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:
University of California, San Francisco
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
| Tracking Information | |||||
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| First Received Date ICMJE | May 9, 2007 | ||||
| Last Updated Date | January 21, 2014 | ||||
| Start Date ICMJE | June 2007 | ||||
| Estimated Primary Completion Date | June 2017 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Hemoglobin A1c [ Time Frame: 1 year ] [ Designated as safety issue: Yes ] blood test |
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| Original Primary Outcome Measures ICMJE |
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 Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) |
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| Condition ICMJE | Type 2 Diabetes | ||||
| Intervention ICMJE | Procedure: fotonovela | ||||
| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 260 | ||||
| Estimated Completion Date | June 2017 | ||||
| Estimated Primary Completion Date | June 2017 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older (Adult, Senior) | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| 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 | ||||
| Plan to Share Data | Not Provided | ||||
| IPD Description | Not Provided | ||||
| Responsible Party | University of California, San Francisco | ||||
| Study Sponsor ICMJE | University of California, San Francisco | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | University of California, San Francisco | ||||
| Verification Date | January 2014 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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