Intervention to Enhance Numeracy in Diabetes (IntEND)

Not Applicable

Completed

• Conditions: Diabetes

• Registration Number: NCT02414217
• Lead Sponsor: University of Colorado, Denver

Brief Summary

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 \[A1c\]).

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 Timeline

• Study First Submitted: 2015-04-02
• Study First Submitted QC: 2015-04-07
• Study First Posted: 2015-04-10
• Study Start: 2015-07
• Primary Completion: 2016-02
• Study Completion: 2016-10-31
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-21
• Last Update Posted: 2017-09-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 65

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in Objective Diabetes Numeracy from Baseline to ≈6 weeks	≈6 weeks	Adapted version of the Diabetes Numeracy Test

Secondary Outcome Measures

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