Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00144027
Status:
COMPLETED
Last Update Posted:
2015-04-24
First Post:
2005-09-01
Brief Title:
Patient-Centered Medication Adherence Intervention for Schizophrenia
Sponsor:
US Department of Veterans Affairs
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Patient-Centered Medication Adherence Intervention for Schizophrenia
Status:
COMPLETED
Status Verified Date:
2014-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AMAIS
Brief Summary:
Efficacious antipsychotic medication treatments for schizophrenia are available however antipsychotic regimens frequently do not achieve their potential because of poor medication adherence To date medication adherence interventions have not been widely adopted or sustained in real-world practice settings One reason for this is the substantial resource investment necessary to implement and sustain available interventions In response to these problems we developed a patient-centered adherence intervention based on patient-identified barriers facilitators and motivators BFMs for medication adherence The intervention includes a BFM survey checklist and preference weighting exercise to determine the patients most important BFM and a brief list of adherence enhancing suggestions Options List tailored to the patient-identified BFMs and compatible with CPRS The long-term objective of this proposed research is to improve antipsychotic medication adherence and clinical outcomes for patients with schizophrenia using a cost-effective medication adherence intervention The short-term objectives are to refine and test a patient-centered medication adherence intervention for VA patients with schizophrenia and specifically to 1 Enhance the feasibility and acceptability of the BFM intervention by reducing the burden on patients and mental health providers through BFM checklist item reduction provider intervention input and patient intervention input We hypothesize that our use of end-user input will result in at least 80 of intervention patients having documentation of a BFM intervention in CPRS 2 Compare the effects of the BFM intervention versus usual care on changes in medication adherence and schizophrenia symptom severity We hypothesize that the intervention will result in a greater medication adherence and b lower schizophrenia symptom severity than usual care 3 Exploratory objective compare the effects of the BFM intervention versus usual care on changes in patient health-related quality of life We hypothesize that the intervention will result in greater health-related quality of life than usual care
Detailed Description:
BFM intervention refinement will be accomplished in five phases Phase one will include reducing the number of items in the BFM checklist by administering the expanded checklist to at least 50 patients with schizophrenia and using the standard psychometric item-reduction strategies to create a shorter checklist In phase two we will conduct mental health provider focus groups to discuss the content of the Options List and the delivery of the intervention In phase three we will automate the BFM intervention using an existing web-based computer touch-screen platform In phase four we will conduct individual patient debriefing interviews with 30 patients to evaluate the understandability of the BFM survey In phase five we will evaluate the testre-test reliability of the survey in a new sample of 30 patients BFM intervention implementation will include a stratified randomization of patients to the BFM intervention or usual care BFM intervention evaluation will include testing the feasibility acceptability and outcomes associated with the intervention versus usual care in a single trial with 200 patients 100 intervention and 100 usual care
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None