Improving Adherence and Commitment to Treatment in Diabetic Patients

January 31, 2018 updated by: Clalit Health Services

Impact:Improving Adherence and Commitment to Treatment

In the IMPACT project, the investigators want to improve adherence and commitment to treatment.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

In this study the investigators use 3 interventions in diabetic patients and one control, to find what is the best intervention to improve adherence to healthy life style and medication therapy. the 3 intervention as followed: 1) meetings and follow-up by the medical team; 2) meetings and follow-up by trained peers; 3) system for sending SMS, operate according to algorithm.

Study Type

Interventional

Enrollment (Anticipated)

500

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Tel Aviv, Israel
        • Recruiting
        • Clalit Health Institute
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. type 2 diabetes
  2. age 30-70
  3. Oral medication or insulin
  4. According to the HbA1c test result, 0.5% above the target for the patient's personal balance and below the 10%, the most recent, but in any event not more than six months prior to the study patient recruitment
  5. BMI<35
  6. Patients speak and read Hebrew
  7. owners of a mobile phone that can receive text messages (SMS messages/ notifications) and have the ability to use the application (relevant for the SMS notification arm)

Exclusion Criteria:

  1. Active malignant disease
  2. creatinine levels above 2
  3. Getting medicines that elevate sugar levels as steroids, chemotherapy
  4. Three months after Myocardial Infraction (myocardial ischemia), surgical intervention, cardiac event
  5. Patients who are planning major surgery
  6. Patients who are planning a residential zone change
  7. Patients with acute complications of diabetes under active treatment (such as limb amputation)
  8. Patients diagnosed with unbalanced mental disorders
  9. patients who can not sign the form on their own "informed consent"
  10. patients suffering from dementia
  11. Patients who are not mobile (dependent on the therapist)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: medical team
personal meetings and follow-up of un-balanced diabetic patients by trained medical team (nurse and doctor), which designed to promote adherence to healthy life style and medical therapy.
Behavioral: medical team
Lowering HbA1c by behavioral changes in meetings with the medical team.
Experimental: peers group
group meetings and follow-up of un-balanced diabetic patients by trained peers (peers: balanced diabetic patients),which designed to promote adherence to healthy life style and medical therapy.
Behavioral: peers group
Lowering HbA1c by behavioral changes in meetings with the peers group.
Experimental: SMS notifications
un-balanced diabetic patients receiving daily SMS with content,which designed to promote adherence to healthy life style and medical therapy.
Behavioral: SMS notification
Lowering HbA1c by behavioral changes in meetings with the SMS notification
No Intervention: control
un-balanced diabetic patients will get the basic and regular treatment for diabetic patients according to Clalit Health Services. In addition, the patients will have the same check-ups like all the patients in the experimental arms.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diabetes Control as Expressed by the Change in HbA1c %
Time Frame: 0, 6, 12 & 18 months
Participants will undergo HbA1c periodical lab test, the data needed for the trial will be extracted from electronic medical record
0, 6, 12 & 18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Clalit Health Services

Investigators

  • Principal Investigator: Margalit Goldfracht, prof., Director of the Department of promoting quality of family medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2014

Primary Completion (Anticipated)

February 1, 2018

Study Completion (Anticipated)

March 1, 2018

Study Registration Dates

First Submitted

August 16, 2015

First Submitted That Met QC Criteria

August 20, 2015

First Posted (Estimate)

August 21, 2015

Study Record Updates

Last Update Posted (Actual)

February 1, 2018

Last Update Submitted That Met QC Criteria

January 31, 2018

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 0025-14-COM

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Type 2 Diabetes

Clinical Trials on medical team

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Egypt

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe