DECADE-pilot: decision aid, action planning, and follow-up support for patients to reduce the 10-year risk of cardiovascular diseases-a protocol of a randomized controlled pilot trial
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DECADE-pilot: decision aid, action planning, and follow-up support for patients to reduce the 10-year risk of cardiovascular diseases-a protocol of a randomized controlled pilot trial. / Tinsel, Iris; Siegel, Achim; Schmoor, Claudia; Buchholz, Anika; Niebling, Wilhelm.
In: PILOT FEASIBILITY ST, Vol. 3, 2017, p. 32.Research output: SCORING: Contribution to journal › SCORING: Journal article › Research › peer-review
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TY - JOUR
T1 - DECADE-pilot: decision aid, action planning, and follow-up support for patients to reduce the 10-year risk of cardiovascular diseases-a protocol of a randomized controlled pilot trial
AU - Tinsel, Iris
AU - Siegel, Achim
AU - Schmoor, Claudia
AU - Buchholz, Anika
AU - Niebling, Wilhelm
PY - 2017
Y1 - 2017
N2 - BACKGROUND: A healthy lifestyle can reduce cardiovascular risk (CVR) and prevent premature death. Usually most patients at increased CVR have difficulties implementing the necessary health behavior changes, such as smoking cessation, increasing of physical activity, healthy diet, stress reduction, etc. In this pilot study, a new intervention (DECADE) that includes a cardiovascular risk calculation, evidence-based decision aids, action planning, and follow-up support for patients to reduce their 10-year risk of cardiovascular diseases will be tested in primary care. The objectives of this trial are to test (1) the feasibility of the study design in preparation for the main trail including (2) the usability and acceptance of DECADE, and (3) initial data to ascertain that changes can be observed in these patients.METHODS: This randomized controlled pilot trial will generate initial data on the potential effects of DECADE on patients' self-evaluated activity and behavior change as well as on clinical outcomes such as blood pressure, cholesterol, body mass index (BMI), HbA1C, and CVR score. In the qualitative part of the study, we will analyze data collected in semi-structured interviews with participating general practitioners (GP) and in patient questionnaires.DISCUSSION: The outcomes of this pilot study will indicate whether DECADE is a promising intervention in the domain of patient-centered prevention of cardiovascular diseases (CVD) and whether a larger multi-center randomized controlled trial is feasible.TRIAL REGISTRATION: German Clinical Trials Register (DRKS), DRKS00010584.
AB - BACKGROUND: A healthy lifestyle can reduce cardiovascular risk (CVR) and prevent premature death. Usually most patients at increased CVR have difficulties implementing the necessary health behavior changes, such as smoking cessation, increasing of physical activity, healthy diet, stress reduction, etc. In this pilot study, a new intervention (DECADE) that includes a cardiovascular risk calculation, evidence-based decision aids, action planning, and follow-up support for patients to reduce their 10-year risk of cardiovascular diseases will be tested in primary care. The objectives of this trial are to test (1) the feasibility of the study design in preparation for the main trail including (2) the usability and acceptance of DECADE, and (3) initial data to ascertain that changes can be observed in these patients.METHODS: This randomized controlled pilot trial will generate initial data on the potential effects of DECADE on patients' self-evaluated activity and behavior change as well as on clinical outcomes such as blood pressure, cholesterol, body mass index (BMI), HbA1C, and CVR score. In the qualitative part of the study, we will analyze data collected in semi-structured interviews with participating general practitioners (GP) and in patient questionnaires.DISCUSSION: The outcomes of this pilot study will indicate whether DECADE is a promising intervention in the domain of patient-centered prevention of cardiovascular diseases (CVD) and whether a larger multi-center randomized controlled trial is feasible.TRIAL REGISTRATION: German Clinical Trials Register (DRKS), DRKS00010584.
KW - Journal Article
U2 - 10.1186/s40814-017-0172-5
DO - 10.1186/s40814-017-0172-5
M3 - SCORING: Journal article
C2 - 28808581
VL - 3
SP - 32
JO - PILOT FEASIBILITY ST
JF - PILOT FEASIBILITY ST
SN - 2055-5784
ER -