Improving Adherence and Commitment to Treatment in Diabetic Patients

NCT ID: NCT02530840

Last Updated: 2018-02-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-31

Study Completion Date

2018-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Type 2 Diabetes

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

medical team

Intervention Type BEHAVIORAL

Lowering HbA1c by behavioral changes in meetings with the medical team.

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.

Group Type EXPERIMENTAL

peers group

Intervention Type BEHAVIORAL

Lowering HbA1c by behavioral changes in meetings with the peers group.

SMS notifications

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

Group Type EXPERIMENTAL

SMS notification

Intervention Type BEHAVIORAL

Lowering HbA1c by behavioral changes in meetings with the SMS notification

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

medical team

Lowering HbA1c by behavioral changes in meetings with the medical team.

Intervention Type BEHAVIORAL

peers group

Lowering HbA1c by behavioral changes in meetings with the peers group.

Intervention Type BEHAVIORAL

SMS notification

Lowering HbA1c by behavioral changes in meetings with the SMS notification

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)
Minimum Eligible Age

30 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Clalit Health Services

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Margalit Goldfracht, prof.

Role: PRINCIPAL_INVESTIGATOR

Director of the Department of promoting quality of family medicine

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Clalit Health Institute

Tel Aviv, , Israel

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Israel

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Margalit Goldfracht, prof.

Role: CONTACT

+972-50-6263-214

Niky Liberman, D"R

Role: CONTACT

+972-50-6263050

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

margalit Goldfracht, prof

Role: primary

+972-506263214

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

0025-14-COM

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

The Medication Adherence Program
NCT00838344 UNKNOWN NA