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Trial registered on ANZCTR


Registration number
ACTRN12619001181190
Ethics application status
Approved
Date submitted
26/06/2019
Date registered
20/08/2019
Date last updated
20/08/2019
Date data sharing statement initially provided
20/08/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Barriers to cardiac rehabilitation in the Czech Republic.
Scientific title
Referral and enrolment barriers to cardiac rehabilitation in patients with coronary artery disease in the Czech Republic (CRBS-CZE).
Secondary ID [1] 298530 0
None
Universal Trial Number (UTN)
Trial acronym
CRBS-CZE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Coronary artery disease 313341 0
Condition category
Condition code
Physical Medicine / Rehabilitation 311783 311783 0 0
Physiotherapy
Cardiovascular 311784 311784 0 0
Coronary heart disease

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The aim of this study is first to translate and cross-culturally adapt the "Cardiac Rehabilitation Barriers Scale" (CRBS) to Czech (CRBS-CZE), and then psychometrically validate the translation and check internal reliability.
The main aim is to identify the barriers which prevent patients from entering the II. phase of cardiac rehabilitation (CR). We need to compare these barriers between enrollers and non-enrollers. The percentage of completers and non-completers must be determined, and finally we will compare the barriers affecting adherence and completition of ambulatory training program.

Study will take place in the Internal Cardiology Clinic of University Hospital Brno - coronary unit, care center, standard department. The research group will be made up of coronary artery disease (CAD) patients meeting the criteria for the II. phase of CR.

Main data collection method is filling the CRBS-CZE.
Patients indicated to the II. phase of CR will be educated in training program and CRBS-CZE through which we find their interest in participation. Physiotherapist will have a conversation with each patient and obtains necessary data (sample characteristics). Then immediatelly (4-12 weeks before CR commencement) each participant will fill in the CRBS-CZE individually (total approximate duration 30 mins).
The standard CR program involves 3 trainings a week for 3 months. The patients attending at least one training session will be considered enrollers. The rest of them will be qualified as non-enrollers. Subsequently we will evaluate the barriers, compare among the enrollers and non-enrollers, prospectively among completers and non-completers. Furthermore, we will express the adherence of training program and percentage of total completition.

Sample characteristics
Diagnoses
Gender
Age
BMI
Waist circumference
Marital status
Education
Average salary
Work status
Commuting time to CR
Genetic factors
Hypertension
Dyslipidemia
Diabetes mellitus
Level of physical activity
Smoking tobacco
Excessive alcohol consumption
Stress
Depression

CRBS original
(I did not attend a cardiac rehabilitation program, or if I did attend, I missed some sessions because:)
CRBS_01… of distance
CRBS_02… of cost
CRBS_03… of transportation problems
CRBS_04… of family responsibilities
CRBS_05… I didn’t know about CR
CRBS_06… I don’t need CR
CRBS_07… I already exercise at home, or in my community
CRBS_08… severe weather
CRBS_09… I find exercise tiring or painful
CRBS_10… travel
CRBS_11… of time constraints
CRBS_12… of work responsibilities
CRBS_13… I don’t have the energy
CRBS_14… other health problems prevent me from going
CRBS_15… I am too old
CRBS_16… my cardiologist or thoracic surgeon did not feel it was necessary
CRBS_17… many people with heart problems don’t go, and they are fine
CRBS_18… I can manage my heart problem on my own
CRBS_19… I think I was referred, but the rehab program didn’t contact me
CRBS_20… it took too long to start the outpatient program after referral
CRBS_21… I prefer to take care of my health alone, not in a group
Likert scale: 1-5 (1 – strongly agree, 5 – strongly disagree, not applicable)



Intervention code [1] 314778 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 320479 0
Mean score of each CRBS-CZE item (from the highest to the lowest), compare among the enrollers and non-enrollers (composite primary outcome).
Timepoint [1] 320479 0
Baseline
Secondary outcome [1] 371987 0
Mean score of each CRBS-CZE item (from the highest to the lowest), compare among completers and non-completers.
Timepoint [1] 371987 0
Baseline
Secondary outcome [2] 371988 0
Internal reliability of CRBS-CZE (Cronbach’s alpha, 0-1).
Timepoint [2] 371988 0
Baseline
Secondary outcome [3] 372601 0
The adherence and completition of training program (calculation from attendance - percentage of total 36 trainings fulfillment; 50 %, 75 %, 100 %).
Timepoint [3] 372601 0
12-weeks after enrolment
Secondary outcome [4] 372602 0
Sample characteristics (obtained via interview with patients, measurement, possibly extract some clinical characteristics from charts; composite secondary outcome).

Diagnoses (primo manifestation, ACS, PCI, CABG, heart failure, arrhythmia, valve defect)
Gender (man, woman)
Age [years]
BMI [kg/m2]
Waist circumference (measuring tape) [cm]
Marital status (single, married)
Education (primary, secondary, university)
Average salary (< 31 500 CZK, average salary in Czech Republic)
Work status (employed, unemployed, retirement, undertaking, shift work – day and night shifts changing, sedentary work, physical work)
Commuting time to CR (> 30 mins; using usual means of transit)
Genetic factors (yes, no; parents, grandparents, siblings had CAD)
Hypertension (yes, no)
Dyslipidemia (yes, no)
Diabetes mellitus (yes, no)
Level of physical activity (active, inactive; evaluation of regular week-long free time activity implemented in last 3 months and fitting the WHO recommendations) [minsMVPA/week]
Smoking tobacco (current smoker, former smoker, non-smoker)
Excessive alcohol consumption (yes, no; to evaluate alcohol consumption, we use "standard drinks" according to Hearth Foundation, remade to situation in Czech Republic)
Stress (yes, no)
Depression (yes, no)
Timepoint [4] 372602 0
Baseline

Eligibility
Key inclusion criteria
Patients
- of University Hospital Brno
- with coronary artery disease
- indicated to II. phase of CR
- without significant cardiovascular risk
- signed written informed consent
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients
- with contraindication to CR
- with potencialy high cardiovascular risk
- with implanted cardioverter-defibrilator or pacemaker
- with orthopedic or neurological disability to exercise
- with mental disadvantage making cooperation impossible

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Data will be password-protected so that only research team can access it. Personal information will be processed and backed up according to currently valid General Data Protection Regulations (GDPR).

We want to capture the date within one year to claim as many participants as possible to reach the most objective description of the situation on our workplace. There are around 1.000 patients hospitalized in the Internal Cardiology Clinic. The expected number of research group patients is between 300 and 600 respondents.

To evaluate the internal reliability of CRBS-CZE we will use Cronbach’s alpha. We will also check factor structure with factor analysis. Data will be processed via common statistical measures – mean, standard deviation. To compare the enrolment barriers and total adherence we will use a t-test.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 21623 0
Czech Republic
State/province [1] 21623 0
Jizni Morava

Funding & Sponsors
Funding source category [1] 303075 0
University
Name [1] 303075 0
Masaryk University
Address [1] 303075 0
Kamenice 5
62500 Brno
Czech Republic
Country [1] 303075 0
Czech Republic
Funding source category [2] 303113 0
Hospital
Name [2] 303113 0
Universtiy Hospital Brno
Address [2] 303113 0
Jihlavska 20
62500 Brno
Czech Republic
Country [2] 303113 0
Czech Republic
Primary sponsor type
Hospital
Name
University Hospital Brno
Address
Jihlavska 20
625 00 Brno
Czech Republic
Country
Czech Republic
Secondary sponsor category [1] 303059 0
None
Name [1] 303059 0
Address [1] 303059 0
Country [1] 303059 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303623 0
Ethical Commission of the University Hospital Brno
Ethics committee address [1] 303623 0
Ethical Commission of the University Hospital Brno
Jihlavska 20
625 00 Brno
Czech Republic
Ethics committee country [1] 303623 0
Czech Republic
Date submitted for ethics approval [1] 303623 0
06/05/2019
Approval date [1] 303623 0
15/05/2019
Ethics approval number [1] 303623 0
03-150519/EK

Summary
Brief summary
Ambulatory training program is an effective method of secondary prevention in patients with CAD. Unfortunately, utilization of CR program is low. The enrolment barriers to CR in the Czech Republic are still unknown or not properly described. Through this study we want to refer to current situation in our region. Results will be used to identify ways to help patients overcome barriers to CR utilization.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 94298 0
Mr Petr Winnige
Address 94298 0
University Hospital Brno
Jihlavska 20
62500 Brno
Czech Republic
Country 94298 0
Czech Republic
Phone 94298 0
+420732509040
Fax 94298 0
Email 94298 0
winnige.petr@fnbrno.cz
Contact person for public queries
Name 94299 0
Mr Filip Dosbaba
Address 94299 0
University Hospital Brno
Jihlavska 20
62500 Brno
Czech Republic
Country 94299 0
Czech Republic
Phone 94299 0
+42053323442
Fax 94299 0
Email 94299 0
dosbaba.filip@fnbrno.cz
Contact person for scientific queries
Name 94300 0
Mr Ladislav Batalik
Address 94300 0
University Hospital Brno
Jihlavska 20
62500 Brno
Czech Republic
Country 94300 0
Czech Republic
Phone 94300 0
+42053222037
Fax 94300 0
Email 94300 0
batalik.ladislav@fnbrno.cz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
The individual participant data collected during the trial.
When will data be available (start and end dates)?
After results publication, no end date.
Available to whom?
Case-by-case basis at the discretion of Primary Sponsor.
Available for what types of analyses?
Any purpose
How or where can data be obtained?
Access subject to approvals by Principal Investigator.
What supporting documents are/will be available?
Study protocol
Statistical analysis plan
Ethical approval
How or where can supporting documents be obtained?
Type [1] 2477 0
Ethical approval
Citation [1] 2477 0
Link [1] 2477 0
Email [1] 2477 0
winnige.petr@fnbrno.cz
Other [1] 2477 0
Type [2] 2516 0
Statistical analysis plan
Citation [2] 2516 0
Link [2] 2516 0
Email [2] 2516 0
winnige.petr@fnbrno.cz
Other [2] 2516 0
Part of study design (statistical methods/analysis).
Attachment [2] 2516 0
Type [3] 3067 0
Study protocol
Citation [3] 3067 0
Link [3] 3067 0
Email [3] 3067 0
winnige.petr@fnbrno.cz
Other [3] 3067 0
Study protocol will be available after trial publication (beginning of 2020).
Attachment [3] 3067 0
Summary results
No Results