Nurse-led Case Management for Diabetes and Cardiovascular Disease Patients With Depression

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Wayne Katon, National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:
NCT00468676
First received: May 1, 2007
Last updated: May 1, 2014
Last verified: May 2014
Results First Received: December 13, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Outcomes Assessor);   Primary Purpose: Treatment
Condition: Depression
Interventions: Behavioral: Nurse-led case management
Behavioral: Treatment as usual

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were recruited from may 2007 to october 2009 from 14 primary care clinics of Group Health Cooperative in Washington State

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Exclusion criteria: terminal illness, residence in long-term care facility, bipolar/schizophrenia, mental confusion suggesting dementia, pregnancy/breast-feeding, use of antipsychotic/mood stabilizer med, severe hearing loss, planned bariatric surgery within 3 months, ongoing psychiatric care

Reporting Groups
  Description
Usual Care Patients in usual care arm were advised to consult with their primary care physician to receive care for depression and for diabetes, coronary artery disease or both. With the patient's permission their primary care physician was notified about their PHQ-9 (Patient Health Questionnaire 9) score of 10 or greater and poor medical disease control. In addition primary care doctors received laboratory results at baseline, 6 and 12 months regarding HbA1c and at baseline and 12 months on fasting LDL
Care Management Intervention Case management intervention: patients assigned to care management received intervention visits with a medical nurse supervised weekly by both a psychiatrist and primary care doctor. Nurses provided psychoeducation, motivational interviewing, behavioral activation and problem solving and carefully tracked medications, side effects, PHQ-9 (Patient Health Questionnaire 9) scores and blood pressure and lab results. Using a registry the medical supervisors recommended changes in medications that the nurse communicated to the patient's individual primary care doctor (who wrote all prescriptions). Nurses also worked with the patient to set self care goals regarding health behaviors such as increasing exercise or improving diet

Participant Flow:   Overall Study
    Usual Care     Care Management Intervention  
STARTED     108     106  
COMPLETED     92     94  
NOT COMPLETED     16     12  
Lost to Follow-up                 14                 11  
Death                 2                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Usual Care Patients in usual care arm were advised to consult with their primary care physician to receive care for depression and for diabetes, coronary artery disease or both. With the patient's permission their primary care physician was notified about their PHQ-9 score of 10 or greater and poor medical disease control. In addition primary care doctors received laboratory results at baseline, 6 and 12 months regarding HbA1c and at baseline and 12 months on fasting LDL
Care Management Intervention Case management intervention: patients assigned to care management received intervention visits with a medical nurse supervised weekly by both a psychiatrist and primary care doctor. Nurses provided psychoeducation, motivational interviewing, behavioral activation and problem solving and carefully tracked medications, side effects, PHQ-9 scores and blood pressure and lab results. Using a registry the medical supervisors recommended changes in medications that the nurse communicated to the patient's individual primary care doctor (who wrote all prescriptions). Nurses also worked with the patient to set self care goals regarding health behaviors such as increasing exercise or improving diet
Total Total of all reporting groups

Baseline Measures
    Usual Care     Care Management Intervention     Total  
Number of Participants  
[units: participants]
  108     106     214  
Age  
[units: participants]
     
<=18 years     1     0     1  
Between 18 and 65 years     82     81     163  
>=65 years     25     25     50  
Age  
[units: years]
Mean ± Standard Deviation
  56.3  ± 12.1     57.4  ± 10.5     56.8  ± 11.3  
Gender  
[units: participants]
     
Female     60     51     111  
Male     48     55     103  
Region of Enrollment  
[units: participants]
     
United States     108     106     214  



  Outcome Measures
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1.  Primary:   Combined Effect of Intervention on SCL-20, Systolic Blood Pressure, LDL and HbA1c   [ Time Frame: Baseline to 12 months ]

2.  Primary:   Symptom Checklist-20 Score at Baseline, 6 Months and 12 Months   [ Time Frame: Measured at Baseline, 6 Months, 12 months ]

3.  Primary:   Systolic Blood Pressure at Baseline, 6 Months and 12 Months   [ Time Frame: Measured at Baseline, 6 Months, 12 months ]

4.  Primary:   LDL Cholesterol at Baseline and 12 Months   [ Time Frame: Measured at Baseline and 12 months ]

5.  Primary:   Glycated Hemoglobin (HbA1c) at Baseline, 6 Months and 12 Months   [ Time Frame: Measured at Baseline, 6 months and 12 months ]

6.  Secondary:   Functional Impairment   [ Time Frame: Measured at Months 6, 12 months ]

7.  Secondary:   Health Care Costs   [ Time Frame: Cumulative outpatient costs over 24 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Limitations include the study being completed in one health care system in one geographic area, inadequate power to determine cardiovascular events or rates of hospitalization, potential "spill-over of intervention to usual care patients.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr Wayne Katon, Professor and Vice Chair
Organization: Dept Psychiatry, University of Washington Medical School
phone: 206-543-7177
e-mail: wkaton@uw.edu


Publications of Results:
Publications automatically indexed to this study:

Responsible Party: Wayne Katon, National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier: NCT00468676     History of Changes
Other Study ID Numbers: R01 MH41739, R01MH041739, DSIR 82-SEPC
Study First Received: May 1, 2007
Results First Received: December 13, 2013
Last Updated: May 1, 2014
Health Authority: United States: Federal Government