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Patient-Centered Medication Adherence Intervention for Schizophrenia

Patient-Centered Medication Adherence Intervention for Schizophrenia

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00144027
Acronym
AMAIS
Enrollment
75
Registered
2005-09-02
Start date
2004-12-31
Completion date
2009-07-31
Last updated
2015-04-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizophrenia

Keywords

patient non-adherence, intervention studies

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 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.

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 test/re-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).

Interventions

BEHAVIORALAntipsychotic medication adherence intervention

The medication adherence intervention will include using a computer to complete a brief set of questions related to medication adherence before mental health clinic visits.

Sponsors

US Department of Veterans Affairs
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Antipsychotic Medication Adherence6-monthsThe self-report adherence measure asked patients to think about the past four weeks and report to what extent they took their medication for mental, emotional, or nervous problems and report the result on a 5-point Likert scale ranging from 'I never missed taking my medicine' to 'I stopped taking the medicine altogether'. Patients who received depot injections were asked to think about the past six months. Self-report adherence was defined as 1=I never missed taking my medicine' and 0=any other response to the medication adherence question.

Countries

United States

Participant flow

Participants by arm

ArmCount
Control/No Intervention
The control group will receive treatment as usual; meaning patients in the control group will not receive the medication adherence intervention.
39
Intervention Group
Antipsychotic medication adherence intervention: The medication adherence intervention will include using a computer to complete a brief set of questions related to medication adherence before mental health clinic visits. The patient will receive a hard copy summary of their responses (top 3 barriers and top 3 facilitators and motivators) with brief adherence tips which are specific to the patient-selected barriers. The provider will received the same information in an electronic health record adherence note.
29
Total68

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall Studydid not complete baseline assessment06
Overall StudyLost to Follow-up13
Overall StudyWithdrawal by Subject22

Baseline characteristics

CharacteristicIntervention GroupTotalControl/No Intervention
Age, Continuous52.9 years
STANDARD_DEVIATION 5.6
53.3 years
STANDARD_DEVIATION 7.3
53.5 years
STANDARD_DEVIATION 8.3
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
22 Participants45 Participants23 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
7 Participants23 Participants16 Participants
Sex: Female, Male
Female
4 Participants7 Participants3 Participants
Sex: Female, Male
Male
25 Participants61 Participants36 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 390 / 30
serious
Total, serious adverse events
0 / 390 / 30

Outcome results

Primary

Antipsychotic Medication Adherence

The self-report adherence measure asked patients to think about the past four weeks and report to what extent they took their medication for mental, emotional, or nervous problems and report the result on a 5-point Likert scale ranging from 'I never missed taking my medicine' to 'I stopped taking the medicine altogether'. Patients who received depot injections were asked to think about the past six months. Self-report adherence was defined as 1=I never missed taking my medicine' and 0=any other response to the medication adherence question.

Time frame: 6-months

Population: Percent of participants who reported never missed taking my medication at 6-months

ArmMeasureValue (NUMBER)
Control/No InterventionAntipsychotic Medication Adherence63.9 percentage of participants
Intervention GroupAntipsychotic Medication Adherence75.0 percentage of participants
p-value: 0.0395% CI: [1.21, 47.53]Regression, Logistic

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026