MySlainte: Testing the Effect of Involving Partners in a CVD Prevention Community Lifestyle Program
MySlainte: Testing the Effect of Involving Partners in a CVD Prevention Community Lifestyle Program
MySláinte is a 12-week community-based, multi-disciplinary preventive and lifestyle
 intervention program to reduce CVD risk factors. It includes weekly exercise classes with
 educational workshops on understanding lifestyle risk factors as well as optimisation of
 cardiovascular medications. It will be delivered by a multidisciplinary team including: a
 nurse, dietician, physiotherapist and physician and builds on the previously developed
 protocols of the successful MyAction program. The MySlainte study aims to expand on the
 MyAction program by looking at a broader range of patients with chronic disease who have
 suboptimal lifestyle drivers for many preventable diseases. Importantly, MySlainte also aims
 to assess if there is a difference in outcome between those who complete the program with
 their partner compared to those who complete the program alone.
The prevalence of chronic diseases in Ireland is increasing and places significant burden
 both on the individual and family unit, but also on an already overstretched healthcare
 system. Many chronic diseases are preventable and frequently share common risk factor and
 unhealthy lifestyle profiles; which offers a unique opportunity to intervene, address and
 modify these common disease drivers, and potentially prevent disease complications.

 The MyAction program and previous similar programs have successfully been run by Croí/NIPC
 (based in Galway, www.nipc.ie) in an effort to combat common cardiovascular risk factors.
 These programs have demonstrated that addressing and modifying risk factors is both effective
 and sustainable. Expanding programs like these to a broader group of chronic disease patients
 with overlapping modifiable risks could lead to multi-factorial benefits: prevention is
 better than cure. While cardiac and pulmonary rehab are well established programs, patients
 with other chronic diseases do not currently have access to such focused interventions in
 Galway. Chronic kidney disease and rheumatoid arthritis are two such chronic diseases that
 have a particularly high cardiovascular risk burden, and so may benefit from a focused
 intervention program.

 Chronic kidney disease is a worldwide public health problem with an estimated prevalence of
 11.8% in Ireland. With chronic kidney disease comes a myriad of other co-morbidities and
 increased rate of all-cause mortality. Significantly, cardiovascular disease is the primary
 contributor to increased morbidity and mortality in this patient cohort. In fact, in patients
 with Stage 3 CKD, the incidence of cardiovascular mortality is higher than the incidence of
 kidney failure. This makes prevention of drivers of cardiovascular disease a key component in
 managing these patients.

 Lifestyle and exercise programs may have an even broader range of benefit in this patient
 group. Through inflammation, uremic toxins, and dysregulation of key proteins and hormones a
 second major consequence of CKD is sarcopenia and skeletal muscle dysfunction. This is
 compounded by the fact that physical activity in all stages of CKD are low, which leads to
 decreased quality of life, increased falls risk and associated morbidity. Previous programs
 have demonstrated the benefits of exercise in this group. The MySláinte program aims to build
 on this by tackling a broader range of modifiable risk factors.

 Similarly, patients with rheumatoid arthritis have an increased risk of cardiovascular
 disease due to a complex interplay between systemic inflammation and a higher prevalence of
 traditional CVD risk factors. Despite recommendations by European League against Rheumatism
 (EULAR) of the importance of emphasising positive lifestyle choices, a recently published
 article by Malm concluded that discussions regarding lifestyle improvements (including
 exercise, smoking, drinking and diet) are suboptimal in these patients. Exercise programs
 have also been shown to be of benefit in these patient groups in decreasing falls rates, as
 well as improving health related quality of life measures.

 It has previously been described that a concordance of behavioural risk factors exists
 between patients with coronary artery disease and their spouses. Similarly, spouses of
 patients with hypertension have increased odds of hypertension themselves. The same is seen
 in patients with type 2 diabetes, with spouses of patients with type 2 diabetes having a
 higher risk of developing type 2 diabetes. In keeping with that, it has been demonstrated
 that including both patients and their partners in lifestyle intervention programs improves
 not only the patients risk factor profile, but also that of the partners. It has also been
 suggested that couples who complete programs together may in fact do better than those who
 enter as individuals. Interestingly, even when lifestyle interventions are aimed only at a
 patient, spouses have shown to benefit indirectly from such programs in a knock on effect
 termed the "ripple effect". These concepts highlight the importance of considering a
 patient's support network when undergoing a lifestyle intervention. They also highlight a
 potentially unique opportunity to improve the lifestyles, and hence risk factor profiles, of
 entire households. Previously, the MyAction program had invited participants to bring their
 partners to the program. Unfortunately, due to funding issues, this part of the program was
 gradually phased out. However, the impact of removing partners form the program was never
 evaluated. The investigators of this study aim to evaluate this.

 Therefore, for the MYSLAINTE study, the investigators aim to include patients with stable
 rheumatoid arthritis and stable 3 or 4 CKD with 2 or more defined uncontrolled cardiovascular
 risk factors. In order to enter the study, each patient must also have a partner who is
 willing to take part. Each partner/patient pair will be randomised in a 1:1 ratio into one of
 two groups: with partner or without partner.

 -  With partner: the patient and their partner will undergo an initial assessment (week 1),
 a 10 week intervention program (weeks 2-11) and then an end of program assessment (week
 12)

 -  Without partner: Both the patient and their partner will undergo an initial assessment
 (week 1) and end of program assessment (week 12) However, only the patient will undergo
 the 10 week intervention program. The patients partner will receive usual care from
 their GP.

 The intervention phase is part of the MySláinte program and involves, a weekly 1 hour group
 supervised exercise session, a weekly 1 hour group health promotion workshop, weekly
 individualised goal setting, weekly individualised exercise prescription and optimisation of
 cardioprotective medications. This is all run over a 10 week period and delivered in a
 community setting by a multidisciplinary team including: a physiotherapist, a dietitian, a
 nurse specialist and physician.

 The primary aim of the study is to assess if the 10 week intervention can improve modifiable
 cardiovascular risk factors in these patients and their partners. A secondary aim of the
 study is to assess the impact of simultaneously including a partner in this lifestyle
 intervention program.
Inclusion Criteria:

 Patients with either stable rheumatoid arthritis OR stable stage 3 or 4 chronic kidney
 disease with at least 2 uncontrolled cardiovascular risk factors AND a partner who is also
 willing to take part in the study.

 -  Stable rheumatoid arthritis (RA). Rheumatoid arthritis as diagnosed by a
 rheumatologist. Stable meaning that there was no escalation of disease modifying
 antirheumatic drugs OR escalation in steroid dose/frequency within the previous 6
 months. Patients on a stable dose of chronic steroids are eligible for inclusion.

 -  Stable chronic kidney disease (CKD). CKD can be of any cause. Stable meaning that
 there was no significant change in renal function over a period of 3 months Stage of
 CKD is based on the 2012 KDIGO guidelines:19

 -  Stage 3 CKD: GFR 30-59ml/min/1.73m2

 -  Stage 4 CKD: GFR of 15-29ml/min/1.73m2.

 GFR will be calculated based on CKD-EPI equation.

 -  At least 2 of the 5 following uncontrolled cardiovascular risk factors:

 -  Hypertension (BP ≥130/80mmHg)

 -  Active smokers

 -  BMI ≥30kg/m2

 -  Dyslipidemia (LDL ≥1.4mmol/L in very high risk, ≥1.8mmol/L with high risk, LDL

 -  2.6mmol/L with moderate risk or ≥3.0mmol/L in low risk)

 -  Poor glycemic control (Defined as: HbA1c ≥53mmol/mol OR ≥48mmol/mol in patients with a
 long-life expectancy or type 2 diabetes controlled by diet alone)

 All patients with RA/CKD must have a partner to be included in the study. Partners do not
 need to have any particular underlying diagnosis and can in theory be completely healthy.
 The partners must not meet any of the exclusion criteria.

 Both the patient and the partner must freely sign informed consent.

 Exclusion Criteria:

 -  Known unstable angina, symptomatic severe aortic stenosis, pregnant patients, severe
 cognitive impairment, physical impairment leading to inability to exercise, currently
 enrolled in another lifestyle program, currently awaiting organ transplant, previous
 renal transplant, patients with End Stage Renal Disease (Stage 5 CKD) or those
 expected to commence dialysis within the next 6 months, acute pulmonary embolus or
 pulmonary infarction