Hepatitis C Translating Initiatives for Depression Into Effective Solutions (HEPTIDES)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT01143896
First received: June 11, 2010
Last updated: April 12, 2016
Last verified: April 2016
Results First Received: January 4, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Health Services Research
Conditions: Hepatitis C
Depression
Intervention: Other: Depression collaborative care model

  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
We recruited a total of 309 patients from CHC clinics at 4 VAs (Houston, St Louis, Little Rock, and Los Angeles) between April 2012 and September 2013. Of these, 292 patients completed baseline interviews. Follow-up data-collection interviews were completed for 263 (90.1%) participants at 6-months and 242 (78.3%) participants at 12-months.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Arm 1: Depression Collaborative Care Depression collaborative care model: The depression collaborative care arm will include a stepped-care model. The five steps are expected to include symptom and self-management monitoring by depression care manager (DCM) and the following: 1) watchful waiting, 2) treatment recommendations (counseling or pharmacotherapy), 3) pharmacotherapy recommended by a Clinical Pharmacist, 4) combination pharmacotherapy and specialty mental health counseling, and 5) referral to mental health. The DCM will provide education about depression and depression treatment options, assess the patient's treatment preferences and barriers, assess the patient's current depression severity and mental health comorbidity, initiate a self-management plan, and assess treatment adherence. The DCM will use the alcohol screening and brief intervention. The DCM will also screen for street drug use and will recommend referral of participants who are using street drugs to the local substance abuse treatment programs.
Arm 2: Usual Care Usual care will include depression screening with the same PHQ-9 screener used for Arm 1. The depression collaborative care team will not be a part of the usual care condition.

Participant Flow:   Overall Study
    Arm 1: Depression Collaborative Care     Arm 2: Usual Care  
STARTED     156     153  
COMPLETED     114     128  
NOT COMPLETED     42     25  
Did not complete Baseline Interview                 5                 4  
Lost to Follow-up                 18                 13  
Withdrawal by Subject                 13                 5  
Death                 6                 3  



  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.
A total of 292 participants completed baseline interviews.

Reporting Groups
  Description
Arm 1: Depression Collaborative Care Depression collaborative care: includes a stepped-care model. The 5 steps include symptom and self-management monitoring by a depression care manager (DCM) and the following: 1) watchful waiting, 2) treatment recommendations (counseling or pharmacotherapy), 3) pharmacotherapy recommended by a Clinical Pharmacist, 4) combination pharmacotherapy and specialty mental health counseling, and 5) referral to mental health. The DCM: provides education about depression and depression treatment options; assesses the patient's treatment preferences and barriers, and the patient's current depression severity and mental health comorbidity; initiates a patient self-management plan, and assess treatment adherence. The DCM uses standard alcohol screening and brief intervention. The DCM also screens for street drug use and recommends referral for to the local substance abuse treatment programs.
Arm 2: Usual Care Usual care will include depression screening with the same PHQ-9 screener used for Arm 1. The depression collaborative care team will not be a part of the usual care condition.
Total Total of all reporting groups

Baseline Measures
    Arm 1: Depression Collaborative Care     Arm 2: Usual Care     Total  
Number of Participants  
[units: participants]
  145     147     292  
Age  
[units: years]
Mean (Standard Deviation)
  59  (5.8)     59  (5.2)     59  (5.5)  
Gender  
[units: participants]
     
Female     6     6     12  
Male     139     141     280  
Race/Ethnicity, Customized  
[units: participants]
     
White Non-Hispanic     59     41     100  
Black or African American     72     91     163  
Other     14     15     29  
Region of Enrollment  
[units: participants]
     
United States     145     147     292  
Marital Status  
[units: participants]
     
Single, Never Married     45     68     113  
Married     14     16     30  
Other (divorced, widowed, separated, no response)     86     63     149  
Annual Income  
[units: participants]
     
Less than $20,000     60     57     117  
Over $20,000     43     41     84  
Don't Know/Refused     42     49     91  
History of Mood Disorders [1]
[units: participants]
     
Yes     65     67     132  
No     80     78     158  
Don't Know/Refused     0     2     2  
Taking antidepressant meds at baseline [2]
[units: participants]
     
Yes     71     67     138  
No     71     79     150  
Don't Know/Refused     3     1     4  
[1] In the last 6 months, did you receive care for personal or emotional problems, feeling down, worried or anxious, or alcohol or drug problem?
[2] Do you have a current prescription for any anti-depressant medications, such as prozac or lexapro?



  Outcome Measures
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1.  Primary:   Number of Patients Who Initiated Hepatitis C Antiviral Treatment Within 12 Months of Enrollment   [ Time Frame: 12 months ]

2.  Primary:   Depression Care: Treatment Response   [ Time Frame: Baseline and 12 months ]

3.  Primary:   Depression Care: Depression Remission   [ Time Frame: Baseline and 12 months ]

4.  Primary:   Depression Care: Change From Baseline in Number of Depression Free Days (DFDs) at 12 Months   [ Time Frame: From Baseline to 12 months ]

5.  Secondary:   Quality of Hepatitis C Care: Quality Indicators: Proportion of QIs Received   [ Time Frame: 12 months ]

6.  Secondary:   Medication Adherence: Medication Possession Ratio   [ Time Frame: 12 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
Primary Outcome Initiation of HCV treatment was affected by the 2012 announcement that new interferon-sparing antiviral drugs might be released within 1 year. Most HCV clinicians advised patients to wait for the new drugs (released in 2014).


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Fasiha Kanwal, MD, MSHS
Organization: Michael E. DeBakey VA Medical Center
phone: (713) 440-4495
e-mail: Fasiha.Kanwal@va.gov


Publications of Results:

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01143896     History of Changes
Other Study ID Numbers: SDP 10-044
10-05 ( Other Identifier: VA Central IRB )
Study First Received: June 11, 2010
Results First Received: January 4, 2016
Last Updated: April 12, 2016
Health Authority: United States: Federal Government