Trial Summary
What is the purpose of this trial?This trial tests a program to help young people aged 16-25 with Type 1 Diabetes manage their condition better by making them feel more in control, confident, and supported.
Do I have to stop taking my current medications for this trial?
The trial protocol does not specify whether you need to stop taking your current medications.
What data supports the idea that Supportive Intervention for Type 1 Diabetes is an effective treatment?
The available research shows that a text-messaging system called Sweet Talk was tested to help young people with Type 1 diabetes. This system aimed to boost their confidence in managing their condition and improve their blood sugar control. The study found that using Sweet Talk helped these young patients better manage their diabetes, suggesting that Supportive Intervention for Type 1 Diabetes can be an effective treatment.
12345What safety data is available for the supportive intervention for Type 1 Diabetes?
The available research primarily focuses on text messaging interventions for asthma management, not Type 1 Diabetes. These studies indicate that text messaging systems are generally well-received and can improve adherence and quality of life in asthma patients. However, specific safety data for the intervention in Type 1 Diabetes is not provided in the available research.
25678Eligibility Criteria
This trial is for young people aged 16-25 with Type 1 Diabetes who have had high blood sugar levels over the past six months. Participants must speak and write English, be able to text, and have been diagnosed with diabetes for at least half a year. It's not open to those with severe mental health issues, developmental delays, or other conditions affecting diabetes management.Inclusion Criteria
I have been diagnosed with type 1 diabetes.
I have had diabetes for at least 6 months.
English fluency, both verbal and written
+3 more
Exclusion Criteria
You have a serious mental illness like schizophrenia or bipolar disorder.
You have a significant learning delay or difficulty reading at a level below sixth grade.
You have thoughts of hurting yourself.
+1 more
Participant Groups
The study tests a behavioral intervention based on self-determination theory aimed at improving how well these young adults manage their diabetes. The program includes a Question Prompt List (QPL), Motivational Enhancement System (MES), and Text Message Reminders (TXT).
8Treatment groups
Experimental Treatment
Active Control
Group I: Text Message Reminders (TXT)Experimental Treatment1 Intervention
Participants will receive 30 days of one-way text messages targeting one of three key daily diabetes care behaviors: monitoring blood glucose, insulin administration, or carbohydrate counting. Participants will set a reminder schedule, i.e., frequency and timing of text message reminders.
Group II: Question Prompt List (QPL)Experimental Treatment1 Intervention
A QPL is a simple, inexpensive communication tool that is comprised of list of questions related to the physical and psychosocial aspects of an illness and treatment components about which patients may want to ask their diabetes care team during a routine diabetes clinic visit.
Group III: QPL & TXTExperimental Treatment2 Interventions
Participants will receive the QPL and TXT interventions as described above.
Group IV: QPL & MESExperimental Treatment2 Interventions
Participants will receive the QPL and MES interventions as described above.
Group V: Motivation Enhancement System (MES)Experimental Treatment1 Intervention
MES is a brief, 2-session computer-delivered intervention to enhance intrinsic motivation for behavior change. MES is grounded in the Motivational Interviewing framework and the Information-Motivation-Behavioral Skills model of health behavior change. Session 1 begins with psychoeducation describing optimal diabetes self-management, then youth motivation for diabetes self-management is assessed and followed by exercises designed to increase or reinforce his/her current motivational state (e.g., decisional balance) and build self-efficacy, (e.g., building on strengths and past success). Session 1 concludes with goal setting to promote autonomous diabetes self-management. Session 2 begins with an assessment of progress toward the behavioral goal and proceeds to build motivation and self-efficacy with exercises consistent with the youth's current motivational state. Session 2 concludes with goal setting to promote autonomous diabetes self-management.
Group VI: MES, QPL & TXTExperimental Treatment3 Interventions
Participants will receive the MES, QPL, and TXT interventions as described above.
Group VII: MES & TXTExperimental Treatment1 Intervention
Participants will receive the MES and TXT interventions as described above.
Group VIII: Standard Medical CareActive Control1 Intervention
Participants will receive standard medical care at one of two participating clinical sites. Clinical practices at these sites are consistent with the standards of T1D care recommended by the American Diabetes Association and will include diabetes clinic visits every 3-4 months for routine diabetes medical care provided by an endocrinologist and/or nurse practitioner.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Detroit Medical CenterDetroit, MI
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Who Is Running the Clinical Trial?
Wayne State UniversityLead Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Collaborator
References
Testing the utility of a cancer clinical trial specific Question Prompt List (QPL-CT) during oncology consultations. [2021]A Question Prompt List (QPL) is a proven, simple intervention to aid patients to be active participants in consultations with their physicians by asking questions. We aimed to further develop and test the efficacy of a targeted QPL for clinical trials (QPL-CT).
Pilot and feasibility test of adolescent-controlled text messaging reminders. [2015]This pilot study assessed the feasibility, acceptability, and utility of a text messaging system that allowed teenagers with asthma to generate and control medical reminders sent to their mobile phones.
The preferences of people with asthma or chronic obstructive pulmonary disease for self-management support: A qualitative descriptive study. [2021]The aim of this study was to explore and describe the self-management support (SMS) preferences of adults with asthma and/or chronic obstructive pulmonary disease (COPD).
A randomized controlled trial of Sweet Talk, a text-messaging system to support young people with diabetes. [2022]To assess Sweet Talk, a text-messaging support system designed to enhance self-efficacy, facilitate uptake of intensive insulin therapy and improve glycaemic control in paediatric patients with Type 1 diabetes.
A Randomized Trial of User-Controlled Text Messaging to Improve Asthma Outcomes: A Pilot Study. [2017]We enrolled 64 patients age 12 to 22 years with a diagnosis of poorly controlled persistent asthma in a 6-month longitudinal crossover study. During the 3 intervention months, participants created personalized text messages to be sent to their phones. Adherence was objectively monitored in 22 of the participants. The adolescent participants gave high ratings on the acceptability of the text messaging system. Asthma control improved from baseline to month 1 regardless of whether teens were in the texting or control group. While participants were in the texting group, their quality of life improved and worry about their asthma decreased. Receiving the text intervention resulted in an increase in adherence of 2.75% each month relative to no intervention, but the improvements were not sustained. There was modest improvement in asthma control and quality of life outcomes, as well as improved adherence during the texting intervention.
Patient Perspectives on a Text Messaging Program to Support Asthma Management: A Qualitative Study. [2022]Introduction. This study investigated participants' acceptance of a short messaging service (SMS) intervention designed to support asthma management, including suggestions regarding program delivery and message content. Methods. Individual and group interviews were conducted with patients from a safety-net health care system in Denver, Colorado. Eligible participants were English or Spanish speakers between the ages of 13 and 40 years, with diagnosed persistent asthma. All individual and group interviews were digitally recorded, transcribed, translated from Spanish to English (where applicable), and analyzed for thematic content by experienced analysts using established qualitative content techniques. The qualitative software package ATLAS.ti was used for data analysis and management. Results. This study included a total of 43 participants. In general, participants were receptive toward the SMS program and supported the use of tailored and interactive messages. Adolescents supported the idea of enhancing care by sending messages to a support person, such as a parent or guardian. However, adults were less receptive toward this idea. Participants also preferred directive educational messages and cues to action, while general messages reminding them of their asthma diagnosis were viewed less favorably. Implications. The results from this study will inform a randomized control trial evaluating the efficacy of the SMS intervention.
A Systematic Review of the Effectiveness of Text Message Reminders on Asthma Medication Adherence. [2022]Cell phone text messaging reminders offers the promise of an efficient technology for the management of chronic diseases, such as asthma. This review aims to evaluate the effectiveness of text message reminders in improving medication adherence for asthma compared to usual care.
The role of text messaging intervention in Inner Mongolia among patients with type 2 diabetes mellitus: a randomized controlled trial. [2020]Short messages service (SMS) provides a practical medium for delivering content to address patients to adherence to self-management. The aim of study was to design some patient-centered health education messages, evaluate the feasibility of messages, and explore the effect of this model.
Development of a motivation-based tool to facilitate individualized self-management interventions for adolescents with asthma. [2022]To develop a questionnaire for segmenting adolescents with asthma into archetypes based on their motivations for individualized self-management interventions.
The development of a motivational interviewing intervention to promote medication adherence among inner-city, African-American adolescents with asthma. [2022]to develop and assess the feasibility of a motivational interviewing (MI) based asthma self-management program for inner-city, African-American, adolescents with asthma.