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Mobile health (mHealth) technologies have the potential to capture dense patient data on the background of real-life behavior. Merck & Co., Inc. (Kenilworth, NJ), in collaboration with Koneksa Health, conducted a phase I clinical trial to validate cardiovascular mHealth technologies for concordance with traditional approaches and to establish sensitivity to detect effects of pharmacological intervention. This two-part study enrolled 18 healthy male subjects. Part I, a 5-day study, compared mHealth measures of heart rate (HR) and blood pressure (BP) to those from traditional methods. Hypotheses of similarity, in the clinic and at home, were tested individually for HR, systolic BP, and diastolic BP, at a 2-sided 0.05 alpha level, with a prespecified criterion for similarity being the percentage differences between the 2 measurements within 15%. Part II, a 7-day, 3-period randomized balanced crossover study, evaluated the mHealth technology's ability to detect effects of bisoprolol and salbutamol. Hypotheses that the changes from baseline in HR were greater in the bisoprolol (reduction in HR) and salbutamol (increase in HR) groups compared with no treatment were tested, at a 1-sided 0.05 alpha level. Linear mixed-effects models, Pearson's correlation coefficients, summary statistics, and exploratory plots were applied to analyze the data. The mHealth measures of HR and BP were demonstrated to be similar to those from traditional methods, and sensitive to changes in cardiovascular parameters induced by bisoprolol and salbutamol. © 2020 Merck Sharp & Dohme Corp. Clinical Pharmacology & Therapeutics © 2020 American Society for Clinical Pharmacology and Therapeutics.

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Citation

Please use this url to cite or link to this publication:

MLA
Huang, Qinlei, et al. “‘In-House’ Data on the Outside-A Mobile Health Approach.” Clinical Pharmacology and Therapeutics, vol. 107, no. 4, 2020.
APA
Huang, Q., Crumley, T., Walters, C., Cluckers, L., Heirman, I., Railkar, R., … Stoch, S. A. (2020). “In-House” Data on the Outside-A Mobile Health Approach. Clinical Pharmacology and Therapeutics, 107(4).
Chicago author-date
Huang, Qinlei, Tami Crumley, Christina Walters, Liesbeth Cluckers, Ingeborg Heirman, Radha Railkar, Gaurav Bhatia, et al. 2020. “‘In-House’ Data on the Outside-A Mobile Health Approach.” Clinical Pharmacology and Therapeutics 107 (4).
Chicago author-date (all authors)
Huang, Qinlei, Tami Crumley, Christina Walters, Liesbeth Cluckers, Ingeborg Heirman, Radha Railkar, Gaurav Bhatia, Matthew Cantor, Christopher Benko, Elena S Izmailova, Sylvie Rottey, and S Aubrey Stoch. 2020. “‘In-House’ Data on the Outside-A Mobile Health Approach.” Clinical Pharmacology and Therapeutics 107 (4).
Vancouver
1.
Huang Q, Crumley T, Walters C, Cluckers L, Heirman I, Railkar R, et al. “In-House” Data on the Outside-A Mobile Health Approach. Clinical pharmacology and therapeutics. 2020;107(4).
IEEE
[1]
Q. Huang et al., “‘In-House’ Data on the Outside-A Mobile Health Approach.,” Clinical pharmacology and therapeutics, vol. 107, no. 4, 2020.
@article{8654969,
  abstract     = {Mobile health (mHealth) technologies have the potential to capture dense patient data on the background of real-life behavior. Merck & Co., Inc. (Kenilworth, NJ), in collaboration with Koneksa Health, conducted a phase I clinical trial to validate cardiovascular mHealth technologies for concordance with traditional approaches and to establish sensitivity to detect effects of pharmacological intervention. This two-part study enrolled 18 healthy male subjects. Part I, a 5-day study, compared mHealth measures of heart rate (HR) and blood pressure (BP) to those from traditional methods. Hypotheses of similarity, in the clinic and at home, were tested individually for HR, systolic BP, and diastolic BP, at a 2-sided 0.05 alpha level, with a prespecified criterion for similarity being the percentage differences between the 2 measurements within 15%. Part II, a 7-day, 3-period randomized balanced crossover study, evaluated the mHealth technology's ability to detect effects of bisoprolol and salbutamol. Hypotheses that the changes from baseline in HR were greater in the bisoprolol (reduction in HR) and salbutamol (increase in HR) groups compared with no treatment were tested, at a 1-sided 0.05 alpha level. Linear mixed-effects models, Pearson's correlation coefficients, summary statistics, and exploratory plots were applied to analyze the data. The mHealth measures of HR and BP were demonstrated to be similar to those from traditional methods, and sensitive to changes in cardiovascular parameters induced by bisoprolol and salbutamol. © 2020 Merck Sharp & Dohme Corp. Clinical Pharmacology & Therapeutics © 2020 American Society for Clinical Pharmacology and Therapeutics.},
  author       = {Huang, Qinlei and Crumley, Tami and Walters, Christina and Cluckers, Liesbeth and Heirman, Ingeborg and Railkar, Radha and Bhatia, Gaurav and Cantor, Matthew and Benko, Christopher and Izmailova, Elena S and Rottey, Sylvie and Stoch, S Aubrey},
  issn         = {1532-6535},
  journal      = {Clinical pharmacology and therapeutics},
  language     = {eng},
  number       = {4},
  title        = {"In-House" Data on the Outside-A Mobile Health Approach.},
  url          = {http://dx.doi.org/10.1002/cpt.1790},
  volume       = {107},
  year         = {2020},
}

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