Heart Failure, Congestive
Conditions
Keywords
Health Information Technology, Patient Care Management, Self Care, Quality of Life, Family or non-Family Informal Caregivers
Brief summary
Informal caregivers, assisted by health information technology may help to fill the gaps in VA care management of heart failure patients by enhancing support for patients' treatment adherence, behavior changes, and symptom monitoring.
Detailed description
Background: Heart failure (HF) is a leading cause of preventable hospitalization and death in the VA and many patients fall short of self-care goals. Numerous efficacy trials have shown that HF care management supported by health information technology (i.e., HITCM) can improve patients' outcomes, although VA care managers in 'real-world' health systems are often overwhelmed by the need to provide monitoring and behavior change services. Informal caregivers may help to fill the gaps in VA care management and enhance support for patients' treatment adherence, behavior changes, and symptom monitoring. The challenge will be to identify ways to leverage assistance from informal caregivers (ICGs) who lack the resources to fill this role effectively. Objectives: We will evaluate the impact of extending the reach of HITCM by incorporating a protocol-driven model for improved monitoring and self-management support by a CarePartner (CP). CPs will be adult children or friends living outside the patient's home who are willing to play a structured role to support self-care. The specific aims of the trial are: (1) to determine whether an intervention that uses automated patient monitoring and behavior change calls with follow-up to HF patients' care manager and CP (HITCM+CP) improves key patient-centered outcomes relative to a system that only uses the same technology to support patients' care management (HITCM-only). Outcomes of interest include patients' health-related quality of life, mental health, health service use, and mortality risk; (2) to evaluate the impact of HITCM+CP on patients' self-care behaviors compared to HITCM-only; and (3) to determine whether the intervention increases the quality and quantity of support for HF patients' self-care compared to HITCM-only. Methods: 372 HF patient-CP pairs will be recruited from the VA Louis Stokes (Cleveland) Healthcare System. Patients will receive automated telephone assessment and behavior change calls weekly for 12 months. For patients in both study arms, a care manager will monitor patients' assessment results via a secure website and will receive reports concerning urgent health problems by fax and pager. In the HITCM+CP group, patients' CPs also will receive tailored e-mail reports based on patients' weekly assessments. HITCM+CP patients and their CPs will use a structured protocol to review the patient's assessment results, identify self-care goals and barriers, and ensure that the patient's in-home caregivers and healthcare team remain involved. All patients and CPs will complete quantitative surveys at baseline, 6, and 12 months. The study will include a mixed-methods approach including qualitative interviews with patients, CPs and clinicians to evaluate intervention use and the service's potential for translation. The primary outcome will be HF-related quality of life at 12 months. Secondary outcomes will include self-care behavior, patient-CP relationship indicators, hospitalization, and death. Impact: This study will evaluate a model for leveraging ICGs and structuring their role in HF patients' overall disease management. If effective, the service may provide the frequent monitoring and behavior change assistance that patients need, allowing VA to extend its impact beyond what current care management programs can realistically deliver.
Interventions
Weekly automated assessment calls with follow-up by a care manager and a CarePartner for 12 months. Baseline, 6-month and 12-month follow-up.
Weekly automated assessment calls with follow-up by a care manager for 12 months. Baseline, 6-month and 12-month follow-up.
Sponsors
Study design
Eligibility
Inclusion criteria
Veterans with heart failure (HF) treated at the VA Louis Stokes (Cleveland) facilities will be eligible if they have New York Heart Association (NYHA) Class II-III diastolic or systolic HF noted by inpatient or outpatient ICD-9 codes.
Exclusion criteria
Veterans treated at the VA Louis Stokes (Cleveland) facilities will be ineligible if they: * have a serious mental illness or cognitive dysfunction, e.g., psychosis, dementia, or active substance abuse (alcohol and/or other drugs); * do not speak English fluently; * are receiving palliative care due to advanced HF or other health problems; * receive the majority of their HF care from providers outside of the VA; * are unable to use a telephone to respond to weekly automated self-management support calls; or * are unable to nominate an eligible informal caregiver.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Heart Failure-specific Quality of Life | twelve-month followup | Measured by the Minnesota Living with Heart Failure Questionnaire (MLHFQ). Lower scores indicate better functioning. MLHFQ contains 21 items with answer choices ranging from 0 to 5. Overall scores on the instrument range from 0 to 105. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Revised Heart Failure Self-Care Behavior Scale (HFSCB) | twelve-month follow-up | Higher scores indicate better Heart Failure self-care. The HFSCB contains 29 items with answer choices ranging from 0 to 5. The total score ranges from 0 to145. |
| Adherent to Heart Failure Medication | twelve-month follow-up | Percent of patients with perfect Heart Failure medication adherence over the prior month as measured by the four Heart Failure Self-Care Behavior items focused on adherence. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Standard mHealth Weekly IVR calls for 12 months | 156 |
| mHealth Plus CarePartner Wkly IVR calls for 12 months+feedback to CarePartner | 153 |
| Total | 309 |
Baseline characteristics
| Characteristic | mHealth Plus CarePartner | Standard mHealth | Total |
|---|---|---|---|
| Adherent to Heart Failure Medication | 84 participants | 81 participants | 165 participants |
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 79 Participants | 86 Participants | 165 Participants |
| Age, Categorical Between 18 and 65 years | 74 Participants | 70 Participants | 144 Participants |
| Age, Continuous | 67.8 years STANDARD_DEVIATION 10.6 | 68.3 years STANDARD_DEVIATION 10.6 | 68.1 years STANDARD_DEVIATION 10.6 |
| Heart Failure-specific Quality of Life | 41.2 units on a scale STANDARD_DEVIATION 23.7 | 40.4 units on a scale STANDARD_DEVIATION 25.1 | 40.8 units on a scale STANDARD_DEVIATION 24.4 |
| Region of Enrollment United States | 153 participants | 156 participants | 309 participants |
| Revised Heart Failure Self-Care Behavior Scale (HFSCB) | 83.1 units on a scale STANDARD_DEVIATION 16.3 | 82.9 units on a scale STANDARD_DEVIATION 19.3 | 83.0 units on a scale STANDARD_DEVIATION 17.8 |
| Sex: Female, Male Female | 0 Participants | 2 Participants | 2 Participants |
| Sex: Female, Male Male | 153 Participants | 154 Participants | 307 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 183 | 0 / 189 |
| serious Total, serious adverse events | 0 / 183 | 0 / 189 |
Outcome results
Heart Failure-specific Quality of Life
Measured by the Minnesota Living with Heart Failure Questionnaire (MLHFQ). Lower scores indicate better functioning. MLHFQ contains 21 items with answer choices ranging from 0 to 5. Overall scores on the instrument range from 0 to 105.
Time frame: twelve-month followup
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard mHealth | Heart Failure-specific Quality of Life | 37.0 units on a scale | Standard Deviation 25.7 |
| mHealth+Carepartner | Heart Failure-specific Quality of Life | 38.6 units on a scale | Standard Deviation 24.8 |
Adherent to Heart Failure Medication
Percent of patients with perfect Heart Failure medication adherence over the prior month as measured by the four Heart Failure Self-Care Behavior items focused on adherence.
Time frame: twelve-month follow-up
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Standard mHealth | Adherent to Heart Failure Medication | 52.6 percentage of participants/perfect adher |
| mHealth+Carepartner | Adherent to Heart Failure Medication | 66.7 percentage of participants/perfect adher |
Revised Heart Failure Self-Care Behavior Scale (HFSCB)
Higher scores indicate better Heart Failure self-care. The HFSCB contains 29 items with answer choices ranging from 0 to 5. The total score ranges from 0 to145.
Time frame: twelve-month follow-up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard mHealth | Revised Heart Failure Self-Care Behavior Scale (HFSCB) | 92.1 units on a scale | Standard Deviation 18.7 |
| mHealth+Carepartner | Revised Heart Failure Self-Care Behavior Scale (HFSCB) | 90.5 units on a scale | Standard Deviation 17 |