Automated Telephone System to Improve Treatment Adherence... | NCT00136240

Studies
Automated Telephone System to Improve Treatment Adherence in People With Depression

NCT00136240

Sponsor

Boston Medical Center

Status

Completed

Last Update Posted

Jul 25, 2013Estimated

Enrollment

144

Phase

Not Applicable

Conditions

Depression

Interventions

Computer Assisted Education for Behavior Change

Countries

United States

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

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

ID	Type	Description	Link
R21MH063937	U.S. NIH Grant/Contract		View source
DAHBR HB-A

Status Module

Record Verification Date

Aug 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2003

Primary Completion Date

Jan 2006Actual

Completion Date

Jan 2006Actual

First Submitted Date

Aug 25, 2005

First Submission Date that Met QC Criteria

Aug 25, 2005

First Posted Date

Aug 29, 2005Estimated

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

Jul 24, 2013

Last Update Posted Date

Jul 25, 2013Estimated

Name	Class
National Institute of Mental Health (NIMH)	NIH

Description Module

Brief Summary

This study will determine the efficacy of a computerized telephone system called Telephone-Linked Care (TLC) in improving adherence to antidepressant medication regimens in people with depression.

Detailed Description

The purpose of this study is to test the efficacy of a computerized telephone system called TLC (Telephone-Linked Care) in helping subjects adhere to their antidepressant medication regimens.

Design Module

Study Type

Interventional

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 Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

144

Name	Type	Description	Arm Group Labels	Other Names
Computer Assisted Education for Behavior Change	Behavioral

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Antidepressant medication adherence		Measured monthly for 4 months
Adherence to scheduled psychiatry clinic visits		Measured monthly for 4 months

Secondary Outcomes

Measure	Description	Time Frame
Depression status, measured by self-administered depression inventory scale		Measured at baseline and at 4 month follow-up
General health status, measured by self-rating health survey		Measured at baseline and at 4 month follow-up

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

A clinical diagnosis of major depressive disorder, dysthymic disorder, depressive disorder not otherwise specified, or any combination of the three
Prescribed at least one antidepressant medication
Access to a telephone with touch-tone service
Speak and understand conversational English

Exclusion Criteria:

Current significant alcohol or drug abuse
Clinical diagnosis of bipolar disorder, schizoaffective disorder, or significant personality disorder
Parkinson's disease, Huntington's disease, amyotrophic lateral sclerosis (ALS), or other neurodegenerative diseases
Alzheimer's disease and other dementia
Cancer, undergoing radiation therapy or chemotherapy
Suffering from Renal disease or on dialysis
Immunologic disorder (rheumatoid arthritis, systemic lupus erythematosus [SLE], etc.)
HIV
Terminal illness
Homeless
Legally blind
Planning to leave the geographic area during the study period

Accepts Healthy Volunteers

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

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ramesh Farzanfar	Boston University	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Boston Medical Center		Boston	Massachusetts	02118	United States

ID	Term
D001526	Behavioral Symptoms
D001519	Behavior