Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611001196932
Ethics application status
Approved
Date submitted
17/11/2011
Date registered
18/11/2011
Date last updated
16/12/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Using telephone and text-messaging to improve an integrated cardiac and diabetes self-management program: A cross cultural international collaborative project
Scientific title
Cardiac patients with diabetes in Australia and in Taiwan who received a cardiac-self-management program incorporating telephone and text-messaging have higher levels of knowledge, self-efficacy, self-behaviour and quality of life compared to those patients who received usual care.
Secondary ID [1] 273405 0
Not applicable. This study has not been registered with any other registry.
Universal Trial Number (UTN)
U1111-1125-7891
Trial acronym
Tel/text Cardiac-Diabetes Self-Management Program (T - CDSMP)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
The efficacy of a Cardiac-Diabetes Self-Management Program 279200 0
Cardiovascular/Coronary heart disease 279201 0
Condition category
Condition code
Cardiovascular 279403 279403 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention – “Cardiac-Diabetes Self-Management Program incorporating telephone and text-messaging (T-CDSMP)” consists of three face-to-face sessions as well as telephone and text-message follow-up. The face-to-face sessions will be commenced within 48 hours of admission. They will be provided by a trained Research Nurse and be conducted while the patients are in hospitals in either Australia and in Taiwan. Follow up will be once a week by telephone call (at 1 week after discharge home), and by text-messages which will be sent a week after the telephone follow up. The length of intervention is 4 weeks.
Intervention code [1] 283739 0
Behaviour
Intervention code [2] 283743 0
Treatment: Other
Comparator / control treatment
The comparator in this study is 'standard care' – Cardiac patients with diabetes admitted to acute hospital receive standard cardiac education and are referred to a cardiac rehabilitation nurse or diabetes educator when necessary.
Control group
Active

Outcomes
Primary outcome [1] 285973 0
Primary outcome 1: Self-efficacy, as assessed by 'Diabetes Self-Efficacy Questionnaire' (Australian-English version) and Chinese versions.
Timepoint [1] 285973 0
Baseline and at 4 weeks following discharge
Primary outcome [2] 285974 0
Primary outcome 2: self-care behaviour, as assessed by 'Summary of Diabetes Self-Care Activities (SDSCA)' English and Chinese versions
Timepoint [2] 285974 0
Baseline and at 4 weeks following discharge
Primary outcome [3] 285975 0
Primary outcome 3: quality of life, as assessed by 'The World Health Organisation Quality of Life (WHOQOL)-BREF' English and Chinese versions
Timepoint [3] 285975 0
Baseline and at 4 weeks following discharge
Secondary outcome [1] 294878 0
readmission rate using hospital records.
Timepoint [1] 294878 0
readmitted to hospital within 1 month of discharge from hospital

Eligibility
Key inclusion criteria
Participants who will be included: males and females aged over 18 years who have given their consent to participate in the study, have had type 2 diabetes for at least one year and have experienced a cardiac event and have been admitted to acute care hospital in Australia and Taiwan (participated study sites), can read and converse in English, are physically stabilised, have a mobile phone.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Potential participants will be excluded if they are: critically ill, unconscious, on respiratory ventilation, stay in hospital less than 48 hours or greater than 14 days, are discharged to nursing home.

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)
Baseline data collection is blinded and will be undertaken before randomisation. Allocation will be concealed by using sealed, numbered, opaque envelopes; list generation will be provided by researcher off site, after randomisation. Patients are not blinded to ‘intervention’ and surveys do not have group ID, thus data entry is blinded.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table (computerised sequence generation) will be used.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Randomised Block Design
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
9/06/2011
Actual
10/06/2011
Date of last participant enrolment
Anticipated
Actual
22/12/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
182
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 3957 0
Taiwan, Province Of China
State/province [1] 3957 0

Funding & Sponsors
Funding source category [1] 284221 0
University
Name [1] 284221 0
Institute of Health and Biomedical Innovation, Queensland University of Technology
Country [1] 284221 0
Australia
Primary sponsor type
University
Name
Institute of Health and Biomedical Innovation, Queensland University of Technology
Address
Institute of Health and Biomedical Innovation (IHBI)
Queensland University of Technology
60 Musk Ave, Kelvin Grove, QLD 4059
Country
Australia
Secondary sponsor category [1] 269176 0
None
Name [1] 269176 0
Address [1] 269176 0
Country [1] 269176 0
Other collaborator category [1] 260353 0
University
Name [1] 260353 0
Tzu Chi college of Technology & Tzu Chi University, Taiwan
Address [1] 260353 0
Department of Nursing, Tzu Chi College of Technology
No. 880, Sec 2, Chien-Kou Road
Hualien, Taiwan 970
Country [1] 260353 0
Taiwan, Province Of China

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286181 0
Royal Brisbane and Women's Hospital Human Research Ethics Committee, Australia
Ethics committee address [1] 286181 0
Ethics committee country [1] 286181 0
Australia
Date submitted for ethics approval [1] 286181 0
18/11/2010
Approval date [1] 286181 0
02/02/2011
Ethics approval number [1] 286181 0
HREC/10/QRBW/479
Ethics committee name [2] 286182 0
Mater Health Services Human Research Ethics Committee , Australia
Ethics committee address [2] 286182 0
Ethics committee country [2] 286182 0
Australia
Date submitted for ethics approval [2] 286182 0
09/11/2010
Approval date [2] 286182 0
02/03/2011
Ethics approval number [2] 286182 0
Ref No: 1662A
Ethics committee name [3] 286183 0
Queensland University of Technology Human Research Ethics Committee, Australia
Ethics committee address [3] 286183 0
Ethics committee country [3] 286183 0
Australia
Date submitted for ethics approval [3] 286183 0
09/03/2011
Approval date [3] 286183 0
25/03/2011
Ethics approval number [3] 286183 0
EC00171

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

Contacts
Principal investigator
Name 33404 0
Dr Chiung-Jung (Jo) Wu
Address 33404 0
Dr Jo Wu,
Faculty of Health Sciences,
Australian Catholic University,
1100 Nudgee Road, Banyo QLD 4014, Australia
Country 33404 0
Australia
Phone 33404 0
61 7 3623 7889
Fax 33404 0
Email 33404 0
[email protected]
Contact person for public queries
Name 16651 0
Chiung-Jung (Jo) Wu
Address 16651 0
Dr Jo Wu,
Faculty of Health Sciences,
Australian Catholic University,
1100 Nudgee Road, Banyo QLD 4014, Australia
Country 16651 0
Australia
Phone 16651 0
61 7 3623 7889
Fax 16651 0
Email 16651 0
[email protected]
Contact person for scientific queries
Name 7579 0
Chiung-Jung (Jo) Wu
Address 7579 0
Dr Jo Wu,
Faculty of Health Sciences,
Australian Catholic University,
1100 Nudgee Road, Banyo QLD 4014, Australia
Country 7579 0
Australia
Phone 7579 0
61 7 3623 7889
Fax 7579 0
Email 7579 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
EmbaseProtocol for a randomised blocked design study using telephone and text-messaging to support cardiac patients with diabetes: a cross cultural international collaborative project.2013
N.B. These documents automatically identified may not have been verified by the study sponsor.