Intervention to Enhance Numeracy in Diabetes (IntEND)

NCT02414217 | Completed

• 1 other identifier: 13-0229
• Study Type: interventional
• Target: 65
• Locations: 0 countries
• Sites: N/A

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 \[A1c\]).

Conditions

Diabetes

Keywords

numeracy; health literacy

Outcome Measures

Primary Outcomes (1)

• Change in Objective Diabetes Numeracy from Baseline to ≈6 weeks

  Adapted version of the Diabetes Numeracy Test

  ≈6 weeks

Secondary Outcomes (18)

• Change in Objective Diabetes Numeracy from Baseline to ≈3 months

  ≈3 months

• Change in Subjective Numeracy from Baseline to ≈6 weeks

  ≈6 weeks

• Change in Subjective Numeracy from Baseline to ≈3 months

  ≈3 months

• Change in Diabetes Knowledge from Baseline to ≈6 weeks

  ≈6 weeks

• Change in Diabetes Knowledge from Baseline to ≈3 months

  ≈3 months

Study Arms (3)

In-Person Diabetes Numeracy Education

EXPERIMENTAL

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

Online Diabetes Numeracy Education

EXPERIMENTAL

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

Control

NO INTERVENTION

Participants were given written educational materials about diabetes.

Interventions

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.

Also known as: Intervention to Enhance Numeracy in Diabetes (IntEND)

In-Person Diabetes Numeracy Education

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.

Also known as: Electronic Diabetes Numeracy Intervention (e-DNI)

Online Diabetes Numeracy Education

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• American Indian/Alaska Native;
• to 89 years old;
• diabetes diagnosis documented in medical records;
• active patient of the Yakama Indian Health Service.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Colorado, Denver: lead

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Angela G. Brega, PhD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2015
• First Posted: April 10, 2015
• Study Start: July 1, 2015
• Primary Completion: February 1, 2016
• Study Completion: October 31, 2016
• Last Updated: September 25, 2017

Record last verified: 2017-09