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NCT Number: NCT02414217

Intervention to Enhance Numeracy in Diabetes (IntEND)

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]).

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Key information

Conditions

Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

In-Person Diabetes Numeracy Education

Behavioral

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)

Online Diabetes Numeracy Education

Behavioral

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)

Primary outcomes

  1. Change in Objective Diabetes Numeracy from Baseline to ≈6 weeks

    Time frame: ≈6 weeks

    Adapted version of the Diabetes Numeracy Test

Secondary outcomes

  1. Change in Objective Diabetes Numeracy from Baseline to ≈3 months

    Time frame: ≈3 months

    Adapted version of the Diabetes Numeracy Test

  2. Change in Subjective Numeracy from Baseline to ≈6 weeks

    Time frame: ≈6 weeks

    Subjective Numeracy Scale

  3. Change in Subjective Numeracy from Baseline to ≈3 months

    Time frame: ≈3 months

    Subjective Numeracy Scale

  4. Change in Diabetes Knowledge from Baseline to ≈6 weeks

    Time frame: ≈6 weeks

    Adapted version of the Diabetes Knowledge Test

  5. Change in Diabetes Knowledge from Baseline to ≈3 months

    Time frame: ≈3 months

    Adapted version of the Diabetes Knowledge Test

  6. Change in Diabetes Self-Efficacy from Baseline to ≈6 weeks

    Time frame: ≈6 weeks

    Adapted items from existing instruments

  7. Change in Diabetes Self-Efficacy from Baseline to ≈3 months

    Time frame: ≈3 months

    Adapted items from existing instruments

  8. Change in Outcome Expectancies from Baseline to ≈6 weeks

    Time frame: ≈6 weeks

    Adapted items from existing instruments

  9. Change in Outcome Expectancies from Baseline to ≈3 months

    Time frame: ≈3 months

    Adapted items from existing instruments

  10. Change in Readiness to Change from Baseline to ≈6 weeks

    Time frame: ≈6 weeks

    Newly developed items

  11. Change in Readiness to Change from Baseline to ≈3 months

    Time frame: ≈3 months

    Newly developed items

  12. Change in Diabetes Self-Care Behavior from Baseline to ≈6 weeks

    Time frame: ≈6 weeks

    Summary of Diabetes Self-Care Activities Scale plus additional relevant items

  13. Change in Diabetes Self-Care Behavior from Baseline to ≈3 months

    Time frame: ≈3 months

    Summary of Diabetes Self-Care Activities Scale plus additional relevant items

  14. Change in Body Mass Index from Baseline to ≈6 weeks

    Time frame: ≈6 weeks

    Body Mass Index

  15. Change in Body Mass Index from Baseline to ≈3 months

    Time frame: ≈3 months

    Body Mass Index

  16. Change in Blood Pressure from Baseline to ≈6 weeks

    Time frame: ≈6 weeks

    Systolic and Diastolic Blood Pressure

  17. Change in Blood Pressure from Baseline to ≈3 months

    Time frame: ≈3 months

    Systolic and Diastolic Blood Pressure

  18. Change in Glycemic Control from Baseline to ≈3 months

    Time frame: ≈3 months

    Hemoglobin A1c

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Registry information

Official study title

Intervention to Enhance Numeracy in Diabetes

Acronym: IntEND

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Apr 10, 2015
Registry last updated
Sep 25, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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