Intervention to Enhance Numeracy in Diabetes (IntEND)

Diabetes Clinical Trial

— IntEND  

Official title:

Intervention to Enhance Numeracy in Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02414217
• Other study ID #: 13-0229
• Status: Completed
• Phase: N/A
• First received: April 2, 2015
• Last updated: September 21, 2017
• Start date: July 2015
• Est. completion date: October 31, 2016

Study information

• Verified date: September 2017
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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]).

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 information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: October 31, 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus

Intervention

Behavioral:
• 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
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Objective Diabetes Numeracy from Baseline to ˜6 weeks	Adapted version of the Diabetes Numeracy Test	˜6 weeks
Secondary	Change in Objective Diabetes Numeracy from Baseline to ˜3 months	Adapted version of the Diabetes Numeracy Test	˜3 months
Secondary	Change in Subjective Numeracy from Baseline to ˜6 weeks	Subjective Numeracy Scale	˜6 weeks
Secondary	Change in Subjective Numeracy from Baseline to ˜3 months	Subjective Numeracy Scale	˜3 months
Secondary	Change in Diabetes Knowledge from Baseline to ˜6 weeks	Adapted version of the Diabetes Knowledge Test	˜6 weeks
Secondary	Change in Diabetes Knowledge from Baseline to ˜3 months	Adapted version of the Diabetes Knowledge Test	˜3 months
Secondary	Change in Diabetes Self-Efficacy from Baseline to ˜6 weeks	Adapted items from existing instruments	˜6 weeks
Secondary	Change in Diabetes Self-Efficacy from Baseline to ˜3 months	Adapted items from existing instruments	˜3 months
Secondary	Change in Outcome Expectancies from Baseline to ˜6 weeks	Adapted items from existing instruments	˜6 weeks
Secondary	Change in Outcome Expectancies from Baseline to ˜3 months	Adapted items from existing instruments	˜3 months
Secondary	Change in Readiness to Change from Baseline to ˜6 weeks	Newly developed items	˜6 weeks
Secondary	Change in Readiness to Change from Baseline to ˜3 months	Newly developed items	˜3 months
Secondary	Change in Diabetes Self-Care Behavior from Baseline to ˜6 weeks	Summary of Diabetes Self-Care Activities Scale plus additional relevant items	˜6 weeks
Secondary	Change in Diabetes Self-Care Behavior from Baseline to ˜3 months	Summary of Diabetes Self-Care Activities Scale plus additional relevant items	˜3 months
Secondary	Change in Body Mass Index from Baseline to ˜6 weeks	Body Mass Index	˜6 weeks
Secondary	Change in Body Mass Index from Baseline to ˜3 months	Body Mass Index	˜3 months
Secondary	Change in Blood Pressure from Baseline to ˜6 weeks	Systolic and Diastolic Blood Pressure	˜6 weeks
Secondary	Change in Blood Pressure from Baseline to ˜3 months	Systolic and Diastolic Blood Pressure	˜3 months
Secondary	Change in Glycemic Control from Baseline to ˜3 months	Hemoglobin A1c	˜3 months