NCT07498764

V-CARE (Virtual Care After REsuscitation)

V-CARE (Virtual Care After REsuscitation): Protocol for a Randomized Feasibility Study of a Virtual Psychoeducational Intervention After Cardiac Arrest-A STEPCARE Sub-Study

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Mid and South Essex NHS Foundation Trust · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

1. Introduction Every year more than 300 000 individuals in Europe suffer an out-of-hospital cardiac arrest (OHCA); only around 8% of them survive to hospital discharge Most survivors make a 'good' recovery-that is, they achieve a quality of life akin to what they had prior to their OHCA-despite this, difficulties with cognition, mood, and physical recovery have been extensively documented. Cognitive deficits, albeit usually mild, affect as many as 40-50% of survivors 6-12 months after their cardiac arrest. Impairments are often found in memory, followed by executive functioning and processing speed, although the heterogeneity of the measures and methodology used reduces the generalizability of these results. Anxiety and depression have also been described in OHCA survivors, with a recent systematic review reporting symptoms of depression, anxiety and post-traumatic stress disorder (PTSD) in 19%, 26%, and 20% of patients, respectively. Psychological distress has been found to contribute to fatigue severity one month after hospital discharge \[9\]; high psychological distress can also impact a variety of health behaviours and influence health-related quality of life and risk of cardiovascular disease. Rates of fatigue, anxiety, depression, reduced mental function, and disability appear to be the same 1 and 5 years after the event, suggesting limited natural recovery. Returning to daily activities and previous occupational roles is often problematic, with around half of survivors experiencing difficulties or the inability to resume work; these rates remain lower compared to patients recovering from myocardial infarction. Co-survivors, including family members and close friends of survivors, also undergo their own process of recovery. Qualitative studies show that this involves overcoming the initial shock of witnessing the arrest and having to support the survivor in their recovery after discharge from hospital, often with little or no support from healthcare professionals. Persistent symptoms of post-traumatic stress disorder (PTSD) and anxiety have also been documented to be common in this population; however, no study thus far has assessed the impact of mental interventions to mitigate their psychological distress. Recent research underlines that both survivors and co-survivors have a need for more resources and education on how to best navigate recovery after an OHCA. 1.1. Rationale for a Psychoeducational Intervention Several questions remain unanswered around the psychosocial impact of survivorship on quality of life, as well as optimal post-discharge rehabilitation and care to maximize recovery for survivors and for their family members. In recent years there has been broad recognition of the importance of providing follow-up for survivors of OHCA and their key supporters (hereby defined as family members, spouses, partners, or friends who provide support from admission to hospital through rehabilitation/recovery and beyond). One such example is a priority-setting exercise completed using the methodology developed by the James Lind Alliance, which identified that the needs of key supporters post-OHCA must be served better, as well as confirming the specific need for post-discharge survivor-focused care. Similarly, a statement from the American Heart Association (AHA) also identifies a knowledge gap in cardiac arrest research concerning the role for support networks/groups after cardiac arrest. Current guidelines and position statements all stress the importance of providing appropriate follow-up care, both to survivors and key supporters, whilst highlighting the lack of evidence-based interventions available. Thus far, few studies have evaluated the impact of post-discharge support and educational interventions on longer-term quality of life. A recent systematic review and meta-analysis highlighted the lack of good-quality evidence and the high heterogeneity in intervention design and the outcome measures used; in addition, rehabilitation interventions have not been described in detail, preventing replication of results. Of the studies published so far, the 'Activity and Life after Survival of a Cardiac Arrest' RCT showed significant benefits in the outcomes of cardiac arrest survivors, with additional analyses suggesting a high probability of cost-effectiveness from a societal perspective. An intense 11-session individual psychological and education intervention was found to reduce risk of cardiovascular death; however, the impact on quality of life was not measured, and the volume and intensity of therapy provided may be a barrier to widespread adoption. A small pilot study focused specifically on chronic fatigue after OHCA showed that an energy-conservation and problem-solving therapy intervention (delivered over the telephone) was feasible, acceptable, and effective in improving outcomes. More recently, a residential rehabilitation intervention focused on fatigue and physical/psychological consequences of an OHCA showed promising results in several domains, such as quality of life, fatigue, and anxiety, even though the high intensity/volume of this intervention may not make it suitable for widespread adoption. A protocol for the remote delivery of individual psychotherapy and cardiac-focused psychoeducation combining mindfulness and exposure-based interventions has also recently been successfully trialled in a small sample of OHCA survivors experiencing PTSD. Other trials focused on exploring interventions to facilitate return to work (ROCK trial), alleviate psychological distress and improve cognitive abilities (ENFORCER trial), and to promote recovery and self-management (CARESSf)\] are currently ongoing. The studies currently available suggest that a programme integrating educational elements and skill training (for example, for the management of fatigue) might be appropriate for improving outcomes after an OHCA. To our knowledge, however, an intervention involving both survivors and key supporters, delivered virtually in a group format, has not been trialled yet. The feasibility and acceptability of this model require exploration; a virtual group intervention for elderly people with depression was found to be feasible and effective \[39\]; however, in another study, a tele-rehabilitation group intervention failed to recruit and retain participants in a geriatric population. 1.2. Study Aims The primary aims are to investigate whether the Virtual Care After REsuscitation (V-CARE) intervention-a bespoke psychoeducational, remotely delivered intervention co-designed with cardiac arrest survivors and their key supporters-is feasible and tolerable 2 to 3 months post-discharge from hospital. A secondary aim is to explore whether participating in the V-CARE intervention leads to beneficial effects in self-management skills and higher satisfaction with the treatment received, compared to a control group receiving a digital information booklet only. 2. Methods 2.1. Study Design This study, a comparative, single-blind randomized pilot trial investigating the psychoeducational V-CARE intervention, is included as a sub-study in the Sedation, TEmperature, and Pressure after Cardiac Arrest and REsuscitation (STEPCARE) trial, an international, multicenter, randomized, factorial, and superiority trial designed to evaluate optimal post-resuscitation care strategies for unconscious adult patients following OHCA. The V-CARE study described here includes participants at selected sites of the STEPCARE trial, in the United Kingdom and Sweden, surviving with a good neurological outcome (mRS) ≤ 3. Patients will be recruited after the scheduled 30-day follow-up of STEPCARE. 2.2. Patient and Public Involvement The development of the V-CARE intervention and of the digital information leaflet were informed by an exploratory sequential mixed-method design, engaging both OHCA survivors and their key supporters. 2.3. Study Population and Randomization In addition to the criteria needed for taking part in STEPCARE, OHCA survivors eligible to take part in V-CARE are also required to have an mRS ≤ 3 at the 30-day follow-up and (a) must not have a diagnosis of dementia that would impact their ability to participate and benefit from the sessions and complete baseline/outcome measure (based on a clinician's evaluation and/or self-report by the patient or family) and (b) must not be actively psychotic/experiencing any other serious acute mental health condition that would affect their participation in this study, based on clinical evaluation. When recruited, consenting patients will be encouraged to take part in the study together with a 'key supporter'; however, this will not be a requirement. Consenting patients will be randomized on an equal basis (1:1) to the V-CARE arm or to the information booklet arm. V-CARE has a randomized block design with a separate randomization list in each country, completed by a local lead site. Custom-built software was developed using Python (v3.12.7) and the Tkinter library to allocate patients into two study conditions-V-CARE or the digital information booklet. A computer-generated pseudo-randomized list with 25 sets of 2 unique numbers per set was pre-generated using an online randomization tool \[https://www.randomizer.org/\] (accessed on 7 October 2024) to ensure an unbiased allocation process. 2.4. Interventions 2.4.1. V-CARE (Virtual CAre After REsuscitation) The intervention focuses on providing early cardiac-arrest-related education, promoting the development of coping skills, encouraging peer support, and signposting survivors and key supporters to relevant resources/services. The V-CARE programme involves 4 structured sessions, one a week, each lasting around one hour, supported by PowerPoint presentations (File S1). 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. As multiple sites in each country are expected to take part in this study, groups will be formed as soon as 3 to 6 patients have been recruited, although smaller groups could be formed if required. Group size will usually be between 4 and 12 participants. The aim is for the intervention to be delivered early to each group, starting around 2 and 3 months after hospital discharge; however, it is expected that it may be delivered to some groups up to-but not beyond-6 months post-discharge. Each session includes broadly equal time for presentation, questions, and discussion, with the aim of encouraging participants to develop self-management skills. A printout of the PowerPoint slides used in each session is provided in Supplementary Material. A single, designated healthcare professional will serve as a facilitator for each group and will be present for all sessions, having been trained by the study team; it is anticipated that it will be delivered by either a clinical psychologist or an occupational therapist, but a clinical nurse specialist could also manage a group. A cardiologist or cardiology resident will attend the first session to answer generic, cardiac-arrest-related questions. 2.4.2. Digital Information Booklet This intervention, also 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. A copy of this intervention is provided in the Supplementary Material (File S2). 3. Conclusions In this study, the investigators examine if a remotely delivered psychoeducational intervention for OHCA survivors and their key supporters is feasible, and in addition if there is trend towards beneficial effects compared to a control group receiving a digital information booklet only. We describe the different phases of the study, namely the rationale for this intervention, conceptualization of the project, structure of the intervention, and outcome measure adopted. The primary outcome is the evaluation of the feasibility and tolerability of delivering this intervention-definitions have been provided to measure this outcome. Secondary outcome measures include the Client Satisfaction Questionnaire and the Self-Management Assessment Scale. Criteria for the success of the study have been reported, and a description of the pre-planned statistical analyses provided. The preliminary results from this pilot trial will provide valuable insights to inform a larger trial to evaluate the effectiveness of an intervention to support recovery post-cardiac arrest. First, the outcome feasibility will provide insights regarding the actual interest of patients and their caregivers to take part in a digital intervention to support recovery in the early phase after a cardiac arrest. Second, the outcomes of tolerability and satisfaction with care will be instrumental for the potential need of adjustments in the design of the intervention for the larger trial. Lastly, hypothesis-generating trends in differences between the two groups in terms of self-management skills and health outcomes will be able to guide the choices of primary outcomes and power calculations for a larger trial.

Conditions

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

Interventions

Type	Name	Description
OTHER	Virtual Care After REsuscitation	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.
OTHER	Digital Information Leaflet	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.

Timeline

• Start date: 2024-08-01
• Primary completion: 2026-07-01
• Completion: 2026-09-01
• First posted: 2026-03-27
• Last updated: 2026-03-27

Locations

1 site across 1 country: United Kingdom