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Text to Move (TTM)Study (TTM)

29 augusti 2020 uppdaterad av: Joseph C. Kvedar, Massachusetts General Hospital

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

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

Studieöversikt

Status

Avslutad

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

126

Fas

  • Fas 2

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

    • Massachusetts
      • Boston, Massachusetts, Förenta staterna, 02114
        • Center for Connected Health
      • Boston, Massachusetts, Förenta staterna, 02114
        • Partners Healthcare Center for Connected Health

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Stödjande vård
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Övrig: Usual care group
Subjects in this group will receive the usual standard of care available at MGH.
  • 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).
Andra namn:
  • Kontrollera
Experimentell: 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.
  • 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.
Andra namn:
  • SMS

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
physical activity
Tidsram: 6 months
Physical activity will be assessed by step counts measured by an ActiHealth pedometer and compared between the study arms.
6 months

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Clinical outcome
Tidsram: over 6 months (Day 1 and day 180)
Will be assessed by pre and post HbA1c measurements
over 6 months (Day 1 and day 180)
Change in physical activity behaviors
Tidsram: 6 months
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
Satisfaction with the program
Tidsram: 6 months
This will be assessed using standardized Questionnaires at closeouts
6 months
Engagement to program
Tidsram: 6 months

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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Samarbetspartners

Utredare

  • Huvudutredare: Kamal Jethwani, MD, MPH, Center for Connected Health

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 juni 2012

Primärt slutförande (Faktisk)

1 oktober 2013

Avslutad studie (Faktisk)

1 oktober 2013

Studieregistreringsdatum

Först inskickad

28 mars 2012

Först inskickad som uppfyllde QC-kriterierna

30 mars 2012

Första postat (Uppskatta)

3 april 2012

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

1 september 2020

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

29 augusti 2020

Senast verifierad

1 augusti 2020

Mer information

Termer relaterade till denna studie

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