Trial Outcomes & Findings for Patient-Centered Heart Failure Trial (NCT NCT00461513)
NCT ID: NCT00461513
Last Updated: 2018-07-12
Results Overview
The primary outcome was average change in the Kansas City Cardiomyopathy Questionnaire Overall Summary Score. This is reported for each group (Intervention and Usual Care). The average for each group and standard deviation are reported. A positive score change represents an improvement in overall patient health status for the group of patients with congestive heart failure. A negative score change represents a worsening in overall patient health status for the group of patients with congestive heart failure.
COMPLETED
384 participants
12 months
2018-07-12
Participant Flow
Participant milestones
| Measure |
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).
|
|---|---|---|
|
Overall Study
STARTED
|
187
|
197
|
|
Overall Study
COMPLETED
|
165
|
172
|
|
Overall Study
NOT COMPLETED
|
22
|
25
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Patient-Centered Heart Failure Trial
Baseline characteristics by cohort
| Measure |
Intervention Group
n=187 Participants
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
n=197 Participants
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
n=384 Participants
Total of all reporting groups
|
|---|---|---|---|
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Age, Continuous
|
67.3 years
STANDARD_DEVIATION 9.6 • n=5 Participants
|
67.9 years
STANDARD_DEVIATION 10.6 • n=7 Participants
|
67.6 years
STANDARD_DEVIATION 10.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
178 Participants
n=5 Participants
|
193 Participants
n=7 Participants
|
371 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White race
|
149 participants
n=5 Participants
|
165 participants
n=7 Participants
|
314 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Non-white race
|
38 participants
n=5 Participants
|
32 participants
n=7 Participants
|
70 participants
n=5 Participants
|
|
Kansas City Cardiomyopathy Overall Score
|
37.9 units on a scale
STANDARD_DEVIATION 13.3 • n=5 Participants
|
36.9 units on a scale
STANDARD_DEVIATION 14.6 • n=7 Participants
|
37.4 units on a scale
STANDARD_DEVIATION 13.8 • n=5 Participants
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PRIMARY outcome
Timeframe: 12 monthsThe primary outcome was average change in the Kansas City Cardiomyopathy Questionnaire Overall Summary Score. This is reported for each group (Intervention and Usual Care). The average for each group and standard deviation are reported. A positive score change represents an improvement in overall patient health status for the group of patients with congestive heart failure. A negative score change represents a worsening in overall patient health status for the group of patients with congestive heart failure.
Outcome measures
| Measure |
Intervention
n=187 Participants
|
Usual Care
n=197 Participants
|
|---|---|---|
|
Change in Chronic Heart Failure Health Status Between Baseline and 12 Months.
|
13.5 units on a scale
Standard Deviation 16.7
|
13.5 units on a scale
Standard Deviation 18.6
|
SECONDARY outcome
Timeframe: 12 monthsMortality at 1 year
Outcome measures
| Measure |
Intervention
n=187 Participants
|
Usual Care
n=197 Participants
|
|---|---|---|
|
Mortality at 1 Year
|
8 Participants
|
19 Participants
|
SECONDARY outcome
Timeframe: 12 monthsHospitalization at 1 year
Outcome measures
| Measure |
Intervention
n=187 Participants
|
Usual Care
n=197 Participants
|
|---|---|---|
|
Hospitalization at 1 Year
|
55 Participants
|
59 Participants
|
Adverse Events
Intervention
Usual Care
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place