None listed
Conditions
Brief summary
Health and Wellness Coaching (HWC) for primary stroke and CVD prevention: a randomised control trial. Aim: to determine the effectiveness of HWC for primary stroke prevention in Maori, Pasifika, Asians and NZ Europeans. Strokes are the main cause of disease burden in older adults, yet evidence suggests more than 80% of strokes are preventable, with adequate control of modifiable risk factors. This proposal to 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. HWC is an innovative, structured, patient-focused multi-dimensional psychological intervention designed to motivate participants to adhere to recommended medication and lifestyle changes. This randomised control trial is being conducted in NZ to address the question: is HWC effective for primary stroke and cardiovascular disease (CVD) prevention in Maori, Pasifika, Asians and NZ Europeans? The primary outcome is a substantial relative risk reduction of CVD The projects aligns well with the Ageing Well NSC mission to “Enable all New Zealanders to realise the potential of the longevity dividend” by testing a means to attenuate the impact of potentially modifiable risk factors for two of the most common and devastating causes of disease burden in the older populations of NZ; stroke and cardiovascular disease. Preventing the occurrence of these conditions will allow individuals and their families to live longer, healthier and more productive lives. If shown to be effective, Health Wellness Coaching will in turn enhance and maintain wellness, independence & autonomy. Research Question: Is HWC effective for primary stroke and CVD prevention in Maori, Pasifika, Asians and NZ Europeans? The primary outcome is a substantial relative risk reduction (RRR) of CVD in the next 5 years at 9 months post-randomisation. This is defined as a 10% RRR amongst those at moderate 5-year CVD risk (10-15%) and a 25% RRR amongst those at high risk (>15%). Additional outcomes will be to evaluate the effectiveness of HWC on (a) self-reported adherence (self-reported use of anti-platelet, statin and BP lowering therapy as prescribed), (b) self-reported changes in adherence to medication and changes in “readiness to change”, (c) cardiovascular events (new stroke or coronary heart disease, both fatal or non-fatal), (d) lifestyle changes (e.g., change in physical activity, smoking status, diet pattern etc), using the Life’s simple 7 Health Behaviour scoring system (e) health related quality of life, (f) change in participants’ expectations of treatment benefits; (g) participant satisfaction, and (h) healthcare resource consumption and cost-effectiveness at 6, 9 and 12 months follow-up. Intervention: The HWC group will have 15 sessions with HWC coaches, of which 12 will be carried out within the first 3 months of the intervention and the remaining three sessions will be done three months
Interventions
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
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.
Sponsors
Otago University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
35 Years to No maximum
Healthy volunteers
No
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.
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.
Outcome results
None listed