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Patient-Centered Heart Failure Trial (PCDM)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00461513
First Posted: April 18, 2007
Last Update Posted: April 27, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
VA Office of Research and Development
Results First Submitted: November 19, 2014  
Study Type: Observational
Study Design: Time Perspective: Prospective
Condition: Heart Failure, Congestive
Intervention: Behavioral: Intervention

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Intervention The PCDM intervention included evaluation of CHF care by the collaborative care (CC) team with treatment recommendations based on current ACC/AHA clinical practice guidelines, telemonitoring, and screening and treatment for comorbid depression. The CC team at each site included a primary care provider, cardiologist and psychiatrist, as well as nurse and pharmacist. For each intervention patient, there was initial assessment of care following the enrollment visit. Each intervention patient was re-reviewed by the CC team a minimum of 2 additional times (at 6-weeks and 6 months). In addition, patients had daily telemonitoring, and their care was reviewed if the telemonitoring data suggested clinical deterioration.
Usual Care Patients randomized to the usual care arm continued to receive care at the discretion of their regular VA providers (for a given patient, this could include cardiology specialty care in addition to PCP care, participation in site-specific CHF programs such as CHF patient education classes, etc.), in direct continuity with the care they were receiving prior to enrollment. Patients in the usual care group were given information sheets that outlined self-care for CHF, and provided with a scale if needed at the enrollment visit. Patients in the usual care group had the same amount of interaction with the study team as the intervention patients (i.e. complete questionnaires at the same frequency; have the same study visits). PCPs of usual care patients were notified of the results of all screening studies (patient survey results, lab tests).

Participant Flow:   Overall Study
    Intervention   Usual Care
STARTED   193   199 
COMPLETED   165   172 
NOT COMPLETED   28   27 



  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.
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Reporting Groups
  Description
Intervention Group Baseline characteristics of patients who enrolled and were randomized to the Intervention Group, and who had at least one follow-up Kansas City Cardiomyopathy Questionnaire (at 3, 6, or 12 months). Therefore the total number completed in the Intervention Arm was 165, but we had at least one follow-up Kansas City Cardiomyopathy Questionnaire result on 187 patients.
Usual Care Group Baseline characteristics of patients who enrolled and were randomized to the Usual Care Group, and who had at least one follow-up Kansas City Cardiomyopathy Questionnaire (at 3, 6, or 12 months).Therefore the total number completed in the Usual Care Arm was 172, but we had at least one follow-up Kansas City Cardiomyopathy Questionnaire result on 197 patients.
Total Total of all reporting groups

Baseline Measures
   Intervention Group   Usual Care Group   Total 
Overall Participants Analyzed 
[Units: Participants]
 187   197   384 
Age 
[Units: Years]
Mean (Standard Deviation)
 67.3  (9.6)   67.9  (10.6)   67.6  (10.0) 
Gender 
[Units: Participants]
     
Female   9   4   13 
Male   178   193   371 
Race/Ethnicity, Customized 
[Units: Participants]
     
White race   149   165   314 
Non-white race   38   32   70 
Kansas City Cardiomyopathy Overall Score [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 37.9  (13.3)   36.9  (14.6)   37.4  (13.8) 
[1] The Kansas City Cardiomyopathy Questionnaire Overall Summary Score ranges from 0-100, where higher scores represent better overall patient health status among patients with congestive heart failure. Here we report the mean and standard deviation of the baseline Kansas City Cardiomyopathy Questionnaire Overall Summary Score for the Intervention and Usual Care groups.


  Outcome Measures

1.  Primary:   Change in Chronic Heart Failure Health Status Between Baseline and 12 Months.   [ Time Frame: 12 months ]

2.  Secondary:   Hospitalization and Mortality, Depressive Symptoms, Patients' Self-efficacy in Management of CHF, Adherence to Prescribed Medications, Patient Satisfaction, Proportion of Patients With Guideline-concordant Care, Cost-effectiveness of the Intervention.   [ Time Frame: 12 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  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
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  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: Dr. Meg Plomondon
Organization: Veterans Health Administration
phone: 303-370-75770
e-mail: Meg.Plomondon@va.gov


Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00461513     History of Changes
Other Study ID Numbers: IIR 06-068
First Submitted: April 17, 2007
First Posted: April 18, 2007
Results First Submitted: November 19, 2014
Results First Posted: December 8, 2014
Last Update Posted: April 27, 2015