Cardiac Arrest With Successful ResuscitationSCARFNCT04114773
Rehabilitation for Survivors of Cardiac Arrest Focused on Fatigue
A study testing SCARF (Survivors of Cardiac Arrest Rehabilitation focused on Fatigue) in people with Cardiac Arrest With Successful Resuscitation, run by Odense University Hospital at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Arrest With Successful Resuscitation
- What is being tested?
- SCARF (Survivors of Cardiac Arrest Rehabilitation focused on Fatigue)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteDenmark
- Study dates
- 11 Oct 2019to 1 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Medical needs requiring in-patient medical treatment
- No permanent residence in Denmark
- Not able to speak and understand Danish
Trial locations and contacts
1 site in 1 country.
Denmark1 site
REHPA The Danish Knowledge Center for Rehabilitation and Palliative Care
Nyborg, Fyn, 5800
About this study
Official title: Restoring Life After Cardiac Arrest - a Pilot Study of a Comprehensive Rehabilitation Intervention Focused on Fatigue for Survivors of Cardiac Arrest
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.
Read the 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.
- Being tested
- SCARF (Survivors of Cardiac Arrest Rehabilitation focused on Fatigue)
- Keywords
- Rehabilitation, Fatigue, Relatives
- Medical subject headings
- Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SCARF (Survivors of Cardiac Arrest Rehabilitation focused on Fatigue)Other
The intervention will be delivered by a multidisciplinary team. There will be individual testing and feedback on physical capacity and cognitive ability. Group sessions will include education on the consequences of cardiac arrest, promotion of techniques to ameliorate these consequences, for example, increasing physical activity or energy conservation. Additional sessions will cover psychological reactions; family life; work life; intimacy; and existential considerations.
Participants will have a course information book with a physical activity training diary and problem-solving therapy worksheets to use at home for 12-weeks. They will receive one phone call from the clinical team during this period. The 2-day return stay will revisit the subjects from the first 5-day stay.
Participating survivors who have a relative that wishes to attend will be included in all the group sessions and individual feedback but will not take part in the physical capacity or cognitive ability tests.
| Study group | Role | What they receive |
|---|---|---|
| SCARF | Experimental | The participants will take part in a rehabilitation intervention focused on the physical, mental, and social consequences of cardiac arrest with an overarching theme of managing fatigue. This will consist of:
* a 5-day residential rehabilitation stay
* followed by a 12 week home-based programme including one telephone call by a member of the clinical rehabilitation team,
* after the 12 week home intervention there will be a further 2-day rehabilitation stay. Receives: Other: SCARF (Survivors of Cardiac Arrest Rehabilitation focused on Fatigue) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment rate for participants
Recruitment rate for participants (survivors and relatives), number of participants recruited per week.
Measured: Time frame: From month 4 to month 1 before intervention start date
Participant satisfaction assessed by a likert scale
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)
Measured: At eleven weeks months
Completion of study outcome measures
Percentage of participants (survivors and relatives) who complete each outcome measure
Measured: Baseline, eleven weeks and 6 months
Adherence to intervention by participants
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.
Measured: At eleven weeks
Secondary outcomes (9)
Efficacy of improving fatigue as measured by the change from baseline in the Modified Fatigue Impact Scale
The Modified Fatigue Impact Scale assesses how fatigue impacts functional activities, the self-report questionnaire has 21 items in three sub-scales (physical, cognitive and psychosocial). Scores are summed to give a total. Total scores range from 0-84. The ranges of scores for each sub-scale are as follows: physical, 0 to 36; cognitive, 0 to 40; and psychosocial, 0 to 8. Higher scores indicate a greater impact of fatigue.
Measured: Baseline, at eleven weeks, 6 months
Efficacy of improving fatigue as measured by the change from baseline in the Multidimensional Fatigue Inventory
The Multidimensional Fatigue Inventory measures fatigue severity, it covers five dimensions; general fatigue, physical fatigue, reduced activity, reduced motivation and mental fatigue. Higher scores indicate a higher level of fatigue, with 4 being no fatigue and 20 the worst imaginable fatigue
Measured: 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
The International Physical Activity Questionnaire Short is a self-report questionnaire that has 7 items providing information on time spent walking, in vigorous- and moderate- intensity activity. Total time spent performing activities is summed and results reported in categories low, medium and high physical activity levels.
Measured: 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
The World Health Organisation Disability Assessment Schedule 2.0 is a self-report questionnaire that assesses disability and functioning in the prior month. It assesses six different adult life tasks: 1) Understanding and communication; 2) Self-care; 3) Mobility (getting around); 4) Interpersonal relationships (getting along with others); 5) Work and household roles (life activities); and 6) Community and civic roles (participation). There are 36 items scored from 0- no difficulty to 4- extreme difficulty or cannot do. Total scores range from 0 to 144 with a higher score indicating greater difficulty with activity and participation. Completed by survivors only.
Measured: 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
Minimum number of problems to be generated and solved during the intervention is two. A problem will be deemed identified and solved if each of the 7 stages in the written problem-solving therapy has been completed and the participant marks the problem as solved.
Measured: 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)
'6 minutes walk test' will be performed at baseline and follow-up. Measurements will be performed by trained health professionals and standardised protocols will be followed. The change in percent will be calculated for each individual survivor participant.
Measured: Baseline and at follow-up after 11 weeks
Percentage change in hand grip strength from baseline to follow up (survivors)
Hand grip strength will be measured with a calibrated hand dynamometer at baseline and at follow up. Measurements will be performed by trained health professionals and standardised protocols will be followed. Three measurements will be performed for each participant and the mean will be calculated. The change in percent will be calculated for each individual participant.
Measured: Baseline and at follow-up after 11 weeks
Percentage change in '30 seconds sit-to-stand-test' from baseline to follow up (survivors)
'6 minutes walk test' will be performed at baseline and follow-up. Measurements will be performed by trained health professionals and standardised protocols will be followed. The change in percent will be calculated for each individual participant.
Measured: 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.
Description: The Hospital Anxiety and Depression Scale consists of a seven-item subscale for anxiety (HADS-A) and a seven-item subscale for depression (HADS-D), and is used to assess symptoms of anxiety and depression.. Each item has a four choice response with scores ranging from 0 for no symptoms to 3 for the maximum number of symptoms. The scores on each subscale range from 0 to 21.
Measured: Baseline, at eleven weeks, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2019
- Study start11 Oct 2019
- Primary completion1 Jun 2021
- Study completion1 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac Arrest With Successful ResuscitationStudies of the same condition, open and under way.
- More trials run by Odense University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- REHPA, The Danish Knowledge Centre for Rehabilitation and Palliative Care, University of Southern Denmark, Odense Patient Data Explorative Network, Center for Rehabilitation of brain injury, Copenhagen
- Responsible party
- Principal investigator, Vicky Joshi, Odense University Hospital
- Investigators
- Ann-Dorthe Zwisler, Professor, PhD, Study director, REHPA, The Danish Knowledge Centre for Rehabilitation and Palliative Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04114773
- Sponsor's protocol ID
- 20192000-66
- Acronym
- SCARF
- Status last verified
- Jul 2021
- First submitted
- 18 Sep 2019
- Last updated
- 27 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Restoring Life After Cardiac Arrest - a Pilot Study of a Comprehensive Rehabilitation Intervention Focused on Fatigue for Survivors of Cardiac Arrest
- ClinicalTrials.gov ID
- NCT04114773
- Acronym / sponsor ID
- SCARF / 20192000-66
- Keywords
- Rehabilitation, Fatigue, Relatives
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Collaborators
- REHPA, The Danish Knowledge Centre for Rehabilitation and Palliative Care, University of Southern Denmark, Odense Patient Data Explorative Network, Center for Rehabilitation of brain injury, Copenhagen
- Study start
- 11 Oct 2019 (actual)
- Primary completion
- 1 Jun 2021 (actual)
- Study completion
- 1 Jun 2021 (actual)
- First posted
- 3 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SCARF | Experimental | Other: SCARF (Survivors of Cardiac Arrest Rehabilitation focused on Fatigue)The participants will take part in a rehabilitation intervention focused on the physical, mental, and social consequences of cardiac arrest with an overarching theme of managing fatigue. This will consist of: * a 5-day residential rehabilitation stay * followed by a 12 week home-based programme including one telephone call by a member of the clinical rehabilitation team, * after the 12 week home intervention there will be a further 2-day rehabilitation stay. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Medical needs requiring in-patient medical treatment
- No permanent residence in Denmark
- Not able to speak and understand Danish
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SCARF (Survivors of Cardiac Arrest Rehabilitation focused on Fatigue)The intervention will be delivered by a multidisciplinary team. There will be individual testing and feedback on physical capacity and cognitive ability. Group sessions will include education on the consequences of cardiac arrest, promotion of techniques to ameliorate these consequences, for example, increasing physical activity or energy conservation. Additional sessions will cover psychological reactions; family life; work life; intimacy; and existential considerations. Participants will have a course information book with a physical activity training diary and problem-solving therapy worksheets to use at home for 12-weeks. They will receive one phone call from the clinical team during this period. The 2-day return stay will revisit the subjects from the first 5-day stay. Participating survivors who have a relative that wishes to attend will be included in all the group sessions and individual feedback but will not take part in the physical capacity or cognitive ability tests. | Other | SCARF |
Primary outcome
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.
9 secondary outcomes
Efficacy of improving fatigue as measured by the change from baseline in the Modified Fatigue Impact Scale
Time frame: Baseline, at eleven weeks, 6 months
Efficacy of improving fatigue as measured by the change from baseline in the Multidimensional Fatigue Inventory
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: Baseline and at follow-up after 11 weeks
Percentage change in hand grip strength from baseline to follow up (survivors)
Time frame: Baseline and at follow-up after 11 weeks
Percentage change in '30 seconds sit-to-stand-test' from baseline to follow up (survivors)
Time frame: 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.
Time frame: Baseline, at eleven weeks, 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ann-Dorthe Zwisler, Professor, PhD study director
REHPA, The Danish Knowledge Centre for Rehabilitation and Palliative Care
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SCARF (Survivors of Cardiac Arrest Rehabilitation focused on Fatigue) in people with Cardiac Arrest With Successful Resuscitation, run by Odense University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment rate for participants (time frame: Time frame: From month 4 to month 1 before intervention start date). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2021; AzTrials last refreshed its copy on 8 Nov 2026.