Evaluating the Impact of Year Long, Augmented Diabetes Self Management Support

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

449 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2017-05-31

Brief Summary

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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.

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Detailed Description

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Diabetes self management support is telephonic and will be provided by health navigators at a central call center

Conditions

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Diabetes Mellitus Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Investigators

Study Groups

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usual care

usual care includes diabetes self management education

Group Type NO_INTERVENTION

No interventions assigned to this group

diabetes self management support

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

Group Type ACTIVE_COMPARATOR

diabetes self management support

Intervention Type OTHER

diabetes self management support is telephonic and provided by health investigators

Interventions

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diabetes self management support

diabetes self management support is telephonic and provided by health investigators

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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

Minimum Eligible Age

21 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No