Clinical trial NCT04114773: Rehabilitation for Survivors of Cardiac Arrest Focused on Fatigue
Official title: Restoring Life After Cardiac Arrest - a Pilot Study of a Comprehensive Rehabilitation Intervention Focused on Fatigue for Survivors of Cardiac Arrest
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiac Arrest With Successful Resuscitation
Keywords: Rehabilitation
Fatigue
Relatives
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
Collaborators: name: REHPA The Danish Knowledge Center for Rehabilitation and Palliative Care
name: University of Southern Denmark
name: Odense Patient Data Explorative Network
name: Center for Rehabilitation of brain injury, Copenhagen
First posted: 2019-10-03
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Recruitment rate for participants
timeFrame: Time frame: From month 4 to month 1 before intervention start date
measure: Participant satisfaction assessed by a likert scale
timeFrame: At eleven weeks months
measure: Completion of study outcome measures
timeFrame: Baseline, eleven weeks and 6 months
measure: Adherence to intervention by participants
timeFrame: At eleven weeks
Secondary outcomes:
measure: Efficacy of improving fatigue as measured by the change from baseline in the Modified Fatigue Impact Scale
timeFrame: Baseline, at eleven weeks, 6 months
measure: Efficacy of improving fatigue as measured by the change from baseline in the Multidimensional Fatigue Inventory
timeFrame: Baseline, at eleven weeks, 6 months
measure: Efficacy of improving physical activity as measured by the change from baseline in the International Physical Activity Questionnaire Short
timeFrame: Baseline, at eleven weeks, 6 months
measure: Efficacy of improving activity and participant as measured by the change from baseline in the World Health Organisation Disability Assessment Schedule 2.0
timeFrame: Baseline, at eleven weeks, 6 months
measure: Percentage of survivor participants who identified and solved the set minimum number of problems in the problem-solving therapy component of the intervention
timeFrame: At end of 2-day follow-up intervention phase, an average of 12 weeks.
measure: Percentage change in survivors '6 minutes walk test' from baseline to follow up (survivors)
timeFrame: Baseline and at follow-up after 11 weeks
measure: Percentage change in hand grip strength from baseline to follow up (survivors)
timeFrame: Baseline and at follow-up after 11 weeks
measure: Percentage change in '30 seconds sit-to-stand-test' from baseline to follow up (survivors)
timeFrame: Baseline and at follow-up after 11 weeks
measure: 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.
timeFrame: Baseline, at eleven weeks, 6 months
Other outcomes:
Locations:
city: Nyborg
country: Denmark
facility: REHPA The Danish Knowledge Center for Rehabilitation and Palliative Care
state: Fyn
Study officials:
affiliation: REHPA The Danish Knowledge Center for Rehabilitation and Palliative Care
name: Ann-Dorthe Zwisler, Professor, PhD
role: STUDY_DIRECTOR
References: