Status:
UNKNOWN
MySlainte: Testing the Effect of Involving Partners in a CVD Prevention Community Lifestyle Program
Lead Sponsor:
National University of Ireland, Galway, Ireland
Conditions:
Rheumatoid Arthritis
Chronic Kidney Diseases
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 u...
Detailed Description
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 d...
Eligibility Criteria
Inclusion
- 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
- 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
- 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
Key Trial Info
Start Date :
March 10 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2021
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT04300465
Start Date
March 10 2020
End Date
December 30 2021
Last Update
September 9 2020
Active Locations (1)
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1
Croí
Galway, Ireland