Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12611000086965
Ethics application status
Approved
Date submitted
20/01/2011
Date registered
24/01/2011
Date last updated
9/02/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Development of a Peer-support based Cardiac-Diabetes Self-Management Program: A study protocol
Scientific title
Cardiac patients with diabetes who received a peer-support cardiac-self-management program have higher levels of knowledge, self-efficacy, self-behaviour compared to those patients received usual care.
Secondary ID [1] 253447 0
Not applicable. This study has not been registered with any other registry.
Universal Trial Number (UTN)
Trial acronym
Cardiac-Diabetes Self-Management Program (CDSMP)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Health behaviour 260996 0
Condition category
Condition code
Cardiovascular 259130 259130 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention – “Peer support based Cardiac-Diabetes Self-Management Program (CDSMP)” consisting of three face-to-face sessions as well as telephone and text-messaging follow-up. The face-to-face sessions will be provided by a trained Research Nurse, conducted while the patients are in Coronary Care Unit, and be continued by trained peers* as the patient makes the transition home after discharge. Peers will firstly telephone the participants 1 week after discharge home and secondly send 2 text-messages a week after telephone follow up. *A peer is someone who has similar conditions to use their own experience to provide information (former patients, not health professionals).
The aims of the CDSMP are to achieve better knowledge, self-efficacy (confidence) levels in managing their conditions and better adherence to their self-management activities. However as this is a pilot study, the overall purpose of this study is to investigate feasibility and applicability of the study.
The frequency and overall duration of the intervention components are:
Face-to-face sessions with approx 30 minutes for each session after participants’ physical condition is stabilised (within 48 hours of admission), and be provided by a trained Research Nurse, commenced while the patients are in Coronary Care Unit, and to be continued by trained peers as the patient makes the transition home after discharge for up to 1 month. Peers will firstly telephone the participants 1 week after discharge home and send 2 text-messages (as reminders) a week after telephone follow up for up to 1 month after baseline.
Intervention code [1] 257888 0
Behaviour
Intervention code [2] 257910 0
Treatment: Other
Comparator / control treatment
The comparator in this study is ‘standard care’ – Cardiac patients with diabetes admitted to a Coronary Care Unit receive relevant cardiac education and are referred to a diabetes educator when necessary.
Control group
Active

Outcomes
Primary outcome [1] 261984 0
Primary outcome 1: Self-efficacy, assessed by Diabetes Self-Efficacy Questionnaire (Australian-English version).
Timepoint [1] 261984 0
Timepoint: Baseline and at 4 weeks
Primary outcome [2] 261985 0
Primary outcome 2: self-care behaviour, assessed by Summary of Diabetes Self-Care Activities (SDSCA)
Timepoint [2] 261985 0
Timepoint: Baseline and at 4 weeks
Secondary outcome [1] 268912 0
Secondary outcome 1: readmission rate using hospital records.
Timepoint [1] 268912 0
Timepoint: 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 been admitted to the coronary care unit with cardiac event in the study hospitals; can read and converse in English; are physically stabilised; have a mobile phone.

The selected peers (A peer support person is someone who has similar conditions) will be those deemed by a Cardiologist to be competent in the management of their conditions and trained by the researchers.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Potential participants will be excluded if they: are unable to read and speak English; are transferred to another hospital; are on reparatory ventilation; are unconscious.

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 (blinded) 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';
survey 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
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
11/02/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
28
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 258360 0
Government body
Name [1] 258360 0
Department of Health & Ageing through the 'Sharing Health Care Initiative'
Country [1] 258360 0
Australia
Primary sponsor type
University
Name
Office of Commercial Services, Queensland University of Technology
Address
Office of Commercial Services
Queensland University of Technology
GPO Box 2342
Brisbane QLD 4000
Country
Australia
Secondary sponsor category [1] 257508 0
University
Name [1] 257508 0
School of Nursing, Queensland University of Technology
Address [1] 257508 0
Victoria Park Road
Kelvin Grove
QLD 4059
Country [1] 257508 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260332 0
Mater Health Services Human Research Ethics Committee
Ethics committee address [1] 260332 0
Research Ethics Coordinator
Mater Health Services
Raymond Terrance
South Brisbane
QLD 4101
Ethics committee country [1] 260332 0
Australia
Date submitted for ethics approval [1] 260332 0
Approval date [1] 260332 0
25/09/2009
Ethics approval number [1] 260332 0
Ref No: 1395AP
Ethics committee name [2] 260333 0
QUT University Human Research Ethics Committee
Ethics committee address [2] 260333 0
Research Ethics Unit
Office of Research
Level 4, 88 Musk Ave
Kelvin Grove
QLD 4059
Ethics committee country [2] 260333 0
Australia
Date submitted for ethics approval [2] 260333 0
Approval date [2] 260333 0
26/10/2009
Ethics approval number [2] 260333 0
0900001131

Summary
Brief summary
People with cardiac disease who have type 2 diabetes have higher readmission rates (22%) than those without diabetes (6%) (Wu & Chang, 2008). Although self-management is an effective approach to achieve better health outcomes, there are no such programs specifically designed for patients with both conditions. Such programs need to be enhanced by user-friendly technology and supported by patient peers. This project aims to extend the development of a peer support based Cardiac-Diabetes Self-Management Program (CDSMP) by preparing a DVD to support persons' engagement in follow-up study.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32114 0
Address 32114 0
Country 32114 0
Phone 32114 0
Fax 32114 0
Email 32114 0
Contact person for public queries
Name 15361 0
Dr Jo Wu
Address 15361 0
School of Nursing & Midwifery
Victoria Park Road
Kelvin Grove
QLD 4059
Country 15361 0
Australia
Phone 15361 0
61 7 3138 3838
Fax 15361 0
Email 15361 0
[email protected]
Contact person for scientific queries
Name 6289 0
Dr Jo Wu
Address 6289 0
School of Nursing & Midwifery
Victoria Park Road
Kelvin Grove
QLD 4059
Country 6289 0
Australia
Phone 6289 0
61 7 3138 3838
Fax 6289 0
Email 6289 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
No additional documents have been identified.