Improving Adherence and Commitment to Treatment in Diabetic Patients

Overview

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

Full Title of Study: “Impact:Improving Adherence and Commitment to Treatment”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Supportive Care
    • Masking: None (Open Label)
  • Study Primary Completion Date: February 2018

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.

Interventions

  • Behavioral: medical team
    • Lowering HbA1c by behavioral changes in meetings with the medical team.
  • Behavioral: peers group
    • Lowering HbA1c by behavioral changes in meetings with the peers group.
  • Behavioral: SMS notification
    • Lowering HbA1c by behavioral changes in meetings with the SMS notification

Arms, Groups and Cohorts

  • 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.
  • 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.
  • Experimental: SMS notifications
    • un-balanced diabetic patients receiving daily SMS with content,which designed to promote adherence to healthy life style and medical therapy.
  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • 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

Participating in This Clinical Trial

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)

Gender Eligibility: All

Minimum Age: 30 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Clalit Health Services
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Margalit Goldfracht, prof., Principal Investigator, Director of the Department of promoting quality of family medicine
  • Overall Contact(s)
    • Margalit Goldfracht, prof., +972-50-6263-214, MargalitGo@clalit.org.il

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