Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000715077
Ethics application status
Approved
Date submitted
27/08/2010
Date registered
27/08/2010
Date last updated
10/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Motivational Interviewing Stroke Trial
Scientific title
Motivational interviews for secondary stroke prevention: A randomised clinical Trial
Secondary ID [1] 252583 0
Health Research Council of New Zealand Ref. number 10/458
Universal Trial Number (UTN)
U1111-1116-7462
Trial acronym
MIST
Linked study record

Health condition
Health condition(s) or problem(s) studied:
stroke 258076 0
Condition category
Condition code
Stroke 258247 258247 0 0
Ischaemic
Stroke 258248 258248 0 0
Haemorrhagic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Motivational interviewing (MI) is a structured, patient-focused, and cost-effective intervention designed to motivate patients to adhere to medication and life-style change recommendations. The MI group will have 4 interviews with trained research nurses. The initial interview will be in-person with patient & family caregivers the day before hospital discharge. Remaining interviews will be done via telephone at 3, 6, and 9 months. Interviews will take up to 1 hr. The intervention will be standardised and sessions will be monitored via standard MI coding, with detailed instructions to guide sessions and ensure consistency across research nurses. Though this study examines the impact of MI on individuals’ post-stroke, recommendations for lifestyle/medication change often fail without support from significant others. Thus, caregivers will be invited to attend the initial session, but this will not be required. Caregiver attendance will be recorded.
Intervention code [1] 257105 0
Behaviour
Intervention code [2] 257108 0
Other interventions
Comparator / control treatment
Usual care. Participants in the usual care group will receive standard care determined by their treating physicians, which doesn’t typically include MI. In some cases, ad hoc individual therapy may address adherence/non-adherence (e.g., discussing diet with nutritionists). Participation in such therapy will be identified and recorded at follow-up assessments.
Control group
Active

Outcomes
Primary outcome [1] 259094 0
adherence to medication and lifestyle changes recommended by treating physicians at and after hospital discharge in stroke patients 12 months post-randomisation, indicated by change in systolic blood pressure (BP) and low-density cholesterol (LDL) levels.
Timepoint [1] 259094 0
baseline and 12 months post-randomisation
Secondary outcome [1] 265389 0
(1) to examine change in systolic BP levels at 3, 6 and 9 months follow-up, and LDL-cholesterol levels at 6 months follow-up
Timepoint [1] 265389 0
baseline, 3, 6 and 9 months post-randomisation
Secondary outcome [2] 265392 0
(2) self-reported adherence (self-reported use of anti-platelet, statin and BP lowering therapy as prescribed)
Timepoint [2] 265392 0
baseline, 3, 6 and 9 months post-randomisation
Secondary outcome [3] 265393 0
(3) self-reported barriers to adherence
Timepoint [3] 265393 0
baseline, 3, 6 and 9 months post-randomisation
Secondary outcome [4] 265394 0
(4) cardiovascular events (new stroke or coronary heart disease, both fatal and non-fatal). This outcome will be assessed by means of questionnaire and extraction of data from medical records.
Timepoint [4] 265394 0
baseline, 3, 6 and 9 months post-randomisation
Secondary outcome [5] 265395 0
(5) quality of life as measured by the Short Form 36 (SF-36) questionnaire
Timepoint [5] 265395 0
baseline, 3, 6 and 9 months post-randomisation
Secondary outcome [6] 265396 0
(6) change in other lipid fractions high-density cholesterol, total cholesterol, triglycerides. This outcome will be assessed by means of blood test and extraction of relevant data from medical records.
Timepoint [6] 265396 0
6 and 12 months post-randomisation
Secondary outcome [7] 265397 0
(7) healthcare resource consumption and cost-effectiveness. The resourse consumption will be estimated from the investigators' point of view. Costs will assessed by means of questionnaires and data from medical records (health service databases) and will include all rehabilitative and medical services, General Medical Service benefit (or other Primary Health Organisation reimbursement), private prescription charges, co-payments, costs for hospitalisations, and resource utilisation costs.
Timepoint [7] 265397 0
12 months after randomisation. The resource consumption will be estimated by means of questionnaire and extraction of relevant data from medical records and health services databases.

Eligibility
Key inclusion criteria
(1) First-ever stroke (excluding subarachnoid haemorrhage)
(2) discharged from hospital
(3) consented to participate in the trial
Minimum age
45 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Individuals will be excluded if they: (a) have significant impairments precluding participation (e.g., aphasia, psychiatric conditions or cognitive impairment [defined as Mini Mental State Examination (MMSE) <23]); (b) are unable to converse in English, which would impact assessment and intervention delivery; (c) cannot give informed consent; (e) are known to have another condition likely to impact their participation in the trial (e.g., life-threatening condition other than cardiovascular disease); (d) receiving psychiatric or clinical psychology treatment that can contaminate the study intervention; or (e) are likely to move out of the study area after discharge.

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)
Randomisation will be concealed via an on-line Internet randomisation service.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A stratified minimization randomization algorithm will be used to balance possible prognostic factors (ie, age [10 year bands], stroke severity [Barthel Index =18, >18], sex, and ethnicity [European, non-European]) across the two groups.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
The trial is powered to provide 85% power at a = 0·05 (two sided) to detect a 0·3 mmol/l difference in LDL- cholesterol and 80% power to detect a 5 mmHg difference in SBP , respectively, between UC and MI groups, assuming 10% loss to follow-up.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/04/2011
Actual
25/03/2011
Date of last participant enrolment
Anticipated
Actual
20/12/2013
Date of last data collection
Anticipated
Actual
20/12/2014
Sample size
Target
386
Accrual to date
Final
386
Recruitment outside Australia
Country [1] 2838 0
New Zealand
State/province [1] 2838 0
Hamilton
Country [2] 2839 0
New Zealand
State/province [2] 2839 0
Auckland

Funding & Sponsors
Funding source category [1] 257551 0
Government body
Name [1] 257551 0
Health Research Council of New Zealand
Country [1] 257551 0
New Zealand
Primary sponsor type
Government body
Name
AUT University
Address
AUT North Shore Campus
90 Akoranga Dr
Northcote 0627
Auckland
Country
New Zealand
Secondary sponsor category [1] 256772 0
Government body
Name [1] 256772 0
University of Auckland
Address [1] 256772 0
Private bag 92019
Auckland
Country [1] 256772 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259575 0
Northern Region X Ethics Committee
Ethics committee address [1] 259575 0
Ethics committee country [1] 259575 0
New Zealand
Date submitted for ethics approval [1] 259575 0
24/08/2010
Approval date [1] 259575 0
09/02/2011
Ethics approval number [1] 259575 0
NTX/10/09/091

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

Contacts
Principal investigator
Name 31580 0
Prof Valery Feigin
Address 31580 0
National Institute for Stroke and Applied Neurosciences
AUT University,
90 Akoranga Drive
Northcote 0627
Auckland
New Zealand
Country 31580 0
New Zealand
Phone 31580 0
+64 (9) 921 9166
Fax 31580 0
+64 (9) 921 9620
Email 31580 0
valery.feigin@aut.ac.nz
Contact person for public queries
Name 14827 0
Valery Feigin
Address 14827 0
National Institute for Stroke & Applied Neurosciences
AUT University
AUT North Shore Campus
AA254, 90 Akoranga Dr
Northcote 0627
Auckland
Country 14827 0
New Zealand
Phone 14827 0
+64 9 921 9166
Fax 14827 0
+64 9 921 9620
Email 14827 0
valery.feigin@aut.ac.nz
Contact person for scientific queries
Name 5755 0
Valery Feigin
Address 5755 0
National Institute for Stroke & Applied Neurosciences
AUT University
AUT North Shore Campus
AA254, 90 Akoranga Dr
Northcote 0627
Auckland
Country 5755 0
New Zealand
Phone 5755 0
+64 9 921 9166
Fax 5755 0
+64 9 921 9620
Email 5755 0
valery.feigin@aut.ac.nz

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.