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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
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ progression of risk over 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~progression of risk over 12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Medication Adherence
Change in Medication adherence
Secondary outcome measures
Change in CollaboRATE
Change in Patient activation measure
Change in UK Prospective Diabetes Study (UKPDS)
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.
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Who is running the clinical trial?
Michigan State UniversityLead Sponsor
186 Previous Clinical Trials
601,729 Total Patients Enrolled
University of MichiganOTHER
1,800 Previous Clinical Trials
6,378,762 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.
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am on medication for blood pressure or cholesterol.I am over 18, have Type 2 diabetes with HbA1c over 8, and may or may not have heart disease.You have a medical record showing problems with memory, thinking, or mental health.
Research Study Groups:
This trial has the following groups:- Group 1: Office Guidelines Applied to Practice (Office-GAP) + mobile phone text messaging
- Group 2: Mobile phone text messaging
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this investigation still open to new participants?
"The data on clinicaltrials.gov reveals that this research project is actively recruiting participants, having been first posted in May 2021 and most recently updated in August 2022."
Answered by AI
How many participants is the trial currently accommodating?
"Affirmative. According to clinicaltrials.gov, the recruitment of participants for this medical trial is still ongoing; it was first posted on May 26th 2021 and last amended on August 24th 2022. A total of 378 patients are needed at one site for enrollment in the study."
Answered by AI
Who else is applying?
What state do they live in?
Michigan
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Met criteria
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