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

ID: NCT02012478
Status: Completed
Phase: N/A
Start Date: February 01, 2014
First Submitted: December 10, 2013
Last Updated: February 22, 2018
Results: N/A
Sponsors & Collaborators: University of Pennsylvania, Center for Healthcare Improvement and Patient Safety, Leonard Davis Institute
Location: United States
Conditions: Type II Diabetes Mellitus
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.

Study Description

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.

Detailed Description

Condition or disease Intervention/treatment Phase

Type II Diabetes Mellitus

Behavioral: MI- informed SMS program
Other Names
N/A

Tracking Information

First Submitted DateDecember 10, 2013
Last Update Posted DateFebruary 22, 2018
Start DateFebruary 01, 2014
Actual Completion DateDecember 01, 2014
Primary Completion DateDecember 01, 2014
Results First Submitted DateN/A
Received Results Disposit DateN/A

Current Primary Outcome Measures

  • hemoglobin A1C [Time Frame: three months]

Original Primary Outcome Measures

Not Available

Current Secondary Outcome Measures

  • PAM scale [Time Frame: 3 months]

Original Secondary Outcome Measures

Not Available

Study Design

Brief TitleUsing a Motivational Interviewing (MI) Informed Text Messaging Program to Lower Blood Sugar in Diabetic Patients.
Official TitleThe 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.
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.

Detailed Description

Study TypeInterventional
Study PhaseN/A
Estimated Enrollment
54
Allocation
Randomized
Interventional Model
Parallel Assignment
Masking
Single
Primary Purpose
Health Services Research
Conditions
Type II Diabetes Mellitus
Target Follow-Up Duration N/A
Biospecimen:
N/A
Sampling MethodN/A
Study PopulationN/A
Intervention
Behavioral: MI- informed SMS program

Other Names
Study Groups/Cohorts
No intervention
baseline session - with surveys and HbA1C only

MI-informed SMS intervention
Baseline session with surveys & HbA1C MI baseline session Technology tutorial Intervention x 3 months

Study Arms
Experimental MI-informed SMS intervention
Baseline session with surveys & HbA1C MI baseline session Technology tutorial Intervention x 3 months
Behavioral : MI- informed SMS program

Arm Intervention/Treatment
Experimental MI-informed SMS intervention
Baseline session with surveys & HbA1C MI baseline session Technology tutorial Intervention x 3 months
Behavioral : MI- informed SMS program

Recruitment Information

Recruitment Status:Completed
Enrollment54
Completion DateDecember 01, 2014
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
GenderAll
Age18 Years to 90 Years
Accepts Healthy VolunteersNo
Contacts
Not Available
Listed Location Countries
United States

Administrative Information

NCT Number:NCT02012478
Other Study ID Numbers
817790
Has Data Monitoring CommitteeNo
U.S. FDA-regulated Product Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Device Product Not Approved or Cleared by U.S. FDA: No
IPD Sharing Statement
Not Available
Responsible PartyIlona Lorincz, University of Pennsylvania
Study Sponsor
University of Pennsylvania
Collaborators
Center for Healthcare Improvement and Patient Safety
Leonard Davis Institute
Investigators
Principal Investigator
Judith Long, MD
University of Pennsylvania