Fotonovela for Type 2 Diabetes Mellitus
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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 Primary Purpose: Supportive Care |
| Official Title: | Utility of a Diabetes Themed Fotonovela to Encourage Glycemic Control: a Culturally Appropriate Tool for Education in Latinos |
- Hemoglobin A1c [ Time Frame: 1 year ]
| Estimated Enrollment: | 260 |
| Study Start Date: | June 2007 |
| Estimated Study Completion Date: | June 2009 |
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 |
Inclusion Criteria:
- A1c> 7.0
Exclusion Criteria:
- Pregnant
Contacts and Locations| Contact: Roger B Mortimer, MD | 559-459-6450 |
| Principal Investigator: | Roger B Mortimimer, MD | UCSF-Fresno Medical Education Program, Department of Family Medicine |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00472095 History of Changes |
| Other Study ID Numbers: | UMC 2007-34 |
| Study First Received: | May 9, 2007 |
| Last Updated: | May 10, 2007 |
| 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 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
ClinicalTrials.gov processed this record on May 23, 2013