MySlainte: Testing the Effect of Involving Partners in a CVD Prevention Community Lifestyle Program

NCT04300465 | Unknown

• 1 other identifier: C.A.2322
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Rheumatoid Arthritis; Chronic Kidney Diseases; Cardiovascular Risk Factor; Partner, Domestic

Keywords

Rheumatoid Arthritis; Chronic Kidney Disease; Cardiovascular Risk Factors; Lifestyle Intervention; Chronic Disease

Outcome Measures

Primary Outcomes (2)

• Improvement in Blood pressure control

  Blood pressure (systolic) as measured in mmHg

  12 weeks

• Change in 10 year Cardiovascular Risk score in percent

  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.

  12 weeks

Secondary Outcomes (18)

• Improvement smoking cessation rate

  12 weeks

• Nicotine Dependence

  12 weeks

• Improvement in lipid control

  12 weeks

• Improvement in glycaemic control

  12 weeks

• Change in body mass index

  12 weeks

Study Arms (4)

Rheumatoid arthritis - With Partner Group

EXPERIMENTAL

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.

Behavioral: 10 week MySlainte Program

Rheumatoid arthritis - Without Partner Group

ACTIVE COMPARATOR

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.

Behavioral: 10 week MySlainte Program

Chronic Kidney Disease - With Partner Group

EXPERIMENTAL

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.

Behavioral: 10 week MySlainte Program

Chronic Kidney Disease - Without Partner Group

ACTIVE COMPARATOR

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.

Behavioral: 10 week MySlainte Program

Interventions

10 week MySlainte Program BEHAVIORAL

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; Chronic Kidney Disease - Without Partner Group; Rheumatoid arthritis - With Partner Group; Rheumatoid arthritis - Without Partner Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 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
• mmol/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)

You may not qualify if:

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

Sponsors & Collaborators

• National University of Ireland, Galway, Ireland: lead

Study Sites (1)

Croí

Galway, Ireland

RECRUITING

Related Publications (1)

• 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.

  PMID: 23884981 BACKGROUND

Related Links

• Used to calculate a participants estimated cardiovascular risk

MeSH Terms

Conditions

Arthritis, Rheumatoid; Renal Insufficiency, Chronic; Chronic Disease

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• John W McEvoy

  National University of Ireland, Galway

  PRINCIPAL INVESTIGATOR

Central Study Contacts

John W McEvoy

CONTACT

+35391544310; johnwilliam.mcevoy@nuigalway.ie

Ella Murphy

CONTACT

+35391544310; ella.murphy@nuigalway.ie

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Randomised parallel design. 2 study groups and within each group there are 2 arms. 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)

Study Record Dates

• First Submitted: March 2, 2020
• First Posted: March 9, 2020
• Study Start: March 10, 2020
• Primary Completion: December 30, 2021
• Study Completion: December 30, 2021
• Last Updated: September 9, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1)