NCT03168633

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)

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable diabetes-mellitus-type-2

Timeline
Completed

Started Jul 2015

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2015

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2017

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

February 1, 2017

Completed
4 months until next milestone

First Posted

Study publicly available on registry

May 30, 2017

Completed
Last Updated

May 30, 2017

Status Verified

May 1, 2017

Enrollment Period

1.6 years

First QC Date

February 1, 2017

Last Update Submit

May 24, 2017

Conditions

Keywords

: Type 2 Diabetes MellitusWeb-based interventionmedication adherencelifestyle changes

Outcome Measures

Primary Outcomes (1)

  • HbA1C values of patients after 6 months

    HbA1C values

    6 months follow up

Secondary Outcomes (1)

  • percentage of messages opened and read

    10-12 messages in 6 months

Study Arms (1)

patients receiving emails

EXPERIMENTAL

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

Behavioral: web-based DM2 information pages

Interventions

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.…

patients receiving emails

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Medication Adherence

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesPatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Irit Hochberg, MD

    Rambam Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 1, 2017

First Posted

May 30, 2017

Study Start

July 1, 2015

Primary Completion

January 30, 2017

Study Completion

January 30, 2017

Last Updated

May 30, 2017

Record last verified: 2017-05