Exploration of smart adherence-monitoring methods in vitamin D-deficient patients : A pilot feasibility clinical study
© 2023 The Authors. Clinical and Translational Science published by Wiley Periodicals LLC on behalf of American Society for Clinical Pharmacology and Therapeutics..
Treatment adherence is an underestimated determinant of treatment success. Poor treatment adherence can also affect the efficacy of clinical trials. A combination of multiple adherence-monitoring methods is required to ensure robustness. We investigated whether multiple adherence-monitoring methods, including a novel smartwatch-based monitoring method, would yield reliable and concordant results. In this open, randomized, decentralized clinical trial, vitamin D-deficient individuals were randomized to an App - only group (an electronic medication diary) or an App + Watch group (i.e., App and smartwatch-based monitoring) groups after a week run-in period. The participants received vitamin D supplements (1000 IU) for 12 weeks (two consecutive periods of 6 weeks) with two pill counts (at the sixth week) and biweekly blood samplings for serum 25(OH) vitamin D concentration. Adherence was assessed and compared between the methods. Sixteen participants were enrolled, of which 13 completed the study. Serum 25(OH) vitamin D levels comparably increased in both groups until the first 7 weeks but trended higher in the App + Watch group in the second period. The number of doses recorded by the pill count and App did not differ significantly between the run-in and Period 1 (p = 0.5534) but became significantly discrepant in Period 2 (p = 0.0225). In contrast, the concordance for smartwatch-based monitoring was consistent in either period (p = 0.5898 and p = 0.5839, respectively). We explored multiple adherence-monitoring methods in this pilot feasibility clinical study. Smartwatch-based adherence monitoring may be an objective and sensitive method for measuring treatment adherence.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2023 |
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| Erschienen: |
2023 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:16 |
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| Enthalten in: |
Clinical and translational science - 16(2023), 10 vom: 18. Okt., Seite 1866-1875 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Huh, Ki Young [VerfasserIn] |
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| Links: |
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| Themen: |
1406-16-2 |
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| Anmerkungen: |
Date Completed 23.10.2023 Date Revised 23.10.2023 published: Print-Electronic Citation Status MEDLINE |
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| doi: |
10.1111/cts.13594 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM359623816 |
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| 520 | |a © 2023 The Authors. Clinical and Translational Science published by Wiley Periodicals LLC on behalf of American Society for Clinical Pharmacology and Therapeutics. | ||
| 520 | |a Treatment adherence is an underestimated determinant of treatment success. Poor treatment adherence can also affect the efficacy of clinical trials. A combination of multiple adherence-monitoring methods is required to ensure robustness. We investigated whether multiple adherence-monitoring methods, including a novel smartwatch-based monitoring method, would yield reliable and concordant results. In this open, randomized, decentralized clinical trial, vitamin D-deficient individuals were randomized to an App - only group (an electronic medication diary) or an App + Watch group (i.e., App and smartwatch-based monitoring) groups after a week run-in period. The participants received vitamin D supplements (1000 IU) for 12 weeks (two consecutive periods of 6 weeks) with two pill counts (at the sixth week) and biweekly blood samplings for serum 25(OH) vitamin D concentration. Adherence was assessed and compared between the methods. Sixteen participants were enrolled, of which 13 completed the study. Serum 25(OH) vitamin D levels comparably increased in both groups until the first 7 weeks but trended higher in the App + Watch group in the second period. The number of doses recorded by the pill count and App did not differ significantly between the run-in and Period 1 (p = 0.5534) but became significantly discrepant in Period 2 (p = 0.0225). In contrast, the concordance for smartwatch-based monitoring was consistent in either period (p = 0.5898 and p = 0.5839, respectively). We explored multiple adherence-monitoring methods in this pilot feasibility clinical study. Smartwatch-based adherence monitoring may be an objective and sensitive method for measuring treatment adherence | ||
| 650 | 4 | |a Randomized Controlled Trial | |
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Research Support, Non-U.S. Gov't | |
| 650 | 7 | |a Vitamin D |2 NLM | |
| 650 | 7 | |a 1406-16-2 |2 NLM | |
| 700 | 1 | |a Lee, Hwiwon |e verfasserin |4 aut | |
| 700 | 1 | |a Lee, SeungHwan |e verfasserin |4 aut | |
| 700 | 1 | |a Yu, Kyung-Sang |e verfasserin |4 aut | |
| 700 | 1 | |a Kim, Kyung Hwan |e verfasserin |4 aut | |
| 700 | 1 | |a Kim, Heejin |e verfasserin |4 aut | |
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