Lifestyle Advises Sent Via Email in Attempt of Improving A1C in DM2 Patients

NCT ID: NCT03168633

Last Updated: 2017-05-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-07-31
• Study Completion Date: 2017-01-30

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.

Conditions

Diabetes Mellitus, Type 2

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

patients receiving emails

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

Group Type: EXPERIMENTAL

web-based DM2 information pages

Intervention Type: BEHAVIORAL

Each email will include information on one of the following topics:

1. The importance of physical activity

2. Correct nutrition

3. 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.…

Interventions

web-based DM2 information pages

Each email will include information on one of the following topics:

1. The importance of physical activity

2. Correct nutrition

3. 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.…

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rambam Health Care Campus

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Irit Hochberg, MD

Role: PRINCIPAL_INVESTIGATOR

Rambam Hospital

Other Identifiers

0456-14-RMB CTIL

Identifier Type: -

Identifier Source: org_study_id