Intervention to Enhance Numeracy in Diabetes (IntEND) (IntEND)

Intervention to Enhance Numeracy in Diabetes

The objective of this project is to test two interventions designed to improve diabetes-related numeracy. Numeracy is the ability to understand and use numbers. People with diabetes use numbers in a variety of ways in managing their condition (e.g., understanding blood sugar values, counting carbohydrates, taking medications at the right dose and time). As part of this project, the investigators developed and pilot tested two interventions to improve diabetes-related numeracy: (1) a series of in-person education classes and (2) a one-time, online diabetes education class. The investigators will look to see whether participants in the education classes show improvements in their diabetes-related numeracy skills, self-care behavior and attitudes, and clinical outcomes (i.e., body mass index, blood pressure, blood sugar [A1c]).

Study Overview

• Status: Completed
• Conditions: Diabetes
• Intervention / Treatment: Behavioral: In-Person Diabetes Numeracy Education; Behavioral: Online Diabetes Numeracy Education

Detailed Description

Sixty-five American Indians with diabetes were enrolled. Each participant was randomly assigned to 1 of 3 study arms: (1) the in-person education group, (2) the online education group, and (3) a control group. The in-person intervention group attended four class sessions addressing numeracy skills used in the management of diabetes (e.g., counting carbohydrates). The online education group completed a single online module providing training on diabetes-related numeracy skills. The control group received written diabetes educational materials. The investigators collected data at baseline, then again immediately after intervention participation (in-person or online classes), and one final time about three months after the conclusion of the intervention. The investigators will conduct analyses to determine if intervention participants experienced positive changes in diabetes numeracy (the primary outcome) as well as several secondary outcome measures following intervention. Secondary outcomes include: diabetes knowledge, self-efficacy, outcome expectancies, readiness to change, self-care behavior, and clinical outcomes (i.e., body mass index, blood pressure, blood sugar [A1c]) . The investigators also will assess whether change in numeracy predicts change in these secondary outcomes.

• Study Type: Interventional
• Enrollment (Actual): 65
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 89 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• American Indian/Alaska Native;
• 18 to 89 years old;
• diabetes diagnosis documented in medical records;
• active patient of the Yakama Indian Health Service.

Exclusion Criteria:

• Does not speak English;
• pregnancy;
• dialysis;
• current cancer treatment;
• blindness;
• active alcohol/substance abuse;
• planning to move out of the area in the next six months.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: In-Person Diabetes Numeracy Education; Participants randomized to the in-person education group attended four group classes, each addressing a specific set of diabetes self-care skills (i.e., understanding and using blood glucose numbers, counting carbohydrates, taking medications at the right dose and time). So that each class included a stable group of 8 and 16 participants, we ran classes in "cohorts" of 8-16 people. A participant always attended classes with his/her cohort.	Behavioral: In-Person Diabetes Numeracy Education; Participants randomized to the in-person education group attended four group classes, each addressing a specific set of diabetes self-care skills (i.e., understanding and using blood glucose numbers, counting carbohydrates, taking medications at the right dose and time). So that each class included a stable group of 8 and 16 participants, we ran classes in "cohorts" of 8-16 people. A participant always attended classes with his/her cohort.; Other Names: Intervention to Enhance Numeracy in Diabetes (IntEND)
Experimental: Online Diabetes Numeracy Education; Participants randomized to the online education group attended a single session, at which he/she completed a computerized education module that addressed understanding blood sugar values and using them to examine the impact of food, exercise, and medicines on blood sugar.	Behavioral: Online Diabetes Numeracy Education; Participants randomized to the online education group attended a single session, at which he/she completed a computerized education module that addressed understanding blood sugar values and using them to examine the impact of food, exercise, and medicines on blood sugar.; Other Names: Electronic Diabetes Numeracy Intervention (e-DNI)
No Intervention: Control; Participants were given written educational materials about diabetes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Objective Diabetes Numeracy from Baseline to ≈6 weeks	Adapted version of the Diabetes Numeracy Test	≈6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Objective Diabetes Numeracy from Baseline to ≈3 months	Adapted version of the Diabetes Numeracy Test	≈3 months
Change in Subjective Numeracy from Baseline to ≈6 weeks	Subjective Numeracy Scale	≈6 weeks
Change in Subjective Numeracy from Baseline to ≈3 months	Subjective Numeracy Scale	≈3 months
Change in Diabetes Knowledge from Baseline to ≈6 weeks	Adapted version of the Diabetes Knowledge Test	≈6 weeks
Change in Diabetes Knowledge from Baseline to ≈3 months	Adapted version of the Diabetes Knowledge Test	≈3 months
Change in Diabetes Self-Efficacy from Baseline to ≈6 weeks	Adapted items from existing instruments	≈6 weeks
Change in Diabetes Self-Efficacy from Baseline to ≈3 months	Adapted items from existing instruments	≈3 months
Change in Outcome Expectancies from Baseline to ≈6 weeks	Adapted items from existing instruments	≈6 weeks
Change in Outcome Expectancies from Baseline to ≈3 months	Adapted items from existing instruments	≈3 months
Change in Readiness to Change from Baseline to ≈6 weeks	Newly developed items	≈6 weeks
Change in Readiness to Change from Baseline to ≈3 months	Newly developed items	≈3 months
Change in Diabetes Self-Care Behavior from Baseline to ≈6 weeks	Summary of Diabetes Self-Care Activities Scale plus additional relevant items	≈6 weeks
Change in Diabetes Self-Care Behavior from Baseline to ≈3 months	Summary of Diabetes Self-Care Activities Scale plus additional relevant items	≈3 months
Change in Body Mass Index from Baseline to ≈6 weeks	Body Mass Index	≈6 weeks
Change in Body Mass Index from Baseline to ≈3 months	Body Mass Index	≈3 months
Change in Blood Pressure from Baseline to ≈6 weeks	Systolic and Diastolic Blood Pressure	≈6 weeks
Change in Blood Pressure from Baseline to ≈3 months	Systolic and Diastolic Blood Pressure	≈3 months
Change in Glycemic Control from Baseline to ≈3 months	Hemoglobin A1c	≈3 months

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Investigators: Principal Investigator: Angela G. Brega, PhD, University of Colorado - Anschutz Medical Campus

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2015
• Primary Completion (Actual): February 1, 2016
• Study Completion (Actual): October 31, 2016

Study Registration Dates

• First Submitted: April 2, 2015
• First Submitted That Met QC Criteria: April 7, 2015
• First Posted (Estimate): April 10, 2015

Study Record Updates

• Last Update Posted (Actual): September 25, 2017
• Last Update Submitted That Met QC Criteria: September 21, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Keywords: health literacy; numeracy
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus
• Other Study ID Numbers: 13-0229

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No