Coping in Heart Failure Partnership Intervention
- Conditions
- Heart Failure
- Interventions
- Other: AttentionBehavioral: COPE-HF Partnership Intervention
- Registration Number
- NCT05337293
- Lead Sponsor
- Florida State University
- Brief Summary
The purpose of this study is to examine the feasibility and preliminary effectiveness of a 12-week support and problem-solving telephone-based intervention (COPE-HF) on heart failure self-care, depression, and healthcare utilization. Heart failure patients will be randomized to one of three groups (intervention, attention, control), with data collected at baseline and at 5, 9, and 13 weeks.
- Detailed Description
The long-term goal of this research is to reduce morbidity and improve heart failure self-care and depression in heart failure patients. The initial step in meeting this goal is to pilot-test a telephone-based, tailored support and problem-solving intervention (COPE-HF Partnership) to improve HF self-care and depression in a sample of heart failure patients. The following research aims are to: 1) test the COPE-HF Partnership intervention and determine its feasibility and acceptability for managing HF-related problems; and 2) evaluate the preliminary effects of the COPE-HF Partnership intervention on heart failure self-care, depression, and healthcare utilization. This study will be guided by quantitative methods and include a repeated measures, randomized controlled trial to evaluate the feasibility, acceptability, and preliminary effectiveness of the 12-week COPE-Partnership intervention in a sample of heart failure patients (n = 90). Participants for this study will be recruited from from the cardiac/telemetry floors at Tallahassee Memorial Hospital and Capital Regional Medical Center in Tallahassee, FL.
The target recruitment size was 90 participants based upon attrition rates reported in previous studies (35%) and the number of participants needed to provide trend data in preparation for a larger, more adequately powered clinical trial. Following verbal informed consent, all participants were screened for cognitive impairment using the 6 Item Cognitive Impairment Test (6CIT) prior to baseline data collection. Data were collected using the following instruments: a Sociodemographic and Clinical Survey (baseline only), the Self-Care of HF Index (SCHFI; v. 6.2), the Heart Failure Symptom Survey (HFSS), the Interpersonal Support Evaluation List-12 (ISEL-12), the Social Problem-Solving Inventory Revised (SPSIR), Healthcare Utilization Survey, the Center for Epidemiological Studies-Depression (CESD), the Family APGAR.
Participants randomized to the intervention group participated in a telephone-based support and problem-solving training intervention over 12 weeks (Weeks 1-4, 6, 8, 10, 12).
Participants randomized to the attention group received usual care plus telephone calls on the same schedule as the intervention group and consisted of a health check with information collected regarding recent healthcare usage.
Participants randomized to the control group received usual care from their healthcare providers and received heart failure self-care education upon discharge from the healthcare facility.
Follow-up data collection occurred at weeks 5, 9, 11, 13. All data were self-report and collected by a trained research assistant who collected study data over the telephone and marked participants answers on a computerized data spreadsheet. Data were analyzed using linear and multi-level modeling approaches.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 106
- Hospitalized with a primary or secondary diagnosis of HF
- Undergoing medical treatment for HF
- BNP >100
- Able to read, speak, and understand English
- Reliable telephone access
- Live within 100 miles of acute care facility
- Diagnosis of heart failure due to a correctable cause or condition
- Reduced life expectancy < 12 months
- History of cognitive impairment or a score >8 on the 6CIT
- Inability to provide informed consent
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Attention Attention Participants in this arm received telephone calls from a trained research assistant on the same schedule as the intervention group. During these calls basic data were collected on several key areas of heart failure self-care. No intervention or patient education took place during these calls. COPE-HF Partnership Intervention COPE-HF Partnership Intervention Working with a trained registered nurse interventionist, participants in this arm were trained to use a 4-step problem-solving process to manage identified problems related to heart failure. Heart failure self-care education and materials were provided as indicated based on specific identified problems.
- Primary Outcome Measures
Name Time Method Self-care Maintenance baseline, 13 weeks Self-care maintenance was self-reported and measured using the Self-care of Heart Failure Index (SCHFI) v. 6.2. Items pertain to treatment adherence and self-monitoring. Scores are standardized (0-100), with higher scores suggesting better self-care maintenance. Scores ≥ 70 are considered adequate, with an improvement of 8 or more considered clinically significant.
Self-care Confidence baseline, 13 weeks Self-care confidence was self-reported and measured using the Self-care of Heart Failure Index (SCHFI) v. 6.2. Items pertain to one's confidence in their ability to perform self-care activities. Scores are standardized (0-100), with higher scores suggesting better self-care confidence. Scores ≥ 70 are considered adequate, with an improvement of 8 or more considered clinically significant.
Self-care Management baseline, 13 weeks Self-care management was self-reported and measured using the Self-care of Heart Failure Index (SCHFI) v. 6.2. Items pertain to symptom recognition and treatment and evaluation of treatment effectiveness. Scores are standardized (0-100), with higher scores suggesting better self-care management. Scores ≥ 70 are considered adequate, with an improvement of 8 or more considered clinically significant.
- Secondary Outcome Measures
Name Time Method Depression baseline, 13 weeks Depression was self-reported and assessed using the 20-item Center for Epidemiological Studies-Depression Scale (CES-D). The CES-D measures the presence of depression. Scores range from 0-60, with higher scores indicative of more symptoms of depression. A cut-off score ≥ 16 indicates depressed versus non-depressed.
Healthcare utilization baseline, 13 weeks Healthcare utilization was determined by the frequency of emergency department visits and 30-day readmissions for HF and assessed via self-report.
Trial Locations
- Locations (2)
Capital Regional Medical Center
🇺🇸Tallahassee, Florida, United States
Tallahassee Memorial Hospital
🇺🇸Tallahassee, Florida, United States