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Financial Incentives to Improve Medication Adherence

Primary Purpose

Schizophrenia, Schizo Affective Disorder, Bipolar Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Wellth - Financial Incentives
Sponsored by
Northwell Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Schizophrenia focused on measuring financial incentives, medication adherence, severe mental illness

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  1. Acute anger to self or others as per investigator assessment
  2. Unwilling or unable to participate

Sites / Locations

  • The Zucker Hillside Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Active

Arm Description

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

Outcomes

Primary Outcome Measures

Change in medication adherence rate
Adherence rate will be measured as pills missed/pills prescribed

Secondary Outcome Measures

Full Information

First Posted
December 2, 2019
Last Updated
September 15, 2023
Sponsor
Northwell Health
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1. Study Identification

Unique Protocol Identification Number
NCT04191876
Brief Title
Financial Incentives to Improve Medication Adherence
Official Title
Financial Incentives to Improve Medication Adherence: a Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
November 1, 2019 (Actual)
Primary Completion Date
May 30, 2020 (Actual)
Study Completion Date
March 2, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Northwell Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Schizo Affective Disorder, Bipolar Disorder, Depression
Keywords
financial incentives, medication adherence, severe mental illness

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active
Arm Type
Experimental
Arm Description
This study has only one arm. All patients enrolled will take part in the experimental arm.
Intervention Type
Other
Intervention Name(s)
Wellth - Financial Incentives
Intervention Description
Patients who are willing to participate will be offered financial incentives for medication adherence through an app (Wellth) over 10 weeks.
Primary Outcome Measure Information:
Title
Change in medication adherence rate
Description
Adherence rate will be measured as pills missed/pills prescribed
Time Frame
Between baseline and study completion (10 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: Acute anger to self or others as per investigator assessment Unwilling or unable to participate
Facility Information:
Facility Name
The Zucker Hillside Hospital
City
Glen Oaks
State/Province
New York
ZIP/Postal Code
11004
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
36222818
Citation
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.
Results Reference
derived

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Financial Incentives to Improve Medication Adherence

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