Back to resultsAdolescent Self-Care and Knowledge Education in Diabetes--Improved by Texting (ASKED-IT)
Primary Purpose
Type 1 Diabetes Mellitus
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Texting
Sponsored by
About this trial
This is an interventional supportive care trial for Type 1 Diabetes Mellitus focused on measuring adolescent, young adult, knowledge, self-care
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of type 1 diabetes mellitus
- Receiving care in the pediatric clinic at the Barbara Davis Center (BDC)
- Age 15-20 at study enrollment
- English literate and English speaking
- Ability to complete the required surveys
- Have a personal cell phone with service compatible with EZTexting Platform
- Able to provide informed assent or consent (if 18 years of age or older) and parental informed consent (if needed).
Exclusion Criteria:
- Not planning to continue care in the pediatric clinic at BDC for at least the next 6 months.
- Diabetes Diagnosis other than Type 1 Diabetes
- Inability for the adolescent to respond to text messages (e.g. due to developmental delay)
Sites / Locations
- Barbara Davis Center
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control
Texting
Arm Description
At baseline enrollment: participants will be asked to fill out a demographic survey, the MWIKAD survey and the SMOD-A survey. HbA1c, frequency of Blood Glucose (BG) checks and percent of glucose values above, within and below the target range will be extracted from chart review. Surveys (with the exception of demographics) and chart extraction will be repeated at 3 months and 6 months post enrollment.
Participants will be asked to complete the same surveys on the same timeline as above. The texting group will be asked to provide their cell phone number to the texting software. From baseline appointment to 26 weeks post enrollment, participants will receive a text message every Monday, Wednesday and Friday. Some text messages will be informational only, others will ask the participant for a response to a multiple-choice question with immediate feedback on the answer chosen.
Outcomes
Primary Outcome Measures
Change in knowledge about type 1 diabetes
Measured by the Mercy-What I Know About Diabetes Test (MWIKAD)
Secondary Outcome Measures
Change in diabetes self-care practices
Assessed by the Self-Management of Type 1 Diabetes in Adolescents (SMOD-A) tool
Change in Hemoglobin A1c
Change in blood glucose testing frequency
Change in percent of blood glucoses high, in range and low
Percent of text messages responded to in the study.
Full Information
NCT ID
NCT03241212
First Posted
August 2, 2017
Last Updated
May 30, 2019
Sponsor
University of Colorado, Denver
1. Study Identification
Unique Protocol Identification Number
NCT03241212
Brief Title
Adolescent Self-Care and Knowledge Education in Diabetes--Improved by Texting
Acronym
ASKED-IT
Official Title
Adolescent Self-Care and Knowledge Education in Diabetes--Improved by Texting (ASKED-IT)
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
September 12, 2017 (Actual)
Primary Completion Date
December 14, 2018 (Actual)
Study Completion Date
December 14, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study is a randomized controlled trial assessing diabetes knowledge (using a Mercy-What I Know About Diabetes Test (MWIKAD) validated survey) and self-care practices (using a validated Self-management of Type 1 Diabetes-Adolescence (SMOD-A) survey) at baseline, 3 months and 6 months. The intervention group will receive a minimum of 78 text messages related to diabetes over the course of 26 weeks from study enrollment. Subjects are invited to respond to some text messages which will be in the form of a multiple-choice question and if they do, they will receive an additional text message in response to their answer.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes Mellitus
Keywords
adolescent, young adult, knowledge, self-care
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
148 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Description
At baseline enrollment: participants will be asked to fill out a demographic survey, the MWIKAD survey and the SMOD-A survey. HbA1c, frequency of Blood Glucose (BG) checks and percent of glucose values above, within and below the target range will be extracted from chart review.
Surveys (with the exception of demographics) and chart extraction will be repeated at 3 months and 6 months post enrollment.
Arm Title
Texting
Arm Type
Experimental
Arm Description
Participants will be asked to complete the same surveys on the same timeline as above. The texting group will be asked to provide their cell phone number to the texting software.
From baseline appointment to 26 weeks post enrollment, participants will receive a text message every Monday, Wednesday and Friday. Some text messages will be informational only, others will ask the participant for a response to a multiple-choice question with immediate feedback on the answer chosen.
Intervention Type
Behavioral
Intervention Name(s)
Texting
Intervention Description
From baseline appointment to 6 month follow up, those participants randomly assigned to the texting intervention will receive a text message every Monday, Wednesday and Friday. Some text messages will be informational only, others will ask the participant for a response to a multiple-choice question with immediate feedback on the answer chosen.
Primary Outcome Measure Information:
Title
Change in knowledge about type 1 diabetes
Description
Measured by the Mercy-What I Know About Diabetes Test (MWIKAD)
Time Frame
6 months from intervention
Secondary Outcome Measure Information:
Title
Change in diabetes self-care practices
Description
Assessed by the Self-Management of Type 1 Diabetes in Adolescents (SMOD-A) tool
Time Frame
at 3 months and 6 months
Title
Change in Hemoglobin A1c
Time Frame
at 3 months and 6 months
Title
Change in blood glucose testing frequency
Time Frame
at 3 months and 6 months
Title
Change in percent of blood glucoses high, in range and low
Time Frame
at 3 months and 6 months
Title
Percent of text messages responded to in the study.
Time Frame
After 6 months of texting intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Diagnosis of type 1 diabetes mellitus
Receiving care in the pediatric clinic at the Barbara Davis Center (BDC)
Age 15-20 at study enrollment
English literate and English speaking
Ability to complete the required surveys
Have a personal cell phone with service compatible with EZTexting Platform
Able to provide informed assent or consent (if 18 years of age or older) and parental informed consent (if needed).
Exclusion Criteria:
Not planning to continue care in the pediatric clinic at BDC for at least the next 6 months.
Diabetes Diagnosis other than Type 1 Diabetes
Inability for the adolescent to respond to text messages (e.g. due to developmental delay)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sonalee Ravi, MD
Organizational Affiliation
University of Colorado, Denver
Official's Role
Principal Investigator
Facility Information:
Facility Name
Barbara Davis Center
City
Aurora
State/Province
Colorado
ZIP/Postal Code
800045
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Adolescent Self-Care and Knowledge Education in Diabetes--Improved by Texting
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