Patient-reported Outcomes in the Bergen Early Cardiac Rehabilitation Study - Clinical Trial for Coronary Artery Disease | NCT03810599

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Primary Purpose

Status

Recruiting

Phase

Not Applicable

Locations

Norway

Study Type

Interventional

Intervention

Early cardiac rehabilitation

About this trial

This is an interventional prevention trial for Coronary Artery Disease focused on measuring Cardiac rehabilitation adherence, Patient-reported outcomes, Post-traumatic growth, Anxiety, Depression, Adherence, Lifestyle, Self-reported health

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Haukeland University HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Early cardiac rehabilitation

Arm Description

Single Group: 5 week cardiac rehabilitation programme. Pre-post comparison.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

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.

Nicotine dependence

The Fagerström test

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).

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

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.

Full Information

NCT ID

NCT03810599

First Posted

December 21, 2018

Last Updated

January 17, 2019

Sponsor

Haukeland University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03810599

Brief Title

Patient-reported Outcomes in the Bergen Early Cardiac Rehabilitation Study

Acronym

BECARES

Official Title

Patient-reported Outcomes in the Bergen Early Cardiac Rehabilitation Study

Study Type

Interventional

2. Study Status

Record Verification Date

November 2018

Overall Recruitment Status

Recruiting

Study Start Date

September 9, 2013 (Actual)

Primary Completion Date

February 2019 (Anticipated)

Study Completion Date

February 2029 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Haukeland University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Coronary Artery Disease

Keywords

Cardiac rehabilitation adherence, Patient-reported outcomes, Post-traumatic growth, Anxiety, Depression, Adherence, Lifestyle, Self-reported health

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

Pre-post comparison.

Masking

None (Open Label)

Allocation

N/A

Enrollment

870 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Early cardiac rehabilitation

Arm Type

Other

Arm Description

Single Group: 5 week cardiac rehabilitation programme. Pre-post comparison.

Intervention Type

Other

Intervention Name(s)

Early cardiac rehabilitation

Intervention Description

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 Measure Information:

Title

Time to composite of total mortality, and hospitalization for heart failure and atherothrombotic disease (including non-fatal MI, unstable angina and stroke).

Description

Time to combined endpoint from inclusion.

Time Frame

Up to 10 years

Secondary Outcome Measure Information:

Title

Change in Self-reported health

Description

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.

Time Frame