read or used the booklet.

Digital Information Leaflet intervention Arm

Eligibility Criteria

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

You may qualify if:

• Meet all eligibility requirements for the STEPCARE trial
• Modified Rankin Scale (mRS) ≤ 3 at the 30-day follow-up

You may not qualify if:

• Diagnosis of dementia expected to limit the ability to participate in sessions or complete baseline/outcome measures, based on clinician evaluation and/or self-report by the patient or family
• Active psychosis or any other acute severe mental health condition that would impair participation, based on clinical evaluation

Sponsors & Collaborators

• Mid and South Essex NHS Foundation Trust: lead

Study Sites (1)

Essex Cardiothoracic Centre

Basildon, Essex, SS165NL, United Kingdom

Location

Related Publications (1)

• Mion M, Lilja G, Bohm M, Nordstrom EB, Toniste D, Heimburg K, Swindell P, Dankiewicz J, Skrifvars MB, Nielsen N, Jakobsen JC, White J, Wise MP, Gorgoraptis N, Keenan M, Hopkins P, Pareek N, Maccaroni M, Keeble TR. V-CARE (Virtual Care After REsuscitation): Protocol for a Randomized Feasibility Study of a Virtual Psychoeducational Intervention After Cardiac Arrest-A STEPCARE Sub-Study. J Clin Med. 2025 Jun 22;14(13):4429. doi: 10.3390/jcm14134429.

  PMID: 40648804 RESULT

Related Links

• V-CARE page on the STEPCARE main trial website

MeSH Terms

Conditions

Out-of-Hospital Cardiac Arrest

Condition Hierarchy (Ancestors)

Heart Arrest; Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: "Participants (OHCA survivors and relatives) are blinded to study allocation. At the moment of consenting, they are informed that the study involves two approaches to post-cardiac arrest support but are not told which is considered the experimental intervention. They are also not told the content of the intervention they did not receive. Investigators and facilitators delivering the intervention are aware of group assignment, but outcome assessment is based on participant self-report measures, completed independently online, which reduces risk of investigator bias. No other parties are masked.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a single-blind, randomized, parallel-group trial. Out-of-hospital cardiac arrest (OHCA) survivors and a relative are randomized to either the intervention arm (a structured virtual psycho-educational group programme delivered online) or the control arm (digital information booklet only). Participants are blinded to allocation, while investigators are aware of group assignment. Each participant remains in the same arm for the duration of follow-up; no crossover is planned

Study Record Dates

• First Submitted: September 1, 2025
• First Posted: March 27, 2026
• Study Start: August 1, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: March 27, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)