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

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ClinicalTrials.gov Identifier: NCT02012478
Recruitment Status : Completed
First Posted : December 16, 2013
Last Update Posted : February 26, 2018
Sponsor:
Collaborators:
Center for Healthcare Improvement and Patient Safety
Leonard Davis Institute
Information provided by (Responsible Party):
University of Pennsylvania

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.


Condition or disease Intervention/treatment Phase
Type II Diabetes Mellitus Behavioral: MI- informed SMS program Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
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 Start Date : February 2014
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. hemoglobin A1C [ Time Frame: three months ]

Secondary Outcome Measures :
  1. PAM scale [ Time Frame: 3 months ]

Other Outcome Measures:
  1. Summary of Diabetes Self-Care Activities [ Time Frame: 3 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02012478


Locations
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United States, Pennsylvania
University of Pennsylvania Hospital
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
Center for Healthcare Improvement and Patient Safety
Leonard Davis Institute
Investigators
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Principal Investigator: Judith Long, MD University of Pennsylvania

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Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT02012478     History of Changes
Other Study ID Numbers: 817790
First Posted: December 16, 2013    Key Record Dates
Last Update Posted: February 26, 2018
Last Verified: February 2018
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases