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Fotonovela for Type 2 Diabetes Mellitus

Primary Purpose

Type 2 Diabetes

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Fotonovela
Placebo Fotonovela
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Type 2 Diabetes focused on measuring diabetes, fotonovela, Latino

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • A1c> 7.0

Exclusion Criteria:

  • Pregnant

Sites / Locations

  • Adventist Health Selma
  • Clinica Sierra Vista
  • Deran Colegian Ambulatory Care Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

diabetes fotonovela

placebo fotonovela

Arm Description

spanish language comic book describing diabetes care and consequences

Outcomes

Primary Outcome Measures

Hemoglobin A1c
blood test

Secondary Outcome Measures

Full Information

First Posted
May 9, 2007
Last Updated
August 20, 2021
Sponsor
University of California, San Francisco
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1. Study Identification

Unique Protocol Identification Number
NCT00472095
Brief Title
Fotonovela for Type 2 Diabetes Mellitus
Official Title
Utility of a Diabetes Themed Fotonovela to Encourage Glycemic Control: a Culturally Appropriate Tool for Education in Latinos
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
June 2007 (undefined)
Primary Completion Date
January 29, 2016 (Actual)
Study Completion Date
January 29, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes
Keywords
diabetes, fotonovela, Latino

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
diabetes fotonovela
Arm Type
Experimental
Arm Description
spanish language comic book describing diabetes care and consequences
Arm Title
placebo fotonovela
Arm Type
Placebo Comparator
Intervention Type
Other
Intervention Name(s)
Fotonovela
Intervention Type
Other
Intervention Name(s)
Placebo Fotonovela
Primary Outcome Measure Information:
Title
Hemoglobin A1c
Description
blood test
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: A1c> 7.0 Exclusion Criteria: Pregnant
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roger B Mortimimer, MD
Organizational Affiliation
UCSF-Fresno Medical Education Program, Department of Family Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Adventist Health Selma
City
Fresno
State/Province
California
Country
United States
Facility Name
Clinica Sierra Vista
City
Fresno
State/Province
California
Country
United States
Facility Name
Deran Colegian Ambulatory Care Center
City
Fresno
State/Province
California
Country
United States

12. IPD Sharing Statement

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Fotonovela for Type 2 Diabetes Mellitus

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