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OpenTrials
Completed

NCT Number: NCT02012478

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

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.

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Pennsylvania Hospital

Philadelphia, Pennsylvania, 19104, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MI- informed SMS program

Behavioral

Primary outcomes

  1. hemoglobin A1C

    Time frame: three months

Secondary outcomes

  1. PAM scale

    Time frame: 3 months

Other outcomes

  1. Summary of Diabetes Self-Care Activities

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Collaborators

  • Center for Healthcare Improvement and Patient Safety
  • Leonard Davis Institute

Registry information

Official study 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.

Acronym: MI-SMS

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Dec 16, 2013
Registry last updated
Feb 26, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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