SchizophreniaSMSNCT00873249
Effect of Daily Short Message System (SMS) Reminders on Medication Adherence to Oral Antipsychotics in Patients With Schizophrenia
An observational study of Schizophrenia, run by AstraZeneca at 25 sites in Spain.
Trial summary
This study is a 6-month, multicenter, randomized study to assess the effect of daily SMS reminders sent during 3 months in the adherence to oral antipsychotic treatment in stabilized outpatients with schizophrenia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Schizophrenia
- How many people
- 339 participants
- Where
- 25 sitesSpain
- Study dates
- Apr 2009to Mar 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Stabilized outpatients with a diagnosis of schizophrenia
Who may be able to join
- Male or female patients older than 18 years
- With a diagnosis of schizophrenia (DSM-IV TR criteria)
- Stabilized out-patients
- Under oral antipsychotic monotherapy
Who cannot join
- Administration of a depot antipsychotic drug
- Suicide risk
Trial locations and contacts
25 sites in 1 country.
25 sites in 1 country
Spain25 sites
Research Site
Alicante, Alicante
Research Site
Almería, Almeria
Research Site
Barcelona, Barcelona
Research Site
Berga, Barcelona
Research Site
Burgos, Burgos
Research Site
Calatayud, Zaragoza
Research Site
Córdoba, Cordoba
Research Site
Granada, Granada
Research Site
León, Leon
Research Site
Lleida, Lerida
Research Site
Madrid, Madrid
Research Site
Málaga, Malaga
Research Site
Murcia, Murcia
Research Site
Oviedo, Oviedo
Research Site
Palma Mallorca, Palma Mallorca
Research Site
Pamplona, Navarre
Research Site
Sabadell, Barcelona
Research Site
Salamanca, Salamanca
Research Site
Santander, Cantabria
Research Site
Seville, Sevilla
Research Site
Tarragona, Tarragona
Research Site
Toledo, Toledo
Research Site
Valencia, Valencia
Research Site
Valladolid, Valladolid
Research Site
Zamora, Zamora
About this study
Official title: Effect of Daily SMS Reminders on Medication Adherence to Oral Antipsychotics in Patients With Schizophrenia
This study is a 6-month, multicenter, randomized study to assess the effect of daily SMS reminders sent during 3 months in the adherence to oral antipsychotic treatment in stabilized outpatients with schizophrenia.
- Conditions
- Schizophrenia
- Keywords
- Schizophrenia, Therapeutic adherence, Short message system, Mobile phone
- Medical subject headings
- Schizophrenia, Treatment Adherence and Compliance
What is being measured
The primary outcome is the main question the study is designed to answer.
Morisky Green Questionnaire
Measured: baseline, at months 3 and 6
Secondary outcomes (2)
Clinical Global Impression- Schizophrenia (CGI-SCH)
Measured: baseline, at months 3 and 6
Register of Adherence to Treatment (RAT)
Measured: baseline, at months 3 and 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2009 (estimated)
- Study startApr 2009
- Primary completionMar 2010
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 339 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00873249
- Sponsor's protocol ID
- NIS-NES-DUM-2007/3
- Acronym
- SMS
- Status last verified
- Mar 2010
- First submitted
- 31 Mar 2009
- Last updated
- 24 Mar 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Daily SMS Reminders on Medication Adherence to Oral Antipsychotics in Patients With Schizophrenia
- ClinicalTrials.gov ID
- NCT00873249
- Acronym / sponsor ID
- SMS / NIS-NES-DUM-2007/3
- Conditions
- Schizophrenia
- Keywords
- Schizophrenia, Therapeutic adherence, Short message system, Mobile phone
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 339 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Apr 2009
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 1 Apr 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a 6-month, multicenter, randomized study to assess the effect of daily SMS reminders sent during 3 months in the adherence to oral antipsychotic treatment in stabilized outpatients with schizophrenia.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Stabilized outpatients with a diagnosis of schizophrenia
Key inclusion criteria (4 listed)
- Male or female patients older than 18 years
- With a diagnosis of schizophrenia (DSM-IV TR criteria)
- Stabilized out-patients
- Under oral antipsychotic monotherapy
Key exclusion criteria (2 listed)
- Administration of a depot antipsychotic drug
- Suicide risk
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Morisky Green Questionnaire
Time frame: baseline, at months 3 and 6
2 secondary outcomes
Clinical Global Impression- Schizophrenia (CGI-SCH)
Time frame: baseline, at months 3 and 6
Register of Adherence to Treatment (RAT)
Time frame: baseline, at months 3 and 6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2010.
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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.
The record lists no contact. Use the official record to reach the sponsor.
25 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Schizophrenia, run by AstraZeneca at 25 sites in Spain.
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 4 inclusion and 2 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 24 Mar 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in Spain. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Morisky Green Questionnaire (time frame: baseline, at months 3 and 6). 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 24 Mar 2010.