NCT02530840

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for not_applicable type-2-diabetes

Timeline
Completed

Started Jul 2014

Longer than P75 for not_applicable type-2-diabetes

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2014

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

August 16, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 21, 2015

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2018

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
Last Updated

February 1, 2018

Status Verified

July 1, 2016

Enrollment Period

3.6 years

First QC Date

August 16, 2015

Last Update Submit

January 31, 2018

Conditions

Type 2 Diabetes

Keywords

imbalanced diabetic patientsHbA1cpeers

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (4)

medical team

EXPERIMENTAL

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

peers group

EXPERIMENTAL

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

SMS notifications

EXPERIMENTAL

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

Behavioral: SMS notification

control

NO INTERVENTION

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.

Interventions

medical teamBEHAVIORAL

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

medical team
peers groupBEHAVIORAL

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

peers group
SMS notificationBEHAVIORAL

Lowering HbA1c by behavioral changes in meetings with the SMS notification

SMS notifications

Eligibility Criteria

Age30 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clalit Health Institute

Tel Aviv, Israel

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Margalit Goldfracht, prof.

    Director of the Department of promoting quality of family medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Margalit Goldfracht, prof.

CONTACT

+972-50-6263-214MargalitGo@clalit.org.il

Niky Liberman, D"R

CONTACT

+972-50-6263050nickyli@clalit.org.il

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 16, 2015

First Posted

August 21, 2015

Study Start

July 1, 2014

Primary Completion

February 1, 2018

Study Completion

March 1, 2018

Last Updated

February 1, 2018

Record last verified: 2016-07

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)