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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

Brief Summary:
An intervention study with longitudinal follow-up of patients with coronary artery disease undergoing early cardiac rehabilitation is designed.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Other: Early cardiac rehabilitation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 870 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Pre-post comparison.
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Patient-reported Outcomes in the Bergen Early Cardiac Rehabilitation Study
Actual Study Start Date : September 9, 2013
Estimated Primary Completion Date : February 2019
Estimated Study Completion Date : February 2029

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Early cardiac rehabilitation
Single Group: 5 week cardiac rehabilitation programme. Pre-post comparison.
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.





Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. Nicotine dependence [ Time Frame: Immediately after the 5 week intervention, and at 9, 31, 57 and 109 weeks ]
    The Fagerström test

  5. 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).

  6. 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

  7. 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.



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

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.

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): NCT03810599


Contacts
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Contact: Tone M Norekvål, PhD +4799044635 tone.merete.norekval@helse-bergen.no
Contact: Nina B Fålun, MSc +4790858527 nina.falun@helse-bergen.no

Locations
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Norway
Haukeland University Hospital Recruiting
Bergen, Norway, 5021
Contact: Tone M Norekvål, PhD    +4799044635    tone.merete.norekval@helse-bergen.no   
Sponsors and Collaborators
Haukeland University Hospital
Investigators
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Principal Investigator: Tone M Norekvål, PhD Haukeland University Hospital

Additional Information:
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Responsible Party: Haukeland University Hospital
ClinicalTrials.gov Identifier: NCT03810599     History of Changes
Other Study ID Numbers: 2014/333
First Posted: January 18, 2019    Key Record Dates
Last Update Posted: January 18, 2019
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Haukeland University Hospital:
Cardiac rehabilitation adherence
Patient-reported outcomes
Post-traumatic growth
Anxiety
Depression
Adherence
Lifestyle
Self-reported health

Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases