Fotonovela for Type 2 Diabetes Mellitus

Tracking Information
First Submitted Date ICMJE	May 9, 2007
First Posted Date ICMJE	May 11, 2007
Last Update Posted Date	January 23, 2014
Study Start Date ICMJE	June 2007
Estimated Primary Completion Date	June 2017 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: January 21, 2014)	Hemoglobin A1c [ Time Frame: 1 year ]; blood test
Original Primary Outcome Measures ICMJE; (submitted: May 10, 2007)	Hemoglobin A1c [ Time Frame: 1 year ]
Change History	Complete list of historical versions of study NCT00472095 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE	Not Provided
Original Secondary Outcome Measures ICMJE	Not Provided
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Fotonovela for Type 2 Diabetes Mellitus
Official Title ICMJE	Utility of a Diabetes Themed Fotonovela to Encourage Glycemic Control: a Culturally Appropriate Tool for Education in Latinos
Brief Summary	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.
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.
Study Type ICMJE	Interventional
Study Phase	Not Applicable
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Investigator)
Condition ICMJE	Type 2 Diabetes
Intervention ICMJE	Procedure: fotonovela
Study Arms	Experimental: diabetes fotonovela spanish language comic book describing diabetes care and consequences Intervention: Procedure: fotonovela; Placebo Comparator: placebo fotonovela
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Unknown status
Estimated Enrollment ICMJE; (submitted: May 10, 2007)	260
Original Estimated Enrollment ICMJE	Same as current
Estimated Study Completion Date	June 2017
Estimated Primary Completion Date	June 2017 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	Inclusion Criteria: A1c> 7.0 Exclusion Criteria: Pregnant
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00472095
Other Study ID Numbers ICMJE	UMC 2007-34
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	University of California, San Francisco
Study Sponsor ICMJE	University of California, San Francisco
Collaborators ICMJE	Not Provided
Investigators ICMJE	Principal Investigator: Roger B Mortimimer, MD UCSF-Fresno Medical Education Program, Department of Family Medicine
PRS Account	University of California, San Francisco
Verification Date	January 2014
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP