Trial Review

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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
ACTRN12608000313336
Ethics application status
Approved
Date submitted
16/04/2008
Date registered
1/07/2008
Date last updated
3/07/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Medication self-management in consumers with diabetes and kidney disease from culturally and linguistically diverse backgrounds
Scientific title
A language-specific, nurse-led medication intervention to enhance medication self-efficacy in consumers with diabetes and kidney disease from culturally and linguistically diverse backgrounds
Universal Trial Number (UTN)
Trial acronym
SEM
Linked study record

Health condition
Health condition(s) or problem(s) studied:
diabetes and kidney disease 3268 0
Condition category
Condition code
Renal and Urogenital 3214 3214 0 0
Kidney disease
Metabolic and Endocrine 3433 3433 0 0
Diabetes
Cardiovascular 3434 3434 0 0
Hypertension

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A subtitled DVD will be shown to the patient during the home visit conducted by the researcher in the presence of an interpreter or English-speaking family member.
The DVD will contain health information for consumers regarding medicines in relation to their chronic conditions to enhance decision-making and behavioural change.
A medication review will be conducted during the home visit by the researcher which involves checking the medication regimen with the patient to reach agreement about their treatment. Fortnightly 5-10 minute follow-up telephone calls will be made by an interpreter in liaison with the researcher or researcher with a family member who can interpret for the patient for a period of 12 weeks exploring any queries or problems relating to their medications. The intervention will last for 12 weeks.
Intervention code [1] 2805 0
Behaviour
Comparator / control treatment
Standard treatment is the usual care provided to patients by the outpatients' clinic. Standard treatment will be assessed by a survey of outpatient clinic physicians. The control group will not receive the intervention but will have the same data collected at all time points with the intervention group.
Control group
Active

Outcomes
Primary outcome [1] 4098 0
Medication self-efficacy will be measured by the
Medication Adherence Self-efficacy scale.
Timepoint [1] 4098 0
Immediately post-intervention at 12 weeks and 3 months post-intervention
Secondary outcome [1] 6898 0
Improved medication adherence which will be measured by the Morisky Medication Adherence scale
Timepoint [1] 6898 0
Immediately post-intervention at 12 weeks and 3 months post-intervention

Eligibility
Key inclusion criteria
Victorians whose preference is to speak either Greek, Italian or Vietnamese at home Diabetes, kidney disease and cardiovascular disease Mentally competent
Minimum age
18 Years
Maximum age
N/A
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Pregnancy
Imminent end stage kidney disease Aggressive form of cancer
Mental illness not stabilised with medication.

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)
Randomisation by an independent person/third party. Allocation involved computer contact with the holder of the allocation schedule who will be off-site.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/11/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
114
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 3489 0
Other Collaborative groups
Name [1] 3489 0
Nurses Board of Victoria
Country [1] 3489 0
Australia
Primary sponsor type
University
Name
The University of Melbourne
Address
Level 5/234 Queensberry Street
Carlton
Victoria 3159
Country
Australia
Secondary sponsor category [1] 2959 0
Hospital
Name [1] 2959 0
Royal Melbourne Hospital
Address [1] 2959 0
Grattan Street
Parkville
Victoria
Country [1] 2959 0
Australia
Secondary sponsor category [2] 2960 0
Hospital
Name [2] 2960 0
St. Vincent's Hospital
Address [2] 2960 0
Victoria Parade
Fitzroy
Victoria
Country [2] 2960 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5520 0
Royal Melbourne Hospital HREC-A
Ethics committee address [1] 5520 0
PO Royal Melbourne Hospital
Parkville Victoria 3050
Ethics committee country [1] 5520 0
Australia
Date submitted for ethics approval [1] 5520 0
Approval date [1] 5520 0
Ethics approval number [1] 5520 0
2006:239

Summary
Brief summary
This project aims to assist culturally and linguistically diverse consumers safely manage their complex medication regimens for the co-existing comorbidities of cardiovascular disease (CVD), diabetes and chronic kidney disease (CKD). Taking medicines as prescribed is critical for well-managed chronic diseases. Approximately 40% of Victorians with CVD, diabetes and CKD speak a language other than English at home, most commonly Greek, Italian, and Vietnamese, which increases the likelihood of medicine-related problems. A language-specific medication intervention to enhance medication self-efficacy will be developed and tested. Better medicine self-efficacy results in improved general wellbeing, medication safety and reduced healthcare costs.

Null hypothesis: 1. Compared to patients receiving standard care, patients who receive the intervention will show no change in medication self-efficacy
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28534 0
Address 28534 0
Country 28534 0
Phone 28534 0
Fax 28534 0
Email 28534 0
Contact person for public queries
Name 11691 0
Dr. Allison Williams
Address 11691 0
Level 5/234 Queensberry Street
Carlton 3053
Victoria
Country 11691 0
Australia
Phone 11691 0
+61 3 83449446
Fax 11691 0
+61 3 93474375
Email 11691 0
afw@unimelb.edu.au
Contact person for scientific queries
Name 2619 0
Dr. Allison Williams
Address 2619 0
Level 5/234 Queensberry Street
Carlton 3053
Victoria
Country 2619 0
Australia
Phone 2619 0
+61 3 83449446
Fax 2619 0
+61 3 93474375
Email 2619 0
afw@unimelb.edu.au

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.