NCT02681718

Brief Summary

The purpose of this study is to compare the efficacy of three approaches in diabetes management: (1) community health worker (CHW) education; (2) text messaging; and (3) usual hospital-based care. The goal is to determine the most cost-effective method of diabetes management among an economically-disadvantaged, minority population.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
272

participants targeted

Target at P75+ for not_applicable diabetes

Timeline
Completed

Started Jan 2016

Geographic Reach
1 country

1 active site

Status
completed

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

January 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 3, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 12, 2016

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

January 26, 2018

Status Verified

January 1, 2018

Enrollment Period

1.7 years

First QC Date

February 3, 2016

Last Update Submit

January 24, 2018

Conditions

Diabetes

Keywords

A1C≥9%minoritieseconomically disadvantaged

Outcome Measures

Primary Outcomes (2)

  • Difference in Hemoglobin A1C (CHW vs. Control)

    To assess whether there is a statistically significant difference in HbA1C level between CHW and control groups at 6 months follow-up.

    6 months

  • Difference in Hemoglobin A1C (Text Message vs. Control)

    To assess whether there is a statistically significant difference in HbA1C level between text message and control groups at 6 months follow-up.

    6 months

Secondary Outcomes (6)

  • Percentage change in diabetes knowledge test scores

    6 months

  • Mean change in diabetes self-efficacy scores

    6 months

  • Mean change in diabetes distress scores

    6 months

  • Mean change in participants' beliefs about using insulin scores

    6 months

  • Mean changes in diabetes self-care activities

    6 months

  • +1 more secondary outcomes

Study Arms (3)

Community Health Worker education

EXPERIMENTAL

During a six-month intervention period, the CHWs will conduct six home-based visitations and provide individualized diabetes education using an intensive diabetes lifestyle curriculum called Diabetes Learning Circle (DLC), developed and used by the Sinai Diabetes Education Program. At each visit, lasting for approximately one hour, the participants will be motivated to set SMART behavioral goals for diabetes self-management. At each visit after the initial visit, CHWs will follow-up with each participant to check their progress on their behavioral SMART goals. In addition, the CHWs will conduct intermittent phone calls (at least one monthly) and home visits as needed.

Behavioral: Community health worker education

Cell phone text messaging

EXPERIMENTAL

The participants in the text messaging group will receive weekly text messages through CareMessage. Each participant will receive 3-4 text messages per week for 6 months.

Behavioral: Cell phone text messaging

Control

NO INTERVENTION

The participants in the control group will receive education as determined by the hospital's diabetes educator, dietitian, physician, or the participant's managed care provider. No additional education will be provided by the research team.

Interventions

Community health worker educationBEHAVIORAL

Diabetes self-management education by community health workers

Community Health Worker education
Cell phone text messagingBEHAVIORAL

Diabetes self-management education through cell phone text messaging

Cell phone text messaging

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • \*Hyperglycemia with A1C ≥9%

You may not qualify if:

  • Lives greater than 20 miles driving distance from Mount Sinai Hospital
  • Pregnant women with gestational diabetes
  • Advanced end-organ complications due to diabetes that include: end-stage renal disease, stroke with paresis, Congestive Heart Failure (NYHA class III or IV), or other major end-organ complication of diabetes
  • Receiving treatment for a major psychiatric disorder (i.e. schizophrenia)
  • Unable to understand and give informed consent in either English or Spanish
  • Currently or previously participated in a diabetes research study
  • Family member currently enrolled in a diabetes research study
  • Previously received diabetes care related cell phone text messages
  • Unable to receive text messages 3-4 times per week
  • Living in a homeless shelter or temporary housing
  • Plans to travel outside of the United States for more than 3 months in next year

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mount Sinai Hospital

Chicago, Illinois, 60608, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

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

Study Record Dates

First Submitted

February 3, 2016

First Posted

February 12, 2016

Study Start

January 1, 2016

Primary Completion

September 1, 2017

Study Completion

September 1, 2017

Last Updated

January 26, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)