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

February 22, 2018 updated by: University of Pennsylvania

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

54

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: HEALTH_SERVICES_RESEARCH
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: No intervention
baseline session - with surveys and HbA1C only
EXPERIMENTAL: MI-informed SMS intervention
Baseline session with surveys & HbA1C MI baseline session Technology tutorial Intervention x 3 months
Behavioral: MI- informed SMS program

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
hemoglobin A1C
Time Frame: three months
three months

Secondary Outcome Measures

Outcome Measure
Time Frame
PAM scale
Time Frame: 3 months
3 months

Other Outcome Measures

Outcome Measure
Time Frame
Summary of Diabetes Self-Care Activities
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pennsylvania

Collaborators

Leonard Davis Institute
Center for Healthcare Improvement and Patient Safety

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2014

Primary Completion (ACTUAL)

December 1, 2014

Study Completion (ACTUAL)

December 1, 2014

Study Registration Dates

First Submitted

December 10, 2013

First Submitted That Met QC Criteria

December 10, 2013

First Posted (ESTIMATE)

December 16, 2013

Study Record Updates

Last Update Posted (ACTUAL)

February 26, 2018

Last Update Submitted That Met QC Criteria

February 22, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 817790

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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