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

NCT ID: NCT03881449

Last Updated: 2020-06-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-04
• Study Completion Date: 2021-11-30

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.

Conditions

Schizophrenia; Major Depressive Disorder; Bi-Polar Disorder; Schizo Affective Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ABILIFY MYCITE Group

If patients are assigned to the ABILIFY MYCITE treatment group, the patients and physician will initiate the system at the baseline visit, and continue to use the system for 3 months. At any time after the first 3 months, a patient and his or her doctor will have the opportunity to either discontinue or continue using ABILIFY MYCITE for the remainder of the trial (9 additional months; 12 months total) as long as clinically appropriate with the goal of measuring adherence to improve clinical decision-making and care.

Both ABILIFY MYCITE and TAU participants will complete a battery of questions related to quality of life, patient usability/satisfaction, etc. at baseline, 3, 6 and 12 months.

Group Type: EXPERIMENTAL

ABILIFY MYCITE

Intervention Type: COMBINATION_PRODUCT

Initiation of ABILIFY MYCITE will commence immediately, with subjects wearing the patch and using the smartphone app for a total of 3 months from baseline visit to the 3 month visit. Following the initial 90-days, the physician and patient may determine to use ABILIFY MYCITE anytime during the following 9 months. Following this period (up to 12 months), the subjects will not use ABILIFY MYCITE and return to standard care. A safety follow-up phone call will occur at 2 weeks after the 12 month/early termination (ET) visit. In addition, individuals in the ABILIFY MYCITE arm will evaluate satisfaction with the use of ABILIFY MYCITE.

Treatment as Usual (TAU) Group

TAU patients will continue receiving care as recommended by their physician which will include the use of Aripiprazole according to the approved labels.

Both ABILIFY MYCITE and TAU participants will complete a battery of questions related to quality of life, patient usability/satisfaction, etc. at baseline, 3, 6 and 12 months.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

ABILIFY MYCITE

Initiation of ABILIFY MYCITE will commence immediately, with subjects wearing the patch and using the smartphone app for a total of 3 months from baseline visit to the 3 month visit. Following the initial 90-days, the physician and patient may determine to use ABILIFY MYCITE anytime during the following 9 months. Following this period (up to 12 months), the subjects will not use ABILIFY MYCITE and return to standard care. A safety follow-up phone call will occur at 2 weeks after the 12 month/early termination (ET) visit. In addition, individuals in the ABILIFY MYCITE arm will evaluate satisfaction with the use of ABILIFY MYCITE.

Intervention Type: COMBINATION_PRODUCT

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Otsuka Pharmaceutical Development and Commercialization, Inc.

UNKNOWN

Sponsor Role: collaborator

Durham VA Medical Center

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hayden Bosworth, PhD

Role: PRINCIPAL_INVESTIGATOR

Durham VA Medical Center

Locations

Durham VA Medical Center

Durham, North Carolina, United States

Michael E. DeBakey VA Medical Center

Houston, Texas, United States

Countries

United States

References

Gonzales S, Okusaga OO, Reuteman-Fowler JC, Oakes MM, Brown JN, Moore S, Lewinski AA, Rodriguez C, Moncayo N, Smith VA, Malone S, List J, Cho RY, Jeffreys AS, Bosworth HB. Digital Medicine System in Veterans With Severe Mental Illness: Feasibility and Acceptability Study. JMIR Form Res. 2022 Dec 22;6(12):e34893. doi: 10.2196/34893.

Reference Type: DERIVED

PMID: 36548028 (View on PubMed)

Other Identifiers

02188

Identifier Type: -

Identifier Source: org_study_id