Lifestyle Advises Sent Via Email in Attempt of Improving A1C in DM2 Patients
Primary Purpose
Diabetes Mellitus, Type 2
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
web-based DM2 information pages
Sponsored by

About this trial
This is an interventional supportive care trial for Diabetes Mellitus, Type 2 focused on measuring : Type 2 Diabetes Mellitus, Web-based intervention, medication adherence, lifestyle changes
Eligibility Criteria
Inclusion Criteria:
- Previous diabetes specialist follow
- Age over 18.
- Diagnosis of diabetes type 2.
- HbA1c over 7%
- Self-admitted less than optimal adherence to physical activity, diet or medications or computer-recorded less than 80% adherence to medication purchase.
- Able to read Hebrew
- Uses Email account that is actively read at least twice weekly.
Exclusion Criteria:
- Patients who did not the inclusion criteria
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
patients receiving emails
Arm Description
Diagnosed DM2 patients who meet inclusion criteria. the patients will receive emails containing information about DM2 as a method of reminding patients of the importance of adjusting post diagnosis life-style changes. web-based DM2 information pages
Outcomes
Primary Outcome Measures
HbA1C values of patients after 6 months
HbA1C values
Secondary Outcome Measures
percentage of messages opened and read
reading of each message will be recorded
Full Information
NCT ID
NCT03168633
First Posted
February 1, 2017
Last Updated
May 24, 2017
Sponsor
Rambam Health Care Campus
1. Study Identification
Unique Protocol Identification Number
NCT03168633
Brief Title
Lifestyle Advises Sent Via Email in Attempt of Improving A1C in DM2 Patients
Official Title
Effects of Reading Information Sent Via Email and Glycemic Control and Compliance to Recommendations Among Patients With Type 2 Diabetes Mellitus -Prospective Research
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
July 2015 (Actual)
Primary Completion Date
January 30, 2017 (Actual)
Study Completion Date
January 30, 2017 (Actual)
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
Diabetic patients need to manage their glucose level, physical activity and food intake to successfully cope with their disease. Previous work has shown that reminders of the disease, be they informational or about ones' condition, can improve management of disease in diabetes.
This trial focuses on delivering these reminders, via email, in attempt to improve the patients glycemic control (measured in Hemoglobin A1C)
Detailed Description
The study initially included 50 patients (men and women, over 18 years of age) who were prior diagnosed with DM2 and unbalanced in their glycemic values (HbA1c above 7%). The patient were sent via email , once every other week, a link to web-based pages which provides information on changing DM2 related such as general DM2 information, the importance of keeping a well-balanced diet, benefits of exercising regularly, drug related information and more.
Furthermore, the patients were sent a questionnaire every other week which they were asked to actively reply to.
Each participating patient was monitored for 6 months, during this time he/she was sent 12 web-based information pages.
During the course of the study, information regarding the patients' glycemic control (in the form of HgA1c levels) was collected.
Additional variables (age, sex, BMI, time passed since diagnosed with DM2) were collected and used for statistical comparison.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
Keywords
: Type 2 Diabetes Mellitus, Web-based intervention, medication adherence, lifestyle changes
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
patients receiving emails
Arm Type
Experimental
Arm Description
Diagnosed DM2 patients who meet inclusion criteria. the patients will receive emails containing information about DM2 as a method of reminding patients of the importance of adjusting post diagnosis life-style changes.
web-based DM2 information pages
Intervention Type
Behavioral
Intervention Name(s)
web-based DM2 information pages
Intervention Description
Each email will include information on one of the following topics:
The importance of physical activity
Correct nutrition
The importance of adhering to medication regimens.
Emails will be either positive (e.g., the importance of good nutrition, and what constitutes good nutrition) or negative (e.g., the risks of not adhering to medications).
The information will be provided by different approaches: medical research results, practical tips, patient testimonies.…
Primary Outcome Measure Information:
Title
HbA1C values of patients after 6 months
Description
HbA1C values
Time Frame
6 months follow up
Secondary Outcome Measure Information:
Title
percentage of messages opened and read
Description
reading of each message will be recorded
Time Frame
10-12 messages in 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Previous diabetes specialist follow
Age over 18.
Diagnosis of diabetes type 2.
HbA1c over 7%
Self-admitted less than optimal adherence to physical activity, diet or medications or computer-recorded less than 80% adherence to medication purchase.
Able to read Hebrew
Uses Email account that is actively read at least twice weekly.
Exclusion Criteria:
Patients who did not the inclusion criteria
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Irit Hochberg, MD
Organizational Affiliation
Rambam Hospital
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Lifestyle Advises Sent Via Email in Attempt of Improving A1C in DM2 Patients
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