- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT01569243
Text to Move (TTM)Study (TTM)
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
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Fase 2
Contatti e Sedi
Luoghi di studio
-
-
Massachusetts
-
Boston, Massachusetts, Stati Uniti, 02114
- Center for Connected Health
-
Boston, Massachusetts, Stati Uniti, 02114
- Partners Healthcare Center for Connected Health
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Terapia di supporto
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Altro: Usual care group
Subjects in this group will receive the usual standard of care available at MGH.
|
Altri nomi:
|
Sperimentale: 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.
|
Altri nomi:
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
physical activity
Lasso di tempo: 6 months
|
Physical activity will be assessed by step counts measured by an ActiHealth pedometer and compared between the study arms.
|
6 months
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Clinical outcome
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 6 months
|
This will be assessed using standardized Questionnaires at closeouts
|
6 months
|
Engagement to program
Lasso di tempo: 6 months
|
This will be measure quantitatively by:
|
6 months
|
Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Kamal Jethwani, MD, MPH, Center for Connected Health
Pubblicazioni e link utili
Pubblicazioni generali
- 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.
- 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(Suppl 1):S87-94. doi: 10.2337/dc09-S087. No abstract available.
- 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. doi: 10.1177/193229680800200422.
- 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. doi: 10.2337/dc07-1667. Epub 2007 Dec 4. No abstract available.
- Jethwani KS, Chandwani HS. The internet: revolutionizing medical research for novices and virtuosos alike. J Postgrad Med. 2008 Jan-Mar;54(1):49-51. doi: 10.4103/0022-3859.39194. No abstract available.
- 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. doi: 10.1177/193229680900300216.
- 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.
- 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.
- Horner GN, Agboola S, Jethwani K, Tan-McGrory A, Lopez L. Designing Patient-Centered Text Messaging Interventions for Increasing Physical Activity Among Participants With Type 2 Diabetes: Qualitative Results From the Text to Move Intervention. JMIR Mhealth Uhealth. 2017 Apr 24;5(4):e54. doi: 10.2196/mhealth.6666.
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 2011-P-002708/1; MGH
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su Usual care
-
Aarogyam UKNMP Medical Research Institute; Croydon Ayurveda Centre; Active Naturals Limited; AVP Research FoundationAttivo, non reclutanteDisturbo psichiatricoIndia
-
Massachusetts General HospitalNational Institutes of Health (NIH); Samaritans of BostonNon ancora reclutamentoIdeazione suicida | Suicidio, tentato | Suicidio
-
French Red CrossInstitut National de la Santé Et de la Recherche Médicale, France; University... e altri collaboratoriReclutamentoAttività fisica | Crescita | Dieta | Comportamento sedentario | InfanteFrancia
-
Vrije Universiteit BrusselUniversitaire Ziekenhuizen KU Leuven; KU LeuvenReclutamentoArtrosi, ginocchio | InsonniaBelgio
-
Medical College of WisconsinReclutamentoDiabete di tipo 2Stati Uniti
-
Henry M. Jackson Foundation for the Advancement...National Institute of Mental Health (NIMH); United States Department of DefenseCompletatoDisturbo post-traumatico da stress (PTSD)Stati Uniti
-
Dana-Farber Cancer InstituteMassachusetts General Hospital; Brigham and Women's HospitalAttivo, non reclutanteSmettere di fumare | Cancro ai polmoniStati Uniti
-
University of Texas at AustinSconosciutoSclerosi multiplaStati Uniti
-
University of PittsburghNational Institute of Nursing Research (NINR)CompletatoTumori cerebrali maligni primariStati Uniti
-
Rhode Island HospitalEunice Kennedy Shriver National Institute of Child Health and Human Development...CompletatoCyber bullismoStati Uniti