Expired Study
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Nashville, Tennessee 37203


Purpose:

This study evaluates a mobile phone-delivered intervention, called REACH (Rapid Education/Encouragement And Communications for Health), in supporting adults with type 2 diabetes in their self-management relative to a control group. The goal of this study is to determine if individually tailored content (based on the Information-Motivation-Behavioral Skills Model) delivered to the participant via text messages can improve the participant's glycemic control and adherence to diabetes medications. We will test whether our intervention improves adherence-related information, motivation, and behavioral skills and whether improving these mechanisms drives improvements in adherence and, in turn, glycemic control.


Criteria:

Inclusion Criteria: - Adults aged 18 years and older - Individuals who have received a diagnosis for type 2 diabetes mellitus - Enrolled as a patient at a participating community health center - Individuals currently being treated with oral and/or injectable diabetes medications Exclusion Criteria: - Non-English speakers - Individuals who report they do not have a cell phone - Individuals unwilling and/or not able to provide written informed consent - Individuals with unintelligible speech (e.g., dysarthria) - Individuals with a severe hearing or visual impairment - Individuals who report a caregiver administers their diabetes medications Individuals who fail the cognitive screener administered during the baseline survey - Individuals who cannot receive, read, and respond to a text after instruction from a trained research assistant - Individuals whose most recent (within 12 months) HbA1c value was 6.8% or greater


Study is Available At:


Original ID:

140562


NCT ID:

NCT02409329


Secondary ID:

1R01DK100694-01A1


Study Acronym:


Brief Title:

Improving Medication Adherence Among Underserved Patients With Type 2 Diabetes


Official Title:

Improving Medication Adherence Among Underserved Patients With Type 2 Diabetes


Overall Status:

Completed


Study Phase:

N/A


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Vanderbilt University Medical Center


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

3


Number of Groups:

0


Total Enrollment:

512


Enrollment Type:

Actual


Overall Contact Information

Official Name:Lindsay S Mayberry, MS, PhD
Principal Investigator
Vanderbilt University Medical Center

Study Dates

Start Date:May 2016
Completion Date:June 4, 2019
Completion Type:Actual
Primary Completion Date:June 4, 2019
Primary Completion Type:Actual
Verification Date:October 2019
Last Changed Date:October 10, 2019
First Received Date:March 9, 2015

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Change in self-reported medication adherence relative to control group as measured by scores on the Adherence to Refills and Medication Scale (ARMS-D) and Summary of Diabetes Self-Care Activities (SDSCA) Medications subscale
Time Frame:Baseline, 3 months, 6, months, 12 months, 15 months
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Change in glycemic control relative to the control group as indicated by hemoglobin A1c (HbA1c)
Time Frame:Baseline, 3 months, 6, months, 12 months, 15 months
Safety Issues:False

Study Interventions

Intervention Type:Behavioral
Name:REACH
Description:The intervention consists of daily text messaging tailored to user's individual barriers to medication adherence, text messages assessing user's adherence with feedback on progress, plus text messaging targeting other self-care behaviors.
Arm Name:REACH
Intervention Type:Behavioral
Name:Helpline and A1c results
Description:Participants complete study assessments, receive text messages advising how to access study A1c results, receive quarterly newsletters on healthy living with diabetes, and have access to a helpline for study- or diabetes medication-related questions.
Arm Name:REACH
Intervention Type:Behavioral
Name:REACH + FAMS
Description:The intervention consists of REACH individually-focused text messaging, plus family-focused phone coaching session, goal-focused text messaging, and the option to invite a family member/support person to receive text messaging.
Arm Name:REACH + FAMS
Other Name:NCT02481596

Study Arms

Study Arm Type:Experimental
Arm Name:REACH
Description:Participants will receive REACH text messages (individual-focused text messaging tailored to user's individual barriers to adherence and targeted to address other self-care behaviors) for 12 months. All participants will also receive text messages advising how to access their study A1c test results, receive quarterly newsletters on healthy living with diabetes, and have access to a Helpline for study- and diabetes medication-related questions.
Study Arm Type:Active Comparator
Arm Name:Helpline and A1c results
Description:Participants assigned to the control group will complete measures at each time point and maintain care as usual (i.e., medical treatment and physician monitoring). All participants will receive text messages advising how to access their study A1c test results, receive quarterly newsletters on healthy living with diabetes, and have access to a Helpline for study- and diabetes medication-related questions.
Study Arm Type:Experimental
Arm Name:REACH + FAMS
Description:In addition to the REACH text messages tailored to user's individual barriers to adherence, participants will receive FAMS components (monthly phone coaching and text messages supporting a goal set in coaching, plus the option to invite a family member/support person to receive text messages) for six months. After six months, participants in this arm will receive REACH text messages only. All participants will also receive text messages advising how to access their study A1c test results, recei

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Vanderbilt University Medical Center
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Reference
Citation:Nelson LA, Mayberry LS, Wallston K, Kripalani S, Bergner EM, Osborn CY. Development and Usability of REACH: A Tailored Theory-Based Text Messaging Intervention for Disadvantaged Adults With Type 2 Diabetes. JMIR Hum Factors. 2016 Sep 8;3(2):e23. doi: 10.2196/humanfactors.6029.
PMID:27609738

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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