|- candidate number||4587|
|- NTR Number||NTR1556|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||24-nov-2008|
|- Secondary IDs||WC-2008-015 (EMGO) 2007-13-004 (Diabetes Fonds)|
|- Public Title||Risk communication for patients with type 2 diabetes.|
|- Scientific Title||The effects of communication of the absolute 10-year risk to develop cardiovascular disease on risk perception in patients with type 2 diabetes.|
|- ACRONYM||@RISK Study|
|- hypothesis||The goal of diabetes care is to provide adequate care in order to decrease the risk to develop severe complications by means of medication and lifestyle advices. |
However, when a patient does not have information on risks accompanying diabetes, then he/she is not motivated to take medication and change lifestyle.
We expect that by providing information on risks, we can improve the risk perception of the patients which might improve the attitude and intention towards lifestyle changes.
|- Healt Condition(s) or Problem(s) studied||Diabetes Mellitus Type 2 (DM type II), Communication, Cardiovascular risk factors|
|- Inclusion criteria||1. Maximum age 75 years|
2. Informed consent
3. Able to communicate in Dutch
|- Exclusion criteria||1. Severe disease|
2. Mobility problems
3. History of stroke or heart attack
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-jan-2009|
|- planned closingdate||31-mrt-2010|
|- Target number of participants||240|
|- Interventions||The control group will receive standard managed care in the Diabetes Care System West-Friesland, which consists of a yearly visit to a diabetes nurse (30 minutes) and a dietician (30 minutes). |
The intervention group will reveive standard managed care and an intervention on risk communication by a diabetes nurse and dietician. This intervention will consist of 6 steps:
1) introduction of risks
2) communication of the absolute risk according to the UKPDS risk engine
3) visual communication by means of a risk card
4) positive framing: explanation that lifestyle changes can help to reduce the risk
5) communication with the patient for a reaction
6) think aloud: patient has to explain the risk him/herself
|- Primary outcome||- Risk perception|
|- Secondary outcome||- Attitude and intention to change behaviour (according to the determinants of the Theory of Planned Behaviour) and illness perception|
|- Timepoints||Baseline, 2 weeks (after visit to diabetes nurse and dietician), 3 months|
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES||Dr. Laura M.C. Welschen|
|- CONTACT for SCIENTIFIC QUERIES||Dr. Laura M.C. Welschen|
|- Sponsor/Initiator ||VU University Medical Center, EMGO+ Institute|
(Source(s) of Monetary or Material Support)
|Diabetes Fund, Amersfoort, the Netherlands|
|- Brief summary||Background of the study:|
It is difficult for patients with diabetes to understand the risk to develop severe diabetes related complications. As a result, they do not recognize the seriousness of changing lifestyle and taking medication in time. The risk to develop cardiovascular disease can be estimated by means of a risk formula. However, these numbers are complicated to understand for patients.
Therefore, it is important to develop a method to improve risk communication for patients. This might improve the understanding of the patient concering the risks that are associated with having diabetes and the motivation to change lifestyle. In addition, the patient will receive information that is needed to become a decision-maker of the treatment which is important to increase patient empowerment.
Objective of the study:
The aim of this study is to investigate the effects of an intervention focussed on the communication of the absolute 10-year risk to develop cardiovascular disease on risk perception, attitude towards a specific behaviour and the intention to change behaviour.
A randomised controlled trial will be performed in the the Diabetes Care System West-Friesland. The patients will be randomised into a control and an intervention group.
Newly diagnosed patients with type 2 diabetes not older than 75 years.
Intervention (if applicable):
The control group will receive standard managed care of the Diabetes Care System West-Friesland, which consists of a visit to a diabetes nurse followed by a visit to a dietician. The intervention group will receive this standard managed care and an intervention on risk communication by a diabetes nurse (part 1) and dietician (part 2)
The primary outcome is risk perception.
Secundary outcomes are the attitude and intention to change behaviour and illness perception
|- Main changes (audit trail)|
|- RECORD||24-nov-2008 - 11-mrt-2009|