Patient Activation Program + Text Messaging for Type 2 Diabetes

AO
Overseen ByAdesuwa Olomu, MD, MS
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Michigan State University
Must be taking: Blood pressure, cholesterol
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if combining a patient support program with text messaging helps people with Type 2 diabetes (T2DM) adhere to their medication better than text messaging alone. It focuses on improving communication between patients and doctors, which may help control blood sugar, cholesterol, and blood pressure, and enhance patient satisfaction. Participants should have T2DM with uncontrolled blood sugar (HbA1c >8), take medication for blood pressure or cholesterol, and be able to read and text in English. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that may improve diabetes management.

Will I have to stop taking my current medications?

The trial does not specify that you need to stop taking your current medications. In fact, all patients will continue to receive their usual care and medication for diabetes and cardiovascular disease prevention.

What prior data suggests that this patient activation program and text messaging intervention is safe for improving medication adherence in patients with Type 2 Diabetes?

Research has shown that using Office-GAP (Office Guidelines Applied to Practice) with mobile text messaging is safe for individuals. This method assists people with diabetes in adhering to their medication plans. Studies have found that these programs enhance communication between patients and doctors, leading to better health outcomes. No reports of harm have emerged from using these methods.

Text messaging alone has also been studied and found to be safe. One study showed that recipients of text messages felt less stressed about their diabetes and experienced better support and understanding of their condition. They also improved their self-care.

Both treatments aim to help patients manage their diabetes more effectively. No evidence of serious side effects exists, making them a safe option for those considering joining a clinical trial.12345

Why are researchers excited about this trial?

Researchers are excited about this trial because it's exploring how digital tools can empower people with Type 2 diabetes to manage their condition more effectively. Unlike standard treatments that often rely heavily on medication alone, this trial combines mobile text messaging with practical office guidelines to support patient self-management. This approach could lead to better adherence to treatment plans and improved health outcomes by providing patients with regular reminders and personalized advice. By leveraging technology, the trial aims to make diabetes management more accessible and engaging for patients, potentially setting a new standard for chronic disease care.

What evidence suggests that this trial's treatments could be effective for Type 2 Diabetes?

Research has shown that using Office Guidelines Applied to Practice (Office-GAP) with mobile text messages can help people with Type 2 diabetes stay more engaged and communicate better with their healthcare providers. Participants in one arm of this trial will receive this combination. This method supports patients and doctors in making decisions together and helps patients take their medications more regularly. One study found that this combination led to better health outcomes than using text messages alone. Participants in another arm of this trial will receive only text messages, which have had mixed success in helping people stick to their medication schedules and manage blood sugar levels. However, when combined with Office-GAP, patients often manage their diabetes better, likely because the approach is more personalized and proactive.678910

Who Is on the Research Team?

AO

Adesuwa Olomu, MD, MS

Principal Investigator

Michigan State University

Are You a Good Fit for This Trial?

This trial is for adults over 18 with Type 2 diabetes and HbA1c >8, who are taking medication for blood pressure or cholesterol. They must be able to consent, have a cell phone (provided if needed), and read/speak English at a grade 6 level. It excludes those planning to move away, with cognitive impairments or in another cellphone program.

Inclusion Criteria

I am on medication for blood pressure or cholesterol.
Patients must have a cell phone with texting (provided by the study for any enrolled patient who does not have one)
Patients must be able to provide informed consent

Exclusion Criteria

Plans to leave the area prior to study completion
Participating in another cellphone program
You have a medical record showing problems with memory, thinking, or mental health.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive either Office-GAP + mobile phone text messaging or mobile phone text messaging alone

12 months
1 group visit, follow-up visits at 0-1, 3, 6, 9, and 12 months

Follow-up

Participants are monitored for medication adherence and health outcomes

3 months

What Are the Treatments Tested in This Trial?

Interventions

  • Mobile text messaging
  • Office Guidelines Applied to Practice (Office-GAP) + Mobile text messaging
Trial Overview The study tests the Office-GAP program plus mobile texting against mobile texting alone in improving medication adherence among diabetic patients. Office-GAP involves shared decision-making during visits; both groups receive usual care and texts encouraging adherence.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Office Guidelines Applied to Practice (Office-GAP) + mobile phone text messagingExperimental Treatment1 Intervention
Group II: Mobile phone text messagingActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Michigan State University

Lead Sponsor

Trials
202
Recruited
687,000+

University of Michigan

Collaborator

Trials
1,891
Recruited
6,458,000+

Published Research Related to This Trial

A study involving 36 adult patients without diabetes found that participants were generally receptive to receiving text messages for HbA1c screening, indicating a potential for mobile health interventions to increase diabetes screening rates.
Key factors for improving engagement included using plain language, personalizing messages, and clearly outlining the steps for screening, as well as considering the patient's relationship with their healthcare provider.
Patient Perspectives on a Targeted Text Messaging Campaign to Encourage Screening for Diabetes: Qualitative Study.Lenoir, KM., Sandberg, JC., Miller, DP., et al.[2023]
A systematic review of 151 studies found that mobile text messaging interventions had no statistically significant effect on increasing physical activity in people with type 2 diabetes mellitus, based on a meta-analysis of 5 studies (P=0.16).
The review also indicated that text messaging did not significantly impact glycemic control or anthropometric measures like weight and BMI, highlighting the need for more high-quality research in this area.
The Effectiveness of Mobile Phone Messaging-Based Interventions to Promote Physical Activity in Type 2 Diabetes Mellitus: Systematic Review and Meta-analysis.Alsahli, M., Abd-Alrazaq, A., Househ, M., et al.[2022]
The SMS4BG intervention, a tailored text message support program for diabetes management, was found to be highly acceptable and useful among participants, with 93% reporting positive experiences after a 3-month pilot study involving 42 adults with poorly controlled diabetes.
Participants experienced a significant decrease in HbA1c levels, indicating improved glycemic control, suggesting that SMS4BG may effectively support diabetes self-management, although further research through a randomized controlled trial is needed to confirm its long-term efficacy.
Diabetes Text-Message Self-Management Support Program (SMS4BG): A Pilot Study.Dobson, R., Carter, K., Cutfield, R., et al.[2018]

Citations

1.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/35258463/
The Effectiveness of Mobile Phone Messaging-Based ...Results: We included 3.8% (6/151) of the retrieved studies. The results of individual studies were contradictory regarding the effectiveness of ...
The Use of SMS Text Messaging to Improve Glycemic ...Results showed significant improvements in glycemic control (ie, decrease in A1C of 1.04%; P = 0.05). The SMS text messaging intervention effectively supports ...
Study Details | Effectiveness of Automated Mobile Phone ...The investigators shall compare effects on glycaemia, other cardiovascular risk factors, lifestyle behaviour and quality of life, with those observed in people ...
Systematic Review and Meta-analysisThis study aims to assess the effectiveness of mobile phone messaging on PA in people with T2DM by summarizing and pooling the findings of previous literature.
What is the effect of mobile phone text message reminders on ...Mobile phone text messages can potentially lead to improved medication adherence levels in patients with Type 2 diabetes despite heterogeneity ...
6.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/35971135/
Improving diabetic patients' adherence to treatment and ...This study will provide a rigorous pragmatic evaluation of the effectiveness of combined mHealth, and patient activation interventions compared to mHealth ...
Improving diabetic patients' adherence to treatment and ...Office-GAP (Office-Guidelines Applied to Practice) is a patient activation intervention to improve communication and patient-provider ...
Patient Activation Program + Text Messaging for Type 2 DiabetesTrial Overview The study tests the Office-GAP program plus mobile texting against mobile texting alone in improving medication adherence among diabetic patients ...
Impact of a Text Messaging Intervention as an In-Between ...Our study showed improved diabetes distress, social support, knowledge, self-care, self-efficacy, and quality of life among patients highly engaged in the SMS ...
Disparities in Text Messaging Interventions to Improve ...Substantial progress has been made in the development of evidence-based interventions to facilitate the management of type 2 diabetes.
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