NCT00214474

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
339

participants targeted

Target at P75+ for not_applicable diabetes

Timeline
Completed

Started Nov 2002

Typical duration for not_applicable diabetes

Geographic Reach
1 country

1 active site

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

November 1, 2002

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

September 19, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2005

Completed
Last Updated

February 13, 2013

Status Verified

February 1, 2013

Enrollment Period

3 years

First QC Date

September 19, 2005

Last Update Submit

February 12, 2013

Conditions

Diabetes

Keywords

Disease ManagementHealth LiteracyTelephone CareGroup Medical VisitsType 2 DiabetesAccess to CareTechnologyLanguage Barriers

Outcome Measures

Primary Outcomes (3)

  • Changes in Diabetes Self-management Behaviors as Measured by Summary of Diabetes Self-Care Activities (SDSCA) Scale

    The Summary of Diabetes Self-Care Activities (SDSCA) Measure is a brief self-report questionnaire on diabetes self-management behaviors. The questionnaire assesses the frequency with which a patient followed a diabetes routine over the prior 7 days in five domains: diet, exercise, blood-glucose testing, foot care, and medication adherence. Based on SDSCA measure's author's recommendations, two separate scores can be derived: a Diabetes Self-management Behaviors score and a Self-reported Medication Adherence score. The Diabetes Self-management Behaviors score is used in this study. For this score, all items pertaining to diet, exercise, blood glucose testing, and foot care are averaged. The result is an average score between 0 and 7 with higher score indicating better diabetes self-management behavior. Change is calculated as 1-year score minus baseline score.

    Baseline and 1 year

  • Changes in Minutes of Moderate Physical Activity

    A measure of patients' physical activity is ascertained by asking patients the following question: "In the last 7 days, how many total minutes or hours did you do physical activity? Like walking, house cleaning or gardening." Number of minutes may range from 0 to 10080, with greater number of minutes indicating more physical activity.

    Baseline and 1 year

  • Changes in Minutes of Vigorous Exercise

    A measure of patients' vigorous exercise is ascertained by asking patients the following question: "In the last 7 days, how many total minutes or hours did you do the kind of exercise that makes you breathe hard, such as swimming, walking fast, or biking?" Number of minutes may range from 0 to 10080, with greater number of minutes indicating more vigorous exercise.

    Baseline and 1 year

Secondary Outcomes (11)

  • Changes in Patient Assessment of Chronic Illness Care (PACIC)

    Baseline and 1 year

  • Changes in Diabetes Self-efficacy as Measured by Diabetes Quality Improvement Project's Patient Self-Management Scale

    Baseline and 1 year

  • Changes in Interpersonal Processes of Care (IPC) Scale

    Baseline and 1 year

  • Changes in the Physical Component Summary of the SF-12 Health Survey

    Baseline and 1 year

  • Changes in the Mental Component Summary of the SF-12 Health Survey

    Baseline and 1 year

  • +6 more secondary outcomes

Study Arms (3)

ATSM Intervention

ACTIVE COMPARATOR

ATSM Intervention: Automated Telephone Self-Management Support

Behavioral: ATSM Intervention

GMV Intervention

ACTIVE COMPARATOR

GMV Intervention: Group Medical Visits

Behavioral: GMV Intervention

Usual Care

NO INTERVENTION

Usual Care: Standard care for diabetic patients

Interventions

ATSM InterventionBEHAVIORAL

Participants randomized to ATSM Intervention received weekly, automated (pre-recorded) telephone calls over 39 weeks (9 months). Patient responses triggered either immediate, automated health education messages and/or subsequent nurse phone follow-up.

Also known as: ATSM: Automated Telephone Self-Management Support
ATSM Intervention
GMV InterventionBEHAVIORAL

GMV Intervention involved 90-minute monthly sessions over 9 months, involving 6-10 participants, co-facilitated by a primary care physician and health educator.

Also known as: GMV: Group Medical Visits
GMV Intervention

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

  • Dementia
  • Psychosis/Schizophrenia
  • End Stage Renal Disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ucsf Dept of Medicine Box 1364

San Francisco, California, 94143-1364, United States

Location

Related Publications (1)

  • 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.

    PMID: 19131469DERIVED

MeSH Terms

Conditions

Diabetes MellitusDiabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Dean Schillinger, MD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 19, 2005

First Posted

September 22, 2005

Study Start

November 1, 2002

Primary Completion

November 1, 2005

Study Completion

November 1, 2005

Last Updated

February 13, 2013

Record last verified: 2013-02

Locations

US(1)