Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000788673
Ethics application status
Approved
Date submitted
25/12/2013
Date registered
24/07/2014
Date last updated
24/07/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
A randomized controlled trial evaluating self-care among three groups of patients with heart failure educated by health educators, by volunteers and a control group
Scientific title
Comparing the efficacy of a new educational strategy involving community health volunteers on self-care in patients with chronic heart failure compared with health workers in western Iran
Secondary ID [1] 283819 0
Nil
Secondary ID [2] 283856 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart Failure 290795 0
Public Health 290834 0
Condition category
Condition code
Cardiovascular 291162 291162 0 0
Other cardiovascular diseases
Public Health 291199 291199 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention included two stages, first training nine female volunteers by a skilled general practitioner in a few workshops.
The duration and number of workshops are depended on situation and necessity realized in the first session by obtaining feedback from participants. The materials obtained from heart failure text books and related sites such as (http://www.heartfoundation.org.au/)translated into a simple language under supervision a cardiologist, was used and provided slides of PowerPoint and pamphlets taught in workshops. Second step was performing educational program for two groups of patients with CHF randomly been allocated into group A or B. The group A was trained face to face at their homes by trained community health volunteers (CHVs) and second group divided into 3 subgroups were trained by two skilled formal health professionals (FHP)at hospital. Trainings were a single session for both groups have been considered. The training duration for each patient in group A (educated by CHVs) was about 2 hours, but the patients in the second group(FHP) taken a 3.5 hours education with half an hour break in mid time. Two months latter they were interviewed again to assess their self-care activities and behaviors.
Intervention code [1] 288506 0
Other interventions
Intervention code [2] 288507 0
Lifestyle
Comparator / control treatment
comparing two educational strategies and a control group, patients with regular health care who are normally given a very brief medical information or even no information more than the dosage of medicines and suggesting to avoid salt consumption .Unfortunately, there is not a practical program for educating all patients with CHF as a part of regular care currently, however those patients with CHF who have gone under surgery of coronary artery bypass during a rehabilitation program are educated by nurses and general practitioner.
Control group
Active

Outcomes
Primary outcome [1] 291152 0
self-care scales (self-care maintenance, self-care management and self-care confidence) are the outcome that are measured using pSCHFI.The pSCHFI is comprised of three scales with 22 questions containing 10 questions for self-maintenance, 6 for self-management and 6 for self-confidence. Each scale is standardized to a possible score of zero to 100(using likert scale)
Timepoint [1] 291152 0
outcome was assessed at 60 days from baseline
Secondary outcome [1] 306208 0
nil
Timepoint [1] 306208 0
nil

Eligibility
Key inclusion criteria
over 18 year
diagnosed by heart failure
signing consent form
lack of mental disorder
Minimum age
18 Years
Maximum age
95 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
less than 18 or more than 95
cognition problems
disagreement

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis
According to the information received from another study of a similar design, it was expected the mean of self-care increase about 22 unit (d=22). Hence to have a power of 90% we needed at least 67 participants for each group.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/06/2012
Actual
1/09/2012
Date of last participant enrolment
Anticipated
Actual
15/09/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
201
Accrual to date
Final
Recruitment outside Australia
Country [1] 5698 0
Iran, Islamic Republic Of
State/province [1] 5698 0
Kermanshah

Funding & Sponsors
Funding source category [1] 288478 0
University
Name [1] 288478 0
Kermanshah University of Medical Sciences
Country [1] 288478 0
Iran, Islamic Republic Of
Primary sponsor type
University
Name
Kermanshah University of Medical Sciences
Address
Kermanshah University of Medical Sciences, Bolvar Shahid Beheshti, Kermanshah, Iran
Country
Iran, Islamic Republic Of
Secondary sponsor category [1] 287178 0
University
Name [1] 287178 0
the university of sydney
Address [1] 287178 0
The University of Sydney NSW 2006
Country [1] 287178 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290341 0
the Human Research Ethics Committee (HREC)
Ethics committee address [1] 290341 0
Level6, Jane Foss Russell Building-G02
The University of Sydney
NSW 2006 Australia
Ethics committee country [1] 290341 0
Australia
Date submitted for ethics approval [1] 290341 0
05/12/2011
Approval date [1] 290341 0
15/03/2012
Ethics approval number [1] 290341 0
14451

Summary
Brief summary
This is an ongoing randomized control trial in which 231 patients with chronic heart failure (CHF) randomly allocated into three groups- two intervention groups and a control group, and approved by ethics committees in Iran and Australia. Two educational approaches; a face to face training by trained volunteers at home and a classic training by skilled health workers at hospital have been established. Data through interviewing before and two months after intervention have been collected using self-care of chronic heart failure index translated and validated into Persian (pSCHFI), as the primary outcome of the current study plus an investigator developed questionnaire. Data will be analysised to compare self-care in three groups, and also determine expected associations between different variables.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 45186 0
Dr soraya siabani
Address 45186 0
Victor Coppleson Building - D02 Menzies Center for Health Policy
Medical School The University of Sydney NSW 2006
Country 45186 0
Australia
Phone 45186 0
+61 2 9036 7000
Fax 45186 0
+61 2 9351 5204
Email 45186 0
[email protected]
Contact person for public queries
Name 45187 0
Dr soraya siabani
Address 45187 0
Victor Coppleson Building - D02 Menzies Center for Health Policy
Medical School The University of Sydney NSW 2006
Country 45187 0
Australia
Phone 45187 0
+61478262727
Fax 45187 0
+61 2 9351 5204
Email 45187 0
[email protected]
Contact person for scientific queries
Name 45188 0
Dr soraya siabani
Address 45188 0
Victor Coppleson Building - D02 Menzies Center for Health Policy
Medical School The University of Sydney NSW 2006
Country 45188 0
Australia
Phone 45188 0
+61478262727
Fax 45188 0
Email 45188 0
[email protected]

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What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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