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

Overview

Journal Pilot Feasibility Stud

Publisher Biomed Central

Date 2017 Aug 16

PMID 28808581

Citations 4

Authors

Iris Tinsel

Achim Siegel

Claudia Schmoor

Anika Buchholz

Wilhelm Niebling

Affiliations

Soon will be listed here.

Abstract

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.

Citing Articles

Encouragement of patients' self-management in primary care for the prevention of cardiovascular diseases (DECADE): protocol for a cluster randomised controlled trial.

Tinsel I, Schmoor C, Borger M, Kamp M, Kaier K, Hardt H BMJ Open. 2023; 13(4):e071230.

PMID: 37185187 PMC: 10151245. DOI: 10.1136/bmjopen-2022-071230.

A randomised controlled trial is not a pilot trial simply because it uses a surrogate endpoint.

Campbell M, Lancaster G, Eldridge S Pilot Feasibility Stud. 2018; 4:130.

PMID: 30069309 PMC: 6065065. DOI: 10.1186/s40814-018-0324-2.

Encouraging Self-Management in Cardiovascular Disease Prevention.

Tinsel I, Siegel A, Schmoor C, Poguntke I, Maun A, Niebling W Dtsch Arztebl Int. 2018; 115(27-28):469-476.

PMID: 30064627 PMC: 6111204. DOI: 10.3238/arztebl.2018.0469.

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 I, Siegel A, Schmoor C, Buchholz A, Niebling W Pilot Feasibility Stud. 2017; 3:32.

PMID: 28808581 PMC: 5549435. DOI: 10.1186/s40814-017-0172-5.

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