Effect of Daily Short Message System (SMS) Reminders on M... | NCT00873249 | Trialant

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Effect of Daily Short Message System (SMS) Reminders on M... | NCT00873249 | Trialant

Studies
Effect of Daily Short Message System (SMS) Reminders on Medication Adherence to Oral Antipsychotics in Patients With Schizophrenia

NCT00873249

Sponsor

AstraZeneca

Status

Completed

Last Update Posted

Mar 24, 2010Estimated

Enrollment

339Actual

Phase

Not provided

Conditions

Schizophrenia

Interventions

Not provided

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

NCT00873249

Obsolete or Duplicate NCT IDs

Not provided

Organization Study

NIS-NES-DUM-2007/3

Secondary IDs

Not provided

Brief Title

Effect of Daily Short Message System (SMS) Reminders on Medication Adherence to Oral Antipsychotics in Patients With Schizophrenia

Official Title

Effect of Daily SMS Reminders on Medication Adherence to Oral Antipsychotics in Patients With Schizophrenia

Acronym

SMS

Organization

AstraZenecaINDUSTRY

Status Module

Record Verification Date

Mar 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

No

Start Date

Apr 2009

Primary Completion Date

Mar 2010Actual

Completion Date

Mar 2010Actual

First Submitted Date

Mar 31, 2009

First Submission Date that Met QC Criteria

Mar 31, 2009

First Posted Date

Apr 1, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 23, 2010

Last Update Posted Date

Mar 24, 2010Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

AstraZenecaINDUSTRY

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

No

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Conditions Module

Conditions

Schizophrenia

Keywords

Schizophrenia
Therapeutic adherence
Short message system
Mobile phone

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

339Actual

Arms/Interventions Module

No data available

No data is available for this block.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Morisky Green Questionnaire		baseline, at months 3 and 6

Secondary Outcomes

Measure	Description	Time Frame
Clinical Global Impression- Schizophrenia (CGI-SCH)		baseline, at months 3 and 6
Register of Adherence to Treatment (RAT)		baseline, at months 3 and 6

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Administration of a depot antipsychotic drug
Suicide risk

Accepts Healthy Volunteers

No

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Stabilized outpatients with a diagnosis of schizophrenia

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Alicante	Alicante		Spain
Research Site

References Module

No data available

No data is available for this block.

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

No data available

No data is available for this block.

Not provided

Intervention Model Description

Not provided

Primary Purpose

Not provided

Observational Model

Not provided

Time Perspective

Prospective

Masking Info

No data available

No data is available for this block.

Almería

Almeria

Spain

Research Site

Barcelona

Barcelona

Spain

Research Site

Berga

Barcelona

Spain

Research Site

Sabadell

Barcelona

Spain

Research Site

Burgos

Burgos

Spain

Research Site

Santander

Cantabria

Spain

Research Site

Córdoba

Cordoba

Spain

Research Site

Granada

Granada

Spain

Research Site

León

Leon

Spain

Research Site

Lleida

Lerida

Spain

Research Site

Madrid

Madrid

Spain

Research Site

Málaga

Malaga

Spain

Research Site

Murcia

Murcia

Spain

Research Site

Pamplona

Navarre

Spain

Research Site

Oviedo

Oviedo

Spain

Research Site

Palma Mallorca

Palma Mallorca

Spain

Research Site

Salamanca

Salamanca

Spain

Research Site

Seville

Sevilla

Spain

Research Site

Tarragona

Tarragona

Spain

Research Site

Toledo

Toledo

Spain

Research Site

Valencia

Valencia

Spain

Research Site

Valladolid

Valladolid

Spain

Research Site

Zamora

Zamora

Spain

Research Site

Calatayud

Zaragoza

Spain

ID	Term
D012559	Schizophrenia
D000074822	Treatment Adherence and Compliance

Ancestor Terms

ID	Term
D019967	Schizophrenia Spectrum and Other Psychotic Disorders
D001523	Mental Disorders
D015438	Health Behavior
D001519	Behavior

Browse Leaves

Not provided

Browse Branches

Not provided