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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03167866
Other study ID # 66666
Secondary ID
Status Not yet recruiting
Phase N/A
First received April 26, 2017
Last updated May 24, 2017
Start date June 1, 2017
Est. completion date December 1, 2020

Study information

Verified date May 2017
Source Rambam Health Care Campus
Contact Irit Hochberg, MD/PhD
Phone 972-4-7772150
Email i_hochberg@rambam.health.gov.il
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 100
Est. completion date December 1, 2020
Est. primary completion date December 1, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
motivational SMS
the participant receives a weekly text message that is aimed to increase motivation
informational SMS
the participant a weekly text message that is provides information on improving lifestyle

Locations

Country Name City State
Israel Rambam Health Care Campus Haifa

Sponsors (1)

Lead Sponsor Collaborator
Rambam Health Care Campus

Country where clinical trial is conducted

Israel, 

References & Publications (5)

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. — View 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. — View 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. — View 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. — View Citation

Text message program improves outcomes, decreases ED utilization among ED patients with poorly controlled diabetes. ED Manag. 2014 Feb;26(2):20-3. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary HbA1c levels at 6 months from beginning of messages Blood HbA1c levels are reflective of how well diabetes is controlled at 6 months from beginning of study
Secondary Diabetes Quality of Life questionnaire To design and test the reliability and validity of a brief treatment at 6 months from beginning of study
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