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

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ClinicalTrials.gov Identifier: NCT03881449
Recruitment Status : Active, not recruiting
First Posted : March 19, 2019
Last Update Posted : June 18, 2020
Sponsor:
Collaborator:
Otsuka Pharmaceutical Development and Commercialization, Inc.
Information provided by (Responsible Party):
Durham VA Medical Center

Tracking Information
First Submitted Date  ICMJE February 19, 2019
First Posted Date  ICMJE March 19, 2019
Last Update Posted Date June 18, 2020
Actual Study Start Date  ICMJE April 4, 2019
Estimated Primary Completion Date January 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 18, 2019)
Aripiprazole refills [ Time Frame: 6 months ]
Aripiprazole refill as operationalized as a continuous measure of the number of days covered over the baseline to 6 month period
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 18, 2019)
  • Population Proportion of Days Covered (PDC) [ Time Frame: 12 months ]
    The secondary outcomes of medication adherence (to Aripiprazole and other psychotic medications), defined as a binary indicators that PDC ≥ 80% for the prior 30-day period, are collected at baseline, 3, 6, and 12 months.
  • Days in acute care settings [ Time Frame: 12 months ]
    The measure of days in acute care (i.e., days not in the community) over the 12-month outcomes interval defined as the total number of days in the ED or inpatient ward.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE DIMES - DIgital MEdicine Study for Adults With Schizophrenia, Bipolar I Disorder, or Major Depression Currently Using Aripiprazole
Official Title  ICMJE 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
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Schizophrenia
  • Major Depressive Disorder
  • Bi-Polar Disorder
  • Schizo Affective Disorder
Intervention  ICMJE Combination Product: 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.
Study Arms  ICMJE
  • Experimental: 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.

    Intervention: Combination Product: ABILIFY MYCITE
  • No Intervention: 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.

Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: June 17, 2020)
46
Original Estimated Enrollment  ICMJE
 (submitted: March 18, 2019)
300
Estimated Study Completion Date  ICMJE November 2021
Estimated Primary Completion Date January 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03881449
Other Study ID Numbers  ICMJE 02188
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Durham VA Medical Center
Study Sponsor  ICMJE Durham VA Medical Center
Collaborators  ICMJE Otsuka Pharmaceutical Development and Commercialization, Inc.
Investigators  ICMJE
Principal Investigator: Hayden Bosworth, PhD Durham VA Medical Center
PRS Account Durham VA Medical Center
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP