New Ways to Help Patients Improve Their Diabetes Control

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

177 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2011-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The percent of glycosylated hemoglobin, also known as a hemoglobin A1C value, is the standard way that clinicians assess a patient's diabetes control. Numerous studies have shown that maintaining a hemoglobin A1C value less than 7% is associated with lower rates of diabetes-related complications. Clinicians use this value to determine whether a patient with diabetes requires changes in their disease management. The main problem with this practice is that many patients do not understand what this number means. The goal of this project is to examine ways to make feedback about glycemic control easier for patients to understand. The hope is that improved patient understanding will result in an improvement in diabetic control and thus a reduction in disease-associated complications. Patients with a diagnosis of diabetes and a hemoglobin A1C value greater than 8% within the preceding three months will be eligible for the study. Pregnant women will be excluded. Given the nature of the intervention we will also exclude patients with cognitive deficits. In this study, patients will be randomized to three groups. The first group with be told their HgbA1C value only, the second group will be told a letter grade interpretation of that value, and the third group will be shown a face. The face emotions will range from happy to sad reflecting the level of control. The main outcome will be trend in hemoglobin A1C values over time. Secondary outcomes will include patient understanding of disease state and the number of hemoglobin A1C values checked following the intervention.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Using Patient Feedback to Improve Communication Regarding Glycemic Control to Patients With Diabetes

NCT01886170

Diabetes

COMPLETED NA

Using a Motivational Interviewing (MI) Informed Text Messaging Program to Lower Blood Sugar in Diabetic Patients.

NCT02012478

Type II Diabetes Mellitus

COMPLETED NA

Implementation of A Patient Centered Self-Management Program for Patients With Type 2 Diabetes

NCT02497170

Type 2 Diabetes

COMPLETED NA

Impact of a Diabetes Education Mobile Web Application on Patients With Uncontrolled Type 2 Diabetes

NCT05893927

Diabetes Mellitus, Type 2 Diabetes Education Lifestyle Modification

RECRUITING NA

Peer-Supported Diabetes Self-Management Support

NCT02746861

Diabetes

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Diabetes Mellitus

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Hemoglobin A1C

Diabetes control related to patients using standard hemoglobin A1C

Group Type OTHER

"Diabetes Report Card"

Intervention Type OTHER

Enrolled participants will receive an individualized "diabetes report card" which depicts their current level of diabetes control in one of three ways--hemoglobin A1C, face, or letter grade.

Face

Face expressing emotion used to depict diabetes control

Group Type EXPERIMENTAL

"Diabetes Report Card"

Intervention Type OTHER

Enrolled participants will receive an individualized "diabetes report card" which depicts their current level of diabetes control in one of three ways--hemoglobin A1C, face, or letter grade.

Letter grade

Letter grade used to express diabetes control

Group Type EXPERIMENTAL

"Diabetes Report Card"

Intervention Type OTHER

Enrolled participants will receive an individualized "diabetes report card" which depicts their current level of diabetes control in one of three ways--hemoglobin A1C, face, or letter grade.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

"Diabetes Report Card"

Enrolled participants will receive an individualized "diabetes report card" which depicts their current level of diabetes control in one of three ways--hemoglobin A1C, face, or letter grade.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1\. Patients over the age of 18 with diabetes mellitus listed as a problem list or in their past medical history on their electronic medical record who have a hemoglobin A1C value greater than 8% within three months of study enrollment.

Exclusion Criteria

1. Pregnant patients
2. Illiterate patients
3. Patients with known cognitive deficits affecting ability to participate in study
4. Any current participants in another active research study

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No