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

NCT02012478 | Completed

• 1 other identifier: 817790
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• hemoglobin A1C

  three months

Secondary Outcomes (1)

• PAM scale

  3 months

Other Outcomes (1)

• Summary of Diabetes Self-Care Activities

  3 months

Study Arms (2)

No intervention

NO INTERVENTION

baseline session - with surveys and HbA1C only

MI-informed SMS intervention

EXPERIMENTAL

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

Behavioral: MI- informed SMS program

Interventions

MI- informed SMS program BEHAVIORAL

MI-informed SMS intervention

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age 18 or older
• type II diabetes
• poorly controlled diabetes (HbA1C \>8 x 2 measurements, with goal \< 8)

You may not qualify if:

• pregnancy
• non-English speaking or reading

Sponsors & Collaborators

• University of Pennsylvania: lead
• Center for Healthcare Improvement and Patient Safety: collaborator
• Leonard Davis Institute: collaborator

Study Sites (1)

University of Pennsylvania Hospital

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Judith Long, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2013
• First Posted: December 16, 2013
• Study Start: February 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: February 26, 2018

Record last verified: 2018-02

Locations

US (1)