NCT02137720

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
812

participants targeted

Target at P75+ for not_applicable type-2-diabetes

Timeline
Completed

Started Jun 2014

Longer than P75 for not_applicable type-2-diabetes

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 8, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 14, 2014

Completed
18 days until next milestone

Study Start

First participant enrolled

June 1, 2014

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 20, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 20, 2019

Completed
Last Updated

July 27, 2020

Status Verified

July 1, 2020

Enrollment Period

5.3 years

First QC Date

May 8, 2014

Last Update Submit

July 24, 2020

Conditions

Type 2 Diabetes

Keywords

DiabetesTreatment AdherenceSelf-managementEmotional DistressDiabetes-related Distress

Outcome Measures

Primary Outcomes (1)

  • HbA1c

    Obtained from electronic medical record.

    Change from baseline at 12 months

Secondary Outcomes (6)

  • Diabetes Self-Management

    Change from baseline at 12 months

  • Medication Adherence

    Change from baseline at 12 months

  • Diabetes-related distress

    Change from baseline at 12 months

  • Depressive symptoms

    Change from baseline at 12 months

  • Blood pressure

    Baseline and 12 months

  • +1 more secondary outcomes

Study Arms (2)

Telephonic Diabetes Self-Management Support

EXPERIMENTAL

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.

Behavioral: Telephonic Diabetes Self-Management Support

Educational Print Materials

ACTIVE COMPARATOR

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

Other: Educational Print Materials

Interventions

Telephonic Diabetes Self-Management SupportBEHAVIORAL
Telephonic Diabetes Self-Management Support
Educational Print MaterialsOTHER
Educational Print Materials

Eligibility Criteria

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New York City Department of Health and Mental Hygiene

New York, New York, 11101, United States

Location

Related Publications (1)

  • Gonzalez JS, Hoogendoorn CJ, Linnell J, Fishman S, Jonas V, Pham-Singer H, Schechter CB, Walker EA, Wu WY. Design and methods of NYC care calls: An effectiveness trial of telephone-delivered type 2 diabetes self-management support. Contemp Clin Trials. 2020 Nov;98:106166. doi: 10.1016/j.cct.2020.106166. Epub 2020 Oct 3.

    PMID: 33022367DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetes MellitusTreatment Adherence and Compliance

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesHealth BehaviorBehavior

Study Officials

  • Jeffrey S Gonzalez, PhD

    Albert Einstein College of Medicine

    PRINCIPAL INVESTIGATOR

  • Winfred Y Wu, MD, MPH

    New York City Department of Health and Mental Hygiene

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

May 8, 2014

First Posted

May 14, 2014

Study Start

June 1, 2014

Primary Completion

September 20, 2019

Study Completion

September 20, 2019

Last Updated

July 27, 2020

Record last verified: 2020-07

Locations

US(1)