Improving Adherence and Commitment to Treatment in Diabetic Patients

Study Overview
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Brief Summary
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In the IMPACT project, the investigators want to improve adherence and commitment to treatment.

Detailed Description
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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.

Official Title
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Impact:Improving Adherence and Commitment to Treatment

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Behavioral: medical team
* Behavioral: peers group
* Behavioral: SMS notification


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: type 2 diabetes age 30-70 Oral medication or insulin 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 BMI<35 Patients speak and read Hebrew 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: Active malignant disease creatinine levels above 2 Getting medicines that elevate sugar levels as steroids, chemotherapy Three months after Myocardial Infraction (myocardial ischemia), surgical intervention, cardiac event Patients who are planning major surgery Patients who are planning a residential zone change Patients with acute complications of diabetes under active treatment (such as limb amputation) Patients diagnosed with unbalanced mental disorders patients who can not sign the form on their own informed consent patients suffering from dementia Patients who are not mobile (dependent on the therapist)

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: medical team<br>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<br>* Lowering HbA1c by behavioral changes in meetings with the medical team.<br>|
| Experimental: peers group<br>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<br>* Lowering HbA1c by behavioral changes in meetings with the peers group.<br>|
| Experimental: SMS notifications<br>un-balanced diabetic patients receiving daily SMS with content,which designed to promote adherence to healthy life style and medical therapy. | Behavioral: SMS notification<br>* Lowering HbA1c by behavioral changes in meetings with the SMS notification<br>|
| No Intervention: control<br>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?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diabetes Control as Expressed by the Change in HbA1c % | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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imbalanced diabetic patients, HbA1c, peers