Support for Patient-Centered Cardiovascular Risk Counseling With Two Components of th e DECADE Intervention

Findings of a multiregional, cluster-randomized controlled trial

Background: Health-conscious behavior can help prevent cardiovascular diseases. The DECADE intervention (“decision aid, action planning, and follow-up support for patients to reduce the 10-year risk of cardiovascular diseases”) is designed to support primary care physicians in cardiovascular risk counseling. We studied the effects of two of its components.

Methods: A trial with a cluster-randomized 2 x 2 design was conducted in three regions of Germany (registration number DRKS00025401). 76 primary care physicians who were randomly allocated to one of four study arms recruited a total of 797 patients with lifestyle-related cardiovascular risk factors. 712 of them were included in the analysis. Cardiovascular risk was calculated for all patients at the start of the intervention and at 12 months. The control group (CG) underwent usual treatment; intervention group (IG) 1 received DECADE patient materials; IG2 had patient-centered DECADE follow-up consultations (at week 1, at months 3, 6, and 12; and additionally at month 9, if necessary); and IG3 received both of these DECADE intervention components. The primary endpoint was the self-reported change in patient activation (Patient Activation Measure, PAM13) at month 6. The secondary endpoints were changes in health behavior and clinical parameters. Linear mixed regression models were used to analyze the effects of DECADE follow-up consultations (IG2 + IG3) versus no follow-up consultations (CG + IG1), and of DECADE materials (IG1 + IG3) versus no materials (CG + IG2), according to the 2 x 2 design.

Results: DECADE follow-up consultations (compared to none) had a small positive, statistically significant effect on the primary endpoint PAM13 score of 1.14 points (95% confidence interval (CI): [0.09; 2.19], p = 0.033). The effect of DECADE patient materials (compared to none) was 0.30 (95% CI: [−0.75; 1.35], p = 0.57). Patients in all study arms showed improved health behavior.

Conclusion: Although the demonstrated effect on the PAM13 score is of uncertain clinical relevance, other findings of this trial imply that DECADE may effectively support physicians in cardiovascular risk counseling. A long-term trial of its clinical effects is recommended.

Cite this as
Tinsel I, Schmoor C, Börger M, Kamp M, Hardt H, Rakebrandt A, Kloppe T, Gräfe W, Kutter S, Riemenschneider H, Maun A: Support for patient-centered cardiovascular risk counseling with two components of the DECADE intervention: Findings of a multiregional, cluster-randomized controlled trial. Dtsch Arztebl Int 2025; 122: 687–94. DOI: 10.3238/arztebl.m2025.0203

Unhealthy behavior and living conditions are leading causes of premature cardiovascular disease (CVD). In 2020, diseases of the heart and circulation were the most common cause of death in Germany and responsible for €56.7 billion in healthcare costs (1, 2). Failure to achieve satisfactory results through medical lifestyle counseling leads to frustration among both physicians and patients; as a result, treatment is often reduced to pharmacotherapy alone (3).

DECADE is a complex intervention designed to improve both lifestyle counseling by primary care physicians and health self-management. Its aim is to reduce the cardiovascular risk (CVR) of patients. The DECADE intervention is based on the Health Action Process Approach (HAPA) model. According to this model, the interaction of risk perception, knowledge, self-efficacy, intention to change, and planning is key to implementing and maintaining behavioral changes (4). DECADE comprises several intervention components with behavior change techniques (BCTs [5]) that are aligned content-wise, but can also be used individually.

A pilot study with 78 patients found that the use of DECADE print materials in combination with four structured, patient-centered DECADE follow-up consultations had a positive effect on the primary endpoint of patient activation (PAM13) at month 4 (6).

In this study, we assessed in parallel whether DECADE materials and/or DECADE follow-up consultations had an effect on PAM13 and additional patient-reported and clinical endpoints at months 6 and 12.

Methods

Study design and intervention

The study had a cluster-randomized 2 × 2 design and was conducted by the Institutes of General Practice at the Universities of Freiburg, Hamburg and Dresden as well as by primary care physicians practicing in the corresponding regions. Using blinded, stratified block randomization, participating primary care physicians (cluster) were assigned to one of the four trial arms in a 1 : 1 : 1 : 1 ratio.

In each study arm, the primary care physicians calculated the cardiovascular risks of participating patients at baseline (T0) and at months 12 after the intervention (M12), using the cardiovascular prevention module of the arriba software (version 3.9.3; www.arriba-hausarzt.de).

No further conditions applied to the control group (CG). Patients in intervention group (IG) 1 received modular DECADE materials for use in print or web-based format along with the CVR calculation. They comprised evidence-based information, decision-making and action aids as well as self-monitoring tools. Patients in IG2 received 4 to 5 structured follow-up consultations with patient-centered consultation techniques (7, 8, 9). After one week, shared decisions on goals and plans were made, and consequences were adressed. At months 3, 6 (if necessary 9) and 12, behavioral changes as well as needs were discussed. Patients in IG3 received both (IG1 and IG2) intervention components. The duration of individual consultations varies between 5 and 20 minutes depending on the situation (eSupplement; pp. 1 ff.).

The regional study teams initiated the trial by carrying out intervention training (duration up to about 20 minutes) to participating primary care physicians. The physicians enrolled patients after having obtained their informed consent, collected clinical data and conducted the intervention. The Section of Health Care Research and Rehabilitation Research was responsible for the management of multiregional data, the Clinical Trial Unit (both at the Medical Center – University of Freiburg) was responsible for statistical planning and analysis (eSupplement).

The ethics committees of the university medical centers and state medical associations approved the study (first approval: Ethics Committee of the Medical Center – University of Freiburg no. 21–1078). The study was registered with the German Clinical Trials Register (DRKS00025401), the study protocol was published in 2023 (10).

Study participants

Patients aged 30 to 75 years, insured in the German statutory health care system and eligible for primary or secondary prevention of cardiovascular disease, could be included in the study if at least one of the following lifestyle-related risk factors for CVD was present:

• Smoking
• Overweight/obesity
• Physical inactivity
• Unhealthy diet
• High alcohol consumption
• Exposure to stress, or
• Sleep problems.

Exclusion criteria included:

• Acute cardiovascular event
• Acute severe illness or short life expectancy
• Need for nursing care
• Severe cognitive impairment or mental illness
• Alcohol dependence
• Severe eating disorder
• Pregnancy
• Planned rehabilitation measure
• Insufficient knowledge of German
• Participation in a previous DECADE study (2016, 2021) or a comparable current study (eSupplement).

Data collection and endpoints

After giving informed consent, patients completed the baseline survey questionnaire; next, the cardiovascular risk was calculated. The study teams were responsible for carrying out the questionnaire surveys at months 6 and 12 (M6 and M12, respectively). The survey ended with a second calculation of the cardiovascular risk (M12) (eSupplement).

The primary endpoint was the change in patient activation from baseline to M6 (11), determined using the Patient Activation Measure (PAM13; German version; sum score: 0–100). PAM13 had already been used in the pilot study. With 13 items, it determines the extent of self-care; score increases ≥ 2.5 were associated with improved health outcomes (11, 12).

Secondary endpoints included:

• Patient-reported information on health status
• Health behavior
• Goal attainment
• Knowledge
• Assessment of the consultations, and
• Clinical parameters (eSupplement; pp. 4–5).

Statistical planning and analysis

Based on the sample size planning for the primary endpoint PAM13, it was initially intended to include 103 primary care physicians, each with twelve patients (N = 1236) in the study. A two-sided significance level of 5% and a power of 90% at an effect size of 0.3 and a dropout rate of 20% were assumed. By mid-January 2023, 76 primary care physicians had enrolled 797 patients. A recalculation for a power of 80% at a dropout rate of 10% yielded a minimum sample size of 717 patients (eSuppelement and study protocol [10]).

In line with the 2 x 2 design prespecified in the study protocol and the ethics committee application, the effect of the DECADE materials was evaluated by comparing the combined intervention groups IG1 + IG3 versus CG + IG2. Similarly, the effect of the DECADE follow-up consultations was evaluated by comparing the combined intervention groups IG2 + IG3 versus CG + IG1. In addition, interaction effects of the two intervention components were calculated. The primary endpoint was analyzed based on a modified full analysis set (FAS), comprising all cluster-randomized patients with at least one PAM13 measurement after the baseline survey. We used a linear mixed model for repeated measurements (MMRM). This regression model included the following variables as fixed effects:

• Baseline scores of PAM13 and CVR
• DECADE materials (yes versus no)
• DECADE follow-up consultations (yes versus no)
• Interaction between DECADE materials and DECADE follow-up consultations
• Time of measurement (M6 versus M12)
• Interactions between interventions and time of measurement.

In the model, the cluster (primary care physician) was included as a random effect (13). The effects of the interventions were estimated with 95% confidence intervals at M6 and M12. The primary test of the effects of the interventions is based on a comparison of the combined intervention groups at month 6. Most secondary endpoints were analyzed in the same way. No alpha adjustment was performed for multiple testing of the secondary endpoints. For this reason, results for the primary endpoint are interpreted as confirmatory, while the p-values of the secondary analyses are interpreted as descriptive (eSupplement; pp. 4–5).

Results

Study procedure and study population

Six of the 82 randomized clusters (primary care physicians) did not enroll patients. At baseline, complete baseline data sets (PAM13 and CVR scores) of 777 patients were available. Data of 712 patients were evaluable for the analysis (91.6% of the baseline data set) (Figure).

Figure

Study procedure and analysis sample

The number of patients per study arm varies (160 to 198) due to differences in the number of patients recruited (2 to 13 per cluster). Patient characteristics were mostly evenly distributed at baseline (Table 1). Minor differences are discussed in the eSupplement (pp. 19–20). The primary endpoint PAM13 was very high at baseline (mean scores between 83.1 and 84.2, on a scale between 0 and 100). In patients without manifest arteriosclerosis (MA), the CVR score was 9.9 ± 9.5%. A comparative CVR calculation for the general population of the same age and gender as the study participants was performed using the arriba module for cardiovascular prevention, yielding a result of 7.0 ± 4.2%. With 1203 minutes/week, the patient-reported level of everyday physical and sports activity was very high (Table 1; eSupplement; pp. 9–10).

Table 1

Characteristics of study population (analysis sample) at baseline survey (T0)

Primary endpoint patient activation

At M6, patient activation (PAM13) was found slightly improved compared to baseline in the three intervention arms (eSupplement; pp. 12–15, Table E-3). In the study arms with DECADE follow-up consultations (IG2 + IG3), PAM13 increased by 1.45 (95% CI: [0.73; 2.17]), in the study arms without follow-up consultations (CG + IG1) by 0.31 [−0.44; 1.07]. There is a small, statistically significant effect of the follow-up consultations on PAM13 of 1.14 ([0.09; 2.19]; p = 0.033). Among participating patients who received DECADE materials (IG1 + IG3), PAM13 increased by 1.03 [0.27; 1.80]. No effect on PAM13 was found for the use of DECADE materials (IG1 + IG3) compared to the group without materials (CG + IG2) (0.30; [−0.75; 1.35]; p = 0.57) (Table 2).

Table 2

Effects of DECADE materials and DECADE consultations on patient-reported endpoints at months 6 and 12 after start of study

Secondary endpoints

Self-reported endpoints improved in all study arms over the course of the study, mostly with a further slight increase at M12. Moreover, improvements in these endpoints were more frequently noted in IG3 (complete intervention) and IG2 (follow-up consultations) compared to IG1 (DECADE materials) and CG (eSupplement; pp. 12–15). In IG3, 42.4% of patients (n = 75) stated at M6 that they were living healthier compared to the time before the start of the study; at M12, this proportion increased to 51.6% (n = 81). In IG2, similar proportions are found, while the proportions are considerably lower in IG1 and CG (eFigure). This general health statement (21) is also reflected in specific changes.

eFigure

Information on changed health behavior at months 6 and 12 after start of study, by study arm

At M6, goal attainment (Goal Attainment Scaling [GAS] score) was highest in IG2 and IG3 and further increased at M12. In all study arms, BMI decreased up to M12, in IG3 by −0.40 kg/m² [−0.62; –0.17]. In IG3, the means at M12 of current health status (EQ-VAS) and PAM13 rose most with + 6.9 [4.79; 9.00] and + 1.69 [0.61; 2.77], respectively. Self-assessment of knowledge growth and participation as well as satisfaction with the cardiovascular risk counseling were higher in IG3 and IG2 compared to IG1 and CG. Overall, the changes in physical activity were heterogeneous (eSupplement; pp. 12–15).

Of 157 smokers at baseline (22.3%), 18 and 21 stopped smoking by M6 and M12, respectively, with only minor differences between the study arms.

By M12, improvements in the clinical parameters “systolic blood pressure“, “total cholesterol“ and “HDL cholesterol” were noted in all study arms, yet to varying degrees. Systolic blood pressure decreased more noticeably in IG1 (−3.75 mm Hg [−6.85; –0.66]) and IG3 (−3.06 mm Hg [−5.98; −0.13]), total cholesterol in CG (−7.85 mg/dL [−13.06; −2.63]) and IG2 (−8.62 mg/dL [−13.78; −3.46]). HDL cholesterol levels increased in IG1 (+1.88 mg/dL [0.12; 3.64]) (eSupplement; pp. 12–15).

Data of 568 patients were available for the analysis of changes in cardiovascular risk. Patients with a first cardiovascular event after the baseline survey (n = 19; 3.3%) were taken into account with the CVR score 53% at M12 (eSupplement; p. 10). Under these conditions, CVR scores changed as follows: :

• CG: +1.16% [−0.40; 2.73]
• IG1: +0.09% [−1.67; 1.85]
• IG2: +2.01% [0.42; 3.60]
• IG3: −0.17% [−1.85; 1.51] (eSupplement; pp. 12–15).

The expected change in cardiovascular risk in a general population with the same age and gender distribution as the DECADE study population was calculated as +0.9% (using the arriba module).

Effects of the interventions on secondary endpoints

Effects of the intervention components (main effects and interaction) on 16 secondary endpoints were calculated (10 of these at M6 and M12). Key findings from the Tables 2 and 3 are reported below.

Table 3

Effects of DECADE materials and DECADE consultations on clinical endpoints at month 12 after start of study

Effects of DECADE follow-up consultations (IG2 + IG3) compared to no follow-up consultations (CG + IG1)

• Healthier diet (scale: 0–4); M12: +0.10 [0.01; 0.19], p = 0.033
• Higher goal attainment (score 0–5); M12: +0.20 [0.07; 0.34], p = 0.003
• Higher knowledge growth (score 0–3); M6: +0.19 [0.07; 0.31], p = 0.003; M12: +0.16 [0.04; 0.28], p = 0.011
• Higher degree of participation (score 0–3); M6: 0.54 [0.40; 0.67], p <0.0001
• Higher satisfaction with CVR consultations (score 1–5); M6: −0.49 [−0.65; −0.33], p = 0.000. M12: −0,30 [−0,47; −0,14], p < 0.0004.

Effects of DECADE materials (IG1 + IG3) compared to no materials (CG + IG2)

• Higher health status (EQ-VAS: 0–100); M6: +2.04 [0.02; 4.06], p = 0.047
• Higher knowledge growth (score 0–3); M6: +0.14 [0.02; 0.26], p = 0.023.
• Lower cardiovascular risk score (0–53%); M12: −1.63 [−3.28; 0.02], p = 0.053.

Interaction effects are noted when the combined use of DECADE follow-up consultations and DECADE materials produces a greater effect than the sum of the individual effects (eSupplement; pp. 16–18). This was present for the following endpoints:

• Reduced alcohol consumption (scale 0–4): M6: −0.38 [−0.60; −0.15], p<0.001
• Higher health status (EQ-VAS: 0–100): M12: +4.83 [0.73; 8.94], p = 0.02.

Discussion

Using a 2 × 2 design, this study evaluated in parallel the effects of DECADE follow-up consultations and DECADE materials in the context of cardiovascular risk counseling by primary care physicians.

The DECADE follow-up consultations (IG2 + IG3) showed a small, statistically significant positive effect on the primary endpoint PAM13 of +1.14 [0.09; 2.19] at M6 despite a high baseline level (83.6), on a scale between 0 and 100. DECADE materials had no effect on PAM13. In previous studies, health changes were associated with an increase in PAM13 scores of >2.5 (12). In international studies, however, the baseline PAM13 scores are about 60 points and thus below the scores in German-speaking countries (68.3 to 88.2) (6, 11, 22). These differences could be attributable to differences in health care systems, settings and in some cases to the exclusion of study participants with PAM baseline scores ≥ 72.5 points (11, 22). As a result, comparability between studies is limited.

While DECADE follow-up consultations (IG2 + IG3) showed more often positive effects on counseling assessment, DECADE materials (IG1 + IG3) showed positive effects on knowledge growth and health status at M6 and CVR score advantages at M12. Without intervention a greater increase in CVR would be expected among participants in the DECADE study due to higher lifestyle risks compared to the general population, for whom a CVR increase of +0.9 was calculated. Positive trends were noted in IG1 and IG3, resulting in a CVR score effect of DECADE materials (IG1 + IG3) of −1.63 compared to no materials (KG + IG2) (p = 0.053). With a p-value of just over 0.05, this result suggests a potential reduction in 10-year risk of cardiovascular events. This finding needs to be confirmed by further studies before any predictions can be made about a long-term reduction in cardiovascular disease.

Positive interaction effects were observed for alcohol consumption (M6: −0.38) and health status (EQ-VAS; M12: +4.83). At baseline, the overall EQ-VAS score of 69.5 was below the reference value (72.9) for persons aged 55–64 years in Germany (23) and increased to 73.9 at M12, most notably in IG3 (+6.9 to 76.3). Patients in IG3 showed the greatest overall improvement, except for the endpoint “physical activity” (eSupplement; pp. 19–22).

While the DECADE intervention components had only minor effects on specific behavioral changes, positive developments in health behavior and most of the assessed clinical endpoints were observed in all four study arms. This is in line with findings from other studies, showing that CVR calculations combined with counseling are associated with more adequate risk perception, adjustments of pharmacotherapy, improved medication adherence, healthier diet and, to some extent, improved clinical parameters (24, 25). In this DECADE study, we found that about 50% of patients in IG2 and IG3 stated at M12 that they were living a healthier life compared to the time before the start of the study. These proportions were lower in CG (25%) and IG1 (32%), but higher compared to a survey in the “Healthier Kinzigtal” model region in 2020 (18%) (26).

In the study arm where patients exclusively received DECADE follow-up consultations (IG2), differences in PAM13 score changes between the pilot study (M4: −1.81) (6) and this study (M6: +1.45) were noted. This is probably due to the optimization of communication training for follow-up consultations. Positive effects of follow-up consultations (IG2 + IG3) on participation (M6: +0.54) and satisfaction with CVR counseling (M6: −0.49; M12: −0.30) support this assumption. Studies highlight the positive effects of patient-centered follow-up consultations and correctly implemented behavior change techniques on behavioral change (27, 28, 29, 30, 31) (eSupplement; pp. 19–22).

Strengths and limitations

Even though not all primary care physician practices recruited twelve patients as intended, the planned sample size (N = 717) was almost achieved with 712 included patients (eSupplement; pp. 19–22). It is not possible to verify the specified structured study inclusion, the correct implementation of the intervention, the active use of DECADE materials, the impact of the COVID-19 pandemic, and potential bias in patient-reported information. Patients without follow-up measurement of PAM13 could not be included in the modified full analysis set. Since this is not an “intention-to-treat (ITT)” analysis, it may introduce bias into the results. The validated arriba module for cardiovascular prevention and calculation of the cardiovascular risk we used in this study is recommended in the German S3-level clinical practice guideline on CVR prevention in primary care (32, 33) and is commonly used as a CVR counseling tool. However, the CVR calculator has limitations that restricted the CVR analysis to patients without manifest arteriosclerosis at baseline. Since the risk calculator was used in all study arms, there was no comparison group without minimal intervention. We used the 2 × 2 design to evaluate two combined interventions as well as interaction effects in parallel. Given that these were considered separate research questions, we performed no alpha adjustment for multiple testing (34).

The numerous secondary endpoints increase the risk of chance findings; thus, we emphasize that it is necessary to interpret these results descriptively.

The findings of the DECADE trial are similar to results reported in reviews: CVR counseling is more likely to have an effect on patient-reported and clinical endpoints when different behavioral goals are addressed simultaneously, individually usable patient materials, and a variety of BCTs are applied in follow-up consultations employing patient-centered communication techniques. This approach promotes self-management, in particular with regard to diet and smoking cessation; effects on physical activities are more heterogeneous (27, 28, 29, 30, 35, 36, 37, 38, 39, 40).

Even though the clinical relevance of the statistically significant effect of DECADE follow-up consultations (IG2 + IG3) on PAM13 scores remains uncertain, the overall findings indicate that communication training for primary care physicians can improve the implementation of the DECADE intervention and that patients benefit from the DECADE materials. The latter is particularly true in combination with patient-centered follow-up consultations.

The DECADE intervention can effectively support primary care physicians in their CVR prevention efforts and is recommended in the current German S3-level, evidence-based clinical practice guideline on CVR counseling by primary care physicians (33). It would be useful to conduct long-term studies, investigating associations between counseling efforts, health changes and cardiovascular events. In addition, reimbursement for behavioral counseling should be discussed. Since the completion of the study, DECADE materials have been freely accessible, and a free e-learning module is currently being created. For further information and contact details, please visit: www.decade-herz.de.

Acknowledgement

The authors thank the Innovation Fund of the Federal Joint Committee (G-BA, Gemeinsamer Bundesauschuss) for funding the project. We would also like to thank Prof. Dr. med. Antje Bergmann, Prof. Dr. med. Martin Scherer und Prof. Dr. Farin-Glattacker for their support in completing the application. Special thanks go to Dr. Kathrin Helm, Sarah Gerbach, Simjon Radloff, Rudolf Korhummel, and Mathias Ehrt of the website team and all student assistants who supported us. We thank Tina Görbing and Lukas Liebig (Dresden), who supported us at the beginning, and Prof. Dr. med. Norbert Donner-Banzhoff for consultations on the arriba module for cardiovascular prevention and interpretation of the cardiovascular risk findings. In addition, we thank the employees of AOK-Baden-Württemberg who informed the primary care physician practices about the study during the COVID 19 pandemic. We thank all primary care physicians and patients who were involved in the DECADE study.

Funding

The DECADE project was funded by the Innovation Fund of the Federal Joint Committee between September 2020 and August 2024 (funding code: 01VSF19021).

Data sharing

The pseudonymized data are available to the consortium partners involved in the project for secondary analyses. Under the license terms for the Patient Activation Measurement (PAM13) instrument, an excerpt of anonymized data is provided to the company for the purpose of advancing scientific health surveys. This includes: PAM13 at three points of measurement with information on age group and gender. As specified in the informed consent obtained from patients participating in the study, no other study data is disclosed to third parties.

Conflict of interest

The authors declare no conflict of interest.

Manuscript received on 2 July 2025, revised version accepted on
29 October 2025

Translated from the original German by Ralf Thoene, M.D.

Corresponding author
Iris Tinsel

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