SchizophreniaNCT04191876
Financial Incentives to Improve Medication Adherence
A study testing Wellth - Financial Incentives in people with Schizophrenia and Schizo Affective Disorder, run by Northwell Health at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Schizophrenia, Schizo Affective Disorder, Bipolar Disorder
- What is being tested?
- Wellth - Financial Incentives
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2019to 2 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Acute anger to self or others as per investigator assessment
- Unwilling or unable to participate
Trial locations and contacts
1 site in 1 country.
United States1 site
The Zucker Hillside Hospital
Glen Oaks, New York, 11004
About this study
Official title: Financial Incentives to Improve Medication Adherence: a Pilot Study
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.
- Conditions
- Schizophrenia, Schizo Affective Disorder, Bipolar Disorder, Depression
- Being tested
- Wellth - Financial Incentives
- Keywords
- financial incentives, medication adherence, severe mental illness
- Medical subject headings
- Schizophrenia, Psychotic Disorders, Bipolar Disorder, Depression, Medication Adherence, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wellth - Financial IncentivesOther
Patients who are willing to participate will be offered financial incentives for medication adherence through an app (Wellth) over 10 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Active | Experimental | This study has only one arm. All patients enrolled will take part in the experimental arm. Receives: Other: Wellth - Financial Incentives |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in medication adherence rate
Adherence rate will be measured as pills missed/pills prescribed
Measured: Between baseline and study completion (10 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2019
- Study start1 Nov 2019
- Primary completion30 May 2020
- Study completion2 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04191876
- Sponsor's protocol ID
- 19-0739-ZHH
- Status last verified
- Sep 2023
- First submitted
- 2 Dec 2019
- Last updated
- 21 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36222818
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Financial Incentives to Improve Medication Adherence: a Pilot Study
- ClinicalTrials.gov ID
- NCT04191876
- Acronym / sponsor ID
- 19-0739-ZHH
- Conditions
- Schizophrenia, Schizo Affective Disorder, Bipolar Disorder, Depression
- Keywords
- financial incentives, medication adherence, severe mental illness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 30 May 2020 (actual)
- Study completion
- 2 Mar 2022 (actual)
- First posted
- 10 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Active | Experimental | Other: Wellth - Financial IncentivesThis study has only one arm. All patients enrolled will take part in the experimental arm. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- Acute anger to self or others as per investigator assessment
- Unwilling or unable to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wellth - Financial IncentivesPatients who are willing to participate will be offered financial incentives for medication adherence through an app (Wellth) over 10 weeks. | Other | Active |
Primary outcome
Change in medication adherence rate
Time frame: Between baseline and study completion (10 weeks)
Adherence rate will be measured as pills missed/pills prescribed
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
- Derived from this study: PubMed 36222818Guinart 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wellth - Financial Incentives in people with Schizophrenia and Schizo Affective Disorder, run by Northwell Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in medication adherence rate (time frame: Between baseline and study completion (10 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04191876, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2023.