NCT03192631

Brief Summary

There is a lack of incentive approach for patients who suffer from schizophrenia yet lack the insight to accept treatment. Most existing approaches involve coercion and involuntary hospitalizations. This study will explore whether patients with poor insight and lacking in competence for treatment decisions will improve their acceptance and adherence of depot injection antipsychotic medication if a financial incentive is offered. Ethical considerations are also explored for this innovative pilot study

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable schizophrenia

Timeline
Completed

Started Jul 2017

Longer than P75 for not_applicable schizophrenia

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 15, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 20, 2017

Completed
11 days until next milestone

Study Start

First participant enrolled

July 1, 2017

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

June 20, 2017

Status Verified

June 1, 2017

Enrollment Period

2.5 years

First QC Date

June 15, 2017

Last Update Submit

June 18, 2017

Conditions

Keywords

financial incentive

Outcome Measures

Primary Outcomes (1)

  • Adherence to depot injection

    The primary outcome is adherence to depot medication during the 18-month study period. Adherence will be measured, objectively, as the percentage of prescribed depot injections actually taken.

    18 months

Secondary Outcomes (12)

  • The time 'delayed' in taking depot

    18 months

  • Clinical status

    18 months

  • Psychosocial status

    18 months

  • Number of involuntary and voluntary hospital admissions

    18 months

  • Number of attempted and completed suicides

    18 months

  • +7 more secondary outcomes

Study Arms (2)

with financial incentive

EXPERIMENTAL

Patients randomized to this arm will start with receiving the financial incentive. Cross-over after 9 months to treatment as usual.

Other: Financial incentive

treatment as usual

NO INTERVENTION

Patients randomized to this arm will start with receiving treatment as usual, cross-over after 9 months to incentive arm.

Interventions

Incentive of $15 Canadian

with financial incentive

Eligibility Criteria

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Priebe S, Burton A, Ashby D, Ashcroft R, Burns T, David A, Eldridge S, Firn M, Knapp M, McCabe R. Financial incentives to improve adherence to anti-psychotic maintenance medication in non-adherent patients - a cluster randomised controlled trial (FIAT). BMC Psychiatry. 2009 Sep 28;9:61. doi: 10.1186/1471-244X-9-61.

MeSH Terms

Conditions

SchizophreniaPsychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Central Study Contacts

Samuel Law, MD; MPH

CONTACT

Arash Nakhost, MD; PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Model Details: Cross-over study of 20 patients randomized to two arms, 9 month before cross-over.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Staff Psychiatrist

Study Record Dates

First Submitted

June 15, 2017

First Posted

June 20, 2017

Study Start

July 1, 2017

Primary Completion

December 31, 2019

Study Completion

December 31, 2021

Last Updated

June 20, 2017

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will not share