This trial is enrolling now. Depending on eligibility and available places in your area, you may be able to enrol in this trial.
About this trial
This is a cohortIn epidemiology, a group of individuals with some characteristics in common. A cohort study is a special kind of clinical trial which looks at a treatment or treatment strategy in a cohort of people. study which follows two groups of participants over a 12 month period. One group will access a team approach to care with the aim of reducing their cardiovascular disease (CVD) risks from a team of doctors, nurses and health care professionals. The other group will continue to access standard care from their treating doctor. Both groups will have CVD risk score evaluated after a 12 month period.
The team care approach will involve specific tests to measure CVD risk as well as smoking cessation, exercise and dietary advice and support, including monitoring such as blood pressure and cholesterolAn essential component of cell membranes and nerve fibre insulation, cholesterol is important for the metabolism and transport of fatty acids and the production of hormones and Vitamin D. Cholesterol is manufactured by the liver, and is also present in certain foods. High blood cholesterol levels have been linked to heart disease and may be a side effect of some anti-HIV medications. levels
Patients randomisedA method based on chance by which study participants are assigned to a treatment group. Randomization minimizes the differences among groups by equally distributing people with particular characteristics among all the trial arms. The researchers do not know which treatment is better. From what is known at the time, any one of the treatments chosen could be of benefit to the participant to the intervention group will follow an intensive 52 week period using a clinicalPertaining to or founded on observation and treatment of participants, as distinguished from theoretical or basic science. protocolA study plan on which all clinical trials are based. The plan is carefully designed to safeguard the health of the participants as well as answer specific research questions. A protocol describes what types of people may participate in the trial; the schedule of tests, procedures, medications, and dosages; and the length of the study. While in a clinical trial, participants following a protocol are seen regularly by the research staff to monitor their health and to determine the safety and effectiveness of their treatment aimed to manage CVD risk in HIV individuals with the use of regular visits to a nurse led CVD risk management clinic, within a multi disciplinary approach to care with the involvement of treating physicians, nurses, dieticians, smoking cessation advisors and an exercise physiologist or personal trainer with the aim to reach their individualised CVD risk target.
GPs managing matched control patients allocated usual care will be unaware of the details of the intervention armAny of the treatment groups in a randomised trial. Most randomised trials have two "arms," but some have three "arms," or even more. and asked to apply their usual pattern of patient visits and treatment strategies to achieve optimal reduction of CVD risk.
|Official title:||Effectiveness of Team Intervention Over 12 Months in Reducing Modifiable CVD Risk Factors on Framingham 10yr Risk Scores Outcomes in HIV-1 Subjects on Antiretroviral Therapy|
|What is this trial studying?||Other|
|Start date:||October 2011|
This may be the proposed or expected start date for trials which have not yet started.
|How many participants will this trial enrol?||80 |
The exact number of participants may be lower or slightly higher than this. Some trials also have specific quotas for participants from each state, city or clinic.
|How long is this trial planned to go for?||Participants in this trial will be asked to follow the trial protocol for 1 years.|
|Links to further information:|
Who can enrol in this trial?
You may be eligible to participate in this trial if you meet the following criteria:
- At least 50 years old
- Currently taking HIV treatments
- Viral load below 50 copies/ml
This is a summary of key inclusion and exclusion criteria for this trial. There may be other criteria which may exclude some people from participation in this trial. Some laboratory tests may also be required. Consult your doctor, or view the trial protocol or informed consent documentation to see the full range of exclusion and inclusion criteria.
The primary outcome measure is the percentage of patients with a reduction of Framingham risk score of at least 10% at 12 months.