Depression, Heart Failure
Conditions
Brief summary
We are doing this study to help patients, caregivers, and providers make decisions about how best to manage depressive symptoms in advanced heart failure. There are two evidence-based treatment approaches to treating depression in patients with advanced heart failure, behavioral action psychotherapy and treatment with anti-depressant medications. In this study we want to compare the effectiveness of these two treatment options to learn which treatment works better.
Detailed description
Aim 1: To compare the effectiveness of BA vs. MEDS, for depressed AHF patients. Hypothesis 1: Compared to depressed AHF patients who receive MEDS, patients receiving BA will have significantly greater improvements in the primary outcome of depressive symptom severity as measured with the PHQ-9 at 6-month follow-up. Significantly greater improvements will also be detected in the secondary outcomes of general physical and mental HRQoL (SF-12v2), heart failure-specific HRQoL (KCCQ), and caregiver burden (CBQ-HF) at 3, 6, and 12 months. Aim 2: To compare the impact of BA vs. MEDS on disadvantageous outcomes of Morbidity (as evidenced by ED visits, hospital readmissions, total days in the hospital), and Mortality among depressed AHF patients. Hypothesis 2: Compared to depressed AHF patients who receive MEDS, those receiving BA will have significantly less Morbidity (as evidenced by less frequent ED visits, lower readmission rates, fewer total days in the hospital), and reduced Mortality at the data collection points of 3, 6, and 12 months.
Interventions
BEHAVIORALBehavioral Activation Therapy
The therapy group will consist of an introductory in person 50-minute treatment session, followed by 12 weekly telephone 50-minute outpatient treatment sessions, then 3 monthly telephone 50-minute outpatient maintenance sessions. A typical BA session will last 50 minutes and include a review of the previous session and completed daily monitoring record forms, an in-depth discussion of life areas and value, and verbal reinforcement of activity engagement.
Collaborative care model will be used. The medication management group will meet with the patient in a one 50 minute in person introductory antidepressant medication treatment session to educate the patient about depression and medication options. Patients will get prescribed a standard of care anti-depressant medication by treating physician, followed by 12 weekly follow up telephone visits, then on a monthly basis for 3 months, and then as needed thereafter.
Sponsors
Patient-Centered Outcomes Research Institute
Cedars-Sinai Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. HF New York Heart Association classes: II-IV. 2. Life expectancy of more than 6 months. 3. PHQ-9 score ≥10. 4. Diagnosis of Major Depressive Disorder, Persistent Depressive Disorder (Dysthymia), and Depressive Disorder Unspecified, as confirmed by the MINI 7.02.
Exclusion criteria
1. Imminent danger to self or others. 2. Cognitive impairments with a MOCA score of \< 23. 3. Bipolar, Psychotic, and Substance-induced Disorders. 4. Patients in active treatment of depression who are already on antidepressants, psychotherapy, or both.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Depressive Symptom Severity as Measured by the Patient Health Questionnaire (PHQ-9) Depression Scale Results at 6 Months Follow up | 6 months from baseline enrollment. | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in the 12-item Questionnaire Used to Assess Health-related Quality of Life (SF-12v2) Scale Results | 3 month, 6 month, and 12 months from baseline enrollment | 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 |
| Change From Baseline on the Kansas City Cardiomyopathy Questionnaire (KCCQ ) Scale Results. | 3 month, 6 month, and 12 months from baseline enrollment | 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 . |
| Change From Baseline on the Caregiver Burden Questionnaire-Heart Failure (CBQ-HF) Scale Results. | 3 month, 6 month, and 12 months from baseline enrollment | 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. |
| Mean Number of Readmissions (Hospitalization) | 3 month, 6 month, and 12 months from baseline enrollment | We recorded the number of readmissions to the hospital. |
| If Hospitalized, Mean Number of Total Days in the Hospital | 3 month, 6 month, and 12 months from baseline enrollment | We recorded the number of total days in the hospital if they were hospitalized. |
| Mortality Was Also Measured | 3 month, 6 month, and 12 months from baseline enrollment | We recorded mortality data on the patients. |
| Mean Number of Emergency Department Visits | 3 month, 6 month, and 12 months from baseline enrollment | We recorded the number of emergency department visits. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Patients: Medication Management (MEDS) The medication management group will meet with the patient in a one 50 minute in person introductory antidepressant medication treatment session to educate the patient about depression and medication options. Patients will get prescribed a standard of care anti-depressant medication by treating physician, followed by 12 weekly follow up telephone visits, then on a monthly basis for 3 months, and then as needed thereafter.
Medication Management: Collaborative care model will be used. The medication management group will meet with the patient in a one 50 minute in person introductory antidepressant medication treatment session to educate the patient about depression and medication options. Patients will get prescribed a standard of care anti-depressant medication by treating physician, followed by 12 weekly follow up telephone visits, then on a monthly basis for 3 months, and then as needed thereafter. | 208 |
| Patients: Behavioral Activation Therapy (BA) BA is an evidence-based psychotherapy with more than 25 randomized trials showing effectiveness in depression. The therapy group will consist of an introductory in person 50-minute treatment session, followed by 12 weekly telephone 50-minute outpatient treatment sessions, then 3 monthly telephone 50-minute outpatient maintenance sessions. A typical BA session will last 50 minutes and include a review of the previous session and completed daily monitoring record forms, an in-depth discussion of life areas and value, and verbal reinforcement of activity engagement.
Behavioral Activation Therapy: The therapy group will consist of an introductory in person 50-minute treatment session, followed by 12 weekly telephone 50-minute outpatient treatment sessions, then 3 monthly telephone 50-minute outpatient maintenance sessions. A typical BA session will last 50 minutes and include a review of the previous session and completed daily monitoring record forms, an in-depth discussion of life areas and value, and verbal reinforcement of activity engagement. | 208 |
| Caregivers: Medication Management (MEDS) Caregivers of patients receiving the the above described Medication Management (MEDS) intervention were monitored for caregiver burden at 3, 6, and 12 months. | 35 |
| Caregivers: Behavioral Activation Therapy (BA) Caregivers of patients receiving the the above described Behavioral Activation Psychotherapy (BA) intervention were monitored for caregiver burden at 3, 6, and 12 months. | 43 |
| Total | 494 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Death | 36 | 27 | 0 | 0 |
| Overall Study | Lost to Follow-up | 21 | 15 | 15 | 18 |
| Overall Study | Withdrawal by Subject | 19 | 16 | 0 | 0 |
Baseline characteristics
| Characteristic | Caregivers: Behavioral Activation Therapy (BA) | Caregivers: Medication Management (MEDS) | Patients: Medication Management (MEDS) | Total | Patients: Behavioral Activation Therapy (BA) |
|---|---|---|---|---|---|
| Age, Continuous MEAN AGE | 55 years STANDARD_DEVIATION 13 | 55 years STANDARD_DEVIATION 16 | 61 years STANDARD_DEVIATION 16 | 61 years STANDARD_DEVIATION 16 | 61 years STANDARD_DEVIATION 16 |
| Age, Continuous MEDIAN AGE (IQR) | 59 years | 57 years | 61 years | 62 years | 64 years |
| Location of Recruitment Inpatient | 22 Participants | 17 Participants | 107 Participants | 245 Participants | 99 Participants |
| Location of Recruitment Outpatient | 21 Participants | 18 Participants | 101 Participants | 249 Participants | 109 Participants |
| Medications ACE + ARB + Entresto | 0 Number of patients taking the medication | 0 Number of patients taking the medication | 105 Number of patients taking the medication | 212 Number of patients taking the medication | 107 Number of patients taking the medication |
| Medications Aldosterone Antagonist | 0 Number of patients taking the medication | 0 Number of patients taking the medication | 50 Number of patients taking the medication | 100 Number of patients taking the medication | 50 Number of patients taking the medication |
| Medications Angiotensin-Converting Enzyme Inhibitor | 0 Number of patients taking the medication | 0 Number of patients taking the medication | 33 Number of patients taking the medication | 66 Number of patients taking the medication | 33 Number of patients taking the medication |
| Medications Angiotensin Receptor Blocker | 0 Number of patients taking the medication | 0 Number of patients taking the medication | 66 Number of patients taking the medication | 135 Number of patients taking the medication | 69 Number of patients taking the medication |
| Medications Angiotensin Receptor Neprilysin Inhibitor | 0 Number of patients taking the medication | 0 Number of patients taking the medication | 38 Number of patients taking the medication | 76 Number of patients taking the medication | 38 Number of patients taking the medication |
| Medications Antiaggregant | 0 Number of patients taking the medication | 0 Number of patients taking the medication | 31 Number of patients taking the medication | 71 Number of patients taking the medication | 40 Number of patients taking the medication |
| Medications Antiarrhythmic | 0 Number of patients taking the medication | 0 Number of patients taking the medication | 27 Number of patients taking the medication | 61 Number of patients taking the medication | 34 Number of patients taking the medication |
| Medications Anticoagulant | 0 Number of patients taking the medication | 0 Number of patients taking the medication | 61 Number of patients taking the medication | 150 Number of patients taking the medication | 89 Number of patients taking the medication |
| Medications Beta Blocker | 0 Number of patients taking the medication | 0 Number of patients taking the medication | 135 Number of patients taking the medication | 268 Number of patients taking the medication | 133 Number of patients taking the medication |
| Medications Calcium Channel Blocker | 0 Number of patients taking the medication | 0 Number of patients taking the medication | 48 Number of patients taking the medication | 97 Number of patients taking the medication | 49 Number of patients taking the medication |
| Medications Cannabinoid | 0 Number of patients taking the medication | 0 Number of patients taking the medication | 7 Number of patients taking the medication | 12 Number of patients taking the medication | 5 Number of patients taking the medication |
| Medications Digoxin | 0 Number of patients taking the medication | 0 Number of patients taking the medication | 13 Number of patients taking the medication | 38 Number of patients taking the medication | 25 Number of patients taking the medication |
| Medications History of Antidepressant | 0 Number of patients taking the medication | 0 Number of patients taking the medication | 60 Number of patients taking the medication | 86 Number of patients taking the medication | 26 Number of patients taking the medication |
| Medications Hydralazine and Nitrate | 0 Number of patients taking the medication | 0 Number of patients taking the medication | 65 Number of patients taking the medication | 123 Number of patients taking the medication | 58 Number of patients taking the medication |
| Medications Ivabradine | 0 Number of patients taking the medication | 0 Number of patients taking the medication | 2 Number of patients taking the medication | 3 Number of patients taking the medication | 1 Number of patients taking the medication |
| Medications Loop Diuretic | 0 Number of patients taking the medication | 0 Number of patients taking the medication | 142 Number of patients taking the medication | 279 Number of patients taking the medication | 137 Number of patients taking the medication |
| Medications Non-Loop Diuretic | 0 Number of patients taking the medication | 0 Number of patients taking the medication | 3 Number of patients taking the medication | 5 Number of patients taking the medication | 2 Number of patients taking the medication |
| Medications Opiate | 0 Number of patients taking the medication | 0 Number of patients taking the medication | 65 Number of patients taking the medication | 116 Number of patients taking the medication | 51 Number of patients taking the medication |
| Medications Sodium-Glucose-Co-Transporter-2 Inhibitor | 0 Number of patients taking the medication | 0 Number of patients taking the medication | 4 Number of patients taking the medication | 12 Number of patients taking the medication | 8 Number of patients taking the medication |
| Medications Statin | 0 Number of patients taking the medication | 0 Number of patients taking the medication | 110 Number of patients taking the medication | 215 Number of patients taking the medication | 105 Number of patients taking the medication |
| Medications Steroid | 0 Number of patients taking the medication | 0 Number of patients taking the medication | 39 Number of patients taking the medication | 70 Number of patients taking the medication | 31 Number of patients taking the medication |
| Race/Ethnicity, Customized Ethnicity Hispanic or Latino | 9 Participants | 7 Participants | 32 Participants | 76 Participants | 28 Participants |
| Race/Ethnicity, Customized Ethnicity Missing | 1 Participants | 4 Participants | 5 Participants | 17 Participants | 7 Participants |
| Race/Ethnicity, Customized Ethnicity Not Hispanic or Latino | 33 Participants | 24 Participants | 171 Participants | 401 Participants | 173 Participants |
| Race/Ethnicity, Customized Race Asian | 2 Participants | 2 Participants | 14 Participants | 25 Participants | 7 Participants |
| Race/Ethnicity, Customized Race Black/African-American | 8 Participants | 6 Participants | 60 Participants | 136 Participants | 62 Participants |
| Race/Ethnicity, Customized Race Caucasian/White | 28 Participants | 19 Participants | 112 Participants | 280 Participants | 121 Participants |
| Race/Ethnicity, Customized Race Other | 5 Participants | 8 Participants | 22 Participants | 53 Participants | 18 Participants |
| Sex: Female, Male Female | 30 Participants | 27 Participants | 85 Participants | 230 Participants | 88 Participants |
| Sex: Female, Male Male | 13 Participants | 8 Participants | 123 Participants | 264 Participants | 120 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 36 / 208 | 27 / 208 |
| other Total, other adverse events | 0 / 208 | 0 / 208 |
| serious Total, serious adverse events | 36 / 208 | 27 / 208 |
Outcome results
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)
Time frame: 6 months from baseline enrollment.
Population: Intention-to-treat: We analyzed all participants in both arms who were randomized to their respective intervention
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Medication Management Group | Depressive Symptom Severity as Measured by the Patient Health Questionnaire (PHQ-9) Depression Scale Results at 6 Months Follow up | PHQ-9 at Baseline | 14.31 score on a scale | Standard Deviation 3.6 |
| Medication Management Group | Depressive Symptom Severity as Measured by the Patient Health Questionnaire (PHQ-9) Depression Scale Results at 6 Months Follow up | PHQ-9 at 6 months | 8.09 score on a scale | Standard Deviation 6.06 |
| Behavioral Activation Therapy | Depressive Symptom Severity as Measured by the Patient Health Questionnaire (PHQ-9) Depression Scale Results at 6 Months Follow up | PHQ-9 at Baseline | 14.54 score on a scale | Standard Deviation 3.45 |
| Behavioral Activation Therapy | Depressive Symptom Severity as Measured by the Patient Health Questionnaire (PHQ-9) Depression Scale Results at 6 Months Follow up | PHQ-9 at 6 months | 7.53 score on a scale | Standard Deviation 5.74 |
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
Time frame: 3 month, 6 month, and 12 months from baseline enrollment
Population: Intention to treat: We analyzed all participants in both arms who were randomized to their respective intervention
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Medication Management Group | Change From Baseline in the 12-item Questionnaire Used to Assess Health-related Quality of Life (SF-12v2) Scale Results | SF-12v2 Physical Component Score at Baseline | 35.56 score on a scale | Standard Deviation 7.74 |
| Medication Management Group | Change From Baseline in the 12-item Questionnaire Used to Assess Health-related Quality of Life (SF-12v2) Scale Results | SF-12v2 Physical Component Score at 3-months | 37.46 score on a scale | Standard Deviation 10.17 |
| Medication Management Group | Change From Baseline in the 12-item Questionnaire Used to Assess Health-related Quality of Life (SF-12v2) Scale Results | SF-12v2 Physical Component Score at 6-months | 37.12 score on a scale | Standard Deviation 10.99 |
| Medication Management Group | Change From Baseline in the 12-item Questionnaire Used to Assess Health-related Quality of Life (SF-12v2) Scale Results | SF-12v2 Physical Component Score at 12-months | 37.72 score on a scale | Standard Deviation 10.81 |
| Medication Management Group | Change From Baseline in the 12-item Questionnaire Used to Assess Health-related Quality of Life (SF-12v2) Scale Results | SF-12v2 MentalComponent Score at Baseline | 37.22 score on a scale | Standard Deviation 9.23 |
| Medication Management Group | Change From Baseline in the 12-item Questionnaire Used to Assess Health-related Quality of Life (SF-12v2) Scale Results | SF-12v2 Mental Component Score at 3-months | 47.63 score on a scale | Standard Deviation 10.77 |
| Medication Management Group | Change From Baseline in the 12-item Questionnaire Used to Assess Health-related Quality of Life (SF-12v2) Scale Results | SF-12v2 Mental Component Score at 6-months | 46.85 score on a scale | Standard Deviation 12.55 |
| Medication Management Group | Change From Baseline in the 12-item Questionnaire Used to Assess Health-related Quality of Life (SF-12v2) Scale Results | SF-12v2 Mental Component Score at 12-months | 47.41 score on a scale | Standard Deviation 12.07 |
| Behavioral Activation Therapy | Change From Baseline in the 12-item Questionnaire Used to Assess Health-related Quality of Life (SF-12v2) Scale Results | SF-12v2 Mental Component Score at 12-months | 47.04 score on a scale | Standard Deviation 9.91 |
| Behavioral Activation Therapy | Change From Baseline in the 12-item Questionnaire Used to Assess Health-related Quality of Life (SF-12v2) Scale Results | SF-12v2 Physical Component Score at Baseline | 35.89 score on a scale | Standard Deviation 9.26 |
| Behavioral Activation Therapy | Change From Baseline in the 12-item Questionnaire Used to Assess Health-related Quality of Life (SF-12v2) Scale Results | SF-12v2 MentalComponent Score at Baseline | 36.87 score on a scale | Standard Deviation 9.16 |
| Behavioral Activation Therapy | Change From Baseline in the 12-item Questionnaire Used to Assess Health-related Quality of Life (SF-12v2) Scale Results | SF-12v2 Physical Component Score at 3-months | 37.69 score on a scale | Standard Deviation 10.6 |
| Behavioral Activation Therapy | Change From Baseline in the 12-item Questionnaire Used to Assess Health-related Quality of Life (SF-12v2) Scale Results | SF-12v2 Mental Component Score at 6-months | 47.33 score on a scale | Standard Deviation 10.97 |
| Behavioral Activation Therapy | Change From Baseline in the 12-item Questionnaire Used to Assess Health-related Quality of Life (SF-12v2) Scale Results | SF-12v2 Physical Component Score at 6-months | 38.82 score on a scale | Standard Deviation 11.09 |
| Behavioral Activation Therapy | Change From Baseline in the 12-item Questionnaire Used to Assess Health-related Quality of Life (SF-12v2) Scale Results | SF-12v2 Mental Component Score at 3-months | 48.25 score on a scale | Standard Deviation 11.08 |
| Behavioral Activation Therapy | Change From Baseline in the 12-item Questionnaire Used to Assess Health-related Quality of Life (SF-12v2) Scale Results | SF-12v2 Physical Component Score at 12-months | 37.89 score on a scale | Standard Deviation 11.74 |
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.
Time frame: 3 month, 6 month, and 12 months from baseline enrollment
Population: The number analyzed in each row differs from the overall number analyzed because of missing caregiver questionnaire data at each timepoint of 3-months, 6-months, and 12-months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Medication Management Group | Change From Baseline on the Caregiver Burden Questionnaire-Heart Failure (CBQ-HF) Scale Results. | CBQ-HF Overall Score at Baseline | 68.06 score on a scale | Standard Deviation 20.04 |
| Medication Management Group | Change From Baseline on the Caregiver Burden Questionnaire-Heart Failure (CBQ-HF) Scale Results. | CBQ-HF Overall Score at 3-months | 61.52 score on a scale | Standard Deviation 19.72 |
| Medication Management Group | Change From Baseline on the Caregiver Burden Questionnaire-Heart Failure (CBQ-HF) Scale Results. | CBQ-HF Overall Score at 6-months | 57.38 score on a scale | Standard Deviation 17.96 |
| Medication Management Group | Change From Baseline on the Caregiver Burden Questionnaire-Heart Failure (CBQ-HF) Scale Results. | CBQ-HF Overall Score at 12-months | 63.19 score on a scale | Standard Deviation 23.63 |
| Behavioral Activation Therapy | Change From Baseline on the Caregiver Burden Questionnaire-Heart Failure (CBQ-HF) Scale Results. | CBQ-HF Overall Score at 12-months | 60.39 score on a scale | Standard Deviation 24.98 |
| Behavioral Activation Therapy | Change From Baseline on the Caregiver Burden Questionnaire-Heart Failure (CBQ-HF) Scale Results. | CBQ-HF Overall Score at Baseline | 65.14 score on a scale | Standard Deviation 20.96 |
| Behavioral Activation Therapy | Change From Baseline on the Caregiver Burden Questionnaire-Heart Failure (CBQ-HF) Scale Results. | CBQ-HF Overall Score at 6-months | 55.27 score on a scale | Standard Deviation 18.13 |
| Behavioral Activation Therapy | Change From Baseline on the Caregiver Burden Questionnaire-Heart Failure (CBQ-HF) Scale Results. | CBQ-HF Overall Score at 3-months | 57.70 score on a scale | Standard Deviation 21.62 |
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 .
Time frame: 3 month, 6 month, and 12 months from baseline enrollment
Population: Intention to treat: We analyzed all participants in both arms who were randomized to their respective intervention
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Medication Management Group | Change From Baseline on the Kansas City Cardiomyopathy Questionnaire (KCCQ ) Scale Results. | KCCQ Overall Summary Score at 3-months | 60.57 score on a scale | Standard Deviation 23.03 |
| Medication Management Group | Change From Baseline on the Kansas City Cardiomyopathy Questionnaire (KCCQ ) Scale Results. | KCCQ Overall Summary Score at 6-months | 61.43 score on a scale | Standard Deviation 24.48 |
| Medication Management Group | Change From Baseline on the Kansas City Cardiomyopathy Questionnaire (KCCQ ) Scale Results. | KCCQ Overall Summary Score at 12-months | 65.48 score on a scale | Standard Deviation 24.83 |
| Medication Management Group | Change From Baseline on the Kansas City Cardiomyopathy Questionnaire (KCCQ ) Scale Results. | KCCQ Clinical Summary Score at 3-months | 64.16 score on a scale | Standard Deviation 24.88 |
| Medication Management Group | Change From Baseline on the Kansas City Cardiomyopathy Questionnaire (KCCQ ) Scale Results. | KCCQ Clinical Summary Score at 6-months | 63.39 score on a scale | Standard Deviation 25.92 |
| Medication Management Group | Change From Baseline on the Kansas City Cardiomyopathy Questionnaire (KCCQ ) Scale Results. | KCCQ Clinical Summary Score at 12-months | 67.02 score on a scale | Standard Deviation 24.43 |
| Behavioral Activation Therapy | Change From Baseline on the Kansas City Cardiomyopathy Questionnaire (KCCQ ) Scale Results. | KCCQ Clinical Summary Score at 6-months | 66.15 score on a scale | Standard Deviation 27.17 |
| Behavioral Activation Therapy | Change From Baseline on the Kansas City Cardiomyopathy Questionnaire (KCCQ ) Scale Results. | KCCQ Overall Summary Score at 3-months | 62.03 score on a scale | Standard Deviation 25.69 |
| Behavioral Activation Therapy | Change From Baseline on the Kansas City Cardiomyopathy Questionnaire (KCCQ ) Scale Results. | KCCQ Clinical Summary Score at 3-months | 64.01 score on a scale | Standard Deviation 26.76 |
| Behavioral Activation Therapy | Change From Baseline on the Kansas City Cardiomyopathy Questionnaire (KCCQ ) Scale Results. | KCCQ Overall Summary Score at 6-months | 64.35 score on a scale | Standard Deviation 26.89 |
| Behavioral Activation Therapy | Change From Baseline on the Kansas City Cardiomyopathy Questionnaire (KCCQ ) Scale Results. | KCCQ Clinical Summary Score at 12-months | 64.00 score on a scale | Standard Deviation 27.19 |
| Behavioral Activation Therapy | Change From Baseline on the Kansas City Cardiomyopathy Questionnaire (KCCQ ) Scale Results. | KCCQ Overall Summary Score at 12-months | 63.24 score on a scale | Standard Deviation 25.88 |
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.
Time frame: 3 month, 6 month, and 12 months from baseline enrollment
Population: Using a Zero Inflated Poisson (ZIP) Model, the ratio of means were compared for total days in the hospital for BA vs. MEDS, at 3, 6, and 12 months respectively.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Medication Management Group | If Hospitalized, Mean Number of Total Days in the Hospital | Mean Number of Total Days in the Hospital at 3-months | 5.50 Mean Number ofTotal Days in the Hospital |
| Medication Management Group | If Hospitalized, Mean Number of Total Days in the Hospital | Mean Number of Total Days in the Hospital at 6-months | 8.79 Mean Number ofTotal Days in the Hospital |
| Medication Management Group | If Hospitalized, Mean Number of Total Days in the Hospital | Mean Number of Total Days in the Hospital at 12-months | 15.19 Mean Number ofTotal Days in the Hospital |
| Behavioral Activation Therapy | If Hospitalized, Mean Number of Total Days in the Hospital | Mean Number of Total Days in the Hospital at 3-months | 3.84 Mean Number ofTotal Days in the Hospital |
| Behavioral Activation Therapy | If Hospitalized, Mean Number of Total Days in the Hospital | Mean Number of Total Days in the Hospital at 6-months | 7.18 Mean Number ofTotal Days in the Hospital |
| Behavioral Activation Therapy | If Hospitalized, Mean Number of Total Days in the Hospital | Mean Number of Total Days in the Hospital at 12-months | 11.11 Mean Number ofTotal Days in the Hospital |
Comparison: Days in the Hospital at 3 monthsp-value: 0.00295% CI: [0.75, 0.92]Zero Inflated Poisson (ZIP) Model
Comparison: Days in the Hospital at 6 MONTHSp-value: 0.00595% CI: [0.75, 0.87]Zero Inflated Poisson (ZIP) Model
Comparison: Days in the Hospital AT 12 MONTHSp-value: <0.000195% CI: [0.6, 0.68]Zero Inflated Poisson (ZIP) Model
Secondary
Mean Number of Emergency Department Visits
We recorded the number of emergency department visits.
Time frame: 3 month, 6 month, and 12 months from baseline enrollment
Population: Using a Zero Inflated Poisson (ZIP) Model, at 3, 6, and 12 months, the mean ratios of ED visits were compared for patients with heart failure who received BA to those who received MEDS.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Medication Management Group | Mean Number of Emergency Department Visits | Mean ED visits at 3-months | 0.90 Mean ED visits |
| Medication Management Group | Mean Number of Emergency Department Visits | Mean ED visits at 6-months | 1.51 Mean ED visits |
| Medication Management Group | Mean Number of Emergency Department Visits | Means ED visits at 12-months | 2.43 Mean ED visits |
| Behavioral Activation Therapy | Mean Number of Emergency Department Visits | Mean ED visits at 3-months | 0.55 Mean ED visits |
| Behavioral Activation Therapy | Mean Number of Emergency Department Visits | Mean ED visits at 6-months | 1.31 Mean ED visits |
| Behavioral Activation Therapy | Mean Number of Emergency Department Visits | Means ED visits at 12-months | 1.87 Mean ED visits |
Comparison: Emergency Department visits AT 3 MONTHSp-value: 0.00595% CI: [0.45, 0.86]Zero Inflated Poisson (ZIP) Model
Comparison: Emergency Department visits AT 6 MONTHSp-value: 0.00895% CI: [0.6, 0.86]Zero Inflated Poisson (ZIP) Model
Comparison: Emergency Department visits AT 12 MONTHSp-value: 0.000195% CI: [0.62, 0.85]Zero Inflated Poisson (ZIP) Model
Secondary
Mean Number of Readmissions (Hospitalization)
We recorded the number of readmissions to the hospital.
Time frame: 3 month, 6 month, and 12 months from baseline enrollment
Population: Using a Zero Inflated Poisson (ZIP) Model, at 3, 6, and 12 months, the mean ratios of Hospital Admissions were compared for patients with heart failure who received BA to those who received MEDS.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Medication Management Group | Mean Number of Readmissions (Hospitalization) | Mean Hospital Readmissions at 3-months | 0.86 Mean Hospital Readmissions |
| Medication Management Group | Mean Number of Readmissions (Hospitalization) | Mean Hospital Readmissions at 6-months | 1.48 Mean Hospital Readmissions |
| Medication Management Group | Mean Number of Readmissions (Hospitalization) | Mean Hospital Readmissions at 12-months | 2.20 Mean Hospital Readmissions |
| Behavioral Activation Therapy | Mean Number of Readmissions (Hospitalization) | Mean Hospital Readmissions at 3-months | 0.67 Mean Hospital Readmissions |
| Behavioral Activation Therapy | Mean Number of Readmissions (Hospitalization) | Mean Hospital Readmissions at 6-months | 1.30 Mean Hospital Readmissions |
| Behavioral Activation Therapy | Mean Number of Readmissions (Hospitalization) | Mean Hospital Readmissions at 12-months | 2.00 Mean Hospital Readmissions |
Comparison: Differences in the number of hospital readmissions between BA and MEDS at 3, 6, and 12 monthsp-value: >0.05Zero Inflated Poisson (ZIP) Model
Secondary
Mortality Was Also Measured
We recorded mortality data on the patients.
Time frame: 3 month, 6 month, and 12 months from baseline enrollment
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Medication Management Group | Mortality Was Also Measured | Total Number of Deaths at 3-months | 16 Participants |
| Medication Management Group | Mortality Was Also Measured | Total Number of Deaths at 6-months | 24 Participants |
| Medication Management Group | Mortality Was Also Measured | Total Number of Deaths at 12-months | 36 Participants |
| Behavioral Activation Therapy | Mortality Was Also Measured | Total Number of Deaths at 3-months | 7 Participants |
| Behavioral Activation Therapy | Mortality Was Also Measured | Total Number of Deaths at 6-months | 15 Participants |
| Behavioral Activation Therapy | Mortality Was Also Measured | Total Number of Deaths at 12-months | 27 Participants |
p-value: >0.05Kaplan Meier survival plots