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

NCT ID: NCT02012478

Last Updated: 2018-02-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-02-28
• Study Completion Date: 2014-12-31

Brief 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.

Conditions

Type II Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

No intervention

baseline session - with surveys and HbA1C only

Group Type: NO_INTERVENTION

No interventions assigned to this group

MI-informed SMS intervention

Baseline session with surveys \& HbA1C MI baseline session Technology tutorial Intervention x 3 months

Group Type: EXPERIMENTAL

MI- informed SMS program

Intervention Type: BEHAVIORAL

Interventions

MI- informed SMS program

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Center for Healthcare Improvement and Patient Safety

UNKNOWN

Sponsor Role: collaborator

Leonard Davis Institute

UNKNOWN

Sponsor Role: collaborator

University of Pennsylvania

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Judith Long, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

University of Pennsylvania Hospital

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

817790

Identifier Type: -

Identifier Source: org_study_id