Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Other |
Difference in biomarkers of autonomic function (change from baseline to 6-week follow-up) |
Difference in biomarkers of autonomic function from baseline to 6-week follow-up (e.g. heart rate variability) |
6 weeks |
|
Other |
Difference in biomarkers of autonomic function (change from baseline to 12-week follow-up) |
Difference in biomarkers of autonomic function from baseline to 12-week follow-up (e.g. heart rate variability) |
12 weeks |
|
Other |
Difference in biomarkers of heart failure (change from baseline to 6-week follow-up) |
Difference in biomarkers of heart failure from baseline to 6-week follow-up (e.g., NT-proBNP) |
6 weeks |
|
Other |
Difference in biomarkers of heart failure (change from baseline to 12-week follow-up) |
Difference in biomarkers of heart failure from baseline to 12-week follow-up (e.g., NT-proBNP) |
12 weeks |
|
Other |
Difference in biomarkers of cardio-vascular diseases (change from baseline to 6-week follow-up) |
Difference in biomarkers of cardiovascular diseases from baseline to 6-week follow-up (e.g., troponin) |
6 weeks |
|
Other |
Difference in biomarkers of cardio-vascular diseases (change from baseline to 12-week follow-up) |
Difference in biomarkers of cardiovascular diseases from baseline to 12-week follow-up (e.g., troponin) |
12 weeks |
|
Other |
Difference in biomarkers of metabolic diseases (change from baseline to 6-week follow-up) |
Difference in biomarkers of metabolic diseases from baseline to 6-week follow-up (e.g., HbA1c) |
6 weeks |
|
Other |
Difference in biomarkers of metabolic diseases (change from baseline to 12-week follow-up) |
Difference in biomarkers of metabolic diseases from baseline to 12-week follow-up (e.g., HbA1c) |
12 weeks |
|
Other |
Difference in biomarkers of renal diseases (change from baseline to 6-week follow-up) |
Difference in biomarkers of renal diseases from baseline to 6-week follow-up (e.g., eGFR) |
6 weeks |
|
Other |
Difference in biomarkers of renal diseases (change from baseline to 12-week follow-up) |
Difference in biomarkers of renal diseases from baseline to 12-week follow-up (e.g., eGFR) |
12 weeks |
|
Other |
Difference in biomarkers of cancer (change from baseline to 6-week follow-up) |
Difference in biomarkers of cancer from baseline to 6-week follow-up (e.g., LDH) |
6 weeks |
|
Other |
Difference in biomarkers of cancer (change from baseline to 12-week follow-up) |
Difference in biomarkers of cancer from baseline to 12-week follow-up (e.g., LDH) |
12 weeks |
|
Other |
Difference in biomarkers of pulmonary diseases (change from baseline to 6-week follow-up) |
Difference in biomarkers of pulmonary diseases from baseline to 6-week follow-up (e.g., FEV1) |
6 weeks |
|
Other |
Difference in biomarkers of pulmonary diseases (change from baseline to 12-week follow-up) |
Difference in biomarkers of pulmonary diseases from baseline to 12-week follow-up (e.g., FEV1) |
12 weeks |
|
Other |
Difference in biomarkers of inflammation (change from baseline to 6-week follow-up) |
Difference in biomarkers of inflammation from baseline to 6-week follow-up (e.g., C-reactive protein) |
6 weeks |
|
Other |
Difference in biomarkers of inflammation (change from baseline to 12-week follow-up) |
Difference in biomarkers of inflammation from baseline to 12-week follow-up (e.g., C-reactive protein) |
12 weeks |
|
Other |
Difference in biomarkers of immunity (change from baseline to 6-week follow-up) |
Difference in biomarkers of immunity from baseline to 6-week follow-up (e.g., leukocytes) |
6 weeks |
|
Other |
Difference in biomarkers of immunity (change from baseline to 12-week follow-up) |
Difference in biomarkers of immunity from baseline to 12-week follow-up (e.g., leukocytes) |
12 weeks |
|
Other |
Difference in biomarkers of oxidative stress (change from baseline to 6-week follow-up) |
Difference in biomarkers of oxidative stress from baseline to 6-week follow-up (e.g., monocytes) |
6 weeks |
|
Other |
Difference in biomarkers of oxidative stress (change from baseline to 12-week follow-up) |
Difference in biomarkers of oxidative stress from baseline to 12-week follow-up (e.g., monoytes) |
12 weeks |
|
Other |
Difference in biomarkers of hypercoagulability (change from baseline to 6-week follow-up) |
Difference in biomarkers of hypercoagulability from baseline to 6-week follow-up (e.g. mean platelet volume) |
6 weeks |
|
Other |
Difference in biomarkers of hypercoagulability (change from baseline to 12-week follow-up) |
Difference in biomarkers of hypercoagulability from baseline to 12-week follow-up (e.g., mean platelet volume) |
12 weeks |
|
Other |
Difference in biomarkers of vascular/endothelial function (change from baseline to 6-week follow-up) |
Difference in biomarkers of vascular/endothelial function from baseline to 6-week follow-up (e.g. pulse-wave velocity) |
6 weeks |
|
Other |
Difference in biomarkers of vascular/endothelial function (change from baseline to 12-week follow-up) |
Difference in biomarkers of vascular/endothelial function from baseline to 12-week follow-up (e.g. pulse-wave velocity) |
12 weeks |
|
Other |
Difference in biomarkers of carotid atherosclerosis (change from baseline to 6-week follow-up) |
Difference in biomarkers of carotid atherosclerosis from baseline to 6-week follow-up (e.g., intima-media-thickness) |
6 weeks |
|
Other |
Difference in biomarkers of carotid atherosclerosis (change from baseline to 12-week follow-up) |
Difference in biomarkers of carotid atherosclerosis from baseline to 12-week follow-up (e.g., intima-media-thickness) |
12 weeks |
|
Other |
Difference in biomarkers of methylation (change from baseline to 6-week follow-up) |
Difference in biomarkers of methylation from baseline to 6-week follow-up (e.g., CpG methylation) |
6 weeks |
|
Other |
Difference in biomarkers of methylation (change from baseline to 12-week follow-up) |
Difference in biomarkers of methylation from baseline to 12-week follow-up (e.g., CpG methylation) |
12 weeks |
|
Other |
Difference in anthropometrics (change from baseline to 6-week follow-up) |
Difference in anthropometrics from baseline to 6-week follow-up (e.g., BMI) |
6 weeks |
|
Other |
Difference in anthropometrics (change from baseline to 12-week follow-up) |
Difference in anthropometrics from baseline to 12-week follow-up (e.g., BMI) |
12 weeks |
|
Other |
Difference in biomarkers of psychosomatic diseases (change from baseline to 12-week follow-up) |
Difference in biomarkers of psychosomatic diseases from baseline to 12-week follow-up (e.g, PHQ-9) |
12 weeks |
|
Other |
Difference in biomarkers of physical activity |
Difference in biomarkers of physical activity (e.g., step count) |
12 weeks |
|
Other |
Difference in biomarkers of sedentary daytime activities |
Difference in biomarkers of sedentary daytime activities (e.g., sleeping time) |
12 weeks |
|
Other |
Differences in accelerometry |
Differences in accelerometry (e.g., measured with the Dynaport MoveMonitor) |
12 weeks |
|
Other |
Evaluation of compliance of study participants with the mobile devices |
Explorative evaluation of compliance as assessed with technical data from the mobile devices (e.g. wearing time) and a qualitative questionnaire on device experience (allowing to evaluate inter alia feasibility and wearability) |
12 weeks |
|
Other |
Evaluation of functionality of the mobile devices |
Explorative evaluation of device functionality (e.g., as measured by number of data points per observation period) |
12 weeks |
|
Other |
Evaluation of realibility of the mobile devices |
Explorative evaluation of realibility of mobile device measurements (e.g. by comparing systolic blood pressure measurements between mobile devices and routine measurements) |
12 weeks |
|
Primary |
Average daily step count (all groups) |
The primary efficacy endpoint is the change in average daily step count between the baseline phase (mean of data collected during the period prior to randomization) and the end of the intervention (mean of data collected during week 12) comparing standard care to a 12-week individualized app-based activity coaching |
12 weeks |
|
Secondary |
Difference in E/E' ratio (change from baseline to 12-week follow-up) |
Difference in E/E' ratio (change from baseline (V1) to 12-week follow-up (V4)) |
12 weeks |
|
Secondary |
Difference in left ventricular ejection fraction (LVEF) from baseline to 12-week follow-up (V4) |
Difference in LVEF (systolic function) from baseline to 12-week follow-up |
12 weeks |
|
Secondary |
Difference in quality of life (change from baseline to 12-week follow-up) |
Difference in quality of life from baseline to 12-week follow-up (measured with The Kansas City Cardiomyopathy Questionnaire (KCCQ)) |
12 weeks |
|
Secondary |
Difference in heart rate variability (HRV) (change from baseline to 12-week follow-up) |
Difference in HRV from baseline to 12-week follow-up (measured with 24-hour Holter ECG) |
12 weeks |
|
Secondary |
Difference in peak VO2 (change from baseline to 12-week follow-up) |
Difference in peak VO2 from baseline to 12-week follow-up (cardiopulmonary exercise testing) |
12 weeks |
|
Secondary |
Change in daily non-sedentary daytime activity from baseline to 12-week follow-up |
Change in daily non-sedentary daytime activity from baseline to 12-week follow-up (composite measure of movement and locomotion as measured by the Dynaport MoveMonitor) (V4) |
12 weeks |
|
Secondary |
Difference in gait speed (change from baseline to 12-week follow-up) |
Change in gait speed from baseline to 12-week follow-up |
12 weeks |
|
Secondary |
Difference in NT-proBNP from baseline to 12-week follow-up |
Difference in the serum concentration of N-terminal brain natriuretic peptide (NT-proBNP) from baseline to 12-week follow-up |
12 weeks |
|
Secondary |
Difference in FEV1 (change from baseline to 12-week follow-up) |
Difference in forced expiratory volume in one second (FEV1) from baseline to 12-week follow-up |
12 weeks |
|
Secondary |
Difference in the augmentation index (change from baseline to 12-week follow-up) |
Difference in the augmentation index from baseline to 12-week follow-up. The augmentation index is an indicator of arterial stiffness; higher values indicate a worse outcome |
12 weeks |
|
Secondary |
Correlations of gait speed |
Correlations of gait speed during an intermittent supervised test to data assessed in patients' home environment |
12 weeks |
|
Secondary |
Difference in METs (change from baseline to 12-week follow-up) |
Change in metabolic equivalents (METs) from baseline to 12-week follow-up |
12 weeks |
|
Secondary |
Difference in daily step count between the intervention groups (change from baseline to 12-week follow-up) |
Difference in daily step count from baseline to end of study (comparing the two intervention groups only) |
12 weeks |
|