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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
Rambam Health Care Campus
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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

    First Posted
    February 1, 2017
    Last Updated
    May 24, 2017
    Sponsor
    Rambam Health Care Campus
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    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

    Learn more about this trial

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

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