Stress Management Among Latinos With Type 2 Diabetes (CALMS-D)
This study has been completed.
Sponsor:
Yale University
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: August 20, 2015
Last verified: August 2015
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Purpose
The primary aims of this study are to:
- Tailor a diabetes stress management intervention for delivery by community health workers (CHWs) serving an urban Latino population.
-
Investigate the efficacy of the stress management intervention on glycemic control.
Secondary aims of this study are to:
- 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:
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
| Enrollment: | 107 |
| Study Start Date: | May 2012 |
| Study Completion Date: | June 2015 |
| 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 (Adult, Senior) |
| 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01578096
Please refer to this study by its ClinicalTrials.gov identifier: NCT01578096
Locations
| United States, Connecticut | |
| Yale University | |
| New Haven, Connecticut, United States | |
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
| Responsible Party: | Yale University |
| ClinicalTrials.gov Identifier: | NCT01578096 History of Changes |
| Other Study ID Numbers: | R01MD005879 |
| Study First Received: | April 12, 2012 |
| Last Updated: | August 20, 2015 |
| 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 September 26, 2016