SchizophreniaNCT01953237
MedActive: A Smartphone Intervention to Improve Adherence to Antipsychotic Medications
A study testing MedActive and Smartphone in people with Schizophrenia, run by University of Maryland, Baltimore at 1 site in United States.
Trial summary
We propose to develop and pilot test the effect of a mobile smartphone intervention, MedActive, on improving antipsychotic adherence among individuals with schizophrenia. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- MedActive and Smartphone
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2013to Dec 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- Has visual, hearing, voice, or motor impairment that would prevent completion of study procedures or use of mobile phone
Trial locations and contacts
1 site in 1 country.
United States1 site
Outpatient clinics within the University of Maryland Division of Community Psychiatry
Baltimore, Maryland, 21201
About this study
We propose to develop and pilot test the effect of a mobile smartphone intervention, MedActive, on improving antipsychotic adherence among individuals with schizophrenia.
Read the 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.
- Conditions
- Schizophrenia
- Being tested
- MedActive, Smartphone
- Keywords
- Schizophrenia, antipsychotic medication adherence, mobile phones
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MedActiveBehavioural
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.
SmartphoneDevice
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | 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. Receives: Device: Smartphone |
| MedActive | Experimental | 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. Receives: Behavioral: MedActive |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to Antipsychotic Medications
A measure of the extent to which participants self-reported taking their antipsychotic medications as prescribed
Measured: 3 month period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2013 (estimated)
- Study startSep 2013
- Primary completionSep 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Julie Kreyenbuhl, University of Maryland, Baltimore
- Investigators
- Julie A Kreyenbuhl, Pharm.D PhD, Principal investigator, University of Maryland, College Park
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01953237
- Sponsor's protocol ID
- HP-00059272
- Status last verified
- Aug 2019
- First submitted
- 25 Sep 2013
- Last updated
- 28 Aug 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MedActive: A Smartphone Intervention to Improve Adherence to Antipsychotic Medications
- ClinicalTrials.gov ID
- NCT01953237
- Acronym / sponsor ID
- HP-00059272
- Conditions
- Schizophrenia
- Keywords
- Schizophrenia, antipsychotic medication adherence, mobile phones
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Sep 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 30 Sep 2013 (estimated)
- Results
- Posted 19 Dec 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Device: SmartphoneIndividuals 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. |
| MedActive | Experimental | Behavioral: MedActiveParticipants 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. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (1 listed)
- Has visual, hearing, voice, or motor impairment that would prevent completion of study procedures or use of mobile phone
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MedActiveParticipants 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. | Behavioural | MedActive |
| Smartphone | Device | Control |
Primary outcome
Adherence to Antipsychotic Medications
Time frame: 3 month period
A measure of the extent to which participants self-reported taking their antipsychotic medications as prescribed
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julie A Kreyenbuhl, Pharm.D PhD principal investigator
University of Maryland, College Park
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MedActive and Smartphone in people with Schizophrenia, run by University of Maryland, Baltimore at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Dec 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence to Antipsychotic Medications (time frame: 3 month period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2019.