Mood and Diabetes Empowerment & Improvement Training

Diabetes Mellitus, Type 2 Clinical Trial

— MADE-IT  

Official title:

University of California, Los Angeles (UCLA)/Drew Project EXPORT: Mood and Diabetes Empowerment & Improvement Training (MADE IT)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02010684
• Other study ID #: MADE-IT Study 1P20MD00148-03
• Status: Completed
• Phase: N/A
• First received: August 1, 2013
• Last updated: May 27, 2015
• Start date: April 2009
• Est. completion date: January 2012

Study information

• Verified date: May 2015
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

In this project, investigators examine the impact of a mood treatment enhanced diabetes self-care intervention for depressed, low-income Latino diabetics. The investigators hypothesize that the mood treatment enhancement will lead to significant improvement in both diabetes and depression outcomes as compared with the self-care intervention alone.

Description:

The Phase I pilot recruited older Latinos from Dr. Mangione's previous study (who agreed to participate in future research) and 10 participants from a community settings. Those with low mood and poor glycemic control were offered a 12-week intervention combining cognitive behavioral therapy mood management techniques and diabetes self-care into one seamless intervention. Drs. Mangione and Miranda supervised and reviewed (through audiotapes) well-trained health educators conducting the intervention sessions. The study manuals were modified following this Phase I pilot intervention.

The final intervention manual was tested in a randomized trial in Phase II, compared the Mood and Diabetes Empowerment and Improvement Training intervention with enhanced care as usual (providing participants with a letter regarding their mood and hemoglobin (Hb)A1c with recommendations for improving care for their provider). The target population was low-income Latinos with depression and poor glycemic control. Both mood and diabetes outcomes are evaluated.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 121
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• Latino men and women age 50 and older

• Must speak English or Spanish

• Hb A1c greater than or equal to 8%

• Currently not taking medication for depression

• A score of 5 or greater on the Geriatric Depression Scale (GDS)

Exclusion Criteria:

• Persons who are legally blind, dialysis dependent, diagnosed with dementia, and/or with hemiparesis from a cerebral vascular accident

• Do not have sufficient hearing or cognitive function

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Behavioral:
• Empowerment and CBT Classes
Participants randomized to the intervention arm will receive a manual with 3 CBT modules and 1 Diabetes Empowerment module. CBT Module 1 covers "Understanding Depression and Diabetes", Module 2 "How Thoughts Affect Your Mood and Diabetes Care", Module 3 "How Activities Affect Your Mood and Diabetes Care". The Diabetes Empowerment Module covers topics including the following: food, exercise, medicine, diabetes and your health, social support, communication skills, and community resources.

Locations

Country	Name	City	State
United States	UCLA Psychr & Biobehav Sci	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Los Angeles

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Hemoglobin A1c at 6 Months	Hemoglobin A1c (HbA1c) measures glycemic control over the past three months. HbA1c was measured by a blood draw and laboratory test.	Baseline and 6 months	No
Primary	Change From Baseline in Depression Measures at 6 Months	The Geriatric Depression Scale (GDS) measures depression in older adults. The short form we used consists of 15 yes or no questions. The scale range is 0 to 15, where higher scores indicate greater severity of depression.; The Patient Health Questionnaire-9 (PHQ-9) measures depression in patients. The questionnaire consists of 9 questions where patients self report how frequently they have depression symptoms over the past two weeks. The scale ranges is 0 to 27 where higher scores indicate greater severity of depression.	Baseline and 6 months	No
Secondary	Change From Baseline in Blood Pressure at 6 Months		Baseline and 6 months	No
Secondary	Change From Baseline in Low Density Lipoprotein-C at 6 Months		Baseline and 6 months	No
Secondary	Change From Baseline in EQ-5D at 6 Months	The EQ-5D measures general quality of life. The index score is based on 5 questions about mobility, self-care, pain, usual activities, and psychological status. The EuroQol Group provides a U.S. preference-weighted algorithm to calculate the index scores. A score of 1 indicates no problems while a score of -0.11 indicates severe problems.; The scale score is based on a visual analog of a thermostat, where 0 represents worst imaginable health and 100 represents best imaginable health. Patients mark a tick for where they feel their health is on that scale.	Baseline and 6 months	No
Secondary	Change From Baseline in Yale Physical Activity Scale - Index Summary Score at 6 Months	The Yale Physical Activity Scale measures physical function and activities of daily living. Five activity indices (vigorous activity, leisurely walking, moving, standing and sitting) are calculated by multiplying the frequency of activity with the duration and a weighted factor. The 5 indices are then summed to create an index summary. Higher scores indicate more activity. The minimum and maximum scores are 0 and 142.	Baseline and 6 months	No
Secondary	Change From Baseline in Self-Efficacy (Diabetes Empowerment Scale) at 6 Months	The Diabetes Empowerment Scale Short Form (DES-SF) measures diabetes-related psychosocial self-efficacy. The questionnaire presents 8 statements on self-efficacy where participants rate how strongly they agree. The answers are summed to create a score where higher scores indicate more empowerment. The score range is 0 to 8.	Baseline and 6 months	No