MySlainte: Testing the Effect of Involving Partners in a CVD Prevention Community Lifestyle Program
NCT ID: NCT04300465
Last Updated: 2020-09-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
64 participants
INTERVENTIONAL
2020-03-10
2021-12-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
The Effects of Cardiac Rehabilitation on Cardiovascular Disease Risk in Rheumatoid Arthritis Patients
NCT01534871
Program Evaluation of People With Arthritis Can Exercise
NCT00153309
Creating Health Course Study for People With Rheumatological Conditions
NCT07180537
Cardiovascular Risk Assessment for Patients With Rheumatoid Arthritis Arthritis:
NCT04488497
Personalized Risk Estimator for Rheumatoid Arthritis Family Study
NCT02046005
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
Patients with stable rheumatoid arthritis (RA) and their partners
* 16 RA patients + 16 partners
* each pairing is randomised into 1 of 2 groups
1. With partner: The RA patients + their partners partake in the the intervention (8 RA patients and 8 partners)
2. Without partner: the RA patients partake in the intervention alone (8 patients) The partner does not partake in the intervention (8 partners).
Patients with stable stage 3 or 4 chronic kidney disease (CKD) and their partners
* 16 CKD patients + 16 partners
* each pairing is randomised into 1 of 2 groups
1. With partner: The CKD patients and their partners partake in the the intervention (8 CKD patients and 8 partners)
2. Without partner: the CKD patients partake in the intervention alone (8 patients). The partner does not partake in the intervention (8 partners)
OTHER
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
10 week MySlainte Program
The intervention consists of a 10 week community based lifestyle intervention program. It consists of a weekly 1 hour exercise class, a weekly 1 hour health promotion workshop as well as individualised goal setting, exercise prescription and optimisation of cardioprotective medications.
This program is delivered by a multi-disciplinary team; including a physiotherapist, occupational therapist, dietitian, clinical nurse specialist and physician. It will be delivered through a registered Irish charity, Croí.
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.
10 week MySlainte Program
The intervention consists of a 10 week community based lifestyle intervention program. It consists of a weekly 1 hour exercise class, a weekly 1 hour health promotion workshop as well as individualised goal setting, exercise prescription and optimisation of cardioprotective medications.
This program is delivered by a multi-disciplinary team; including a physiotherapist, occupational therapist, dietitian, clinical nurse specialist and physician. It will be delivered through a registered Irish charity, Croí.
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.
10 week MySlainte Program
The intervention consists of a 10 week community based lifestyle intervention program. It consists of a weekly 1 hour exercise class, a weekly 1 hour health promotion workshop as well as individualised goal setting, exercise prescription and optimisation of cardioprotective medications.
This program is delivered by a multi-disciplinary team; including a physiotherapist, occupational therapist, dietitian, clinical nurse specialist and physician. It will be delivered through a registered Irish charity, Croí.
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.
10 week MySlainte Program
The intervention consists of a 10 week community based lifestyle intervention program. It consists of a weekly 1 hour exercise class, a weekly 1 hour health promotion workshop as well as individualised goal setting, exercise prescription and optimisation of cardioprotective medications.
This program is delivered by a multi-disciplinary team; including a physiotherapist, occupational therapist, dietitian, clinical nurse specialist and physician. It will be delivered through a registered Irish charity, Croí.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
10 week MySlainte Program
The intervention consists of a 10 week community based lifestyle intervention program. It consists of a weekly 1 hour exercise class, a weekly 1 hour health promotion workshop as well as individualised goal setting, exercise prescription and optimisation of cardioprotective medications.
This program is delivered by a multi-disciplinary team; including a physiotherapist, occupational therapist, dietitian, clinical nurse specialist and physician. It will be delivered through a registered Irish charity, Croí.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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)
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
18 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National University of Ireland, Galway, Ireland
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Prof. John William McEvoy
Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
John W McEvoy
Role: PRINCIPAL_INVESTIGATOR
National University of Ireland, Galway
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Croí
Galway, , Ireland
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
John W McEvoy
Role: primary
References
Explore related publications, articles, or registry entries linked to this study.
Gibson I, Flaherty G, Cormican S, Jones J, Kerins C, Walsh AM, Costello C, Windle J, Connolly S, Crowley J. Translating guidelines to practice: findings from a multidisciplinary preventive cardiology programme in the west of Ireland. Eur J Prev Cardiol. 2014 Mar;21(3):366-76. doi: 10.1177/2047487313498831. Epub 2013 Jul 24.
Related Links
Access external resources that provide additional context or updates about the study.
Used to calculate a participants estimated cardiovascular risk
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
C.A.2322
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.