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Digital mental health
Validity and characteristics of patient-evaluated adherence to medication via smartphones in patients with bipolar disorder: exploratory reanalyses on pooled data from the MONARCA I and II trials
  1. Maria Faurholt-Jepsen1,
  2. Mads Frost2,
  3. Ellen Margrethe Christensen1,
  4. Jakob Eyvind Bardram3,
  5. Maj Vinberg1,
  6. Lars Vedel Kessing1
  1. 1 Psychiatric Center Copenhagen, Rigshospitalet, Department O. Copenhagen, Copenhagen, Denmark
  2. 2 Monsenso Aps, Copenhagen, Denmark
  3. 3 Department of Health Technology, Technical University of Denmark, Lyngby, Denmark
  1. Correspondence to Dr Maria Faurholt-Jepsen, Psychiatric Center Copenhagen, Copenhagen 2100, Denmark; maria{at}


Background Non-adherence to medication is associated with increased risk of relapse in patients with bipolar disorder (BD).

Objectives To (1) validate patient-evaluated adherence to medication measured via smartphones against validated adherence questionnaire; and (2) investigate characteristics for adherence to medication measured via smartphones.

Methods Patients with BD (n=117) evaluated adherence to medication daily for 6–9 months via smartphones. The Medication Adherence Rating Scale (MARS) and the Rogers’ Empowerment questionnaires were filled out. The 17-item Hamilton Depression Rating Scale, the Young Mania Rating Scale and the Functional Assessment Short Test were clinically rated. Data were collected multiple times per patient. The present study represents exploratory pooled reanalyses of data collected as part of two randomised controlled trials.

Findings During the study 90.50% of the days were evaluated as ‘medication taken’, 6.91% as ‘medication taken with changes’ and 2.59% as ‘medication not taken’. Adherence to medication measured via smartphones was valid compared with the MARS (B: −0.049, 95% CI −0.095 to −0.003, p=0.033). Younger age and longer illness duration were significant predictors for non-adherence to medication (model concerning age: B: 0.0039, 95% CI 0.00019 to 0.0076, p=0.040). Decreased affective symptoms measured with smartphone-based patient-reported mood and clinical ratings as well as decreased empowerment were associated with non-adherence.

Conclusions Smartphone-based monitoring of adherence to medication was valid compared with validated adherence questionnaire. Younger age and longer illness duration were predictors for non-adherence. Increased empowerment was associated with adherence.

Clinical implications Using smartphones for empowerment of adherence using patient-reported measures may be helpful in everyday clinical settings.

Trial registration number NCT01446406 and NCT02221336.

  • Bipolar disorder
  • Adherence to medication
  • Smartphone

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  • Contributors MFJ and LVK performed the statistical analyses and wrote the first draft of the manuscript. All authors contributed to and have approved the final version of the manuscript.

  • Funding The MONARCA I trial was funded by the EU 7th 564 Frame Program, the Mental Health Services in the Capital Region of Denmark, the Tryg Foundation, the Gert Einar Joergensens Foundation, and the AP Moeller and Hustru Chastine Mc-Kinney Moellers Foundation for general purposes. The MONARCA II trial was funded by the Mental Health Services in the Capital Region of Denmark, including the Centre for Telemedicine in the Capital Region of Denmark and the EU 7th Frame Program, the IT University of Copenhagen, the Tryg Foundation and the Lundbeck Foundation.

  • Disclaimer The research team has no financial connection to any of the funders. The funding organisations had no role in the design and conduct of the study; collection, management, analysis and interpretation of data; preparation, review or approval of the manuscript; and decision to submit the manuscript for publication.

  • Competing interests MFJ has no conflicts of interest. MF and JEB are co-founders and shareholders in Monsenso ApS. EMC has been a consultant for Eli Lilly, AstraZeneca, Servier, Bristol-Myers Squibb, Lundbeck and Medilink. MV has been a consultant for Lundbeck within the last 3 years. LVK has been a consultant for Lundbeck during the recent 3 years.

  • Patient consent for publication Not required.

  • Ethics approval The trials were approved by the Regional Ethics Committee of the Capital Region of Denmark (H-2-2011-056, H-2-2014-059 and H-7-2014-007) and the Danish Data Protection Agency (2013-41-1710). The law regarding the handling of personal data was respected. The electronic data collected from the smartphones were stored at a secure server at Concern IT, Capital Region, Denmark (I-suite number RHP-292 2011-03). The trials complied with the Helsinki Declaration of 1975, as revised in 2008.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Data availability statement No data are available.