Empowerment and Support for the Diabetic Patient

NCT ID: NCT02179385

Last Updated: 2015-08-06

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

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Brief Summary

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CHANGE-D objectives are to evaluate to what extent personal coaching for healthy lifestyle and treatment adherence improves clinical outcomes among uncontrolled diabetic patients.

Evaluate to what extent personal coaching for healthy lifestyle and treatment adherence improves self treatment among uncontrolled diabetic patients.

Detailed Description

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Research Group 300 type 2 diabetics: 150 from Jewish sector and 150 from Arab sector will be recruited from 7-10 clinics in each district: North District and Haifa District A personal coaching intervention will be tailored from the offered tools: Face to face, group, telephone Participants will be monitored for clinical and self treatments outcomes Comparison Group 300 patients with similar characteristics to the research group will receive Clalit's standard of care Participants will be monitored for clinical and self treatments outcomes like the research group

Conditions

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Type 2 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Health coaching

Patients receive health coaching via the phone, face to face or group support, according to patients' choice

Group Type EXPERIMENTAL

Health Coaching

Intervention Type BEHAVIORAL

Standard of Care

Group Type PLACEBO_COMPARATOR

No interventions assigned to this group

Interventions

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Health Coaching

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Type 2 diabetes
* At least one oral anti diabetic drug
* HbA1c above 7.5% ot above 0.5% of personal target
* Preparedness for change
* Fluent Hebrew or Arabic

Exclusion Criteria

* Type 1 diabetes
* Pregnancy or lactation
* Incompetency to sign consent
* Participation in another clinical trial
* Unstable psychotic disease
* Complex health condition
Minimum Eligible Age

21 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role collaborator

Clalit Health Services

OTHER

Sponsor Role lead

Responsible Party

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Margalit (Margita) Goldfracht

Department Manager of Quality Promotion, Community Medical Division

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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0130-13-COM

Identifier Type: -

Identifier Source: org_study_id

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