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Fotonovela for Type 2 Diabetes Mellitus

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by University of California, San Francisco
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00472095
First received: May 9, 2007
Last updated: January 21, 2014
Last verified: January 2014
  Purpose

Diabetes with poor sugar control can lead to blindness, heart attacks, and amputations. Latinos are more at risk for diabetes. A fotonovela is a type of comic book commonly read by Latinos that might be a way to teach them about the risk of high sugars. The researchers will give patients either a fotonovela about diabetes or one with nothing to do with diabetes. Then they will compare how well sugars were controlled afterward in each group. This way they can see if these fotonovelas were useful.


Condition Intervention
Type 2 Diabetes
Procedure: fotonovela

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Official Title: Utility of a Diabetes Themed Fotonovela to Encourage Glycemic Control: a Culturally Appropriate Tool for Education in Latinos

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Hemoglobin A1c [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    blood test


Estimated Enrollment: 260
Study Start Date: June 2007
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: diabetes fotonovela
spanish language comic book describing diabetes care and consequences
Procedure: fotonovela
Placebo Comparator: placebo fotonovela

Detailed Description:

Elevated glucose in diabetics is a risk for amputation, renal failure, coronary artery disease, neuropathy, and blindness. Controlling glucose better as measured by hemoglobin A1c (A1c) reduces risk for these complications. Information itself is often not enough to change behaviors that increase risk for these complications. Latinos in America are particularly at risk for diabetes (DM) and its complications. A fotonovela is a booklet telling a story using photos with superimposed speech bubbles much like an American style comic book. These are commonly read by Latinos. A fotonovela that tells a story about diabetes complications in a culturally appropriate context that emphasized impact on family might help motivate Hispanic patients to control their sugar better. We propose a single-blinded, randomized, controlled trial of a DM themed fotonovela against a non-DM themed fotonovela to assess its effect on glycemia as measured by A1c. After a primary care provider has seen a Latino type 2 diabetic patient, the investigator will consent them then give them an envelope with the DM themed fotonovela or another that is indistinguishable in the sealed envelope. The primary outcome is hemoglobin A1c one month or more after randomization. Secondary outcomes will A1c in the 1-5 month and 6-12 month time period looking for durability of effect. A sample size of 260 allows for a 30% fallout and gives an 80% power to detect a 0.5% change in A1c with a 1.2% standard deviation on that change with a two-tailed alpha of 0.05.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • A1c> 7.0

Exclusion Criteria:

  • Pregnant
  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: NCT00472095

Contacts
Contact: Roger B Mortimer, MD 559-459-6450

Locations
United States, California
Adventist Health Selma Recruiting
Fresno, California, United States
Contact: Roger Mortimer, MD         
Clinica Sierra Vista Recruiting
Fresno, California, United States
Contact: Roger Mortimer, MD         
Deran Colegian Ambulatory Care Center Recruiting
Fresno, California, United States
Contact: Roger Mortimer, MD         
Principal Investigator: Roger Mortimer, MD         
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: Roger B Mortimimer, MD UCSF-Fresno Medical Education Program, Department of Family Medicine
  More Information

No publications provided

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00472095     History of Changes
Other Study ID Numbers: UMC 2007-34
Study First Received: May 9, 2007
Last Updated: January 21, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Francisco:
diabetes
fotonovela
Latino

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on November 20, 2014