Effective Care Management of Depressed Diabetes Patients (The Positive Steps Study)
1 other identifier
interventional
339
1 country
3
Brief Summary
Evaluation of telephone care management intervention designed to improve outcomes among depressed diabetes patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable diabetes
Started May 2005
Longer than P75 for not_applicable diabetes
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2009
CompletedFirst Submitted
Initial submission to the registry
April 15, 2010
CompletedFirst Posted
Study publicly available on registry
April 20, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2011
CompletedApril 28, 2015
April 1, 2015
4.4 years
April 15, 2010
April 24, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Participant HbA1c levels
one year
Participant cardiovascular risk index
one year
Secondary Outcomes (5)
Proximal intervention targets
one year
Other self-care behaviors
one year
Health-related quality of life
one year
Treatment satisfaction
one year
Resource use
one year
Study Arms (2)
Enhanced Usual Care
NO INTERVENTIONAdult patients with diabetes and depression. * Report screening results * Notify PCP of screening results (optional per patient) * PCP referrals * Educational materials regarding diabetes, physical activity, and depression
Staged Care Management
EXPERIMENTALAdult patients with diabetes and depression
Interventions
* Basic physical activity counseling * Notify PCP and facilitate initiation of antidepressants * Medication monitoring calls at 1, 2, 4, 6, 8, 10, and 12 weeks\* * 1/mo monitoring in continuation phase (mos. 4-12)\* * Report \& recommendations to PCP after each patient call * Note: \*average of 10 minutes of telephone time each (series is repeated if second antidepressant trial is needed)
* Notify PCP * CBT Manual * Weekly CBT focused counseling for 12 weeks\*\* * Monthly CBT in months 4-12\*\* * Behavioral physical activity counseling * Report \& recommendations to PCP after each patient call * Note: \*\*average of 50 minutes of telephone time each
Eligibility Criteria
You may qualify if:
- Active Diabetes (Type 1 \& 2)
- Diagnosis of depression
- Using hypoglycemic medications
- At least 1 outpatient visit in last 12 months
- At least 21 years old
You may not qualify if:
- Limited life expectancy (heart failure/ on oxygen/ advanced stage cancer/ dialysis)
- End stage renal disease
- Lung cancer
- Dementia
- Bipolar
- Schizophrenia
- Can't speak English
- Memory problems
- Alcohol problems
- Illegal drug use
- Minimal depressive symptoms
- Blood pressure 180/110 or higher
- Problems with loss of consciousness
- Can't walk 10 minutes on level surface
- Not planning to get their care at study site
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Michiganlead
- US Department of Veterans Affairscollaborator
- Genesys Health Systemcollaborator
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)collaborator
Study Sites (3)
VA Ann Arbor Healthcare System
Ann Arbor, Michigan, 48105, United States
University of Michigan Health System
Ann Arbor, Michigan, 48109, United States
Genesys Regional Medical Center
Grand Blanc, Michigan, 48439, United States
Related Publications (1)
Piette JD, Valenstein M, Himle J, Duffy S, Torres T, Vogel M, Richardson C. Clinical complexity and the effectiveness of an intervention for depressed diabetes patients. Chronic Illn. 2011 Dec;7(4):267-78. doi: 10.1177/1742395311409259. Epub 2011 Aug 12.
PMID: 21840915DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
John D Piette, PhD
VA Ann Arbor Healthcare System
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- VA Senior Research Career Scientist and Professor of Internal Medicine
Study Record Dates
First Submitted
April 15, 2010
First Posted
April 20, 2010
Study Start
May 1, 2005
Primary Completion
October 1, 2009
Study Completion
April 1, 2011
Last Updated
April 28, 2015
Record last verified: 2015-04