Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Rehabilitation for Survivors of Cardiac Arrest Focused on Fatigue (SCARF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04114773
Recruitment Status : Recruiting
First Posted : October 3, 2019
Last Update Posted : October 3, 2019
Sponsor:
Collaborators:
REHPA The Danish Knowledge Center for Rehabilitation and Palliative Care
University of Southern Denmark
Odense Patient Data Explorative Network
Center for Rehabilitation of brain injury, Copenhagen
Information provided by (Responsible Party):
Vicky Joshi, Odense University Hospital

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.


Condition or disease Intervention/treatment Phase
Cardiac Arrest With Successful Resuscitation Other: SCARF (Survivors of Cardiac Arrest Rehabilitation focused on Fatigue) Not Applicable

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Restoring Life After Cardiac Arrest - a Pilot Study of a Comprehensive Rehabilitation Intervention Focused on Fatigue for Survivors of Cardiac Arrest
Estimated Study Start Date : October 11, 2019
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : February 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
Other: 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.





Primary Outcome Measures :
  1. 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.

  2. 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)


  3. Completion of study outcome measures [ Time Frame: Baseline, eleven weeks and 6 months ]
    Percentage of participants (survivors and relatives) who complete each outcome measure

  4. 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 Outcome Measures :
  1. 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 ]
    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.

  2. Efficacy of improving fatigue as measured by the change from baseline in the Multidimensional Fatigue Inventory [ Time Frame: Baseline, at eleven weeks, 6 months ]
    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

  3. 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 ]
    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.

  4. 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 ]
    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.

  5. 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. ]
    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.

  6. Percentage change in survivors '6 minutes walk test' from baseline to follow up (survivors) [ Time Frame: Baseline and at follow-up after 11 weeks ]
    '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.

  7. Percentage change in hand grip strength from baseline to follow up (survivors) [ Time Frame: Baseline and at follow-up after 11 weeks ]
    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.

  8. 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 ]
    '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.

  9. 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 ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04114773


Contacts
Layout table for location contacts
Contact: Vicky L Joshi, MSc +4550229798 victoria.louise.joshi@rsyd.dk

Locations
Layout table for location information
Denmark
REHPA The Danish Knowledge Center for Rehabilitation and Palliative Care Recruiting
Nyborg, Fyn, Denmark, 5800
Contact: Birthe Kargaard Jensen    3057 1059    rehpa.ophold@rsyd.dk   
Sponsors and Collaborators
Odense University Hospital
REHPA The Danish Knowledge Center for Rehabilitation and Palliative Care
University of Southern Denmark
Odense Patient Data Explorative Network
Center for Rehabilitation of brain injury, Copenhagen
Investigators
Layout table for investigator information
Study Director: Ann-Dorthe Zwisler, Professor, PhD REHPA The Danish Knowledge Center for Rehabilitation and Palliative Care

Layout table for additonal information
Responsible Party: Vicky Joshi, Principal investigator, Odense University Hospital
ClinicalTrials.gov Identifier: NCT04114773     History of Changes
Other Study ID Numbers: 20192000-66
First Posted: October 3, 2019    Key Record Dates
Last Update Posted: October 3, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Vicky Joshi, Odense University Hospital:
Rehabilitation
Fatigue
Relatives
Additional relevant MeSH terms:
Layout table for MeSH terms
Heart Arrest
Fatigue
Signs and Symptoms
Heart Diseases
Cardiovascular Diseases