Adolescent Self-Care and Knowledge Education in Diabetes--Improved by Texting

NCT ID: NCT03241212

Last Updated: 2019-06-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

148 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-12

Study Completion Date

2018-12-14

Brief Summary

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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.

Detailed Description

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Conditions

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Type 1 Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Control

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Texting

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.

Group Type EXPERIMENTAL

Texting

Intervention Type BEHAVIORAL

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.

Interventions

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Texting

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

1. Diagnosis of type 1 diabetes mellitus
2. Receiving care in the pediatric clinic at the Barbara Davis Center (BDC)
3. Age 15-20 at study enrollment
4. English literate and English speaking
5. Ability to complete the required surveys
6. Have a personal cell phone with service compatible with EZTexting Platform
7. Able to provide informed assent or consent (if 18 years of age or older) and parental informed consent (if needed).

Exclusion Criteria

1. Not planning to continue care in the pediatric clinic at BDC for at least the next 6 months.
2. Diabetes Diagnosis other than Type 1 Diabetes
3. Inability for the adolescent to respond to text messages (e.g. due to developmental delay)
Minimum Eligible Age

15 Years

Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Colorado, Denver

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sonalee Ravi, MD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

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Barbara Davis Center

Aurora, Colorado, United States

Site Status

Countries

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United States

Other Identifiers

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17-1135

Identifier Type: -

Identifier Source: org_study_id

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