Text to Move (TTM)Study

This study has been completed.
Sponsor:
Collaborator:
McKesson Foundation
Information provided by (Responsible Party):
Kamal Jethwani, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01569243
First received: March 28, 2012
Last updated: February 4, 2014
Last verified: February 2014
  Purpose

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


Condition Intervention Phase
Type 2 Diabetes Mellitus
Other: Text messages
Other: Usual care
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Using Activity Monitoring and Text Messaging For Behavior Change in a Diabetes Self-Management Program

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • physical activity [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Physical activity will be assessed by step counts measured by an ActiHealth pedometer and compared between the study arms.


Secondary Outcome Measures:
  • Clinical outcome [ Time Frame: over 6 months (Day 1 and day 180) ] [ Designated as safety issue: No ]
    Will be assessed by pre and post HbA1c measurements

  • Change in physical activity behaviors [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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.

  • Satisfaction with the program [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    This will be assessed using standardized Questionnaires at closeouts

  • Engagement to program [ Time Frame: 6 months ] [ Designated as safety issue: No ]

    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


Enrollment: 126
Study Start Date: June 2012
Study Completion Date: October 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Usual care group
Subjects in this group will receive the usual standard of care available at MGH.
Other: 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).
Other Name: Control
Experimental: Text messaging group
Subjects in this group will be enrolled to receive text messages aimed at providing bite-sized coaching based on measured step count to help improve activity levels and providing reminder, educational and motivation messages aimed at helping patients to meet their diabetes self-management goals.
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.
Other Name: SMS

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01569243

Locations
United States, Massachusetts
Center for Connected Health
Boston, Massachusetts, United States, 02114
Partners Healthcare Center for Connected Health
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
McKesson Foundation
Investigators
Principal Investigator: Kamal Jethwani, MD, MPH Center for Connected Health
  More Information

Publications:

Responsible Party: Kamal Jethwani, Lead Research Scientist, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01569243     History of Changes
Other Study ID Numbers: 2011-P-002708/1; MGH
Study First Received: March 28, 2012
Last Updated: February 4, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
Diabetes mellitus
Text messaging
Physical activity

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on April 17, 2014