Effect of Motivation Text Messages on Diabetes Patients
Primary Purpose
Diabetes Mellitus, Type 2
Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
motivational SMS
informational SMS
Sponsored by
About this trial
This is an interventional diagnostic trial for Diabetes Mellitus, Type 2
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
Sites / Locations
- Rambam Health Care Campus
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
control group
test group
Arm Description
DM patients who receive a weekly informational Short Message Service (SMS) by phone for 26 weeks. informational SMS
DM patients who receive a weekly motivational Short Message Service (SMS) for 26 weeks. motivational SMS
Outcomes
Primary Outcome Measures
HbA1c levels at 6 months from beginning of messages
Blood HbA1c levels are reflective of how well diabetes is controlled
Secondary Outcome Measures
Diabetes Quality of Life questionnaire
To design and test the reliability and validity of a brief treatment
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03167866
Brief Title
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
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Unknown status
Study Start Date
June 1, 2017 (Anticipated)
Primary Completion Date
December 1, 2019 (Anticipated)
Study Completion Date
December 1, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rambam Health Care Campus
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Masking Description
Randomization will be by study personell that is not in contact with participants
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
control group
Arm Type
Placebo Comparator
Arm Description
DM patients who receive a weekly informational Short Message Service (SMS) by phone for 26 weeks. informational SMS
Arm Title
test group
Arm Type
Experimental
Arm Description
DM patients who receive a weekly motivational Short Message Service (SMS) for 26 weeks. motivational SMS
Intervention Type
Behavioral
Intervention Name(s)
motivational SMS
Intervention Description
the participant receives a weekly text message that is aimed to increase motivation
Intervention Type
Behavioral
Intervention Name(s)
informational SMS
Intervention Description
the participant a weekly text message that is provides information on improving lifestyle
Primary Outcome Measure Information:
Title
HbA1c levels at 6 months from beginning of messages
Description
Blood HbA1c levels are reflective of how well diabetes is controlled
Time Frame
at 6 months from beginning of study
Secondary Outcome Measure Information:
Title
Diabetes Quality of Life questionnaire
Description
To design and test the reliability and validity of a brief treatment
Time Frame
at 6 months from beginning of study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Irit Hochberg, MD/PhD
Phone
972-4-7772150
Email
i_hochberg@rambam.health.gov.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Irit Hochberg, MD/PhD
Organizational Affiliation
Rambam Healthcare Campus
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rambam Health Care Campus
City
Haifa
Country
Israel
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
24505864
Citation
Text message program improves outcomes, decreases ED utilization among ED patients with poorly controlled diabetes. ED Manag. 2014 Feb;26(2):20-3.
Results Reference
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PubMed Identifier
22730940
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.
Results Reference
background
PubMed Identifier
22524591
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.
Results Reference
background
PubMed Identifier
26822328
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.
Results Reference
background
PubMed Identifier
24622367
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.
Results Reference
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Effect of Motivation Text Messages on Diabetes Patients
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