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Stress Management Among Latinos With Type 2 Diabetes (CALMS-D)

This study is not yet open for participant recruitment.
Verified April 2012 by Yale University
Sponsor:
Collaborators:
Hartford Hospital
University of Connecticut Health Center
Hispanic Health Council
Information provided by (Responsible Party):
Yale University
ClinicalTrials.gov Identifier:
NCT01578096
First received: April 12, 2012
Last updated: NA
Last verified: April 2012
History: No changes posted
  Purpose

The primary aims of this study are to:

  1. Tailor a diabetes stress management intervention for delivery by community health workers (CHWs) serving an urban Latino population.

  2. Investigate the efficacy of the stress management intervention on glycemic control.

    Secondary aims of this study are to:

  3. Investigate the efficacy of the stress management intervention on stress hormones, psychosocial functioning, and stress-glucose reactivity.

Study hypothesis:

A CHW-led group-based diabetes education model enhanced with stress management education will improve glycemic control more than CHW-led group-based diabetes education alone.


Condition Intervention
Diabetes Mellitus, Type 2
 Behavioral: stress management

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Stress Management Among Latinos With Type 2 Diabetes Mellitus

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Yale University:

Primary Outcome Measures:
  • Hemoglobin A1c [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Blood will be drawn from participants and hemoglobin A1c levels will be measured

  • Hemoglobin A1c [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]
    Blood will be drawn from participants and hemoglobin A1c levels will be measured

  • Hemoglobin A1c [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Blood will be drawn from participants and hemoglobin A1c levels will be measured


Secondary Outcome Measures:
  • Diabetes specific distress [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Participants will be asked questions assessing their perspective of emotional distress from living with diabetes

  • Diabetes specific distress [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]
    Participants will be asked questions assessing their perspective of emotional distress from living with diabetes

  • Diabetes specific distress [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Participants will be asked questions assessing their perspective of emotional distress from living with diabetes


Estimated Enrollment: 250
Study Start Date: May 2012
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Diabetes education
Group-based diabetes education delivered to participants through community health workers
Experimental: Diabetes education plus stress management
Group-based diabetes education plus stress management delivered to participants through community health workers
 Behavioral: stress management
The study is a randomized, controlled,single-site, parallel group clinical trial comparing the effectiveness of CHW led diabetes education with CHW led diabetes education plus CHW led stress management in Latinos with Type 2 Diabetes.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Latinos age 18 or older that are ambulatory
  • Spanish speaking
  • Diagnosed with type 2 diabetes for at least 1 year
  • Hemoglobin A1c levels greater than 7.0

Exclusion Criteria:

  • Medical instability or medical treatment requiring inpatient care
  • Diagnoses of bipolar disorder or thought disorder (or taking medications prescribed for either); current substance abuse or dependence disorder
  • Current suicidality or history of suicide attempt
  • History of psychiatric hospitalization
  • Taking antidepressant medications prescribed for the treatment of depression accompanied by either a) changes to the antidepressant regimen within previous 6 weeks, or b) anticipated changes to the regimen during period of study. Such patients will be deferred and re-evaluated for eligibility after 6 months
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01578096

Contacts
Contact: Rafael Pérez-Escamilla, Ph.D. 203-737-5882 rafael.perez-escamilla@yale.edu
Contact: Julie A Wagner, Ph.D. (860) 679-4508 juwagner@uchc.edu

Locations
United States, Connecticut
Yale University Not yet recruiting
New Haven, Connecticut, United States
Contact: Rafael Pérez-Escamilla, Ph.D.     203-737-5882     rafael.perez-escamilla@yale.edu    
Sponsors and Collaborators
Yale University
Hartford Hospital
University of Connecticut Health Center
Hispanic Health Council
Investigators
Principal Investigator: Rafael Pérez-Escamilla, Ph.D. Yale University
  More Information

No publications provided

Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT01578096     History of Changes
Other Study ID Numbers: R01MD005879
Study First Received: April 12, 2012
Last Updated: April 12, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Yale University:
Type 2 Diabetes

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 19, 2013