Clinical trial NCT03167866: Effect of Motivation Text Messages on Diabetes Patients
Official title: The Influence of Motivational Text Messages on Glycemic Control and Healthy Lifestyle Choices in Patients With Diabetes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2017-05-30
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The investigators will examine the influence of increasing motivation on healthy lifestyle and glycemic control in diabetes patients. Participants will be randomized to two groups, the control group gets informational text message and the intervention group gets motivational SMS. The patients get a weekly text message and after 26 weeks the HbA1c and quality of life will be assessed.

Detailed description: The investigators will examine the influence of increasing motivation on healthy lifestyle and glycemic control in diabetes patients. Participants will provide demographic and clinical information, fill human value questionnaires and quality of life questionnaires and decide on personal lifestyle-improvement goals. They will then be randomized to one of two groups: the control group gets informational text message and the intervention group gets motivational text message. The patients get a weekly text message and after 26 weeks we will check the HbA1c and quality of life. The text message will be personalized by including personal details acquired by a questionnaire. They will provide demographic and clinical information.

In addition, the influence of demographic characters and related DM character on the benefit of the motivational SMS will be assessed.

Eligibility criteria: Inclusion Criteria:

* Uncontrolled DM 2 patients (HbA1c \> 8%)
* Know to read (Hebrew or Arabic)
* Have a cellular phone
* Can sign informed consent.

Exclusion Criteria:

* A life expectancy of less than one year

Primary outcomes:
measure: HbA1c levels at 6 months from beginning of messages
timeFrame: at 6 months from beginning of study
Secondary outcomes:
measure: Diabetes Quality of Life questionnaire
timeFrame: at 6 months from beginning of study
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Rambam Health Care Campus
Study officials:
affiliation: Rambam Healthcare Campus
name: Irit Hochberg, MD/PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Text message program improves outcomes, decreases ED utilization among ED patients with poorly controlled diabetes. ED Manag. 2014 Feb;26(2):20-3.
citation: Reinhardt JA, van der Ploeg HP, Grzegrzulka R, Timperley JG. lmplementing lifestyle change through phone-based motivational interviewing in rural-based women with previous gestational diabetes mellitus. Health Promot J Austr. 2012 Apr;23(1):5-9. doi: 10.1071/he12005.
citation: Arora S, Peters AL, Agy C, Menchine M. A mobile health intervention for inner city patients with poorly controlled diabetes: proof-of-concept of the TExT-MED program. Diabetes Technol Ther. 2012 Jun;14(6):492-6. doi: 10.1089/dia.2011.0252. Epub 2012 Apr 23.
citation: Hochberg I, Feraru G, Kozdoba M, Mannor S, Tennenholtz M, Yom-Tov E. Encouraging Physical Activity in Patients With Diabetes Through Automatic Personalized Feedback via Reinforcement Learning Improves Glycemic Control. Diabetes Care. 2016 Apr;39(4):e59-60. doi: 10.2337/dc15-2340. Epub 2016 Jan 28. No abstract available.
citation: Ramachandran A, Snehalatha C, Ram J, Selvam S, Simon M, Nanditha A, Shetty AS, Godsland IF, Chaturvedi N, Majeed A, Oliver N, Toumazou C, Alberti KG, Johnston DG. Effectiveness of mobile phone messaging in prevention of type 2 diabetes by lifestyle modification in men in India: a prospective, parallel-group, randomised controlled trial. Lancet Diabetes Endocrinol. 2013 Nov;1(3):191-8. doi: 10.1016/S2213-8587(13)70067-6. Epub 2013 Sep 11.