Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Depressive Symptom Severity as Measured by the Patient Health Questionnaire (PHQ-9) Depression Scale Results at 6 Months Follow up |
PHQ-9 is used to measure depressive symptoms severity. The PHQ-9 is a self-report instrument that corresponds with the validated Primary Care Evaluation of Mental Disorders PRIME-MD clinician-administered instrument. The PHQ-9 measures all nine dimensions of depression assessed in the DSM criteria for MDD on a 0-3 scale. Minimum score = 0 (no depression). Maximum scores = 21 (worst depression) |
6 months from baseline enrollment. |
|
Secondary |
Change From Baseline in the 12-item Questionnaire Used to Assess Health-related Quality of Life (SF-12v2) Scale Results |
The SF-12v2 is a 12-item questionnaire used to assess Health-related Quality of Life (HRQoL) from the patient's perspective. The SF-12v2 consists of 12 questions from the SF-36 that evaluate the same eight health domains: physical function, the role-physical, bodily pain, general health, vitality, social function, the role-emotional, and mental health. The Physical Component Summary (PCS) and Mental Component Summary (MCS) scores are norm-based scores ranging from 0 to 100 calculated from the responses to the 12 questions using scoring software from QualityMetric.com. In the general US population, the mean normal score is 50, with a standard deviation (SD) of 10. Higher scores indicate better outcomes with better HRQoL. Health-related Quality of Life - Physical Health as measured by SF-12 physical component and Health |
3 month, 6 month, and 12 months from baseline enrollment |
|
Secondary |
Change From Baseline on the Kansas City Cardiomyopathy Questionnaire (KCCQ ) Scale Results. |
The KCCQ is a 23-item, self-administered instrument that quantifies 6 domains and yields 2 summary scores. The 6 domains are physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. The 2 summary scores are the Clinical Summary Score and the Overall Summary Score. The Clinical Summary score includes total symptom and physical function scores to correspond with NYHA Classification. The Overall Summary Score includes the total symptom, physical function, social limitations and quality of life scores. Domain scores and summary scores are scaled from the raw item scores using a software available from the authors (SPERTUSJ@UMKC.EDU) to a range from 0 (worst) to 100 (best), in which higher scores reflect better heart-failure-specific quality of life and health status. Heart failure-specific quality of life are measured by the KCCQ Overall Summary Score and the Clinical Summary Score . |
3 month, 6 month, and 12 months from baseline enrollment |
|
Secondary |
Change From Baseline on the Caregiver Burden Questionnaire-Heart Failure (CBQ-HF) Scale Results. |
The Caregiver Burden Questionnaire - Heart Failure Version 3.0 (CBQ-HF) is a quantitative survey of 26 questions covering the past four weeks of the caregiver's experience is evaluated as caregiver burden. The scale uses a 5-point Likert severity scale (Not at all=0, A little=1, Somewhat=2, Quite a lot=3, A lot=4) assessing 4 domains of physical, emotional/psychological, social and lifestyle burdens. The score is summed from all the questions for each domain, and then summed to a total score that ranges from 0 (no burden) to 104 (worst burden), in which higher scores reflect worse outcomes of higher burden on the caregiver. We will measure the caregiver burden measured by the CBQ-HF. |
3 month, 6 month, and 12 months from baseline enrollment |
|
Secondary |
Mean Number of Emergency Department Visits |
We recorded the number of emergency department visits. |
3 month, 6 month, and 12 months from baseline enrollment |
|
Secondary |
Mean Number of Readmissions (Hospitalization) |
We recorded the number of readmissions to the hospital. |
3 month, 6 month, and 12 months from baseline enrollment |
|
Secondary |
If Hospitalized, Mean Number of Total Days in the Hospital |
We recorded the number of total days in the hospital if they were hospitalized. |
3 month, 6 month, and 12 months from baseline enrollment |
|
Secondary |
Mortality Was Also Measured |
We recorded mortality data on the patients. |
3 month, 6 month, and 12 months from baseline enrollment |
|