Using a Motivational Interviewing (MI) Informed Text Messaging Program to Lower Blood Sugar in Diabetic Patients.

Type II Diabetes Mellitus Clinical Trial

— MI-SMS  

Official title:

The Impact of a Motivational Interviewing (MI) Informed Text Messaging (SMS) Program Tailored to Level of Patient Activation on Glycemic Control in a Population of Poorly Controlled Diabetic Patients.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02012478
• Other study ID #: 817790
• Status: Completed
• Phase: N/A
• First received: December 10, 2013
• Last updated: February 22, 2018
• Start date: February 2014
• Est. completion date: December 2014

Study information

• Verified date: February 2018
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Despite advances in medical therapy for diabetes, significant numbers of patients fail to achieve adequate blood glucose control. Diabetic patients who engage in more self-care behaviors have better glycemic control, as measured by HbA1C. Patient "activation", defined as the knowledge, skills, beliefs, and behaviors to manage a chronic disease, is key to the performance of these self-care behaviors.

There is a growing literature on diabetes behavioral change interventions; however interventions are often developed and implemented without consideration of patients readiness to engage in lifestyle changes. Additionally, patient-tailored interventions require intensive clinical and financial resources, making them difficult to integrate into clinical practice. Mobile text messaging (SMS) programs have been successfully used to promote smoking cessation, alcohol cessation, and weight loss in diverse patient populations. SMS interventions for diabetes have also been developed, but they have been designed primarily to provide feedback on blood glucose management, rather than to motivate behavioral change. The few studies that included motivational content as a primary feature, did not tailor their intervention to a patient's readiness for change or rigorously describe their motivational intervention, and show limited efficacy.

To address these concerns, we will perform a three-month randomized controlled pilot study to develop and test a Motivational Interviewing (MI)-informed SMS intervention tailored to patient level of activation for patients with poorly controlled type II diabetes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• age 18 or older

• type II diabetes

• poorly controlled diabetes (HbA1C >8 x 2 measurements, with goal < 8)

Exclusion Criteria:

• pregnancy

• non-English speaking or reading

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type II Diabetes Mellitus

Intervention

Behavioral:
• MI- informed SMS program

Locations

Country	Name	City	State
United States	University of Pennsylvania Hospital	Philadelphia	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
University of Pennsylvania	Center for Healthcare Improvement and Patient Safety, Leonard Davis Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Summary of Diabetes Self-Care Activities		3 months
Primary	hemoglobin A1C		three months
Secondary	PAM scale		3 months