Intervention to Enhance Numeracy in Diabetes (IntEND)

Study Overview
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Brief Summary
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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
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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.

Official Title
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Intervention to Enhance Numeracy in Diabetes

Conditions
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Diabetes

Intervention / Treatment
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* Behavioral: In-Person Diabetes Numeracy Education
* Behavioral: Online Diabetes Numeracy Education


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 89 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: In-Person Diabetes Numeracy Education<br>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<br>* 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.<br>* Other names: Intervention to Enhance Numeracy in Diabetes (IntEND);|
| Experimental: Online Diabetes Numeracy Education<br>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<br>* 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.<br>* Other names: Electronic Diabetes Numeracy Intervention (e-DNI);|
| No Intervention: Control<br>Participants were given written educational materials about diabetes. | |

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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numeracy, health literacy