NCT02179385

Brief Summary

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.

Trial Health

50
Monitor

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for not_applicable type-2-diabetes

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2014

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

June 25, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 1, 2014

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Last Updated

August 6, 2015

Status Verified

August 1, 2015

Enrollment Period

2 years

First QC Date

June 25, 2014

Last Update Submit

August 4, 2015

Conditions

Type 2 Diabetes

Keywords

Type 2 diabetesType II diabetes

Outcome Measures

Primary Outcomes (1)

  • Clinical composite

    Change from baseline in a composite endpoint of HbA1c, BMI, Blood Pressure, Lipids at 6, 12 and 18 months from randomization

    0, 6, 12, 18 months from randomization

Secondary Outcomes (2)

  • Change in Self Treatment Score

    0, 6, 12, 18 months from randomization

  • Change in Self Efficacy Score

    0, 6, 12, 18 months from randomization

Other Outcomes (1)

  • Change in Quality of life score

    0, 12 months from randomization

Study Arms (2)

Health coaching

EXPERIMENTAL

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

Behavioral: Health Coaching

Standard of Care

PLACEBO COMPARATOR

Interventions

Health CoachingBEHAVIORAL
Health coaching

Eligibility Criteria

Age21 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Department Manager of Quality Promotion, Community Medical Division

Study Record Dates

First Submitted

June 25, 2014

First Posted

July 1, 2014

Study Start

June 1, 2014

Primary Completion

June 1, 2016

Last Updated

August 6, 2015

Record last verified: 2015-08