NCT00873249

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
339

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2009

Shorter than P25 for all trials

Geographic Reach
1 country

25 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 31, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 1, 2009

Completed
Same day until next milestone

Study Start

First participant enrolled

April 1, 2009

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
Last Updated

March 24, 2010

Status Verified

March 1, 2010

Enrollment Period

11 months

First QC Date

March 31, 2009

Last Update Submit

March 23, 2010

Conditions

Keywords

SchizophreniaTherapeutic adherenceShort message systemMobile phone

Outcome Measures

Primary Outcomes (1)

  • Morisky Green Questionnaire

    baseline, at months 3 and 6

Secondary Outcomes (2)

  • Clinical Global Impression- Schizophrenia (CGI-SCH)

    baseline, at months 3 and 6

  • Register of Adherence to Treatment (RAT)

    baseline, at months 3 and 6

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Stabilized outpatients with a diagnosis of schizophrenia

You may qualify if:

  • Male or female patients older than 18 years
  • With a diagnosis of schizophrenia (DSM-IV TR criteria)
  • Stabilized out-patients
  • Under oral antipsychotic monotherapy

You may not qualify if:

  • Administration of a depot antipsychotic drug
  • Suicide risk

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (25)

Research Site

Alicante, Alicante, Spain

Location

Research Site

Almería, Almeria, Spain

Location

Research Site

Barcelona, Barcelona, Spain

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Berga, Barcelona, Spain

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Sabadell, Barcelona, Spain

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Burgos, Burgos, Spain

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Santander, Cantabria, Spain

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Córdoba, Cordoba, Spain

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Granada, Granada, Spain

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León, Leon, Spain

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Lleida, Lerida, Spain

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Madrid, Madrid, Spain

Location

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Málaga, Malaga, Spain

Location

Research Site

Murcia, Murcia, Spain

Location

Research Site

Pamplona, Navarre, Spain

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Research Site

Oviedo, Oviedo, Spain

Location

Research Site

Palma Mallorca, Palma Mallorca, Spain

Location

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Salamanca, Salamanca, Spain

Location

Research Site

Seville, Sevilla, Spain

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Tarragona, Tarragona, Spain

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Toledo, Toledo, Spain

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Valencia, Valencia, Spain

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Valladolid, Valladolid, Spain

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Zamora, Zamora, Spain

Location

Research Site

Calatayud, Zaragoza, Spain

Location

MeSH Terms

Conditions

SchizophreniaTreatment Adherence and Compliance

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersHealth BehaviorBehavior

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 31, 2009

First Posted

April 1, 2009

Study Start

April 1, 2009

Primary Completion

March 1, 2010

Study Completion

March 1, 2010

Last Updated

March 24, 2010

Record last verified: 2010-03

Locations