Clinical trial NCT00214474: Improving Diabetes Efforts Across Language and Literacy (IDEALL)
Official title: Improving Diabetes Efforts Across Language and Literacy (IDEALL)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Keywords: Disease Management
Health Literacy
Telephone Care
Group Medical Visits
Type 2 Diabetes
Access to Care
Technology
Language Barriers
Lead sponsor: Agency for Healthcare Research and Quality (AHRQ)
Sponsor class: FED
Collaborators: name: The Commonwealth Fund
name: California HealthCare Foundation
First posted: 2005-09-22
Enrollment: 339
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The IDEALL Project (Improving Diabetes Efforts Across Language and Literacy) is a 3-arm randomized controlled trial to explore contextual factors at the patient, clinician, and organizational level of two patient self-management support strategies. A communication technology-based intervention (automated telephone diabetes management) and an interpersonally-oriented intervention (group medical visits)will be compared to usual care for their ability to improve diabetes outcomes among vulnerable populations in 4 safety-net health centers in the University of California, San Francisco (UCSF) Collaborative Research Network.

Detailed description: See above

Eligibility criteria: Inclusion Criteria:

* have type 2 diabetes
* have a HbA1c equal to or \> 8.0%
* must speak English, Spanish, or Cantonese.

Exclusion Criteria:

* Dementia
* Psychosis/Schizophrenia
* End Stage Renal Disease

Primary outcomes:
measure: Changes in Diabetes Self-management Behaviors as Measured by Summary of Diabetes Self-Care Activities (SDSCA) Scale
timeFrame: Baseline and 1 year
measure: Changes in Minutes of Moderate Physical Activity
timeFrame: Baseline and 1 year
measure: Changes in Minutes of Vigorous Exercise
timeFrame: Baseline and 1 year
Secondary outcomes:
measure: Changes in Patient Assessment of Chronic Illness Care (PACIC)
timeFrame: Baseline and 1 year
measure: Changes in Diabetes Self-efficacy as Measured by Diabetes Quality Improvement Project's Patient Self-Management Scale
timeFrame: Baseline and 1 year
measure: Changes in Interpersonal Processes of Care (IPC) Scale
timeFrame: Baseline and 1 year
measure: Changes in the Physical Component Summary of the SF-12 Health Survey
timeFrame: Baseline and 1 year
measure: Changes in the Mental Component Summary of the SF-12 Health Survey
timeFrame: Baseline and 1 year
measure: Number of Days Spent in Bed Due to Health Problems
timeFrame: 1 year
measure: Proportion of Patients Reporting Diabetes Interference of Normal Daily Activities
timeFrame: 1 year
measure: Changes in Hemoglobin A1c Levels
timeFrame: Baseline and 1 year
measure: Changes in Systolic Blood Pressure (SBP)
timeFrame: Baseline and 1 year
measure: Changes in Diastolic Blood Pressure (DBP)
timeFrame: Baseline and 1 year
measure: Changes in Body Mass Index (BMI)
timeFrame: Baseline and 1 year
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Ucsf Dept of Medicine Box 1364
state: California
Study officials:
affiliation: University of California, San Francisco
name: Dean Schillinger, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schillinger D, Handley M, Wang F, Hammer H. Effects of self-management support on structure, process, and outcomes among vulnerable patients with diabetes: a three-arm practical clinical trial. Diabetes Care. 2009 Apr;32(4):559-66. doi: 10.2337/dc08-0787. Epub 2009 Jan 8.