Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000834954
Ethics application status
Approved
Date submitted
14/07/2011
Date registered
9/08/2011
Date last updated
9/08/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
Baltic Heart Study- effects of telemedicine and distance
learning applications in the prevention of chronic heart failure
Scientific title
Effects of telemedicine and distance learning applications in the prevention of further hospitalisations in patients with chronic heart failure
Secondary ID [1] 262636 0
'Nil'
Universal Trial Number (UTN)
'Nil'
Trial acronym
Baltic Heart Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic heart failure 268345 0
Condition category
Condition code
Cardiovascular 268471 268471 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
1 group: the standard home care program plus a 6 month
telemonitoring program and plus 6 month tele-education program; Telemonitoring involves: self blood pressure measurement and body wheight monitoring every day on routine basis, using GSM service; Tele-education program involves training on webbased education platform on individual risk factors and its control; Patients on tele-education have to complete 1 hour basic education program "SALUDA" and every 3 week period will receive educational messages on individual risk factors. Telemonitoring and tele-education programs are delivered simultaneously at the same time.

2 group: the standard home care program plus plus 6 month teleeducation program. Teleeducation program involves training on webbased education platform on individual risk factors control.
Intervention code [1] 266984 0
Behaviour
Intervention code [2] 269140 0
Prevention
Intervention code [3] 269147 0
Lifestyle
Comparator / control treatment
only standard home care. Patients on standard care will receive usual care provided by the hospitals, it means that patients receive 15 min consultation and reading material before leaving the hospital and next scheduled visit to the physician. The study does not aim to affect the selection of the treatment mode.
Control group
Active

Outcomes
Primary outcome [1] 269221 0
Number of days alive without worsening heart failure. During study period all patient data will arrive to patient diary, all contacts to the physiciant will be recorded
Timepoint [1] 269221 0
at 6 and 12 month of observation
Primary outcome [2] 269222 0
Number of hospitalization days; During study period all patient hospitalization data, all contacts to the physiciants will be recorded
Timepoint [2] 269222 0
at 6 and 12 month of observation
Primary outcome [3] 269223 0
Number of contacts to any medical specialists; During study period all patient data will arrive to patient diary, all contacts to the physiciants will be recorded.
Timepoint [3] 269223 0
at 6 and 12 month of observation
Secondary outcome [1] 279155 0
Number of days experiencing worsening heart failure per 100 days at risk; During study period all patient data will arrive to patient diary, all contacts to the physiciant will be recorded
Timepoint [1] 279155 0
at 6 and 12 month of observation
Secondary outcome [2] 279156 0
Quality of Life; QoL will be assessed by MacNew quality of life questionnaire
Timepoint [2] 279156 0
at 0; 6 and 12 month of observation
Secondary outcome [3] 279157 0
NYHA class change
Timepoint [3] 279157 0
at 0; 6 and 12 month of observation
Secondary outcome [4] 279158 0
eHealth acceptance; eHealth acceptace will be assessed by EAI questionnaire
Timepoint [4] 279158 0
at 0; 6 and 12 month of observation

Eligibility
Key inclusion criteria
1. Written informed consent obtained.
2. Male and female patients over 18 years of age.
3. Chronic heart failure diagnosed at least before study involvement. Treated
with relevant long-term oral treatment.
4. Relevant NYHA II-III symptoms at screening and at baseline.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. NYHA I or IV
2. Therapeutic education impossible
3. Severe renal insufficiency (serum creatinine >450 mmol/l [5.0 mg/dl]) or on dialysis
4. Severe anaemia (blood haemoglobin <10 g/dl) at screening
5. Other serious diseases limiting life expectancy considerably (e.g. end-stage cancer)

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patient allocation based on patient possibilities to use telemedicine applications, availability and competence for internet use - Intervention group. Those who do not agree to intervention and/or dont have internet connection and/or are incompetent users are assigned for the standard care if agree.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
no randomization
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
prospective, non randomised concurrent control study
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/09/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
792
Accrual to date
Final
Recruitment outside Australia
Country [1] 3730 0
Lithuania
State/province [1] 3730 0
Country [2] 3731 0
Germany
State/province [2] 3731 0
Country [3] 3732 0
Poland
State/province [3] 3732 0
Country [4] 3733 0
Sweden
State/province [4] 3733 0
Country [5] 3734 0
Norway
State/province [5] 3734 0
Country [6] 3735 0
Finland
State/province [6] 3735 0

Funding & Sponsors
Funding source category [1] 267457 0
Government body
Name [1] 267457 0
European Commission BSR Interreg IVB program
Country [1] 267457 0
Germany
Primary sponsor type
Government body
Name
European Commission
Address
Joint Technical Secretariat Rostock
Investitionsbank Schleswig-Holstein
Grubenstrasse 20
18055 Rostock, Germany
Country
Germany
Secondary sponsor category [1] 266501 0
Government body
Name [1] 266501 0
Lithuanian Ministry of Internal Affairs
Address [1] 266501 0
Sventaragio g. 2, LT-01510 Vilnius,
Country [1] 266501 0
Lithuania

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269431 0
Lithuanian Bioethics Committee
Ethics committee address [1] 269431 0
Ethics committee country [1] 269431 0
Lithuania
Date submitted for ethics approval [1] 269431 0
20/02/2011
Approval date [1] 269431 0
07/03/2011
Ethics approval number [1] 269431 0
BE-2-11

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32883 0
Address 32883 0
Country 32883 0
Phone 32883 0
Fax 32883 0
Email 32883 0
Contact person for public queries
Name 16130 0
Dr. Giedrius Vanagas
Address 16130 0
Lithuanian University of Health Sciences
Academy of Medicine
Dept. Preventive Medicine
Eiveniu 4-408, LT-50161 Kaunas
Lithuania
Country 16130 0
Lithuania
Phone 16130 0
+37065091393
Fax 16130 0
Email 16130 0
[email protected]
Contact person for scientific queries
Name 7058 0
Dr. Giedrius Vanagas
Address 7058 0
Lithuanian University of Health Sciences
Academy of Medicine
Dept. Preventive Medicine
Eiveniu 4-408, LT-50161 Kaunas
Lithuania
Country 7058 0
Lithuania
Phone 7058 0
+37065091393
Fax 7058 0
Email 7058 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseEffectiveness of telemedicine and distance learning applications for patients with chronic heart failure. A protocol for prospective parallel group non-randomised open label study.2012https://dx.doi.org/10.1136/bmjopen-2012-001346
N.B. These documents automatically identified may not have been verified by the study sponsor.