Reducing the Rate and Duration of Re-ADMISsions Among Patients with Unipolar Disorder and Bipolar Disorder Using Smartphone-based Monitoring and Treatment - the RADMIS Trials: Study Protocol for Two Randomized Controlled Trials

Overview

Journal Trials

Publisher Biomed Central

Specialties General Medicine
Pharmacology

Date 2017 Jun 17

PMID 28619114

Citations 13

Authors

Maria Faurholt-Jepsen

Mads Frost

Klaus Martiny

Nanna Tuxen

Nicole Rosenberg

Jonas Busk

Ole Winther

Jakob Eyvind Bardram

Lars Vedel Kessing

Affiliations

Soon will be listed here.

Abstract

Background: Unipolar and bipolar disorder combined account for nearly half of all morbidity and mortality due to mental and substance use disorders, and burden society with the highest health care costs of all psychiatric and neurological disorders. Among these, costs due to psychiatric hospitalization are a major burden. Smartphones comprise an innovative and unique platform for the monitoring and treatment of depression and mania. No prior trial has investigated whether the use of a smartphone-based system can prevent re-admission among patients discharged from hospital. The present RADMIS trials aim to investigate whether using a smartphone-based monitoring and treatment system, including an integrated clinical feedback loop, reduces the rate and duration of re-admissions more than standard treatment in unipolar disorder and bipolar disorder.

Methods: The RADMIS trials use a randomized controlled, single-blind, parallel-group design. Patients with unipolar disorder and patients with bipolar disorder are invited to participate in each trial when discharged from psychiatric hospitals in The Capital Region of Denmark following an affective episode and randomized to either (1) a smartphone-based monitoring system including (a) an integrated feedback loop between patients and clinicians and (b) context-aware cognitive behavioral therapy (CBT) modules (intervention group) or (2) standard treatment (control group) for a 6-month trial period. The trial started in May 2017. The outcomes are (1) number and duration of re-admissions (primary), (2) severity of depressive and manic (only for patients with bipolar disorder) symptoms; psychosocial functioning; number of affective episodes (secondary), and (3) perceived stress, quality of life, self-rated depressive symptoms, self-rated manic symptoms (only for patients with bipolar disorder), recovery, empowerment, adherence to medication, wellbeing, ruminations, worrying, and satisfaction (tertiary). A total of 400 patients (200 patients with unipolar disorder and 200 patients with bipolar disorder) will be included in the RADMIS trials.

Discussion: If the smartphone-based monitoring system proves effective in reducing the rate and duration of re-admissions, there will be basis for using a system of this kind in the treatment of unipolar and bipolar disorder in general and on a larger scale.

Trial Registration: ClinicalTrials.gov, ID: NCT03033420 . Registered 13 January 2017. Ethical approval has been obtained.

Citing Articles

Telemedicine as a Tool to Improve Medicine Adherence in Patients with Affective Disorders - A Systematic Literature Review.

Leiz M, Pfeuffer N, Rehner L, Stentzel U, Berg N Patient Prefer Adherence. 2023; 16:3441-3463.

PMID: 36605330 PMC: 9809413. DOI: 10.2147/PPA.S388106.

Mood and Activity Measured Using Smartphones in Unipolar Depressive Disorder.

Tonning M, Faurholt-Jepsen M, Frost M, Bardram J, Kessing L Front Psychiatry. 2021; 12:701360.

PMID: 34366933 PMC: 8336866. DOI: 10.3389/fpsyt.2021.701360.

Measurement of unnecessary psychiatric readmissions in the context of care transition interventions: a scoping review.

Kim B, Weatherly C, Benjamin Wolk C, Proctor E BMJ Open. 2021; 11(2):e045364.

PMID: 33558362 PMC: 7871679. DOI: 10.1136/bmjopen-2020-045364.

Universal mental health screening with a focus on suicidal behaviour using smartphones in a Mexican rural community: protocol for the SMART-SCREEN population-based survey.

Arenas-Castaneda P, Aroca Bisquert F, Martinez-Nicolas I, Castillo Espindola L, Barahona I, Maya-Hernandez C BMJ Open. 2020; 10(7):e035041.

PMID: 32690505 PMC: 7371217. DOI: 10.1136/bmjopen-2019-035041.

Forecasting Mood in Bipolar Disorder From Smartphone Self-assessments: Hierarchical Bayesian Approach.

Busk J, Faurholt-Jepsen M, Frost M, Bardram J, Kessing L, Winther O JMIR Mhealth Uhealth. 2020; 8(4):e15028.

PMID: 32234702 PMC: 7367518. DOI: 10.2196/15028.

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