NCT00523029

Brief Summary

This study seeks to adapt an existing chronic disease self-management program for people with both chronic medical illness and depression.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
104

participants targeted

Target at P50-P75 for not_applicable depression

Timeline
Completed

Started Feb 2006

Typical duration for not_applicable depression

Geographic Reach
1 country

2 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

Study Start

First participant enrolled

February 1, 2006

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

August 28, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 30, 2007

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
Last Updated

December 10, 2013

Status Verified

December 1, 2013

Enrollment Period

2.3 years

First QC Date

August 28, 2007

Last Update Submit

December 9, 2013

Conditions

Keywords

Self-management programsChronic medical illness

Outcome Measures

Primary Outcomes (3)

  • PRIME-MD Patient Health Questionnaire (PHQ-9)

    Measured at Week 8

  • Qualitative interviews of participants and leaders

    Measured at Week 8

  • Post-intervention assessments, including self-efficacy, health behaviors, health status, and service utilization

    Measured at Week 8

Study Arms (1)

1

EXPERIMENTAL

Participants will receive a chronic disease self-management program

Behavioral: Chronic Disease Self-Management Program

Interventions

Chronic disease self-management is a 6-week group program that teaches participants how to manage their chronic medical illness. Group leaders, also suffering from a chronic medical condition, will lead discussions based on the following topics: nutrition; exercise; appropriate use of medications; ways to communicate effectively with family, friends, and health care professionals; and how to make informed treatment decisions.

1

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Currently attending the Edward R. Roybal Comprehensive Health Center or the LAC+USC Outpatient Department for primary care
  • English- or Spanish-speaking
  • Screens positive for major depressive disorder or minor depression based on the PRIME MD PHQ-9
  • Suffers from a chronic medical illness (e.g., lung disease, asthma, emphysema or trouble breathing; heart disease or heart problems; high blood sugar or diabetes; arthritis or rheumatism)
  • Prior experience facilitating a chronic disease self-management program within 6 to 9 months of study entry (including the groups held at Roybal Comprehensive Health Center)

You may not qualify if:

  • Acutely suicidal
  • Screens positive for bipolar disorder, psychotic disorder, or cognitive impairment disorder
  • History of alcohol or drug abuse

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Edward R. Roybal Comprehensive Health Center

Los Angeles, California, 90022, United States

Location

LAC and USC Medical Center, Outpatient Department

Los Angeles, California, 90033, United States

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Isabel T. Lagomasino, MD, MSHS

    University of Southern California

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Study Principal Investigator

Study Record Dates

First Submitted

August 28, 2007

First Posted

August 30, 2007

Study Start

February 1, 2006

Primary Completion

June 1, 2008

Study Completion

June 1, 2008

Last Updated

December 10, 2013

Record last verified: 2013-12

Locations