DIMES - DIgital MEdicine Study for Adults With Schizophrenia, Bipolar I Disorder, or Major Depression Currently Using Aripiprazole

Last updated: June 17, 2020
Sponsor: Durham VA Medical Center
Overall Status: Active - Not Recruiting

Phase

4

Condition

Mood Disorders

Bipolar Disorder

Tourette's Syndrome

Treatment

N/A

Clinical Study ID

NCT03881449
02188
  • Ages > 18
  • All Genders

Study Summary

This is a 12 month, pragmatic trial designed to assess the differences in a digital medicine system (DMS)- ABILIFY MYCITE (Aripiprazole tablets with sensor)- measuring adherence versus treatment as usual (TAU) for adult patients with schizophrenia, bipolar I disorder, and major depression. Outcomes of interest will be adherence as measured by refill rates and all-cause and psychiatric health care use. Each patient will be in the study for a duration of 12 months.

All treatment medication decisions will be made by the healthcare professionals (HCPs) and not by protocol. Psychiatrist(s), nurse(s) and/or team manager(s) who will be responsible for subjects' care, will be considered as HCPs in this trial.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients aged 18 years of age or older.

  • Patients with a primary diagnosis of schizophrenia (including schizoaffectivedisorder), bipolar I disorder, or major depressive disorder based on the DiagnosticStatistical Manual of Mental Disorders, 5th edition (DSM-5) criteria.

  • Patients have an active prescription for oral Aripiprazole.

  • Patients may have general medical conditions that are deemed safe for the patient toenter an interventional trial per investigator judgment.

  • Patients deemed fit for participation in the study by verbal or written confirmationfrom their mental health provider

Exclusion

Exclusion Criteria:

  • Patients with a current neurocognitive disorder (i.e. dementia), intellectualdisorder, or any other diagnosis that could impact the patient's ability toparticipate in the trial.

  • Any patient who, in the opinion of the patient's mental health provider, studyphysician or investigator, is unfit to participate in the trial.

  • Any patient who has participated in an investigational drug trial 30 days prior totrial enrollment.

  • Females who are breastfeeding, and/or who have a positive pregnancy test prior totrial enrollment, or females who are planning to become pregnant during the trial. Noclinical trials have been conducted on the use of ABILIFY MYCITE during pregnancy orbreastfeeding.

  • Patients who do not have skin on the anterior chest just above the lower edge of therib cage that is free of any dermatological problems (e.g., dermatosis or dermatitis,open wounds, or other skin disorders such as warts, rashes, atopic dermatitis, orirritations).

  • Patients who are unwilling to refrain from the use of topical products on the skinpatch sites.

  • Has 2 or more errors on the brief, 6-item cognitive screener administered at baseline.

  • <20% Proportion of Days Covered (PDC) Aripiprazole over the last 6 months prior toenrollment. This is to ensure that all individuals enrolled will have at least filledtheir Aripiprazole prescription.

Study Design

Total Participants: 46
Study Start date:
April 04, 2019
Estimated Completion Date:
November 30, 2021

Study Description

This is a phase 4, 12-month, pragmatic trial designed to assess adherence in patients using ABILIFY MYCITE versus patients receiving treatment as usual (TAU). Both groups will complete surveys at baseline, 90, 180, and 360 days and will receive care at the discretion of their physician. The usual care group will not receive the ABILIFY MYCITE intervention. The primary outcome will assess refill rates at 6 months.

Eligible patients will enroll at their screening/baseline visit and ABILIFY MYCITE onboarding will be provided in the clinic, with commercial informational materials and additional call center support. Patients will then initiate 3 months of treatment with ABILIFY MYCITE at the baseline visit. At the Day 90 visit, patients will have the opportunity to either stop or continue using ABILIFY MYCITE for the remainder of the study (9 months). This decision must be a joint decision with the patient and his or her treating physician. During this optional interventional phase, patients may start and stop ABILIFY MYCITE as clinically indicated.

All enrolled patients will have required in-person visits at baseline, 90-days, and 180-days. The day 360 (final) visit can be in-person or via telephone.

Medical and actual pharmacy dispensing data will be collected from day 1 through day 360 using the VA's electronic medical record system.

Connect with a study center

  • Durham VA Medical Center

    Durham, North Carolina 27705
    United States

    Site Not Available

  • Michael E. DeBakey VA Medical Center

    Houston, Texas 77030
    United States

    Site Not Available

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