Improving Adherence and Commitment to Treatment in Diabetic Patients

Clalit Health Services

Status: Unknown

Conditions: Type 2 Diabetes

Treatments: Behavioral: SMS notification; Behavioral: medical team; Behavioral: peers group

Study type: Interventional

Funder types: Other

Identifiers

NCT02530840

0025-14-COM

Details and patient eligibility

About

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

Full 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.

Enrollment: 500 estimated patients

Sex: All

Ages: 30 to 70 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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500 participants in 4 patient groups

medical team

Experimental group

Description:

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.

Treatment:

Behavioral: medical team

peers group

Experimental group

Description:

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.

Treatment:

Behavioral: peers group

SMS notifications

Experimental group

Description:

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

Treatment:

Behavioral: SMS notification

control

No Intervention group

Description:

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.