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

May 9, 2007
January 21, 2014
June 2007
June 2017   (final data collection date for primary outcome measure)
Hemoglobin A1c [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
blood test
Hemoglobin A1c [ Time Frame: 1 year ]
Complete list of historical versions of study NCT00472095 on ClinicalTrials.gov Archive Site
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Fotonovela for Type 2 Diabetes Mellitus
Utility of a Diabetes Themed Fotonovela to Encourage Glycemic Control: a Culturally Appropriate Tool for Education in Latinos

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Type 2 Diabetes
Procedure: fotonovela
  • Experimental: diabetes fotonovela
    spanish language comic book describing diabetes care and consequences
    Intervention: Procedure: fotonovela
  • Placebo Comparator: placebo fotonovela
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
260
June 2017
June 2017   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • A1c> 7.0

Exclusion Criteria:

  • Pregnant
Both
18 Years and older
No
Contact: Roger B Mortimer, MD 559-459-6450
United States
 
NCT00472095
UMC 2007-34
No
University of California, San Francisco
University of California, San Francisco
Not Provided
Principal Investigator: Roger B Mortimimer, MD UCSF-Fresno Medical Education Program, Department of Family Medicine
University of California, San Francisco
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP