Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000077864
Ethics application status
Approved
Date submitted
9/01/2012
Date registered
16/01/2012
Date last updated
16/01/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Managing depression and anxiety risk in those with cardiovascular disease - A nurse led intervention
Scientific title
A pilot study of a nurse-led Intervention that will facilitate the modification of health related behaviours through motivational interviewing and further education on self care strategies in patients at risk of depression and anxiety following an acute cardiac event.
Secondary ID [1] 279687 0
NIL
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression in cardiovascular patients. 285512 0
Anxiety in cardiovascular patients. 285517 0
Adherence to secondary prevention guidelines. 285519 0
Condition category
Condition code
Cardiovascular 285702 285702 0 0
Coronary heart disease
Mental Health 285703 285703 0 0
Depression
Public Health 285704 285704 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Managing depression and anxiety in cardiovascular patients via Motivational interviewing.

There will be an initial one hour nurse led consultation followed by weekly 15-30 minute telephone calls for the first month, then fortnightly for the next month. At 3 months, participants will be invited to attend a second face-to-face consultation with the nurse. After the second consultation the participant will have monthly follow up calls for the next two months and a final face-to face consultation at 6 months
Intervention code [1] 283980 0
Behaviour
Intervention code [2] 283981 0
Rehabilitation
Intervention code [3] 283982 0
Prevention
Comparator / control treatment
Before - after study design
Control group
Uncontrolled

Outcomes
Primary outcome [1] 286230 0
To improve psychological (depression, anxiety and quality of life) outcomes in those with CVD.

The Hospital Anxiety and Depression Scale (HADS) will be used to assess ongoing depressive and anxiety symptomatology. The SF-12 Health Survey will be used to indicate ongoing physical and emotional health status. Comparing ENRICHD scores along the data collection period will indicate social support.
Timepoint [1] 286230 0
On recruitment, 3 months, 6 months
Primary outcome [2] 286231 0
To examine if improved physiological outcomes in patients with CVD are associated with adherence to guideline risk factor modification.

The participants will be asked several questions in regards to their walking and sport habits to assess their level of physical activity using the International Physical Activity Questionnaire (IPAQ). Additional ongoing measure of modifiable biometric and lifestyle risk factors (RR, body weight, BMI, blood cholesterol) will indicate adherence / change to secondary prevention guidelines.
Timepoint [2] 286231 0
On recruitment, 3months, 6 months
Primary outcome [3] 286232 0
To identify the components of the nurse-led intervention that participants perceive as most beneficial.

A modified Michigan Academic Consortium Patient-Satisfaction Questionnaire (MAC-PSQ) will be used to assess patient satisfaction
Timepoint [3] 286232 0
6 months
Secondary outcome [1] 295423 0
NIL
Timepoint [1] 295423 0
NIL

Eligibility
Key inclusion criteria
*Primary diagnosis of one or more of the following atherosclerotic related events acute coronary syndrome, coronary artery bypass grafts, stroke, transient ischemic attack, or peripheral vascular disease.
* Aged 18 and above
* Telephone access
* HADS score = / >11
* Fluent in English
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Diagnosed with a terminal illness
* Cognitive impairment that may impact upon ability to participate in the trial
* Participant is housebound
* Existing diagnosis of a psychiatric condition including bipolar illness, psychotic illness, dementia, severe personality disorder
* Dependence on alcohol or other substances other than nicotine
* Participation in other research trial that may interfere with the trial
* Inability to give informed consent
* Any other factor impacting upon ability to give informed consent or participate in the study

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
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
1/02/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 284468 0
Charities/Societies/Foundations
Name [1] 284468 0
beyondblue
Country [1] 284468 0
Australia
Primary sponsor type
University
Name
Australian Catholic University
Address
115 Victoria Parade
Fitzroy Victoria 3065
Country
Australia
Secondary sponsor category [1] 283394 0
Hospital
Name [1] 283394 0
St Vincents Hospital Melbourne
Address [1] 283394 0
41 Victoria Parade
Fitzroy VICTORIA 3065
Country [1] 283394 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286451 0
HREC STV Melbourne
Ethics committee address [1] 286451 0
Ethics committee country [1] 286451 0
Australia
Date submitted for ethics approval [1] 286451 0
Approval date [1] 286451 0
20/05/2011
Ethics approval number [1] 286451 0
HRECA 048/11

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

Contacts
Principal investigator
Name 33602 0
Address 33602 0
Country 33602 0
Phone 33602 0
Fax 33602 0
Email 33602 0
Contact person for public queries
Name 16849 0
Karen Daws
Address 16849 0
St Vincent's / ACU Centre for Nursing Research
VECCI Building Locked Bag 4115
Fitzroy MDS 3065
Victoria
Country 16849 0
Australia
Phone 16849 0
+61 3 9953 3701
Fax 16849 0
+61 3 9662 1857
Email 16849 0
Karen.Daws@acu.edu.au
Contact person for scientific queries
Name 7777 0
Karen Daws
Address 7777 0
St Vincent's / ACU Centre for Nursing Research
VECCI Building Locked Bag 4115
Fitzroy MDS 3065
Victoria
Country 7777 0
Australia
Phone 7777 0
+61 3 9953 3701
Fax 7777 0
+61 3 9662 1857
Email 7777 0
Karen.Daws@acu.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.