Intervention to Enhance Numeracy in Diabetes (IntEND)
- Conditions
- Diabetes
- Interventions
- Behavioral: In-Person Diabetes Numeracy EducationBehavioral: Online Diabetes Numeracy Education
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 65
- American Indian/Alaska Native;
- 18 to 89 years old;
- diabetes diagnosis documented in medical records;
- active patient of the Yakama Indian Health Service.
- 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
- Arm && Interventions
Group Intervention Description In-Person Diabetes Numeracy Education 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. Online Diabetes Numeracy Education 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.
- 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