Supportive Intervention for Type 1 Diabetes

(IDEA Trial)

Overseen By Abigale Vaquera, MPH

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Wayne State University

Disqualifiers: Psychosis, Suicidal, Developmental delay, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 3 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help older teens and young adults with type 1 diabetes improve blood sugar control using a mix of support tools. Participants will try different combinations of interventions, such as motivational sessions (Motivational Enhancement System), question lists for doctors (Question Prompt List), and text reminders (Text Message Reminders) to better manage diabetes tasks. The trial seeks individuals with type 1 diabetes who have had the condition for at least six months and have struggled with blood sugar control. Those who meet these criteria might find this trial a good opportunity to explore new diabetes management methods. As an unphased trial, this study offers a unique chance to explore innovative diabetes management strategies without the constraints of traditional clinical trial phases.

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that the treatments tested in this project are generally safe and well-tolerated.

For the Motivational Enhancement System (MES), studies indicate that motivational interviewing, a component of this system, helps individuals with Type 1 Diabetes (T1D) improve self-care. Previous participants reported no major safety issues, and this approach is considered safe as it focuses on enhancing communication and motivation.

The Question Prompt List (QPL) is also safe. It consists of questions that help patients communicate more effectively with their healthcare team. Research shows it can boost confidence and involvement in healthcare discussions, with no known risks.

Text Message Reminders (TXT) have been widely studied. Research indicates they are safe and assist individuals in better managing their diabetes. In studies, teens who received text reminders demonstrated improved blood sugar control without any safety concerns.

Overall, these behavioral and motivational tools aim to support diabetes management without posing risks to participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores innovative, supportive interventions for managing Type 1 Diabetes (T1D) beyond traditional medical care, which typically involves regular monitoring and insulin therapy. The Motivational Enhancement System (MES) stands out by using a computer-delivered approach to boost intrinsic motivation for self-management, leveraging techniques from motivational interviewing. The Question Prompt List (QPL) empowers patients by providing them with a structured list of questions to engage more effectively with their healthcare providers during clinic visits. Text Message Reminders (TXT) offer a tech-savvy way to keep patients on track with daily diabetes care tasks like blood glucose monitoring and insulin administration. By integrating these methods, researchers hope to enhance patient engagement and self-efficacy, potentially leading to better health outcomes for those living with T1D.

What evidence suggests that this trial's treatments could be effective for improving metabolic control in older adolescents and emerging adults with Type 1 Diabetes?

Studies have shown that the Motivational Enhancement System (MES), one of the interventions in this trial, can help lower HbA1c levels, a measure of blood sugar control, in people with type 1 diabetes. It employs techniques like motivational interviewing to encourage better self-care habits. Another intervention, the Question Prompt List (QPL), can enhance patient communication with their healthcare team, although results vary. Some studies suggest these tools can improve diabetes management. Text Message Reminders (TXT), also tested in this trial, have improved blood sugar control when participants use them regularly. These reminders assist patients in remembering important daily diabetes tasks like checking blood sugar and taking insulin. ^{6 7 8 9 10}

Who Is on the Research Team?

April Carcone, PhD

Principal Investigator

Wayne State University

Are You a Good Fit for This Trial?

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

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a multi-component behavioral intervention including MES, QPL, and TXT to improve metabolic control

3 months

2 sessions (in-person) for MES, routine diabetes clinic visits every 3-4 months

Follow-up

Participants are monitored for changes in HbA1c and diabetes management behaviors post-treatment

3 months

What Are the Treatments Tested in This Trial?

Interventions

• Motivational Enhancement System (MES)
• Question Prompt List (QPL)
• Text Message Reminders (TXT)

Trial Overview 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).

How Is the Trial Designed?

Group I: Text Message Reminders (TXT) Experimental Treatment 1 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 Treatment 1 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 & TXT Experimental Treatment 2 Interventions

Participants will receive the QPL and TXT interventions as described above.

Group IV: QPL & MES Experimental Treatment 2 Interventions

Participants will receive the QPL and MES interventions as described above.

Group V: Motivation Enhancement System (MES) Experimental Treatment 1 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 & TXT Experimental Treatment 3 Interventions

Participants will receive the MES, QPL, and TXT interventions as described above.

Group VII: MES & TXT Experimental Treatment 1 Intervention

Participants will receive the MES and TXT interventions as described above.

Group VIII: Standard Medical Care Active Control 1 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.

Who Is Running the Clinical Trial?

Wayne State University

Lead Sponsor

Trials

318

Recruited

111,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

Published Research Related to This Trial

A new 17-item questionnaire was developed to categorize adolescents with asthma into six motivation-based archetypes, which can help tailor self-management interventions for better adherence.

This study demonstrates that a brief questionnaire can effectively identify different motivational profiles, allowing healthcare professionals to customize interventions like motivational interviewing during clinic visits, especially in time-constrained primary care settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a motivation-based tool to facilitate individualized self-management interventions for adolescents with asthma. Byczkowski, TL., Vockell, AB., Krier, DJ., et al.[2022]

In a 6-month study with 64 adolescents aged 12 to 22 with poorly controlled asthma, personalized text messaging improved adherence to asthma management by 2.75% each month during the intervention period.

Participants reported better quality of life and reduced worry about their asthma while receiving text messages, although these improvements in asthma control were not sustained after the intervention ended.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Randomized Trial of User-Controlled Text Messaging to Improve Asthma Outcomes: A Pilot Study. Britto, MT., Rohan, JM., Dodds, CM., et al.[2017]

The Question Prompt List for Clinical Trials (QPL-CT) was developed and tested with 30 cancer patients, showing that it effectively encourages patients to ask questions about their personal benefits from clinical trials during consultations with oncologists.

Despite the QPL-CT's potential to improve communication, some patients still had unasked and unanswered questions, indicating that further research is needed to fully assess its impact on patient outcomes in clinical trial discussions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Testing the utility of a cancer clinical trial specific Question Prompt List (QPL-CT) during oncology consultations. Brown, RF., Bylund, CL., Li, Y., et al.[2021]

A study involving 43 participants with persistent asthma showed that most were receptive to an SMS intervention for asthma management, particularly favoring tailored and interactive messages.

Adolescents expressed interest in sending messages to a support person, while adults were less enthusiastic; participants preferred directive educational content over general reminders about their condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient Perspectives on a Text Messaging Program to Support Asthma Management: A Qualitative Study. Doyle, R., Albright, K., Hurley, LP., et al.[2022]

A study involving 20 adults with asthma and/or COPD highlighted the importance of accessible and timely support from healthcare professionals, particularly during exacerbations, to enhance self-management.

Participants emphasized the need for comprehensive, person-centered care and valued strong relationships with healthcare providers who acknowledge their concerns, suggesting that effective communication and continuity of care are crucial for managing their conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The preferences of people with asthma or chronic obstructive pulmonary disease for self-management support: A qualitative descriptive study. O'Connell, S., McCarthy, VJC., Queally, M., et al.[2021]

A systematic review of five randomized controlled trials found mixed results regarding the effectiveness of text message reminders in improving asthma medication adherence, indicating that while results vary, reminders can help address forgetfulness.

Despite limited evidence supporting widespread effectiveness, text messaging is recognized as a promising tool for enhancing medication adherence in patients with asthma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Systematic Review of the Effectiveness of Text Message Reminders on Asthma Medication Adherence. Dong, J., Reeves, L., Ali, A., et al.[2022]

A motivational interviewing (MI) based asthma self-management program was developed and successfully implemented with 37 inner-city African-American adolescents, showing high completion rates (95%) and positive feedback from caregivers and adolescents about its benefits.

Post-intervention, caregivers reported improved medication adherence and adolescents expressed increased motivation to manage their asthma, along with significant improvements in asthma-related quality of life, indicating that MI could be an effective strategy for enhancing asthma management in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The development of a motivational interviewing intervention to promote medication adherence among inner-city, African-American adolescents with asthma. Riekert, KA., Borrelli, B., Bilderback, A., et al.[2022]

The Sweet Talk text-messaging system significantly improved diabetes self-efficacy and adherence among adolescents with Type 1 diabetes, with patients reporting better self-management and a desire to continue using the service.

While Sweet Talk alone did not lead to improved glycaemic control, it was effective in supporting the transition to intensive insulin therapy, suggesting its potential as a valuable tool in managing diabetes in young patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized controlled trial of Sweet Talk, a text-messaging system to support young people with diabetes. Franklin, VL., Waller, A., Pagliari, C., et al.[2022]

A pilot study with 12 teenagers showed that a customizable text messaging system for asthma reminders was well-received, with high ratings for usefulness and ease of use.

While the teens created 18 unique medication reminders, there was no change in their self-reported asthma control, suggesting that while the system is acceptable, it may not directly improve asthma management outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot and feasibility test of adolescent-controlled text messaging reminders. Britto, MT., Munafo, JK., Schoettker, PJ., et al.[2015]

A study involving 171 patients showed that SMS-based health education messages significantly improved fasting plasma glucose levels and control rates compared to regular education, indicating the effectiveness of this intervention for managing chronic diseases.

The intervention group also demonstrated better self-management behaviors, including increased vegetable and fruit consumption, weight control, and physical activity, highlighting the feasibility of using SMS to promote healthier habits in patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of text messaging intervention in Inner Mongolia among patients with type 2 diabetes mellitus: a randomized controlled trial. Wang, X., Liu, D., Du, M., et al.[2020]

Citations

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