Rehabilitation for Survivors of Cardiac Arrest Focused on Fatigue

NCT04114773 | Completed

• 1 other identifier: 20192000-66
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiac Arrest With Successful Resuscitation

Keywords

Rehabilitation; Fatigue; Relatives

Outcome Measures

Primary Outcomes (4)

• Recruitment rate for participants

  Recruitment rate for participants (survivors and relatives), number of participants recruited per week.

  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)

  At eleven weeks months

• Completion of study outcome measures

  Percentage of participants (survivors and relatives) who complete each outcome measure

  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.

  At eleven weeks

Secondary Outcomes (9)

• 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.

Study Arms (1)

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.

Other: SCARF (Survivors of Cardiac Arrest Rehabilitation focused on Fatigue)

Interventions

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.

SCARF

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Medical needs requiring in-patient medical treatment
• No permanent residence in Denmark
• Not able to speak and understand Danish

Sponsors & Collaborators

• Odense University Hospital: lead
• REHPA The Danish Knowledge Center for Rehabilitation and Palliative Care: collaborator
• University of Southern Denmark: collaborator
• Odense Patient Data Explorative Network: collaborator
• Center for Rehabilitation of brain injury, Copenhagen: collaborator

Study Sites (1)

REHPA The Danish Knowledge Center for Rehabilitation and Palliative Care

Nyborg, Fyn, 5800, Denmark

Location

MeSH Terms

Conditions

Fatigue

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ann-Dorthe Zwisler, Professor, PhD

  REHPA The Danish Knowledge Center for Rehabilitation and Palliative Care

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: September 18, 2019
• First Posted: October 3, 2019
• Study Start: October 11, 2019
• Primary Completion: June 1, 2021
• Study Completion: June 1, 2021
• Last Updated: July 27, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)