Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000288022
Ethics application status
Not yet submitted
Date submitted
17/06/2009
Date registered
9/04/2010
Date last updated
11/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Nurse led cardiovascular (CVD) risk intervention and screening clinic (NL-RISC)
Scientific title
A randomised controlled study to investigate the impact of a nurse led clinic on modifiable risk factors in those with cardiovascular disease
Universal Trial Number (UTN)
Trial acronym
(NL-RISC)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiovascular disease 237051 0
Condition category
Condition code
Physical Medicine / Rehabilitation 237371 237371 0 0
Other physical medicine / rehabilitation
Cardiovascular 257198 257198 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Those in the NL-RISC group will receive an appointment to attend an initial consultation within a month of discharge where the nurse will review the patient’s cardiovascualr risk factors and medications in relation to the national guidelines. This appointment will be for one hour. The nurse will utilise psychotherapeutic skills, including motivational interviewing techniques to engage the participant in the rehabilitative process facilitating behaviour change and guiding decisions regarding risk factor modification. This will be followed by a 10-minute telephone follow-up at 2 months following discharge. More frequent follow up will occur should it be identified that further follow up is required. At 6 months both the control and NL-RISC groups will attend an outpatient setting to have their risk factor profile measured and compared to baseline. Lipids will be measured on a fasting blood sample, resting blood pressure (BP) using an automatic BP monitor and smoking status by self-report. Physical activity will be assessed using the 7-day International Physical Activity Recall Questionnaire, and depressive mood using the Cardiac Depression Scale.
Intervention code [1] 236773 0
Prevention
Comparator / control treatment
Usual Care, will be as decided by the patients treating team. The patient will receive medication counselling from the pharmacist prior to discharge. Risk factor education will have been undertaken by the nurse approximately of approximately 20 minutes duration. Patients will receive an outpatients appointment for 4 - 6 weeks following discharge. Those with coronary artery disease would also receive a referral to an outpatient cardiac rehabilitation program. A letter detailing their admission and follow-up would also be sent to their General Practitioner.
Control group
Active

Outcomes
Primary outcome [1] 238175 0
Fasting serum Total Cholestrol and serum Triglicerides will be collected. High Density Lipid Cholestrol and Low Density Lipid Cholestrol will also be requested, as markers of the anti- and pro-atherogenic lipid particles. The reason for this is that some people with mildly increased Total Cholestrol may actually be at lower risk because their High Density Lipid Cholestrol is high and their Low Density Lipid Cholestrol is relatively low.
Timepoint [1] 238175 0
At 6 months post-initial NL-RISC consultation visit.
Secondary outcome [1] 242470 0
Improvement in baseline cardiovascular risk profile through comparison of the following measures:
Manual Blood Pressure via sphygmomanometer
Weigh via electronic scales
Waist Circumference by tape measure starting at the top of the hip bone, and then bring it all the way around -- level with the umbilicus.
Mood Status via the cardiac depression Scale and the health related quality of life tool
Exercise via the 7 day international physical activity recall questionnaire
Smoking, alcohol and diet via self report
Diabetes via Glycosylated hemoglobin Hb1AC serum levels
Timepoint [1] 242470 0
At 6 months post-initial NL-RISC consultation visit.
Secondary outcome [2] 242479 0
Mortality
Timepoint [2] 242479 0
At 6 months post-initial NL-RISC consultation visit.
Secondary outcome [3] 242480 0
Any unplanned admissions to an in patient unit within 12 months, of first clinic visit
Timepoint [3] 242480 0
At 6 months post-initial NL-RISC consultation visit.

Eligibility
Key inclusion criteria
cardiovascular disease
Minimum age
18 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Limited English
Cognitive Impairment
Living in a nursing home

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Those individuals meeting the inclusion criteria without exclusion criteria will be informed about the study, a plain language participant information sheet will be given. Those individuals who consent to particpate will have a detailed history of the CVD risk factors recorded with demographic and medical history information prior to randomisation. This recording will be undertaken by a trained research assistant (RA) not directly associated with the study.

Allocation is not concealed, there will be central randomisation via a computer program. The research assistant will contact the central adminstrative site to receive the allocation number.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using a randomisation table created by computer software (i.e., computerised sequence generation).
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
17/08/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
216
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 237171 0
Commercial sector/Industry
Name [1] 237171 0
Nurses Board Victoria
Country [1] 237171 0
Australia
Primary sponsor type
University
Name
Australian Catholic University
Address
115 VICTORIA PARADE
FITZROY
VIC, 3065
Country
Australia
Secondary sponsor category [1] 4660 0
Hospital
Name [1] 4660 0
St Vincent's Melbourne
Address [1] 4660 0
27 Victoria Parade
Fitzroy
Vic, 3065
Country [1] 4660 0
Australia
Other collaborator category [1] 710 0
Commercial sector/Industry
Name [1] 710 0
Nurses Board Victoria
Address [1] 710 0
595 Ltl Collins St
Melbourne VIC 3000
Country [1] 710 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 239263 0
St Vincents Hospital Human Research ethics Committee
Ethics committee address [1] 239263 0
Ethics committee country [1] 239263 0
Australia
Date submitted for ethics approval [1] 239263 0
19/06/2009
Approval date [1] 239263 0
16/07/2009
Ethics approval number [1] 239263 0
HREC-A 089/09

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

Contacts
Principal investigator
Name 29763 0
Address 29763 0
Country 29763 0
Phone 29763 0
Fax 29763 0
Email 29763 0
Contact person for public queries
Name 13010 0
Dr Karen Page
Address 13010 0
St Vincents,
level 7 Aikenhead Building
27 Victoria Parade
Fitzroy
VIC, 3065
Country 13010 0
Australia
Phone 13010 0
61 3 9288 3689
Fax 13010 0
61 3 9288 3529
Email 13010 0
karen.page@svhm.org.au
Contact person for scientific queries
Name 3938 0
Dr Karen Page
Address 3938 0
St Vincents,
level 7 Aikenhead Building
27 Victoria Parade
VIC, Fitzroy
3065
Country 3938 0
Australia
Phone 3938 0
61 3 9288 3689
Fax 3938 0
61 3 9288 3529
Email 3938 0
karen.page@svhm.org.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.