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

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

Study Overview

• Status: Recruiting
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Other: Early cardiac rehabilitation

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: Interventional
• Enrollment (Anticipated): 870
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tone M Norekvål, PhD; Phone Number: +4799044635; Email: tone.merete.norekval@helse-bergen.no
• Study Contact Backup: Name: Nina B Fålun, MSc; Phone Number: +4790858527; Email: nina.falun@helse-bergen.no

Study Locations

• Norway
  • Bergen, Norway, 5021
    • Recruiting
    • Haukeland University Hospital
    • Contact: Tone M Norekvål, PhD; Phone Number: +4799044635; Email: tone.merete.norekval@helse-bergen.no

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to composite of total mortality, and hospitalization for heart failure and atherothrombotic disease (including non-fatal MI, unstable angina and stroke).	Time to combined endpoint from inclusion.	Up to 10 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Self-reported health	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.	Immediately after the 5 week intervention, and at 9, 31, 57 and 109 weeks
Change in self-reported global health	The VAS scale from the EQ-5D-5L assess global health. The scale goes from 0 to 100 were lower score indicates worse health.	Immediately after the 5 week intervention, and at 9, 31, 57 and 109 weeks
Change in post traumatic growth	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.	Immediately after the 5 week intervention, and at 9, 31, 57 and 109 weeks
Nicotine dependence	The Fagerström test	Immediately after the 5 week intervention, and at 9, 31, 57 and 109 weeks
Change in anxiety and depression	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).	Immediately after the 5 week intervention, and at 9, 31, 57 and 109 weeks
Change in physical and mental dimensions of health	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	Immediately after the 5 week intervention, and at 9, 31, 57 and 109 weeks
Change in health status following myocardial infarction	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.	Immediately after the 5 week intervention, and at 9, 31, 57 and 109 weeks

Collaborators and Investigators

• Sponsor: Haukeland University Hospital
• Investigators: Principal Investigator: Tone M Norekvål, PhD, Haukeland University Hospital

Publications and helpful links

Helpful Links

• Study website

Study record dates

Study Major Dates

• Study Start (Actual): September 9, 2013
• Primary Completion (Anticipated): February 1, 2019
• Study Completion (Anticipated): February 1, 2029

Study Registration Dates

• First Submitted: December 21, 2018
• First Submitted That Met QC Criteria: January 17, 2019
• First Posted (Actual): January 18, 2019

Study Record Updates

• Last Update Posted (Actual): January 18, 2019
• Last Update Submitted That Met QC Criteria: January 17, 2019
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: Depression; Adherence; Anxiety; Lifestyle; Patient-reported outcomes; Post-traumatic growth; Cardiac rehabilitation adherence; Self-reported health
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease
• Other Study ID Numbers: 2014/333

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No