Rehabilitation for Survivors of Cardiac Arrest Focused on Fatigue

NCT ID: NCT04114773

Last Updated: 2021-07-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-11
• Study Completion Date: 2021-06-01

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.

Conditions

Cardiac Arrest With Successful Resuscitation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SCARF

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.

Group Type: EXPERIMENTAL

SCARF (Survivors of Cardiac Arrest Rehabilitation focused on Fatigue)

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

REHPA The Danish Knowledge Center for Rehabilitation and Palliative Care

UNKNOWN

Sponsor Role: collaborator

University of Southern Denmark

OTHER

Sponsor Role: collaborator

Odense Patient Data Explorative Network

OTHER

Sponsor Role: collaborator

Center for Rehabilitation of brain injury, Copenhagen

UNKNOWN

Sponsor Role: collaborator

Odense University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Vicky Joshi

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ann-Dorthe Zwisler, Professor, PhD

Role: STUDY_DIRECTOR

REHPA The Danish Knowledge Center for Rehabilitation and Palliative Care

Locations

REHPA The Danish Knowledge Center for Rehabilitation and Palliative Care

Nyborg, Fyn, Denmark

Countries

Denmark

Other Identifiers

20192000-66

Identifier Type: -

Identifier Source: org_study_id