Automated Telephone System to Improve Treatment Adherence in People With Depression

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Boston Medical Center
ClinicalTrials.gov Identifier:
NCT00136240
First received: August 25, 2005
Last updated: July 24, 2013
Last verified: August 2008
  Purpose

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.


Condition Intervention
Depression
Behavioral: Computer Assisted Education for Behavior Change

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Official Title: Telecom System to Improve Adherence to Antidepressants

Resource links provided by NLM:


Further study details as provided by Boston Medical Center:

Primary Outcome Measures:
  • Antidepressant medication adherence [ Time Frame: Measured monthly for 4 months ] [ Designated as safety issue: No ]
  • Adherence to scheduled psychiatry clinic visits [ Time Frame: Measured monthly for 4 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Depression status, measured by self-administered depression inventory scale [ Time Frame: Measured at baseline and at 4 month follow-up ] [ Designated as safety issue: No ]
  • General health status, measured by self-rating health survey [ Time Frame: Measured at baseline and at 4 month follow-up ] [ Designated as safety issue: No ]

Estimated Enrollment: 144
Study Start Date: April 2003
Study Completion Date: January 2006
Primary Completion Date: January 2006 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00136240

Locations
United States, Massachusetts
Boston Medical Center
Boston, Massachusetts, United States, 02118
Sponsors and Collaborators
Boston Medical Center
Investigators
Study Director: Ramesh Farzanfar Boston University
  More Information

No publications provided

Responsible Party: Ramesh Farzanfar
ClinicalTrials.gov Identifier: NCT00136240     History of Changes
Other Study ID Numbers: R21 MH63937, R21MH063937, DAHBR HB-A
Study First Received: August 25, 2005
Last Updated: July 24, 2013
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on August 28, 2014