Cardiac Arrest REcovery, Self-management and Support (CARESS) feasibility study
| ISRCTN | ISRCTN16382742 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16382742 |
| IRAS number | 339054 |
| Secondary identifying numbers | CPMS 63599, NIHR Central Commissioning Facility Grant Code: NIHR204049 |
- Submission date
- 11/12/2024
- Registration date
- 28/01/2025
- Last edited
- 31/03/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Circulatory System
Plain English Summary
Background and study aims
A cardiac arrest occurs when someone’s heart suddenly stops beating. In the UK, around 5,500 people survive their cardiac arrest each year. For most of these people, life is never the same again. Many cardiac arrest survivors have long-term problems with memory, emotions, fatigue, and physical and social difficulties which can reduce their quality of life. People are often anxious about carrying out daily activities. These changes can also be upsetting for family members or friends affected by the arrest (‘co-survivors’), particularly if they were present at the time of the arrest. As well as caring for the survivor and the changes in the survivor, this can include processing the trauma of the event, and emotional concern that there will be a repeat event.
However, little is known about how to support survivors and their co-survivors, and they have said that they need more help and support on their recovery journey once they have returned home from the hospital. A new online programme of one-to-one and group education, support, and exercise rehabilitation for cardiac arrest survivors has been developed in collaboration with cardiac arrest survivors and co-survivors. This programme is expected to be provided soon after survivors return home from the hospital. A similar programme of education and support has also been developed for co-survivors. This study aims to test the programmes with up to 30 survivors and 30 co-survivors to see if they can be delivered in the NHS.
Who can participate?
Cardiac arrest survivors and co-survivors aged 18 years old and over
What does the study involve?
CARESS is an early, targeted care pathway. It has two routes: one specific for cardiac arrest survivors, and one for their close family, friends and others (‘co-survivors’). CARESS is an exercise and support rehabilitation care pathway. Each route consists of 8 sessions. One session will run per week. Each session will last approximately 1 hour. They will be delivered virtually using video-conferencing software. Survivors will also be able to take part in an exercise programme, too. The CARESS facilitators are experts in providing rehabilitative care to cardiac patients. The components are:
1. Individual assessment: A one-hour, online assessment with a trained CARESS facilitator to holistically assess participant needs, introduce the programme, provide individualised advice and set goals.
2. Online group support programme: seven online group sessions for up to an hour each, led by a CARESSf facilitator. Each session will focus on different key needs of participants (e.g., fatigue).
3. Online exercise programme (survivors only): Up to 30 minutes of exercise two to three times per week for 6-8 weeks. This will include a weekly supervised live session and two self-directed sessions.
What are the possible benefits and risks of participating?
The CARESS programme has been designed by survivors and co-survivors to address some of the common ‘big’ issues. Affected participants may access help and support. If parts of this support are not relevant, then taking part may not offer them any direct benefits. However, participants may find the opportunity to speak to others within the care programme helpful. Further, the findings from this study may help people recovering from cardiac arrests, and their co-survivors, in the future.
Taking part in group support sessions may feel sensitive for some people and could be upsetting. Participants will have the support of the group facilitator and peers, and if they need to, they can take a short break. For survivors, exercise may feel a little scary but the live exercise sessions involve light exercise, tailored to them, and delivered by experienced exercise physiologists – these are experts in delivering physical rehabilitation for patients. If any problems or concerns arise, participants can speak to the facilitator who will advise them appropriately.
Where is the study run from?
The study is a collaboration between Warwick University and University Hospitals Coventry and Warwickshire NHS Trust (UHCW). Warwick University is the sponsor of this study, and the CARESS care programme is being delivered by UHCW.
When is the study starting and how long is it expected to run for?
November 2023 to April 2026
Who is funding the study?
National Institute for Health Research (NIHR) Research for Patient Benefit (RfPB) programme
Who is the main contact?
Professor Kirstie Haywood (Chief Investigator), k.l.haywood@warwick.ac.uk
Contact information
Scientific
Warwick Research in Nursing, Warwick Medical School, University of Warwick
Coventry
CV4 7AL
United Kingdom
 ORCID ID |
0000-0002-5405-187X |
|---|---|
| Phone | +44 (0)24 7615 061 |
| k.l.haywood@warwick.ac.uk |
Public, Scientific
Research and Development, University Hospitals Coventry and Warwickshire NHS Trust
Coventry
CV2 2DX
United Kingdom
| Nathan.Pearson@UHCW.nhs.uk |
Study information
| Study design | Non-randomised study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Community, Home, Internet/virtual, Medical and other records, Telephone |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | The Cardiac Arrest Recovery Enablement and Self-management Support feasibility (CARESSf) study |
| Study acronym | CARESSf v1.1 |
| Study hypothesis | Cardiac arrest is characterised by the sudden cessation of heart function. In the UK approximately 5,500 individuals survive their cardiac arrest each year. These survivors often face significant long-term challenges, including memory issues, emotional disturbances, fatigue, and physical difficulties, which collectively diminish their quality of life. Anxiety about daily activities is common, and these changes can also distress family members and friends (‘co-survivors’), especially those present during the arrest, leading to their own long-term emotional difficulties. Currently, there is limited understanding of the optimal support strategies for cardiac arrest survivors and their co-survivors. While some survivors participate in cardiac rehabilitation, these programmes do not adequately address their specific physical and emotional needs, resulting in poor attendance. This study aims to develop and test the feasibility of a new care programme designed in collaboration with cardiac arrest survivors, their co-survivors, and healthcare professionals. The programme will be piloted with up to 30 survivors and 30 co-survivors following hospital discharge. Feedback will be collected post-programme to refine the intervention. The ultimate goal is to conduct a future study to evaluate whether this new programme enhances the quality of life for cardiac arrest survivors and their co-survivors. The study proposal and ethics application have been developed with input from a public research partner group. Findings will be disseminated through accessible articles, events with clinical and survivor networks, conference presentations, and publications. |
| Ethics approval(s) |
Approved 27/09/2024, North East – Newcastle & North Tyneside 2 Research Ethics Committee (2 Redman Place, Stratford, London, E20 1JQ, United Kingdom; -; newcastlenorthtyneside2.rec@hra.nhs.uk), ref: 24/NE/0135 |
| Condition | Feasibility of a new care program designed in collaboration with cardiac arrest survivors, co-survivors, and healthcare professionals |
| Intervention | CARESS intervention delivery: CARESS will be delivered over 8 weeks and consists of three components. 1. One-to-one individual assessment: One-hour, online assessment with a CARESS facilitator (trained and supported by a health psychologist throughout the study) to holistically assess participant needs, introduce the programme, provide individualised advice and set goals. All participants will be directed to validated and relevant external resources, such as those provided by Sudden Cardiac Arrest UK (https://www.SCAUK.org). 2. Psychosocial group support: Over the week intervention period, participants will attend seven weekly online group sessions each lasting for up to one hour, led by a CARESSf facilitator who will be trained and supported by a health psychologist during the study. Core theoretical principles have been drawn on to inform the psychosocial content, structure, and delivery. These include the biopsychosocial model of behaviour change, Michie’s behaviour change wheel and taxonomy, Michie’s COM-B model (Capability, Opportunity and Motivation), and psychological theories of self-efficacy (perceived confidence in the ability to engage and implement the strategies learnt), cognitive behaviour-change, and motivational interviewing. 3. Online, supervised, home-based, exercise/support rehabilitation (survivors only): Up to 30 minutes of exercise one to three times per week (two of which will be self-directed/independent) for up to 7 weeks; individualised and progressive multi-modality exercise at a manageable intensity, regulated with breathlessness and/ or perceived exertion scales. Participants will be encouraged to attend the live online group exercise session every week for up to 7 weeks led by a CARESS facilitator, using equipment-free exercise to improve confidence, cardiovascular fitness, strength, balance, and coordination. Where possible, groups will be arranged to allow those of similar age, ability, and gender to exercise together as a group. |
| Intervention type | Behavioural |
| Primary outcome measure | 1. Feasibility outcomes: Rates of recruitment and retention across the recruitment window measured using screening logs at baseline, 4 months (16 weeks) and 8 months (32 weeks) 2. Outcomes measurement: acceptability, respondent burden, and completion (missing data) of outcome measures measured using descriptive statistics at baseline and follow-up (11 weeks) 3. Quality of the intervention: assessment of delivery procedures for fidelity with study participants and facilitators measured by reviewing recordings of a subset of delivered sessions assessed post-intervention (9-13 weeks) 4. Process evaluation: of recruiter, participant and facilitator perspectives and experiences of delivery or participant in the study measured using data collected from interviews conducted post-intervention (9-13 weeks) |
| Secondary outcome measures | 1. Demographic information (age, gender, socioeconomic factors) measured using a questionnaire, captured at baseline. 2. Physical and mental health summary scoring measured using PROMIS® 29+2 Profile v2.1 (PROPr) at baseline and post-intervention (11 weeks) 3. Mental wellbeing measured using the Warwick-Edinburgh Mental Wellbeing Scales (WEMWBS) at baseline and post-intervention (11 weeks). 4. Fatigue measured using the Functional Assessment of Chronic Illness Therapy – Fatigue (FACIT-F) at baseline and post-intervention (11 weeks). 5. Depression and anxiety measured using the Hospital Anxiety and Depression Scale (HADS) at baseline and post-intervention (11 weeks). 6. PTSD symptom severity measured using the Impact of Events Scale-Revised (IES-R) at baseline and post-intervention (11 weeks). 7. Health utility measured using the EuroQoL 5-dimensions 5-levels (EQ-5D-5L) at baseline and post-intervention (11 weeks). 8. Health and social care resource use measured using the Modular Resource-Use Measure (ModRUM) core, at post-intervention only (11 weeks). 9. Personal resource use questionnaire measured using an internally generated questionnaire, at post-intervention only (11 weeks). |
| Overall study start date | 06/11/2023 |
| Overall study end date | 30/04/2026 |
Eligibility
| Participant type(s) | Patient, Service user |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 60; UK Sample Size: 60 |
| Participant inclusion criteria | Survivors will be included if they meet the following inclusion criteria: 1. Adult aged 18+ years 2. A cardiac arrest survivor 3. Discharged from the hospital to their usual place of residence within 30 days of their cardiac arrest 4. Recruited before, or within 8 weeks of hospital discharge 5. Proficient in the English language 6. Ability to complete online follow-up and attend online sessions Key supporters will be included if they meet the following inclusion criteria: 1. Adult aged 18+ years 2. Self-refer into the study or are referred to as a nominated adult family member, friend or significant other (key supporter) of a cardiac arrest survivor 3. Recruited within 8 weeks of the survivor being discharged from the hospital 4. Proficient in the English language 5. Ability to complete online follow-up and attend online sessions |
| Participant exclusion criteria | Survivors will be excluded if they meet any of the following exclusion criteria: 1. Unable to give informed consent 2. Have severe mental health difficulties or cognitive impairment that prevents engagement 3. Are participating in another exercise, psychological support or structured rehabilitation study Key supporters will be excluded if they meet any of the following exclusion criteria: 1. Unable to give informed consent 2. Have severe mental health difficulties or cognitive impairment that prevents engagement 3. Are participating in another exercise, psychological support, or structured rehabilitation study 4. Key supporters of cardiac arrest victims who do not survive to hospital discharge |
| Recruitment start date | 01/04/2025 |
| Recruitment end date | 30/11/2025 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Clifford Bridge Road
Coventry
CV2 2DX
United Kingdom
Sponsor information
Hospital/treatment centre
Research & Impact Services, University House
Coventry
CV4 8UW
England
United Kingdom
| Phone | +44 (0) 24 765 75733 |
|---|---|
| sponsorship@warwick.ac.uk | |
| Website | https://warwick.ac.uk/ |
"ROR" |
https://ror.org/01a77tt86 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- NIHR Research for Patient Benefit Programme, RfPB
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 30/04/2027 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal within a year of the feasibility study end date. |
| IPD sharing plan | The data sharing plans for the current study are unknown and will be made available at a later date |
Editorial Notes
31/03/2025: The recruitment start date was changed from 01/03/2025 to 01/04/2025.
11/12/2024: Study's existence confirmed by the National Institute for Health and Care Research (NIHR) (UK).
