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Trial registered on ANZCTR


Registration number
ACTRN12614001317684
Ethics application status
Approved
Date submitted
25/11/2014
Date registered
16/12/2014
Date last updated
27/10/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of a tailored Cardiac-Diabetes Trans-Care program compared to usual care on hospital readmission rates and health-related quality of life in patients with dual diagnoses of acute coronary syndrome and type 2 diabetes
Scientific title
Effect of a tailored Cardiac-Diabetes Trans-Care program compared to usual care on hospital readmission rates and health-related quality of life in patients with dual diagnoses of acute coronary syndrome and type 2 diabetes
Secondary ID [1] 285738 0
None. This study has not been registered with any other registry.
Universal Trial Number (UTN)
U1111-1164-5013
Trial acronym
Cardiac/Diabetes TRANS-CARE: Cardiac/Diabetes transitional care program
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute coronary syndrome 293624 0
Type 2 diabetes 293676 0
Condition category
Condition code
Cardiovascular 293914 293914 0 0
Coronary heart disease
Metabolic and Endocrine 293915 293915 0 0
Diabetes
Public Health 293974 293974 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The "Cardiac/Diabetes TRANS-CARE program", which consists of two face-to-face sessions, a home visit and telephone follow-up. Purpose of the intervention: to increase self-efficacy to enhance self-management behaviours and thus improve health outcomes and reduce hospital readmissions.

Contents/Duration (Reference: Wu & Chang 2014 http://onlinelibrary.wiley.com/doi/10.1111/inr.12104/pdf ):
- 2 sessions (2 x 30 minute sessions, separated by 1 day) while in hospital: these sessions will be provided by a trained research nurse, and focusing on 1) assessing patient’s knowledge of their conditions and skills and confidence in self-management; 2) providing patient examples or models of someone in a similar situation.
- 1 in-home visit with duration of approx 1 hour: The home visit will be provided by a trained research nurse within the first week post discharge. This visit is to ensure that patients will be sufficient support, information, self-management activities including their treatment regimens are carried out in home environment, reinforcement and further explanation of self-management program
- weekly telephone calls for 4 weeks after home visit, and monthly up to 6 months. These calls will be undertaken by the trained research nurse. The telephone follow up calls are to ensure that patients have sufficient support, to encourage and reinforce the participant to continue practising the knowledge and skills to self-manage their conditions. Each phone call will take 20-30 minutes.
Intervention code [1] 290693 0
Behaviour
Intervention code [2] 290694 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] 293689 0
Six month readmission rate: data linkage to patient medical record
Timepoint [1] 293689 0
at 6 months post discharge
Secondary outcome [1] 311595 0
Health-related quality of life: will be measured by Assessment of Quality of Life (AQoL)
Timepoint [1] 311595 0
at 3 and 6 months post discharge
Secondary outcome [2] 311759 0
Biomedical markers: will be measured by patient medical records
Timepoint [2] 311759 0
at baseline, 1, 3, 6 months post discharge
Secondary outcome [3] 311760 0
Self-management behaviour: will be measured by Self-efficacy for managing chronic disease 6-item scale
Timepoint [3] 311760 0
at 3 months and 6 months post discharge

Eligibility
Key inclusion criteria
patients who are admitted to hospital with acute coronary syndrome (ACS) and diagnosed with type 2 diabetes
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients who are critically ill, or unconscious, being referred for cardiac surgery, on respiratory ventilation, have a current significant cognitive impairment.

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?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
An initial target of 432 eligible subjects will be recruited to the study. It is anticipated that there will be approximately 20% attrition over the 6 month follow-up period, to enable >90% power to detect a difference between groups in 6-month readmission rate. To inform the effect size for this sample size calculation we performed a subgroup analyses from our previous randomised trial that investigated an intervention with a home visit and 6-month telephone follow-up. That sub-group analysis (n=49) indicated a between group difference in 6-month readmission rate of 31.5% (Medium effect size), with statistical significance level of .05.
1) Baseline data for both the intervention and control groups will be examined to check for similarity of the groups.
2) Comparisons between groups will be undertaken. e.g. Chi square tests will be used for proportions of patients re-admitted.
3) Repeated measures regression model will be used to investigate differences over the 4 data collection points and determine the effect of the intervention over time.
4) The economic evaluation will comprise a cost-effectiveness (cost-utility) modelling conducted alongside the RCT

Because the sample size estimate for this investigation was not calculated from pilot data obtained from this specific target population, an interim analysis of hospital re-presentation event rate in the sample will be undertaken. This analysis will examine the 3-month representation rate (both groups combined) to see whether it is higher or lower than rates used in the sample size calculation. This will be conducted using the first (approximately) 10% of the target sample to reached the 3-month re-assessment point by a statistician not involved in the day-to-day operations of the trial. The statistician will be provided with a dataset from each trial site that does not include a variable for group allocation and no attempt to compare event rates between groups during the interim analysis will occur. Rather the sole purpose of the event rate interim analysis is to verify or refute whether the effect size used in the initial sample size estimate is plausible based on the rate at which patients in the target sample are re-presenting to the participating hospitals. If the event rate is substantially discordant with the sample size estimate the investigator team will decide (in conjunction with the local ethics committees) whether an amendment to the trial protocol (to increase the sample size or cease the trial early) is warranted.

Recruitment
Recruitment status
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 in Australia
Recruitment state(s)
QLD,VIC

Funding & Sponsors
Funding source category [1] 290310 0
University
Name [1] 290310 0
Australian Catholic University
Address [1] 290310 0
School of Nursing, Midwifery and Paramedicine, Faculty of Health Sciences, Australian Catholic University
1100 Nudgee Road, Banyo Queensland 4014 Australia
Country [1] 290310 0
Australia
Primary sponsor type
University
Name
Australian Catholic University (ACU)
Address
School of Nursing, Midwifery and Paramedicine, Faculty of Health Sciences, Australian Catholic University
1100 Nudgee Road, Banyo Queensland 4014 Australia
Country
Australia
Secondary sponsor category [1] 289023 0
Hospital
Name [1] 289023 0
Royal Brisbane and Women's Hospital (RBWH)
Address [1] 289023 0
Butterfield St, Herston QLD 4006
Country [1] 289023 0
Australia
Secondary sponsor category [2] 289024 0
Hospital
Name [2] 289024 0
St Vincent’s Hospital Melbourne (SVHM)
Address [2] 289024 0
Victoria Parade, Fitzroy, VIC 3065
Country [2] 289024 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292016 0
Royal Brisbane and Women’s Hospital Human Research Ethics Committee
Ethics committee address [1] 292016 0
Butterfield Street, Herston, QLD 4029
Ethics committee country [1] 292016 0
Australia
Date submitted for ethics approval [1] 292016 0
Approval date [1] 292016 0
22/08/2014
Ethics approval number [1] 292016 0
HREC/14/QRBW/301
Ethics committee name [2] 292017 0
St Vincent's Hospital (Melbourne) Human Research Ethics Committee-A
Ethics committee address [2] 292017 0
41 Victoria Parade, Fitzroy VIC 3065
Ethics committee country [2] 292017 0
Australia
Date submitted for ethics approval [2] 292017 0
15/10/2014
Approval date [2] 292017 0
12/12/2014
Ethics approval number [2] 292017 0
HREC-A 127/14
Ethics committee name [3] 292021 0
Australian Catholic University Human Research Ethics Committee
Ethics committee address [3] 292021 0
Australian Catholic University, PO Box 456, Virginia, QLD 4014
Ethics committee country [3] 292021 0
Australia
Date submitted for ethics approval [3] 292021 0
29/10/2014
Approval date [3] 292021 0
16/12/2014
Ethics approval number [3] 292021 0
2014 309Q

Summary
Brief summary
Participants with dual diagnoses of acute coronary syndrome and type 2 diabetes in both intervention and control groups will be evaluated on primary and secondary outcomes to determine whether aims of the study have achieved.
Aims: 1)To evaluate the effect of the Cardiac/Diabetes TRANS-CARE on: 6-month re-admission rates, time to first readmission, unplanned emergency department presentations, general practitioner visits after discharge, self-reported health status, psychosocial well-being at 1, 3 and 6 months. 2) To evaluate the cost-effectiveness of this intervention from the perspective of the health system
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 53070 0
Prof Mary Courtney
Address 53070 0
National Head, School of Nursing, Midwifery and Paramedicine, Faculty of Health Sciences, Australian Catholic University
1100 Nudgee Road, Banyo Queensland 4014 Australia


Country 53070 0
Australia
Phone 53070 0
+61 7 3623 7719
Fax 53070 0
Email 53070 0
Mary.Courtney@acu.edu.au
Contact person for public queries
Name 53071 0
Dr Jo Wu
Address 53071 0
Faculty of Health Sciences, Australian Catholic University
1100 Nudgee Road, Banyo Queensland 4014 Australia

Country 53071 0
Australia
Phone 53071 0
+61 7 3623 7889
Fax 53071 0
Email 53071 0
Jo.Wu@acu.edu.au
Contact person for scientific queries
Name 53072 0
Dr Jo Wu
Address 53072 0
Faculty of Health Sciences, Australian Catholic University
1100 Nudgee Road, Banyo Queensland 4014 Australia
Country 53072 0
Australia
Phone 53072 0
+61 7 3623 7889
Fax 53072 0
Email 53072 0
Jo.Wu@acu.edu.au

No information has been provided regarding IPD availability
Summary results
No Results