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SPRING: Self monitoring and Prevention of RIsk factors by Nurse practitioners in the region of Groningen. A randomised controlled trial about prevention of cardiovascular disease in general practice.


- candidate number7683
- NTR NumberNTR2188
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR25-jan-2010
- Secondary IDs2007/232 (formerly 2005/053) METC Groningen
- Public TitleSPRING: Self monitoring and Prevention of RIsk factors by Nurse practitioners in the region of Groningen. A randomised controlled trial about prevention of cardiovascular disease in general practice.
- Scientific TitleSPRING: Self monitoring and Prevention of RIsk factors by Nurse practitioners in the region of Groningen. A randomised controlled trial about prevention of cardiovascular disease in general practice.
- ACRONYMSPRING
- hypothesisWe expect that the effect on the cardiovascular risk profile will be higher in people receiving intensive feedback based on home monitoring compared to people receiving usual care.
- Healt Condition(s) or Problem(s) studiedCardiovascular prevention, General practice, Nurse practitioners
- Inclusion criteria1. Men aged 50-75y and women aged 55-75y;
2. BMI >/= 25 kg/m2 or smoking or physical inactivity;
3. SCORE 10-year risk of fatal cardiovascular disease >/= 5%.
- Exclusion criteria1. History of cardiovascular disease;
2. Diabetes;
3. Thyroid dysfunction;
4. Severe or terminal illness/severely diminished life expectancy.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jun-2008
- planned closingdate1-aug-2010
- Target number of participants200
- InterventionsAll participants had a moderately elevated cardiovascular risk profile (SCORE >/= 5%) and received 1 year of life style counseling and medication according to Dutch General Practitioner's Guidelines (which are based on the European guideline that was published in 2003), by specially trained nurse practitioners. One group received usual care based on these guidelines, the other group received the same care with additional intensive feedback based on home monitoring from home blood pressure measurement, pedometers etc.
- Primary outcomeSCORE 10-year risk of fatal cardiovascular disease.
- Secondary outcome1. Determinants of SCORE: smoking, blood pressure (which will be measured twice during the examination), fasting serum lipids;
2. Other cardiovascular risk factors: weight and BMI, waist circumference, fasting serum glucose en serum creatinine, physical activity (SQUASH questionnaire), food intake (FFQ, food frequency questionnaire), standardised questionnaire about motivation to change lifestyle;
3. Health related quality of life (RAND 36 questionnaire);
4. Medication use.
- TimepointsBaseline and one year follow up: interview (including general characteristics), physical examination, blood tests and standardised questionnaires (as mentioned above).
- Trial web siteN/A
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIES A.H. Tiessen
- CONTACT for SCIENTIFIC QUERIES A.H. Tiessen
- Sponsor/Initiator University Medical Center Groningen (UMCG), Stichting Hypertensiedienst Groningen
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development, Van Gaverefonds
- PublicationsN/A
- Brief summaryCardiovascular diseases are one of the leading causes of death. The aim of the SPRING study is to investigate the effects of lifestyle counselling and medication on patients with a moderately elevated cardiovascular risk (SCORE >/= 5%). The treatment is based on Dutch General Practitioner's Guidelines (which are based on the European guideline that was published in 2003) and is carried out by specially trained nurse practitioners working in general practice. From 20 practices, middle aged men and women, with no history of cardiovascular disease, diabetes or thyroid dysfunction, were invited to establish their risk. People were included if they had a moderately elevated cardiovascular risk (SCORE >/= 5%) and at least one of the following risk factors: smoking, overweight or physical inactivity. Screening started during spring 2008 and finished during spring 2009, from 218 participants informed consent was obtained. The participants were randomly divided into 2 groups and for each participant an individual advice was composed based on the risk profile that was obtained during screening. One group received usual care based on the guidelines, the other group received the same care with additional intensive feedback based on home monitoring from home blood pressure measurement, pedometers etc. After one year follow-up, the effect on the SCORE risk profile and the separate risk factors will be investigated.
- Main changes (audit trail)
- RECORD25-jan-2010 - 11-feb-2010


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