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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03168633
Other study ID # 0456-14-RMB CTIL
Secondary ID
Status Completed
Phase N/A
First received February 1, 2017
Last updated May 24, 2017
Start date July 2015
Est. completion date January 30, 2017

Study information

Verified date May 2017
Source Rambam Health Care Campus
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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)


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.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date January 30, 2017
Est. primary completion date January 30, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

1. Previous diabetes specialist follow

2. Age over 18.

3. Diagnosis of diabetes type 2.

4. HbA1c over 7%

5. Self-admitted less than optimal adherence to physical activity, diet or medications or computer-recorded less than 80% adherence to medication purchase.

6. Able to read Hebrew

7. Uses Email account that is actively read at least twice weekly.

Exclusion Criteria:

- Patients who did not the inclusion criteria

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
web-based DM2 information pages
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.…

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Rambam Health Care Campus

Outcome

Type Measure Description Time frame Safety issue
Primary HbA1C values of patients after 6 months HbA1C values 6 months follow up
Secondary percentage of messages opened and read reading of each message will be recorded 10-12 messages in 6 months
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