Translating Telephonic Diabetes Self-management Support to Primary Care Practice

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

812 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Study Completion Date

2019-09-20

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The goal of this study is to evaluate the implementation and effectiveness of an intervention to improve diabetes self-management, emotional distress and metabolic control among adults with type 2 diabetes receiving care in primary care practices throughout New York City. The program will be implemented by the New York City Department of Health, through their Primary Care Improvement Project.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Improving Diabetes Outcomes With Activity, Nutrition and Medication

NCT00179374

Diabetes Mellitus, Type 2

COMPLETED NA

The Diabetes TeleCare Study

NCT00288132

Diabetes Mellitus, Type 2

COMPLETED NA

Automated Calls With Nurse Follow-Up to Improve Diabetes Ambulatory Care

NCT00012753

Diabetes

COMPLETED PHASE3

Enhancing Telemedicine for T2D

NCT06740435

Type 2 Diabetes

RECRUITING NA

Impact of an Automated Telephone Intervention on Glycosylated Hemoglobin (HbA1c) in Type 2 Diabetes

NCT00700908

Type 2 Diabetes

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Type 2 Diabetes

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Telephonic Diabetes Self-Management Support

This group receives all the Educational Print Materials received by the comparison condition plus telephone calls from a health educator to provide tailored diabetes self-management training and support. Participants with significant emotional distress at baseline also receive additional calls focused on distress management.

Group Type EXPERIMENTAL

Telephonic Diabetes Self-Management Support

Intervention Type BEHAVIORAL

Educational Print Materials

Participants randomized to this arm will receive print materials on diabetes, glycemic control, self-management, and distress/depression.

Group Type ACTIVE_COMPARATOR

Educational Print Materials

Intervention Type OTHER

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Telephonic Diabetes Self-Management Support

Intervention Type BEHAVIORAL

Educational Print Materials

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 21 years of age and older
* Receiving treatment for diabetes at selected primary care practices throughout New York City
* Most recent HbA1c ≥ 7.5% (max 3 months prior to randomization)
* Ability to speak and read English or Spanish (or someone in the household who will read to them)
* Access to a telephone
* Willing to give informed consent to participate and accept random assignment.

Exclusion Criteria

* Stated intention to move out of the New York City area during the next year
* Mental incapacity (e.g., confusion) evident on first telephone contact by Department of Health staff
* Treatment provider deems that the patient is inappropriate for the trial

Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No