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Patient Activation Program + Text Messaging for Type 2 Diabetes

N/A
Recruiting
Led By Adesuwa Olomu, MD, MS
Research Sponsored by Michigan State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients should be taking at least one prescribed medication for BP or cholesterol management
Patients aged >18 at participating Federally Qualified Health Care centers (FQHCs) with a diagnosis of Type 2 diabetes (T2DM) with HbA1c >8, with or without CVD
Timeline
Screening 3 weeks
Treatment Varies
Follow Up progression of risk over 12 months
Awards & highlights
No Placebo-Only Group

Summary

This trial will test if a patient activation program combined with mobile text messaging reinforcement can improve medication adherence in patients with diabetes, compared to mobile texting alone.

Who is the study for?
This trial is for adults over 18 with Type 2 diabetes and HbA1c >8, who are taking medication for blood pressure or cholesterol. They must be able to consent, have a cell phone (provided if needed), and read/speak English at a grade 6 level. It excludes those planning to move away, with cognitive impairments or in another cellphone program.
What is being tested?
The study tests the Office-GAP program plus mobile texting against mobile texting alone in improving medication adherence among diabetic patients. Office-GAP involves shared decision-making during visits; both groups receive usual care and texts encouraging adherence.
What are the potential side effects?
Since this trial focuses on communication strategies rather than new medications, traditional side effects aren't expected. However, participants may experience increased engagement or changes in their routine due to more frequent communications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am on medication for blood pressure or cholesterol.
Select...
I am over 18, have Type 2 diabetes with HbA1c over 8, and may or may not have heart disease.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~progression of risk over 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and progression of risk over 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Medication Adherence
Change in Medication adherence
Secondary study objectives
Change in CollaboRATE
Change in Patient activation measure
Change in UK Prospective Diabetes Study (UKPDS)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Office Guidelines Applied to Practice (Office-GAP) + mobile phone text messagingExperimental Treatment1 Intervention
Participants receive Office Guidelines Applied to Practice (Office-GAP) + mobile phone text messaging for 12 months.
Group II: Mobile phone text messagingActive Control1 Intervention
Participants receive mobile phone text messaging alone for 12 months.

Find a Location

Who is running the clinical trial?

Michigan State UniversityLead Sponsor
198 Previous Clinical Trials
684,862 Total Patients Enrolled
University of MichiganOTHER
1,857 Previous Clinical Trials
6,437,306 Total Patients Enrolled
Adesuwa Olomu, MD, MS4.54 ReviewsPrincipal Investigator - Michigan State University
Michigan State University
5Patient Review
She was very personable and caring. She listened to everything I had to say.

Media Library

Mobile text messaging Clinical Trial Eligibility Overview. Trial Name: NCT04874116 — N/A
Type 2 Diabetes Research Study Groups: Office Guidelines Applied to Practice (Office-GAP) + mobile phone text messaging, Mobile phone text messaging
Type 2 Diabetes Clinical Trial 2023: Mobile text messaging Highlights & Side Effects. Trial Name: NCT04874116 — N/A
Mobile text messaging 2023 Treatment Timeline for Medical Study. Trial Name: NCT04874116 — N/A
~33 spots leftby Apr 2025
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