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N/A N=75 Randomized Single-blind

Patient-Centered Medication Adherence Intervention for Schizophrenia

Schizophrenia

Enrolled (actual)
75
Serious AEs
0.0%
Results posted
Dec 2014
Primary outcome: Primary: Antipsychotic Medication Adherence — 63.9; 75.0 percentage of participants — p=0.03

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Antipsychotic medication adherence intervention (Behavioral)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
US Department of Veterans Affairs
Primary completion
Jun 2009

Outcome Measures

OutcomeResultp-value
PRIMARY
Antipsychotic Medication Adherence
63.9; 75.0 0.03 sig

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 patient's 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.

Eligibility Criteria

Inclusion Criteria

  • medical chart diagnosis of schizophrenia or schizoaffective disorder;
  • currently prescribed outpatient antipsychotic medication (oral or depot);
  • patient must have adequate capacity to provide informed consent, understand the nature of the study, and sign an informed consent document.

Exclusion Criteria

  • significant cognitive impairment as indicated by a score > 10 on the Blessed Orientation-Memory-Concentration (BOMC) Test.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00144027). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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