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

Primary Purpose

Type II Diabetes Mellitus

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MI- informed SMS program
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Type II Diabetes Mellitus

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Pennsylvania Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

No intervention

MI-informed SMS intervention

Arm Description

baseline session - with surveys and HbA1C only

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

Outcomes

Primary Outcome Measures

hemoglobin A1C

Secondary Outcome Measures

PAM scale

Full Information

First Posted
December 10, 2013
Last Updated
February 22, 2018
Sponsor
University of Pennsylvania
Collaborators
Center for Healthcare Improvement and Patient Safety, Leonard Davis Institute
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1. Study Identification

Unique Protocol Identification Number
NCT02012478
Brief Title
Using a Motivational Interviewing (MI) Informed Text Messaging Program to Lower Blood Sugar in Diabetic Patients.
Acronym
MI-SMS
Official 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.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
February 2014 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania
Collaborators
Center for Healthcare Improvement and Patient Safety, Leonard Davis Institute

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type II Diabetes Mellitus

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
No intervention
Arm Type
No Intervention
Arm Description
baseline session - with surveys and HbA1C only
Arm Title
MI-informed SMS intervention
Arm Type
Experimental
Arm Description
Baseline session with surveys & HbA1C MI baseline session Technology tutorial Intervention x 3 months
Intervention Type
Behavioral
Intervention Name(s)
MI- informed SMS program
Primary Outcome Measure Information:
Title
hemoglobin A1C
Time Frame
three months
Secondary Outcome Measure Information:
Title
PAM scale
Time Frame
3 months
Other Pre-specified Outcome Measures:
Title
Summary of Diabetes Self-Care Activities
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Judith Long, MD
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pennsylvania Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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