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Patient-reported Outcomes in the Bergen Early Cardiac Rehabilitation Study (BECARES)

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ClinicalTrials.gov Identifier: NCT03810599
Recruitment Status : Recruiting
First Posted : January 18, 2019
Last Update Posted : January 18, 2019
Sponsor:
Information provided by (Responsible Party):
Haukeland University Hospital

Tracking Information
First Submitted Date  ICMJE December 21, 2018
First Posted Date  ICMJE January 18, 2019
Last Update Posted Date January 18, 2019
Actual Study Start Date  ICMJE September 9, 2013
Estimated Primary Completion Date February 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 17, 2019)
Time to composite of total mortality, and hospitalization for heart failure and atherothrombotic disease (including non-fatal MI, unstable angina and stroke). [ Time Frame: Up to 10 years ]
Time to combined endpoint from inclusion.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: January 17, 2019)
  • Change in Self-reported health [ Time Frame: Immediately after the 5 week intervention, and at 9, 31, 57 and 109 weeks ]
    The EuroQol 5-dimensions-5 level questionnaire (EQ-5D-5L) is an 5 item self-report-questionnaire assessing self-reported health. The respondent rates each item on a 5-point scale ranging from 1(indicating no problem) to 5 (indicating extreme problems). This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.
  • Change in self-reported global health [ Time Frame: Immediately after the 5 week intervention, and at 9, 31, 57 and 109 weeks ]
    The VAS scale from the EQ-5D-5L assess global health. The scale goes from 0 to 100 were lower score indicates worse health.
  • Change in post traumatic growth [ Time Frame: Immediately after the 5 week intervention, and at 9, 31, 57 and 109 weeks ]
    The Posttraumatic Growth Inventory-Short Form (PTGI-SF) is a 10 item scale measuring post traumatic growth. The respondent rates each item on a 6-point scale ranging from 0 (I did not experience this change as a result of my crisis) to 5 (I experienced this change to a very great degree as a result of my crisis). The scale is scored by adding all the responses.Individual factors are scored by adding responses to items on each factor. Factors are indicated by the Roman numerals after each item.
  • Nicotine dependence [ Time Frame: Immediately after the 5 week intervention, and at 9, 31, 57 and 109 weeks ]
    The Fagerström test
  • Change in anxiety and depression [ Time Frame: Immediately after the 5 week intervention, and at 9, 31, 57 and 109 weeks ]
    The Hospital Anxiety and Depression Scale (HADS) is a fourteen item scale where seven of the items relate to anxiety and seven relate to depression. The respondent rates each item on a 4-point scale ranging from 0 (absence) to 3 (extreme presence). The total score is 42 (21 per subscale).
  • Change in physical and mental dimensions of health [ Time Frame: Immediately after the 5 week intervention, and at 9, 31, 57 and 109 weeks ]
    The Short Form Health Survey (SF-12) include 12 items with 3 to 5 response levels. It generates two health indices: mental health and physical health. The score range between 0 and 100, with 100 representing the highest level of health
  • Change in health status following myocardial infarction [ Time Frame: Immediately after the 5 week intervention, and at 9, 31, 57 and 109 weeks ]
    The Myocardial Infarction Dimensional Assessment Scale (MIDAS) is a PRO measure developed and validated to specifically measure the health status of individuals who have suffered a myocardial infarction. It consist of 7 domains, and is a 35 item scale where respondents rate each item on a 5-point scale ranging from 1 (never) to 5 (always). The function of the MIDAS is to indicate the extent of ill health in each of the seven domains assessed, therefore each dimension is scored separately using a simple scoring methodology.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Patient-reported Outcomes in the Bergen Early Cardiac Rehabilitation Study
Official Title  ICMJE Patient-reported Outcomes in the Bergen Early Cardiac Rehabilitation Study
Brief Summary An intervention study with longitudinal follow-up of patients with coronary artery disease undergoing early cardiac rehabilitation is designed.
Detailed Description The main objective of the study is to investigate patient-reported outcomes, their relation to clinical characteristics of the patients and the potential to predict health outcomes and adverse events in coronary artery disease patients participating in an early cardiac rehabilitation programme.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Intervention Model Description:
Pre-post comparison.
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Coronary Artery Disease
Intervention  ICMJE Other: Early cardiac rehabilitation

This is an early cardiac rehabilitation programme starting 1-2 weeks after hospital discharge (Phase 2A rehabilitation). The programme provided by a multidisciplinary team includes individual counseling, educational sessions and discussion in groups, and exercise training sessions three days a week for five weeks.

For additional analysis there will be a comparison group that did not receive the intervention for practical reasons.

Study Arms  ICMJE Early cardiac rehabilitation
Single Group: 5 week cardiac rehabilitation programme. Pre-post comparison.
Intervention: Other: Early cardiac rehabilitation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 17, 2019)
870
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 2029
Estimated Primary Completion Date February 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Diagnosis of coronary artery disease
  • >=18 years of age
  • Has performed a negative exercise test (bike or treadmill) and thereby able to participate in exercise training.

Exclusion Criteria:

  • Cognitive impairment
  • Unstable angina pectoris
  • Aortic stenosis
  • Left ventricular ejection fraction <30%
  • Heart failure NYHA class III-IV
  • Serious arrhythmia in need of treatment
  • Being on the waiting list for percutaneous coronary intervention or coronary artery bypass grafting.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Tone M Norekvål, PhD +4799044635 tone.merete.norekval@helse-bergen.no
Contact: Nina B Fålun, MSc +4790858527 nina.falun@helse-bergen.no
Listed Location Countries  ICMJE Norway
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03810599
Other Study ID Numbers  ICMJE 2014/333
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Haukeland University Hospital
Study Sponsor  ICMJE Haukeland University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Tone M Norekvål, PhD Haukeland University Hospital
PRS Account Haukeland University Hospital
Verification Date November 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP