Improving Adherence and Commitment to Treatment in Diabetic Patients

Type 2 Diabetes Clinical Trial

Official title:

Impact:Improving Adherence and Commitment to Treatment

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02530840
• Other study ID #: 0025-14-COM
• Status: Recruiting
• Phase: N/A
• First received: August 16, 2015
• Last updated: January 31, 2018
• Start date: July 2014
• Est. completion date: March 2018

Study information

• Verified date: July 2016
• Source: Clalit Health Services
• Contact: Margalit Goldfracht, prof.
• Phone: +972-50-6263-214
• Email: MargalitGo[@]clalit.org.il
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: March 2018
• Est. primary completion date: February 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 70 Years

Eligibility

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)

Related Conditions & MeSH terms

• Type 2 Diabetes

Intervention

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

Locations

Country	Name	City	State
Israel	Clalit Health Institute	Tel Aviv

Sponsors (1)

Lead Sponsor	Collaborator
Clalit Health Services

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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