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Landmark Study III - A randomised controlled trial comparing the impact of aggressive risk factor and lifestyle modification utilising nurse led co-ordinated care with standard care to limit the progression of cardiovascular disease in patients with chronic kidney disease.

Landmark Study III - A randomised controlled trial comparing the impact of aggressive risk factor and lifestyle modification utilising nurse led co-ordinated care with standard care to limit the progression of cardiovascular disease in patients with chronic kidney disease.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12608000337370
Acronym
Landmark III
Enrollment
200
Registered
2008-07-17
Start date
2008-03-18
Completion date
Unknown
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Chronic kidney disease (CKD) is associated with a twenty-fold increase in the death from heart and blood vessel disease (cardiovascular disease -CVD). Patients with CKD have multiple risk factors for CVD and include high cholesterol, hypertension, anaemia, abnormalities of blood chemistry, diabetes, obesity and sedentary lifestyle. Intervention may decrease the progression of CVD and treatment guidelines have been developed. However, patients with CKD have complex health issues and audit data suggests that within the current model of care, many do not reach treatment targets. Co-ordinated care clinics utilizing a nurse led, case management approach and a multidisciplinary team have been demonstrated to optimize CKD care and decrease progression of kidney dysfunction. However, the impact on progression of CVD has not been studied. The hypothesis of this proposal is therefore: Nurse led co-ordinated care approach to cardiovascular risk factor and lifestyle modification will reduce the progression of CVD when compared with standard care, in patients with CKD. Additional hypotheses are: The nurse led clinic improves service quality and patient satisfaction AND This model of care will be cost effective.

Interventions

Aggressive cardivascular risk factor and lifestyle modification utilising nurse led co-ordinated care. The trial clinic will be additional to the patients' usual medical care. The trial clinic will use a co-ordinated care approach to achieving cardiovascular risk factor modification and include a significant lifestyle and diet modification component customized to the patients' health care needs. There will be focus on patient self-management and motivation for sustainable behavior change. Patie

Aggressive cardivascular risk factor and lifestyle modification utilising nurse led co-ordinated care. The trial clinic will be additional to the patients' usual medical care. The trial clinic will use a co-ordinated care approach to achieving cardiovascular risk factor modification and include a significant lifestyle and diet modification component customized to the patients' health care needs. There will be focus on patient self-management and motivation for sustainable behavior change. Patients will be followed for up to 3 years. For patients in the Nurse coordinated care arm, they will be seen for an initial assessment (approximately 1 hour) about 2 weeks after enrollment. Then out to monthly or further apart follow up (half hour session) depending on their needs and stage of chronic kidney disease (CKD). These visits with the nurses alternate with visits to Nephrology outpatients department (shared care). This for the duration of the trial which is 3 years.

Sponsors

CCRE - Centres of Clinical Research Excellence
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

Patients with stage 3 or 4 chronic kidney disease (eGFR - estimated Glomerular Filtration Rate <60ml/min and >25 ml/min); Must have one of the following risk factors – Blood pressure not at target; Overweight (BMI - Body Mass Index >25) ; Poor diabetic control; or Lipids not at target

Exclusion criteria

Patients from areas in Queensland where follow-up vascular studies can not be carried out for logistic reasons; Unable or unwilling to give informed consent; estimated Glomerular Filtration Rate (eGFR) < 25ml/min; Pregnant; Life expectancy less than 6 months; Current involvement in other research study; Organ transplant

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026