Schizophrenia
Conditions
Keywords
Schizophrenia, antipsychotic medication adherence, mobile phones
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.
Interventions
BEHAVIORALMedActive
Participants randomized to the MedActive condition will complete a 1-hour training session on MedActive, which will include ascertaining their antipsychotic administration schedule that will be pre-programmed into the application along with other personalized features. Each participate will be asked to use the medActive application over the following three months. All participants randomized to this condition will also have their antipsychotic medication adherence assessed over the 3-month period.
DEVICESmartphone
Sponsors
University of Maryland, Baltimore
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
* Decisional capacity to provide informed consent * Chart diagnosis of schizophrenia or schizoaffective disorder * Currently prescribed at least one oral antipsychotic medication * Self administers at least one oral antipsychotic medication * 18-64 years of age * English Speaking * Be able to read English
Exclusion criteria
* Has visual, hearing, voice, or motor impairment that would prevent completion of study procedures or use of mobile phone
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adherence to Antipsychotic Medications | 3 month period | A measure of the extent to which participants self-reported taking their antipsychotic medications as prescribed |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Control Individuals randomized to the control condition will be provided with a smartphone free of charge with unlimited use of the phone's voice and internet capabilities. All participants randomized to this condition will also have their antipsychotic medication adherence assessed over the 3-month period. All participants will be contacted by research staff to trouble-shoot problems with the smartphone at the end of the first week, but will receive no additional contact from research staff until the end of the trial. | 10 |
| MedActive Participants randomized to the MedActive condition will complete a 1-hour training session on MedActive, which will include ascertaining their antipsychotic administration schedule that will be pre-programmed into the application along with other personalized features. Each participate will be asked to use the medActive application over the following three months. All participants randomized to this condition will also have their antipsychotic medication adherence assessed over the 3-month period. | 21 |
| Total | 31 |
Baseline characteristics
| Characteristic | MedActive | Total | Control |
|---|---|---|---|
| Age, Continuous | 49.5 years STANDARD_DEVIATION 10.2 | 48.3 years STANDARD_DEVIATION 11.1 | 45.7 years STANDARD_DEVIATION 12.9 |
| Race/Ethnicity, Customized Race Black or African American | 18 Participants | 28 Participants | 10 Participants |
| Race/Ethnicity, Customized Race Multiple races | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Race White | 2 Participants | 2 Participants | 0 Participants |
| Sex: Female, Male Female | 9 Participants | 13 Participants | 4 Participants |
| Sex: Female, Male Male | 12 Participants | 18 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 10 | 0 / 21 |
| serious Total, serious adverse events | 0 / 10 | 0 / 21 |
Outcome results
Primary
Adherence to Antipsychotic Medications
A measure of the extent to which participants self-reported taking their antipsychotic medications as prescribed
Time frame: 3 month period
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Adherence to Antipsychotic Medications | 92.6 percentage of days adherent | Standard Deviation 10.6 |
| MedActive | Adherence to Antipsychotic Medications | 93.4 percentage of days adherent | Standard Deviation 10.3 |
p-value: 0.558Mixed Models Analysis