Evaluating the Effects of the MySláinte Community Lifestyle Intervention Program in Addressing Common Drivers of Disease in a Cohort of Chronic Disease Patients and Their Partners: a Pilot Study
试验速览
- 阶段
- 不适用
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Improvement in Blood pressure control
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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/1.73m
- •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
排除标准
- •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
研究组 & 干预措施
Rheumatoid arthritis - With Partner Group
In this group patients with stable rheumatoid arthritis and their partners both undergo an initial assessment, the 10 week intervention phase and then an end of program assessment together. The intervention phase includes weekly exercise classes, individualised exercise prescription, health promotion workshops, individualised goal setting and optimisation of cardioprotective medications.
干预措施: 10 week MySlainte Program (Behavioral)
Rheumatoid arthritis - Without Partner Group
In this group patients with stable rheumatoid arthritis undergo an initial assessment, the 10 week intervention phase and then the end of program assessment. Their partners attend the initial assessment and the end of program assessment but do not partake in the 10 week intervention phase. During the 10 week period these partners receive usual care from their GP's.
For the patients with rheumatoid arthritis, the 10 week intervention phase includes weekly exercise classes, individualised exercise prescription, health promotion workshops, individualised goal setting and optimisation of cardioprotective medications.
干预措施: 10 week MySlainte Program (Behavioral)
Chronic Kidney Disease - With Partner Group
In this group patients with stable stage 3 or 4 chronic kidney disease and their partners both undergo an initial assessment, the 10 week intervention phase and then an end of program assessment together. The intervention phase includes weekly exercise classes, individualised exercise prescription, health promotion workshops, individualised goal setting and optimisation of cardioprotective medications.
干预措施: 10 week MySlainte Program (Behavioral)
Chronic Kidney Disease - Without Partner Group
In this group patients with stable stage 3 or 4 chronic kidney disease undergo an initial assessment, the 10 week intervention phase and then the end of program assessment. Their partners attend the initial assessment and the end of program assessment but do not partake in the 10 week intervention phase. During the 10 week period these partners receive usual care from their GP's.
For the patients with chronic kidney disease, the 10 week intervention phase includes weekly exercise classes, individualised exercise prescription, health promotion workshops, individualised goal setting and optimisation of cardioprotective medications.
干预措施: 10 week MySlainte Program (Behavioral)
结局指标
主要结局
Improvement in Blood pressure control
时间窗: 12 weeks
Blood pressure (systolic) as measured in mmHg
Change in 10 year Cardiovascular Risk score in percent
时间窗: 12 weeks
Expressed as a percentage change. Calculated using the following link http://www.HeartScore.org As all patients will be assessed in Ireland the low risk cardiovascular chart will be used.
次要结局
- Improvement in diet(12 weeks)
- Change in alcohol consumption(12 weeks)
- Improvement smoking cessation rate(12 weeks)
- Nicotine Dependence(12 weeks)
- Improvement in glycaemic control(12 weeks)
- Change in participant reported anxiety(12 weeks)
- To assess the adherence of a group of chronic disease patients to a 12-week lifestyle intervention program(12 weeks)
- Improvement in lipid control(12 weeks)
- Change in disease activity score 28-C Reactive Protein (DAS28-CRP) in patients with Rheumatoid Arthritis(12 weeks)
- Change in waist circumference(12 weeks)
- Change in body mass index(12 weeks)
- Change Health assessment questionnaire disability index (HAQ-DI) score(12 weeks)
- Change in participant reported depression(12 weeks)
- Improvement in physical activity levels(12 weeks)
- Change in health related quality of life(12 weeks)
- To assess if partners who do not partake in the 10-week intervention phase of the program experience a change in their risk factor profile over the 10-week period by virtue of their partner being involved in the program ("ripple effect")(12 weeks)
- To assess the adherence of the partners to a 12-week lifestyle intervention program(12 weeks)
- Change in urine albumin creatinine ratio (ACR) in patients with chronic kidney disease(12 weeks)
研究者
Prof. John William McEvoy
Professor
National University of Ireland, Galway, Ireland