Clinical trial NCT03881449: DIMES - DIgital MEdicine Study for Adults With Schizophrenia, Bipolar I Disorder, or Major Depression Currently Using Aripiprazole
Official title: A Multicenter, 52-week, Provider- Randomized, Pragmatic Trial to Assess the Differences in ABILIFY MYCITE - a Digital Medicine System (DMS) Versus Treatment as Usual (TAU) for Adults With Schizophrenia, Bipolar I Disorder, or Major Depression Currently Using Aripiprazole
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Schizophrenia
Major Depressive Disorder
Bi-Polar Disorder
Schizo Affective Disorder
Keywords: digital medicine
Lead sponsor: Durham VA Medical Center
Sponsor class: FED
Collaborators: name: Otsuka Pharmaceutical Development and Commercialization, Inc.
First posted: 2019-03-19
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is an open-label 2-site (Durham and Houston Veterans Affairs (VA) Health Care Systems), provider randomized, prospective 2-arm (intervention vs. TAU) pragmatic trial. We will enroll 300 adult patients with schizophrenia, bipolar I disorder, or major depressive disorder currently being treated with oral Aripiprazole from either the Durham, North Carolina or Houston, Texas Veterans Affairs (VA) Health Care System.
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* Patients aged 18 years of age or older.
* Patients with a primary diagnosis of schizophrenia (including schizoaffective disorder), bipolar I disorder, or major depressive disorder based on the Diagnostic Statistical 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 to enter an interventional trial per investigator judgment.
* Patients deemed fit for participation in the study by verbal or written confirmation from their mental health provider

Exclusion Criteria:

* Patients with a current neurocognitive disorder (i.e. dementia), intellectual disorder, or any other diagnosis that could impact the patient's ability to participate in the trial.
* Any patient who, in the opinion of the patient's mental health provider, study physician or investigator, is unfit to participate in the trial.
* Any patient who has participated in an investigational drug trial 30 days prior to trial enrollment.
* Females who are breastfeeding, and/or who have a positive pregnancy test prior to trial enrollment, or females who are planning to become pregnant during the trial. No clinical trials have been conducted on the use of ABILIFY MYCITE during pregnancy or breastfeeding.
* Patients who do not have skin on the anterior chest just above the lower edge of the rib 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, or irritations).
* Patients who are unwilling to refrain from the use of topical products on the skin patch 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 to enrollment. This is to ensure that all individuals enrolled will have at least filled their Aripiprazole prescription.

Primary outcomes:
measure: Aripiprazole refills
timeFrame: 6 months
Secondary outcomes:
measure: Population Proportion of Days Covered (PDC)
timeFrame: 12 months
measure: Days in acute care settings
timeFrame: 12 months
Other outcomes:
Locations:
city: Durham
country: United States
facility: Durham VA Medical Center
state: North Carolina
city: Houston
country: United States
facility: Michael E. DeBakey VA Medical Center
state: Texas
Study officials:
affiliation: Durham VA Medical Center
name: Hayden Bosworth, PhD
role: PRINCIPAL_INVESTIGATOR
References: