search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


Lifestyle intervention with or without risk-factor passport to reduce cardiovascular disease risk factors at the HIV outpatient clinic.


- candidate number18015
- NTR NumberNTR4622
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR2-jun-2014
- Secondary IDsNL4711001814 METC
- Public TitleLifestyle intervention with or without risk-factor passport to reduce cardiovascular disease risk factors at the HIV outpatient clinic.
- Scientific TitleLifestyle intervention with or without risk-factor passport to reduce cardiovascular disease risk factors at the HIV outpatient clinic.
- ACRONYM-
- hypothesisTo investigate if providing visual feedback about an individuals’ personal CVD risk (risk factor passport) and the target risk that can be reached if lifestyle factors are optimally treated has additional value in reducing CVD risk, among patients who participate in a lifestyle intervention protocol at the HIV outpatient clinic of the AMC.
- Healt Condition(s) or Problem(s) studiedHIV infection, HIV-positive patients, Cardiovascular disease risk, Life style
- Inclusion criteria-Adult (>18 yrs)
-Patients who are current smokers or patients who have overweight (BMI > 25 kg/m2)
-Participating in the lifestyle intervention protocol at the HIV outpatient clinic.
-Willing to sign written informed consent.
- Exclusion criteria-None
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupFactorial
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jul-2014
- planned closingdate30-dec-2015
- Target number of participants250
- InterventionsBoth the intervention group with the risk factor passport and the control group without risk factor passport will receive routine care according to the lifestyle intervention protocol at months 0, 3, 6, 9 and 12. In both groups, lipid levels and blood pressure will be measured at each follow-up visit.

In addition to routine care, patients assigned to the intervention group will receive the risk factor passport. At baseline (month 0) the HIV counseling nurse will explain the presence of modifiable and un-modifiable CVD risk factors. Second, the patient will receive a risk-factor passport that will serve as a risk communication tool. The risk-factor passport shows a graphical presentation of the patient’s calculated 5-year CVD risk. It will also show the target risk that could be reached if all the patient’s modifiable risk factors are optimally treated. The nurse will calculate the patients CVD risk using the online DAD risk calculator, specifically designed for HIV infected patients (7, 8). The patients’ CVD risk will also be calculated at follow-up visits at month 3, 6, 9 and 12 and the risk factor passport will be updated accordingly.
- Primary outcomeThe difference between the intervention and the control group in the 5-year absolute CVD-risk score at month 12.
- Secondary outcome-Number of cigarettes smoked per day.
-Percentage of patients who stopped smoking.
-Percentage of patients willing to be referred to a dietician.
-Reduction in body weight (BMI).
-Lipid levels
-Blood pressure
-Plasma HIV RNA concentration
-Percentage of patients with missing follow-up visits
-Number of contacts with HIV counselling nurses
-Duration of contacts with HIV counselling nurses.
- TimepointsMonths 0, 3, 6, 9 and 12.
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES P.T. Nieuwkerk
- CONTACT for SCIENTIFIC QUERIES M. Valk, van der
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
None
- Publications
- Brief summaryHIV infected individuals have a greater risk of cardiovascular disease (CVD) than HIV-negative individuals of the same age and gender. Non-pharmacological lifestyle interventions to reduce CDV are deemed first choice in HIV infected patients to prevent polypharmacy and its potential complications. Research has shown that CVD risk factors are highly prevalent among HIV infected persons >45 years attending the HIV outpatient clinic of the AMC. HIV infected persons from the AMC will be approached to participate in a lifestyle intervention protocol, targeting smoking cessation and weight reduction, to reduce CVD risk as part of routine clinical care. Achieving and sustaining behaviour change is a major and perpetual challenge in medicine, however. Providing individuals with personalised health-related risk information with visual feedback about disease risks may be a method of increasing motivation for behaviour change.
With the present study we aim to investigate if providing visual feedback about an individuals’ personal CVD risk and to show the target risk that can be reached if lifestyle factors are optimally treated (“risk factor passport”) has additional value in reducing CVD risk, among patients who participate in a lifestyle intervention protocol at the HIV outpatient clinic of the AMC.
Both patients randomly assigned to the intervention group with the risk factor passport and the control group without risk factor passport will receive routine care according to the lifestyle intervention protocol at months 0, 3, 6, 9 and 12. In both groups, lipid levels and blood pressure will be measured at each follow-up visit. The 5-year CVD risk score at month 12 is the primary outcome measure.
- Main changes (audit trail)
- RECORD2-jun-2014 - 1-jul-2014


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl