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

Bipolar Disorder Clinical Trial

— RADMIS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03033420
• Other study ID #: RADMIS
• Status: Completed
• Phase: N/A
• Start date: May 15, 2017
• Est. completion date: May 1, 2021

Study information

• Verified date: September 2022
• Source: Psychiatric Centre Rigshospitalet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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 is a major burden. Smartphones comprise an innovative and unique platform for monitoring and treatment of depression and mania.

The RADMIS trials use a randomized controlled single-blind parallel-group design. Patients with unipolar or bipolar disorder discharged from psychiatric hospitals in The Capital Region of Denmark are invited to participate. Patients are at discharge from the psychiatric hospitals randomized, separately according to psychiatric diagnosis (thus, the RADMIS trial consists of two separate trials according to diagnosis, bipolar disorder or unipolar disorder), to: 1) a smartphone-based monitoring system including a) an integrated feedback loop between patients and clinicians and b) context-aware CBT modules (intervention group) or 2) treatment-as-usual (control group) for a 6-months trial period. The trial is started in March 2017. The outcomes are 1) differences in the number and duration of re-admissions between the intervention group and the control group (primary), 2) differences in severity of depressive and manic symptoms (manic symptoms only for patients with bipolar disorder); differences in psychosocial functioning; and differences in number of affective episodes between the intervention group and the control group (secondary), and 3) differences in perceived stress, quality of life, self-rated depressive symptoms, self-rated manic symptoms (only for patients with bipolar disorder), recovery, empowerment, adherence to medication, well-being, ruminations, worrying, and satisfaction between the intervention group and the control group (tertiary).

Description:

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 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.

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 their 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 CBT modules (intervention group) or 2) standard treatment (control group) for a 6-months trial period. The trial is started in March 2017. The outcomes are 1) differences in the number and duration of re-admissions between the intervention group and the control group (primary), 2) differences in severity of depressive and manic symptoms (manic symptoms only for patients with bipolar disorder); differences in psychosocial functioning; and differences in number of affective episodes between the intervention group and the control group (secondary), and 3) differences in perceived stress, quality of life, self-rated depressive symptoms, self-rated manic symptoms (only for patients with bipolar disorder), recovery, empowerment, adherence to medication, well-being, ruminations, worrying, and satisfaction between the intervention group and the control group (tertiary).

Analysis Recruitment is ongoing.

Discussion If the smartphone-based monitoring system is proved 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 in a larger scale.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: May 1, 2021
• Est. primary completion date: March 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Unipolar disorder or bipolar disorder diagnoses according to ICD-10

• Patients who are discharged from a psychiatric hospital in The Capital Region of Denmark following an affective episode (depression or mania)

Exclusion Criteria:

• Pregnancy

• A lack of Danish language skills

Related Conditions & MeSH terms

• Affective Disorders
• Bipolar Disorder
• Depressive Disorder
• Disease
• Mood Disorders
• Unipolar Depression

Intervention

Device:
• A smartphone-based monitoring system including a) an integrated feedback loop between patients and clinicians and b) context-aware CBT modules
A smartphone-based monitoring system including a) an integrated feedback loop between patients and clinicians and b) context-aware CBT modules

Locations

Country	Name	City	State
Denmark	Psychiatric Center Copenhagen, Rigshospitalet	Copenhagen

Sponsors (2)

Lead Sponsor	Collaborator
Psychiatric Centre Rigshospitalet	Technical University of Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Perceived stress	Differences in perceived stress (The Cohen's Perceived stress scale) between the intervention group and the control group.	6 months trial period
Other	Quality of life	Differences in quality of life (The WHO Quality of Life-BREF) between the intervention group and the control group.	6 months trial period
Other	Self-rated manic symptoms	Differences in self-rated manic symptoms (The Altman Self Rating scale for Mania) between the intervention group and the control group.	6 months trial period
Other	Self-rated depressive symptoms	Differences in self-rated depressive symptoms (The Becks Depressive Inventory) between the intervention group and the control group.	6 months trial period
Other	Self-rated depressive symptoms	Differences in self-rated depressive symptoms (The Hamilton Depression Self-rating Scale 6-item) between the intervention group and the control group.	6 months trial period
Other	Recovery	Differences in recovery (The Recovery Assessment Scale) between the intervention group and the control group.	6 months trial period
Other	Empowerment	Differences in empowerment (Rogers empowerment scale) between the intervention group and the control group.	6 months trial period
Other	Adherence to medication	Differences in adherence to medication (The Medicine Adherence Rating Scale) between the intervention group and the control group.	6 months trial period
Other	Well-being	Differences in well-being according (The WHO (five) well-being index) between the intervention group and the control group.	6 months trial period
Other	Rumination	Differences in rumination (The Rumination Response Scale) between the intervention group and the control group.	6 months trial period
Other	Worrying	Differences in worrying (The Penn State Worry Questionnaire) between the intervention group and the control group.	6 months trial period
Other	Satisfaction	Differences in satisfaction (The Verona Satisfaction Scale-Affective Disorder) between the intervention group and the control group.	6 months trial period
Primary	Number of re-admissions	Differences in the number of re-admissions between the intervention group and the control group. Data will be collected from Danish registers.	6 months trial period
Primary	Duration of re-admissions	Differences in the duration of re-admissions between the intervention group and the control group.	6 months trial period
Secondary	Severity of depressive symptoms	Differences in the severity of depressive (The Hamilton Depression Rating Scale) symptoms between the intervention group and the control group.	6 months trial period
Secondary	Severity of manic symptoms	Differences in the severity of manic (The Young Mania Rating Scale) symptoms between the intervention group and the control group.	6 months trial period
Secondary	Psychosocial functioning	Differences in psychosocial functioning (The Psychosocial Functioning Assessment Short Test - FAST) between the intervention group and the control group.	6 months trial period
Secondary	Number of affective episodes	Differences in the number of affective episodes between the intervention group and the control group.	6 months trial period