NCT04191876

Brief Summary

Medication adherence is a challenge in all of medicine and is associated with multiple negative outcomes. Strategies to better measure and enhance adherence to medication are urgent and necessary to minimize unwanted health outcomes, hospitalizations, poorer quality of life and excessive costs for individuals, insurers and caregivers. Recently, behavioral economics-based approaches have emerged as a promising tool to address this unmet need, but its effectiveness in oral antipsychotic treatment remains to be assessed. For this project, investigators will use an app that offers financial incentives to increase compliance for patients with chronic diseases. Investigators intend to enroll 25 patients in a pilot project to assess feasibility of offering financial incentives to improve medication adherence in severe mental illness.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable schizophrenia

Timeline
Completed

Started Nov 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2019

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 2, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 10, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2020

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 2, 2022

Completed
Last Updated

September 21, 2023

Status Verified

September 1, 2023

Enrollment Period

7 months

First QC Date

December 2, 2019

Last Update Submit

September 15, 2023

Conditions

Keywords

financial incentivesmedication adherencesevere mental illness

Outcome Measures

Primary Outcomes (1)

  • Change in medication adherence rate

    Adherence rate will be measured as pills missed/pills prescribed

    Between baseline and study completion (10 weeks)

Study Arms (1)

Active

EXPERIMENTAL

This study has only one arm. All patients enrolled will take part in the experimental arm.

Other: Wellth - Financial Incentives

Interventions

Patients who are willing to participate will be offered financial incentives for medication adherence through an app (Wellth) over 10 weeks.

Active

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Psychiatric patients with suspected or confirmed poor oral medication adherence.
  • Age 18-80 years old
  • English speaking, since the app being used is only available in English
  • Owning a Smartphone, since the app requires a Smartphone to work
  • Willing and able to participate.

You may not qualify if:

  • Acute anger to self or others as per investigator assessment
  • Unwilling or unable to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Zucker Hillside Hospital

Glen Oaks, New York, 11004, United States

Location

Related Publications (1)

  • Guinart D, Sobolev M, Patil B, Walsh M, Kane JM. A Digital Intervention Using Daily Financial Incentives to Increase Medication Adherence in Severe Mental Illness: Single-Arm Longitudinal Pilot Study. JMIR Ment Health. 2022 Oct 12;9(10):e37184. doi: 10.2196/37184.

MeSH Terms

Conditions

SchizophreniaPsychotic DisordersBipolar DisorderDepressionMedication AdherenceMental Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersBipolar and Related DisordersMood DisordersBehavioral SymptomsBehaviorPatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth Behavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 2, 2019

First Posted

December 10, 2019

Study Start

November 1, 2019

Primary Completion

May 30, 2020

Study Completion

March 2, 2022

Last Updated

September 21, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations