Text to Move (TTM)Study

Type 2 Diabetes Mellitus Clinical Trial

— TTM  

Official title:

Using Activity Monitoring and Text Messaging For Behavior Change in a Diabetes Self-Management Program

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01569243
• Other study ID #: 2011-P-002708/1; MGH
• Status: Completed
• Phase: Phase 2
• Start date: June 2012
• Est. completion date: October 2013

Study information

• Verified date: August 2020
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is a 2-arm randomized controlled trial examining the effect of personalized text messages on physical activity and clinical outcomes in patients with type 2 diabetes mellitus.

The investigators hypothesize that:

i. The use of personalized text messages will promote physical activity in patients with T2DM.

ii. Increased physical activity and behavior change correlate with better clinical outcomes (Change in HbA1c).

iii. The text messaging program will lead to sustained physical activity behavior change in patients with T2DM

Description:

Patients are referred into a Diabetes Self-Management Education (DSME) Support Program at Massachusetts General Hospital by a primary care provider at the time of diagnosis or as needed to gain better knowledge, awareness and understanding of their disease. Majority of the patients in the DSME program experience favorable outcomes; however, in key areas of T2DM management such as physical activity and nutrition, fewer patients experience success with their behavior goals, owing to the higher level of motivation required, and our inability to provide more frequent individually tailored feedback and coaching. In addition, we have observed that patients' behavior change is not sustained over time after finishing the DSME program.

In the proposed study, the investigators intend to augment DSME's evidence-based approach with two key connected health cornerstones - objective data collection and targeted personalized feedback. Using these two tools, we hypothesize that patients will be able to acquire new behaviors much sooner than status quo, and also maintain them for longer. Also, the scalability of the mobile component of the innovation will help us offer this evidence-based program to a much larger pool of patients, contributing greatly to the overall quality of diabetes management at our hospital.

The research team at Center for Connected Health will recruit participants from a pool of patients with T2DM who are participating in or who have gone through the DSME program at MGH Chelsea, MGH Revere or MGH Charlestown. These practices represent the most medically under served areas and serve low-income population. All of these practices have received recognition from the American Diabetes Association as having high-quality diabetes self-management education programs that meet the National Standards for Diabetes Self-Management Education.

120 participants will be enrolled and randomly assigned to one of the two groups.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 126
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adults over the age of 18 years.

• HbA1c over 7.0%

• Patients with a diagnosis of T2DM at MGH Chelsea, MGH Revere MGH Charlestown or MGH Everett will be offered enrollment in the study.

• Must be willing to attend initial and close-out study visits

• Willingness to receive a maximum of 60 text messages/month for 6 months on their personal cellular phone.

• PC computer with internet access

• Fluency in English or Spanish (spoken and written)

Exclusion Criteria:

• Disability, medical or surgical condition preventing or precluding moderate physical activity.

• Significant cognitive deficits.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Type 2 Diabetes Mellitus

Intervention

Other:
• Text messages
Participants will receive diabetic medical care as usual. Participants will be given an ActiHealth pedometer to measure daily activity. In addition, they will be enrolled to receive the study text messages.
• Usual care
Participants will receive diabetic medical care as usual. In addition, participants in the control group will be given an ActiHealth pedometer to measure daily activity (step counts will be used as a proxy for activity).

Locations

Country	Name	City	State
United States	Center for Connected Health	Boston	Massachusetts
United States	Partners Healthcare Center for Connected Health	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	McKesson Foundation

Country where clinical trial is conducted

United States, 

References & Publications (8)

Funnell MM, Brown TL, Childs BP, Haas LB, Hosey GM, Jensen B, Maryniuk M, Peyrot M, Piette JD, Reader D, Siminerio LM, Weinger K, Weiss MA. National standards for diabetes self-management education. Diabetes Care. 2009 Jan;32 Suppl 1:S87-94. doi: 10.2337/dc09-S087. — View Citation

Gibson TB, Song X, Alemayehu B, Wang SS, Waddell JL, Bouchard JR, Forma F. Cost sharing, adherence, and health outcomes in patients with diabetes. Am J Manag Care. 2010 Aug;16(8):589-600. — View Citation

Jethwani KS, Chandwani HS. The internet: revolutionizing medical research for novices and virtuosos alike. J Postgrad Med. 2008 Jan-Mar;54(1):49-51. — View Citation

Kulshreshtha A, Kvedar JC, Goyal A, Halpern EF, Watson AJ. Use of remote monitoring to improve outcomes in patients with heart failure: a pilot trial. Int J Telemed Appl. 2010;2010:870959. doi: 10.1155/2010/870959. Epub 2010 May 19. — View Citation

Watson AJ, Bell AG, Kvedar JC, Grant RW. Reevaluating the digital divide: current lack of internet use is not a barrier to adoption of novel health information technology. Diabetes Care. 2008 Mar;31(3):433-5. Epub 2007 Dec 4. — View Citation

Watson AJ, Bergman H, Williams CM, Kvedar JC. A randomized trial to evaluate the efficacy of online follow-up visits in the management of acne. Arch Dermatol. 2010 Apr;146(4):406-11. doi: 10.1001/archdermatol.2010.29. — View Citation

Watson AJ, Grant RW, Bello H, Hoch DB. Brave new worlds: how virtual environments can augment traditional care in the management of diabetes. J Diabetes Sci Technol. 2008 Jul;2(4):697-702. — View Citation

Watson AJ, Kvedar JC, Rahman B, Pelletier AC, Salber G, Grant RW. Diabetes connected health: a pilot study of a patient- and provider-shared glucose monitoring web application. J Diabetes Sci Technol. 2009 Mar 1;3(2):345-52. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	physical activity	Physical activity will be assessed by step counts measured by an ActiHealth pedometer and compared between the study arms.	6 months
Secondary	Clinical outcome	Will be assessed by pre and post HbA1c measurements	over 6 months (Day 1 and day 180)
Secondary	Change in physical activity behaviors	This will be assessed by Pre and post stage of behavior change based on the Stages of Motivational Readiness for Change model of the TTM.	6 months
Secondary	Satisfaction with the program	This will be assessed using standardized Questionnaires at closeouts	6 months
Secondary	Engagement to program	This will be measure quantitatively by: number of days participant wore their pedometers in the study; number of logins to the ActiHealth step count web portal; percentage of messages a user responds to, in 2-way text messages	6 months