Restoring Life After Cardiac Arrest - a Pilot Study of a Comprehensive Rehabilitation Intervention Focused on Fatigue for Survivors of Cardiac Arrest
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cardiac Arrest With Successful Resuscitation
- Sponsor
- Odense University Hospital
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Recruitment rate for participants
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
More people are surviving a cardiac arrest due to improvements in bystander resuscitation and acute hospital care. However, many survivors of cardiac arrest are left with physical, mental and social problems impacting negatively on their quality of life. At present there are no specialist interventions for survivors of cardiac arrest in Denmark and very few have been evaluated internationally. Rehabilitation for people after cardiac events or brain injury have shown significant physical and mental well-being benefits, indicating the same may be true for survivors of cardiac arrest.
This pilot study will test the feasibility and acceptability of a residential rehabilitation intervention focused on fatigue, and the physical, mental and social consequences of cardiac arrest. In addition, the pilot study will discover if the intervention has any effect on self-report measures, including fatigue, mental well-being and activity of the survivors of cardiac arrest who participate, and on the mental well-being of relatives of these survivors.
Detailed Description
The number of people surviving a cardiac arrest is increasing every year due to advances in pre-hospital and acute medical care. In Denmark, one year survival after out-of-hospital cardiac arrest improved from 4-13% between 2001 and 2014; this amounts to at least 500 new survivors every year. But after the acute phase ends, many survivors of cardiac arrest (SCA) suffer an uncertain future. Most SCA will have a new or ongoing cardiac condition. They may suffer from mental trauma due to surviving a near death experience. Further, reduced oxygen levels to the brain during a cardiac arrest, can cause brain injury in up to 50% of SCA. This combination of cardiac, traumatic and neurological factors causes survivors to suffer from a wide range of physical, psychological and cognitive problems impacting negatively on their quality of life. Relatives of SCA have also been found to suffer from emotional problems due to becoming a carer for their loved one. Normally in Denmark, a patient population with such a heavy burden, like SCA and their relatives would receive help to restore them to daily life but at present there are no specialist rehabilitation interventions provided for SCA in Denmark. Research involving rehabilitation interventions for people after brain injury or cardiac events has shown significant physical, psychological and quality of life benefits, indicating the same may be true for SCA. The European Resuscitation Council and other international experts recommend all SCA receive rehabilitation tailored to their needs but very few research studies exist on which to base the design of these rehabilitation interventions. The Medical Research Council (MRC) in the United Kingdom state that in clinical research there is too strong a focus on the main evaluation of an intervention. This means inadequate development and piloting work, leading to weaker interventions that are less likely to be implemented. Before performing large-scale testing of an intervention, the MRC advocates a systematic development phase that tests the feasibility of the new intervention. Though examination of current literature and workshops with researchers, clinicians, survivors of cardiac arrest and their relatives a new comprehensive rehabilitation intervention has been developed. The objectives of this study are to, firstly, test the feasibility and acceptability of the intervention. Secondly, to determine the effect of the intervention on patient reported outcomes covering fatigue, physical activity, psychological well-being and quality of life. In addition, the effect of the intervention on the mental well-being of any relatives who take part in the intervention. Recruitment will take place via publicity through REHPA, the five cardiac centers in Denmark and via the Danish Heart Foundation. Potential participants will apply via an application form and be screened by the research team for eligibility.
Investigators
Vicky Joshi
Principal investigator
Odense University Hospital
Eligibility Criteria
Inclusion Criteria
- •At least 3-months post-cardiac arrest
- •Self-identified need for rehabilitation as measured by a score of 3 or above on the Dallund scale, a linear analog self-assessment scale, where participants indicate how close they are to living the life they desire after their cardiac arrest, indicating rehabilitation needs. The scale is rated between 0 (goal reached) and 10 (infinitely far from).
- •Self-reliant with personal care and medication
Exclusion Criteria
- •Medical needs requiring in-patient medical treatment
- •No permanent residence in Denmark
- •Not able to speak and understand Danish
Outcomes
Primary Outcomes
Recruitment rate for participants
Time Frame: Time frame: From month 4 to month 1 before intervention start date
Recruitment rate for participants (survivors and relatives), number of participants recruited per week.
Participant satisfaction assessed by a likert scale
Time Frame: At eleven weeks months
Participant (survivors and relatives) satisfaction with intervention as assessed by a 5-point likert scale for each component of the intervention. In addition, qualitative interviews with participants (survivors and relatives)
Completion of study outcome measures
Time Frame: Baseline, eleven weeks and 6 months
Percentage of participants (survivors and relatives) who complete each outcome measure
Adherence to intervention by participants
Time Frame: At eleven weeks
Percentage of participants (survivors and relatives) who achieve minimum adherence levels, that is attendance at both the 5-day rehabilitation stay and 2-day follow-up rehabilitation stay.
Secondary Outcomes
- Efficacy of improving fatigue as measured by the change from baseline in the Modified Fatigue Impact Scale(Baseline, at eleven weeks, 6 months)
- Efficacy of improving fatigue as measured by the change from baseline in the Multidimensional Fatigue Inventory(Baseline, at eleven weeks, 6 months)
- Efficacy of improving physical activity as measured by the change from baseline in the International Physical Activity Questionnaire Short(Baseline, at eleven weeks, 6 months)
- Efficacy of improving activity and participant as measured by the change from baseline in the World Health Organisation Disability Assessment Schedule 2.0(Baseline, at eleven weeks, 6 months)
- Percentage of survivor participants who identified and solved the set minimum number of problems in the problem-solving therapy component of the intervention(At end of 2-day follow-up intervention phase, an average of 12 weeks.)
- Percentage change in survivors '6 minutes walk test' from baseline to follow up (survivors)(Baseline and at follow-up after 11 weeks)
- Percentage change in hand grip strength from baseline to follow up (survivors)(Baseline and at follow-up after 11 weeks)
- Percentage change in '30 seconds sit-to-stand-test' from baseline to follow up (survivors)(Baseline and at follow-up after 11 weeks)
- Efficacy of improving anxiety and depression as measured by the change from baseline in the Hospital Anxiety and Depression Scale. To be completed by survivors and relatives.(Baseline, at eleven weeks, 6 months)