Fotonovela for Type 2 Diabetes Mellitus
| Status: | Recruiting |
|---|---|
| Conditions: | Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/2/2016 |
| Start Date: | June 2007 |
| End Date: | June 2017 |
| Contact: | Roger B Mortimer, MD |
| Phone: | 559-459-6450 |
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.
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.
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.
Inclusion Criteria:
- A1c> 7.0
Exclusion Criteria:
- Pregnant
We found this trial at
3
sites
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