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

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ClinicalTrials.gov Identifier: NCT01578096
Recruitment Status : Completed
First Posted : April 16, 2012
Last Update Posted : August 21, 2015
Sponsor:
Collaborators:
Hartford Hospital
UConn Health
Hispanic Health Council
Information provided by (Responsible Party):
Yale University

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:

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 or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Behavioral: stress management Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 107 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Stress Management Among Latinos With Type 2 Diabetes Mellitus
Study Start Date : May 2012
Actual Primary Completion Date : December 2014
Actual Study Completion Date : June 2015

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U.S. FDA Resources

Arms and Interventions
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. Hemoglobin A1c [ Time Frame: Baseline ]
    Blood will be drawn from participants and hemoglobin A1c levels will be measured

  2. Hemoglobin A1c [ Time Frame: 9 weeks ]
    Blood will be drawn from participants and hemoglobin A1c levels will be measured

  3. Hemoglobin A1c [ Time Frame: 6 months ]
    Blood will be drawn from participants and hemoglobin A1c levels will be measured


Secondary Outcome Measures :
  1. Diabetes specific distress [ Time Frame: Baseline ]
    Participants will be asked questions assessing their perspective of emotional distress from living with diabetes

  2. Diabetes specific distress [ Time Frame: 9 weeks ]
    Participants will be asked questions assessing their perspective of emotional distress from living with diabetes

  3. Diabetes specific distress [ Time Frame: 6 months ]
    Participants will be asked questions assessing their perspective of emotional distress from living with diabetes


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01578096


Locations
United States, Connecticut
Yale University
New Haven, Connecticut, United States
Sponsors and Collaborators
Yale University
Hartford Hospital
UConn Health
Hispanic Health Council
Investigators
Principal Investigator: Rafael Pérez-Escamilla, Ph.D. Yale University
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT01578096     History of Changes
Other Study ID Numbers: R01MD005879 ( U.S. NIH Grant/Contract )
First Posted: April 16, 2012    Key Record Dates
Last Update Posted: August 21, 2015
Last Verified: August 2015

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