Fotonovela for Type 2 Diabetes Mellitus

NCT ID: NCT00472095

Last Updated: 2021-08-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-06-30
• Study Completion Date: 2016-01-29

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.

Conditions

Type 2 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

diabetes fotonovela

spanish language comic book describing diabetes care and consequences

Group Type: EXPERIMENTAL

Fotonovela

Intervention Type: OTHER

placebo fotonovela

Group Type: PLACEBO_COMPARATOR

Placebo Fotonovela

Intervention Type: OTHER

Interventions

Fotonovela

Intervention Type: OTHER

Placebo Fotonovela

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• A1c> 7.0

Exclusion Criteria

• Pregnant

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Roger B Mortimimer, MD

Role: PRINCIPAL_INVESTIGATOR

UCSF-Fresno Medical Education Program, Department of Family Medicine

Locations

Adventist Health Selma

Fresno, California, United States

Clinica Sierra Vista

Fresno, California, United States

Deran Colegian Ambulatory Care Center

Fresno, California, United States

Countries

United States

Other Identifiers

UMC 2007-34

Identifier Type: -

Identifier Source: org_study_id