NCT02160639

Brief Summary

Improving diabetes social support is associated with health improvement benefits. This study is a prospective randomized controlled trial comparing the effects of telephone-based diabetes self-management support (DSMS) compared with usual care, which includes diabetes self-management education (DSME), during a 1-year period. It will determine whether this specific model for providing on-going support to people with diabetes will better enable them to maintain the engagement in self-care behaviors, clinical improvements and diabetes-specific knowledge gained during the course of diabetes self-management education.

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
449

participants targeted

Target at P75+ for not_applicable diabetes-mellitus-type-2

Timeline
Completed

Started Jan 2015

Typical duration for not_applicable diabetes-mellitus-type-2

Geographic Reach
1 country

4 active sites

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

First Submitted

Initial submission to the registry

June 6, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 11, 2014

Completed
7 months until next milestone

Study Start

First participant enrolled

January 1, 2015

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

July 12, 2016

Status Verified

July 1, 2016

Enrollment Period

2.3 years

First QC Date

June 6, 2014

Last Update Submit

July 11, 2016

Conditions

Diabetes Mellitus Type 2

Keywords

diabetes self management educationdiabetes self management supporttype 2 diabetes

Outcome Measures

Primary Outcomes (6)

  • Change from baseline HbA1c at 3, 9, 15, and 27 months

    HbA1c assessment

    0, 3, 9, 15, and 27 months

  • Change from baseline blood pressure at 3, 9, 15, and 27 months

    blood pressure assessments

    0, 3, 9, 15, and 27 months

  • Change from baseline cholesterol at 3, 9, 15, and 27 months

    cholesterol assessments

    0, 3, 9, 15, and 27 months

  • Change from baseline BMI at 3, 9, 15, and 27 months

    body mass index (BMI) assessments

    0, 3, 9, 15, and 27 months

  • Change from baseline weight at 3, 9, 15, and 27 months

    weight assessments

    0, 3, 9, 15, and 27 months

  • Change from baseline fasting glucose at 3, 9, 15, and 27 months

    fasting glucose assessments

    0, 3, 9, 15, and 27 months

Secondary Outcomes (3)

  • Change from baseline patient credential at 3, 9, 15, and 27 months

    0, 3, 9, 15, and 27 months

  • Change from baseline depression at 3, 9, 15, and 27 months

    0, 3, 9, 15, and 27 months

  • Change from baseline food security at 3, 9, 15, and 27 months

    0, 3, 9, 15, and 27 months

Study Arms (2)

usual care

NO INTERVENTION

usual care includes diabetes self management education

diabetes self management support

ACTIVE COMPARATOR

diabetes self management support in addition to usual care, which includes diabetes self management education

Other: diabetes self management support

Interventions

diabetes self management supportOTHER

diabetes self management support is telephonic and provided by health investigators

diabetes self management support

Eligibility Criteria

Age21 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • English or Spanish speaking
  • Diagnosis of type 2 diabetes mellitus
  • HbA1c \> 8
  • Have not completed a diabetes self management education program in the past year

You may not qualify if:

  • Current engagement in cancer treatment
  • Diagnosis of end-stage renal disease
  • Pregnant
  • Receiving immunosuppressant therapy following transplant
  • Diagnosis of serious mental illness
  • Undergoing systemic treatment with prednisone

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

El Rio Community Health Center

Tucson, Arizona, 85701, United States

Location

Cross Trails Medical Center

Cape Girardeau, Missouri, 63703, United States

Location

Triad Adult and Pediatric Medicine, Inc.

High Point, North Carolina, 27262, United States

Location

FamilyCare Health Center

Scott Depot, West Virginia, 25560, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Dawn Sherr, MS, RD, CDE

    American Association of Diabetes Educators

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 6, 2014

First Posted

June 11, 2014

Study Start

January 1, 2015

Primary Completion

May 1, 2017

Study Completion

May 1, 2017

Last Updated

July 12, 2016

Record last verified: 2016-07

Locations

US(4)