Improving Adherence and Commitment to Treatment in Diabetic Patients

Not Applicable

• Conditions: Type 2 Diabetes
• Interventions: Behavioral: medical team; Behavioral: peers group; Behavioral: SMS notification

• Registration Number: NCT02530840
• Lead Sponsor: Clalit Health Services

Brief Summary

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

• Study Start: 2014-07
• Study First Submitted: 2015-08-16
• Study First Submitted QC: 2015-08-20
• Study First Posted: 2015-08-21
• Status Verified: 2016-07
• Last Update Submitted: 2018-01-31
• Primary Completion: 2018-02
• Last Update Posted: 2018-02-01
• Study Completion: 2018-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
medical team	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.
peers group	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.
SMS notifications	SMS notification	un-balanced diabetic patients receiving daily SMS with content,which designed to promote adherence to healthy life style and medical therapy.

Primary Outcome Measures

Name	Time	Method
Diabetes Control as Expressed by the Change in HbA1c %	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

Trial Locations

Locations (1)

Clalit Health Institute; 🇮🇱 Tel Aviv, Israel