Improving Diabetes Efforts Across Language and Literacy (IDEALL)

NCT ID: NCT00214474

Last Updated: 2013-02-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

339 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-11-30

Study Completion Date

2005-11-30

Brief Summary

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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

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See above

Conditions

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Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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ATSM Intervention

ATSM Intervention: Automated Telephone Self-Management Support

Group Type ACTIVE_COMPARATOR

ATSM Intervention

Intervention Type BEHAVIORAL

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.

GMV Intervention

GMV Intervention: Group Medical Visits

Group Type ACTIVE_COMPARATOR

GMV Intervention

Intervention Type BEHAVIORAL

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

Usual Care

Usual Care: Standard care for diabetic patients

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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ATSM Intervention

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.

Intervention Type BEHAVIORAL

GMV Intervention

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

Intervention Type BEHAVIORAL

Other Intervention Names

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ATSM: Automated Telephone Self-Management Support GMV: Group Medical Visits

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Commonwealth Fund

OTHER

Sponsor Role collaborator

California HealthCare Foundation

OTHER

Sponsor Role collaborator

Agency for Healthcare Research and Quality (AHRQ)

FED

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dean Schillinger, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

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Ucsf Dept of Medicine Box 1364

San Francisco, California, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 19131469 (View on PubMed)

Other Identifiers

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1R21HS014864-01

Identifier Type: AHRQ

Identifier Source: org_study_id

View Link

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