Ignite Creation Date:
2024-05-06 @ 2:03 AM
Last Modification Date:
2024-10-26 @ 11:13 AM
Study NCT ID:
NCT01953237
Status:
COMPLETED
Last Update Posted:
2019-08-28
First Post:
2013-09-25
Brief Title:
MedActive A Smartphone Intervention to Improve Adherence to Antipsychotic Medications
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
MedActive A Smartphone Intervention to Improve Adherence to Antipsychotic Medications
Status:
COMPLETED
Status Verified Date:
2019-08
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:
None
Brief Summary:
We propose to develop and pilot test the effect of a mobile smartphone intervention MedActive on improving antipsychotic adherence among individuals with schizophrenia
Detailed Description:
Up to 60 of individuals with schizophrenia do not take their antipsychotic medications as prescribed which can lead to symptom relapse decreased functioning hospitalization and increased healthcare costs Recent studies of both patient- and pharmacy-based interventions utilizing behavioral tailoring environmental supports and medication monitoring have shown promise in improving antipsychotic adherence However there is continued need for effective adherence-enhancing interventions AEIs that are less resource intensive and more widely accessible by the broad range of individuals in need of assistance with medication management Over the last decade technological advances in internet and cellular communication including the emergence of mobile smartphones have revolutionized the way our society communicates Whereas a variety of mobile phone-based applications have been shown to be effective for improving health outcomes such as medication adherence for a number of medical conditions few such applications have been developed for individuals with schizophrenia Therefore in response to NIMH PAR-09-173 we propose to develop and pilot test the effect of a mobile smartphone intervention MedActive on improving antipsychotic adherence among this population We used the Information-Motivation-Behavioral IMB Skills Model of adherence as the theoretical framework to inform the conceptualization of MedActive The IMB Skills Model posits that individuals who are well-informed and motivated to adhere will enact adherence-related behavioral skills that lead to adherence behaviors and favorable health outcomes MedActive will provide personalized reminders to patients to take their antipsychotic medications as prescribed and will query them about their intentions to take the medication the occurrence of side effects and the presence of positive psychotic symptoms Summaries of these ecological momentary assessments of adherence symptoms and side effects will be made available to the individual on the phone and to their psychiatrist through a secure online clinician interface Using an iterative user-centered design approach the specific aims of this proposal are to 1 collaborate with individuals with schizophrenia psychiatrists and an expert advisory group to develop the initial version of MedActive 2 conduct laboratory usability testing and a short-term field trial in 10 individuals with schizophrenia and their psychiatrists to determine the preliminary acceptability and feasibility of MedActive in clinical practice and 3 conduct a randomized pilot trial of MedActive compared to providing a smartphone alone in 40 individuals with schizophrenia and their psychiatrists to evaluate its effect on antipsychotic adherence We will also explore whether psychiatric symptoms and neuropsychological impairments moderate the effect of MedActive on adherence If shown to be effective MedActive will introduce a paradigm shift in medication self-management by individuals with schizophrenia and in treatment monitoring by their clinicians
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