Intervention to Enhance Numeracy in Diabetes (IntEND)

University of Colorado Denver (CU Denver)

Status: Completed

Conditions: Diabetes

Treatments: Behavioral: In-Person Diabetes Numeracy Education; Behavioral: Online Diabetes Numeracy Education

Study type: Interventional

Funder types: Other

Identifiers

NCT02414217

13-0229

Details and patient eligibility

About

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]).

Full 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.

Enrollment: 65 patients

Sex: All

Ages: 18 to 89 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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65 participants in 3 patient groups

In-Person Diabetes Numeracy Education

Experimental group

Description:

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.

Treatment:

Behavioral: In-Person Diabetes Numeracy Education

Online Diabetes Numeracy Education

Experimental group

Description:

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.

Treatment:

Behavioral: Online Diabetes Numeracy Education

Control

No Intervention group

Description:

Participants were given written educational materials about diabetes.