Trial Review

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
ACTRN12607000044426
Ethics application status
Approved
Date submitted
24/10/2006
Date registered
12/01/2007
Date last updated
3/07/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Improving safety and quality: psychosocial influences of managing medicines by consumers with chronic health problems
Scientific title
Consumers with diabetes and kidney disease: a nurse-led intervention to improve medication adherence
Universal Trial Number (UTN)
Trial acronym
MESMI
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes, kidney disease and hypertension 3058 0
Condition category
Condition code
Metabolic and Endocrine 2161 2161 0 0
Diabetes
Renal and Urogenital 2162 2162 0 0
Kidney disease
Cardiovascular 3436 3436 0 0
Hypertension

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A DVD will be shown to participants during the home visit. There is only one planned home visit in the 12-week period. The DVD will contain health information for consumers regarding medicines in relation to their chronic conditions to enhance decision-making and behavioural change. Patients will be taught how to take their blood pressure using an electronic self-monitoring blood pressure machine during the home visit. A medication review will be conducted at this time, which will involve checking the medication regimen with the patient to reach agreement about their treatment and development of a tailored drug chart for the patient. Fortnightly follow-up telephone calls will be made thereafter to the patients for 12 weeks. The intervention will be 12 weeks in total.
Intervention code [1] 1418 0
Behaviour
Comparator / control treatment
Standard treatment is the usual care provided to patients by the outpatients clinic. Standard care will be assessed prior to the randomised controlled trial (RCT) by survey of consulting physicians of the clinics.
Control group
Active

Outcomes
Primary outcome [1] 3013 0
A difference in systolic blood pressure of 3- 5 mm Hg between the intervention and control groups.
Timepoint [1] 3013 0
Immediately post-intervention at 12 weeks and then at 3 months post-intervention.
Primary outcome [2] 4099 0
reduction in blood pressure
Timepoint [2] 4099 0
Immediately post-intervention at 12 weeks and then at 3 months post-intervention.
Secondary outcome [1] 5064 0
Clinical laboratory surrogate blood sample measurements indicative of medicine adherence such as serum creatinine, urea, haemoglobin, iron, calcium, phosphate and lipids.
Medication self-efficacy
General wellbeing
Health care utilisation
Timepoint [1] 5064 0
Immediately post-intervention at 12 weeks and then at 3 months post-intervention.

Eligibility
Key inclusion criteria
Mentally competent Australians Comprehend English
Diabetes, kidney disease and systolic hypertension treated with antihypertensive medication
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Imminent end stage kidney disease (ESKD) Pregnancy 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)
Randomised 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
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/08/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
144
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 3309 0
Government body
Name [1] 3309 0
Australian Research Council
Country [1] 3309 0
Australia
Primary sponsor type
University
Name
The University of Melbourne
Address
Level 5/234 Queensberry Street
Carlton 3053
Victoria
Country
Australia
Secondary sponsor category [1] 2971 0
Hospital
Name [1] 2971 0
Royal Melbourne Hospital
Address [1] 2971 0
Grattan St, Parkville, VIC
Country [1] 2971 0
Australia
Secondary sponsor category [2] 2972 0
Hospital
Name [2] 2972 0
St. Vincent's Hospital
Address [2] 2972 0
Victoria Parade, Fitzroy, VIC
Country [2] 2972 0
Australia
Secondary sponsor category [3] 2973 0
Commercial sector/Industry
Name [3] 2973 0
TrueCare Pty. Ltd.
Address [3] 2973 0
23 Clarendon Street, East Melbourne, VIC
Country [3] 2973 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4128 0
St. Vincent's Hospital
Ethics committee address [1] 4128 0
Victoria Parade
Fitzroy
Ethics committee country [1] 4128 0
Australia
Date submitted for ethics approval [1] 4128 0
Approval date [1] 4128 0
05/07/2007
Ethics approval number [1] 4128 0
042/07
Ethics committee name [2] 4129 0
The University of Melbourne
Ethics committee address [2] 4129 0
Victoria 3010
Ethics committee country [2] 4129 0
Australia
Date submitted for ethics approval [2] 4129 0
Approval date [2] 4129 0
23/08/2007
Ethics approval number [2] 4129 0
0713622
Ethics committee name [3] 5295 0
Royal Melbourne Hospital
Ethics committee address [3] 5295 0
Grattan Street, Parkville, Victoria 3010, Victoria 3065
Ethics committee country [3] 5295 0
Australia
Date submitted for ethics approval [3] 5295 0
Approval date [3] 5295 0
23/02/2007
Ethics approval number [3] 5295 0
2006:239

Summary
Brief summary
Australians are experiencing an increased prevalence of chronic diseases which require sustained self-management of medicines and long term monitoring by health professionals. The proposed study will determine the psychosocial influences affecting self-management of medicines by consumers with co-existing chronic diseases, specifically diabetes, kidney disease and hypertension. The aims of the study are to develop and test the effectiveness of a medicine self-management training package (MESMI). Null hypothesis: Compared to patients receiving standard care, patients who receive the intervention will show no change in blood pressure
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27352 0
Address 27352 0
Country 27352 0
Phone 27352 0
Fax 27352 0
Email 27352 0
Contact person for public queries
Name 10607 0
Dr. Allison Williams
Address 10607 0
School of Nursing & Social Work
Level 5/234 Queensberry Street
Carlton VIC 3053
Country 10607 0
Australia
Phone 10607 0
+61 3 83449446
Fax 10607 0
+61 3 93474375
Email 10607 0
[email protected]
Contact person for scientific queries
Name 1535 0
Dr. Allison Williams
Address 1535 0
School of Nursing & Social Work
Level 5/234 Queensberry Street
Carlton VIC 3053
Country 1535 0
Australia
Phone 1535 0
+61 3 83449446
Fax 1535 0
+61 3 93474375
Email 1535 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.