Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000379415
Ethics application status
Approved
Date submitted
18/03/2016
Date registered
23/03/2016
Date last updated
22/01/2019
Date data sharing statement initially provided
22/01/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Efficacy of a health and wellness coaching program for the prevention of cardiovascular disease and stroke in New Zealand adults
Scientific title
Efficacy of a health and wellness coaching program for the prevention of cardiovascular disease and stroke in New Zealand adults
Secondary ID [1] 288797 0
nil
Universal Trial Number (UTN)
Trial acronym
PreventS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 298063 0
Cardiovascular Disease 298064 0
Condition category
Condition code
Cardiovascular 298225 298225 0 0
Coronary heart disease
Stroke 298226 298226 0 0
Ischaemic
Stroke 298239 298239 0 0
Haemorrhagic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study will test the effectiveness of Health and Wellness Coaching (HWC) for primary prevention of stroke, is particularly relevant to the ageing population where most strokes occur. Participants in this trial will be randomly allocated to the Health and Wellness Coaching (HWC) Intervention (n=160) or Usual Care (n=160) over a 9 month period.
The Health Wellness Intervention will be administered 15 x sessions over a 9 month period. The first session will be face to face for approximately 60 minutes, and the remaining sessions conducted over the phone (30 minutes). The first 12 sessions will be carried out within the first 3 months (weekly or fortnightly depending on the need of the study participant). The 3 remaining session will be carried out 2 months apart at 5, 7 and 9 months) Trained Health Wellness Coaches (research assistant, post graduate level) will have completed an intensive 6 week course run by Momentum Coaching Ltd. All participants will complete questionnaires at baseline, 3,6,9 and 12 months. The questionnaire will include outcome measures including lifes simple 7 (measure diet and lifestyle), PHQ-9 (measure mood), ED-5D-5L (health-related quality of life), Readiness to change measure, MMAS-8 medication adherence Scale.
We will be monitoring adherence by logging phone calls, recording all information, duration, frequency of phone calls in the data base.
HWC is an innovative, structured, patient-focused multi-dimensional psychological intervention designed to motivate participants to adhere to recommended medication and lifestyle changes.
HWC is goal oriented and a health coach can help a person and their family/whanau/supporters identify individual strengths, empowering them to focus on lifestyle-related behaviours that the individual wants to, and can, change. Individuals who receive HWC are shown to have increased perceived health status, medication adherence, and physical activity, with decreases in stress levels.
Intervention code [1] 294247 0
Prevention
Intervention code [2] 294256 0
Lifestyle
Intervention code [3] 294257 0
Behaviour
Comparator / control treatment
the control group will receive usual care (continue daily routine) they just will not receive the health wellness coaching intervention
Control group
Active

Outcomes
Primary outcome [1] 297750 0
Proportion of baseline moderate (10-15%) 5 year CVD risk participants with a relative risk reduction of 25% following the intervention, assessed by PREDICT score from primary health care group data.
Timepoint [1] 297750 0
This will be assessed through the GP at the 9 month time-point
Secondary outcome [1] 322025 0
Adherence to Medication will be assessed by Medication Adherence Scale (MMAS-8)
Timepoint [1] 322025 0
The secondary outcomes will be measured at baseline, 3,6,9 and 12 months for both groups,
Secondary outcome [2] 322121 0
Health related quality of life, assessed by EQ-5D-5L
Timepoint [2] 322121 0
3,6,9 and 12 months
Secondary outcome [3] 322122 0
We would now like to examine the efficacy of the intervention in terms of long-term behaviour change over a time period of two years. To test the effectiveness of the intervention we will use a score recommended by the American Heart Foundation as a way to predict who is at a higher risk of cardiovascular disease. This score, known as the Life's Simple 7 uses information such as diet, body mass index, cholesterol, blood glucose, physical activity levels, blood pressure, and smoking habits, to categorize individuals into various levels of health. We will compare the changes in this score between those who are allocated to the HWC group and those who receive usual care. This is so that we can evaluate if the effectiveness of the Health and Wellness Coaching is sustained over an extended time after the coaching has ended.
Timepoint [3] 322122 0
The added time point will be a further assessment at 24 months in addition to the other time points at Baseline, 3, 6, 9, and 12 months
Secondary outcome [4] 322123 0
Mood will be assessed by the Patient Health Questionnaire (PHQ-9)
Timepoint [4] 322123 0
baseline,3,6,9 and 12 months
Secondary outcome [5] 322124 0
life satisfaction as measured by the life satisfaction scale
Timepoint [5] 322124 0
baseline,3,6,9 and 36 months

Eligibility
Key inclusion criteria
Participants will include 320 adults : minimum age range will be 35 years old for Maori and Pasifika due to earlier age of stroke in these ethnic groups; older than 45 years old for other ethnic groups) with absolute 5-year CVD risk of higher than 10%. The participants will be identified through GP practices that use PREDICT or a similar tool for CVD risk calculation. Must be able to converse in english, have not had a previous stroke or heart attack. There is no upper age limit. Information we have received from the PHO's indicates that most people who are at moderate to high risk are around the 35 to 60 year age bracket.
Minimum age
35 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) is unable to converse in English (b) had previous stroke or heart attack; (c) have significant impairments or medical conditions precluding participation; (d) cannot give informed consent; (e) deemed inappropriate for the intervention by the participant’s GP; (f) receiving treatment that can contaminate the study intervention; or (g) are likely to move out of the study area during the year (h) have clinical depression and/or anxiety as assessed by a screening tool.

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)
Eligible participants will be randomised into HWC or Usual Care groups using the online randomisation process on the ART database. A predetermined algorithm will stratify participants by age, sex, ethnicity and CVD risk score. The CVD risk score would have been obtained at the time of initial participant selection. After randomisation is complete, participants will be informed of their group allocation and requested not to inform the RA conducting the assessments

Allocation concealment will be done by central randomisation by computer. When a consented participant has completed the screening criteria and signed consent, the RA will enter in their details and the computer program will allocate them to either HWC group or Usual Care. The RA will be blinded to the allocation of the allocation. Only the study manager and HWC Coaches will know.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
A prospective, randomised, open-treatment, blinded end-point trial.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Intention-to-treat analysis will be employed. Assuming 20% non-compliance and loss to follow-up, 320 participants (80 Maori, 80 Pasifika, 80 Asians and 80 NZ Europeans) are required to provide 90% power at two sided a=0.05 to detect a clinically significant, 10% and 25% relative risk reduction ethnic specific difference in the absolute 5-year CVD risk in moderate (10-15%) and high (>15%) CVD risk participants respectively between HWC and UC groups in each ethnic group at nine months after randomization.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
20/05/2016
Actual
20/06/2016
Date of last participant enrolment
Anticipated
20/07/2018
Actual
20/07/2018
Date of last data collection
Anticipated
1/05/2020
Actual
Sample size
Target
320
Accrual to date
Final
320
Recruitment outside Australia
Country [1] 7712 0
New Zealand
State/province [1] 7712 0
Auckland

Funding & Sponsors
Funding source category [1] 293162 0
University
Name [1] 293162 0
Otago University
Country [1] 293162 0
New Zealand
Funding source category [2] 301726 0
Charities/Societies/Foundations
Name [2] 301726 0
Brain Research New Zealand
Country [2] 301726 0
New Zealand
Primary sponsor type
University
Name
Otago University
Address
Ageing Well National Science Challenge,
Otago University
P.O BOX 56
Dunedin 9054
Country
New Zealand
Secondary sponsor category [1] 291957 0
None
Name [1] 291957 0
none
Address [1] 291957 0
none
Country [1] 291957 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294655 0
HDEC
Ethics committee address [1] 294655 0
Ethics committee country [1] 294655 0
New Zealand
Date submitted for ethics approval [1] 294655 0
04/04/2016
Approval date [1] 294655 0
16/05/2016
Ethics approval number [1] 294655 0

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

Contacts
Principal investigator
Name 64506 0
Prof Valery Feigin
Address 64506 0
AUT University
90 Akoranga Drive
Northcote
Auckland 0627
Country 64506 0
New Zealand
Phone 64506 0
+6499219166
Fax 64506 0
+6499219620
Email 64506 0
[email protected]
Contact person for public queries
Name 64507 0
Susan Mahon
Address 64507 0
AUT University
90 Akoranga Drive
Northcote
Auckland 0627
Country 64507 0
New Zealand
Phone 64507 0
+6499219999 ex 7438
Fax 64507 0
+6499219620
Email 64507 0
[email protected]
Contact person for scientific queries
Name 64508 0
Rita Krishanmurthi
Address 64508 0
AUT University
90 Akoranga Drive
Northcote
Auckland 0627
Country 64508 0
New Zealand
Phone 64508 0
+6499219999 ex7809
Fax 64508 0
+6499219620
Email 64508 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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
SourceTitleYear of PublicationDOI
EmbasePrimary prevention of stroke and cardiovascular disease in the community (PREVENTS): Methodology of a health wellness coaching intervention to reduce stroke and cardiovascular disease risk, a randomized clinical trial.2018https://dx.doi.org/10.1177/1747493017730759
N.B. These documents automatically identified may not have been verified by the study sponsor.