Clinical trial NCT05337293: Coping in Heart Failure Partnership Intervention
Official title: Coping in Heart Failure Partnership (COPE-HF): A Telephone-Based Intervention Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Keywords: heart failure
problem-solving
social support
self-care
Lead sponsor: Florida State University
Sponsor class: OTHER
Collaborators: name: American Nurse Pracititioner Foundation (ANPF)
First posted: 2022-04-20
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This parallel 3-arm (intervention, attention, control) randomized controlled trial (N = 90) will concurrently enroll patients with heart failure to either a 12-week intervention (COPE-HF Partnership), a 12-week attention group (contacts spaced similarly to that of the intervention group), or a control group. All data collection contacts occur at identical intervals among groups.
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: Inclusion Criteria:

1. Hospitalized with a primary or secondary diagnosis of HF
2. Undergoing medical treatment for HF
3. BNP \>100
4. Able to read, speak, and understand English
5. Reliable telephone access
6. Live within 100 miles of acute care facility

Exclusion Criteria:

1. Diagnosis of heart failure due to a correctable cause or condition
2. Reduced life expectancy \< 12 months
3. History of cognitive impairment or a score \>8 on the 6CIT
4. Inability to provide informed consent

Primary outcomes:
measure: Self-care Maintenance
timeFrame: baseline, 5 weeks
measure: Self-care Maintenance
timeFrame: baseline, 9 weeks
measure: Self-care Maintenance
timeFrame: baseline, 13 weeks
measure: Self-care Management
timeFrame: baseline, 5 weeks
measure: Self-care Management
timeFrame: baseline, 9 weeks
measure: Self-care Management
timeFrame: baseline, 13 weeks
measure: Self-care Confidence
timeFrame: baseline, 5 weeks
measure: Self-care Confidence
timeFrame: baseline, 9 weeks
measure: Self-care Confidence
timeFrame: baseline, 13 weeks
Secondary outcomes:
measure: Depression
timeFrame: baseline, 5 weeks
measure: Depression
timeFrame: baseline, 9 weeks
measure: Depression
timeFrame: baseline, 13 weeks
measure: Healthcare utilization
timeFrame: baseline, 5 weeks
measure: Healthcare utilization
timeFrame: baseline, 9 weeks
measure: Healthcare utilization
timeFrame: baseline, 13 weeks
Other outcomes:
measure: Heart Failure Symptoms
timeFrame: baseline, 5 weeks
measure: Heart Failure Symptoms
timeFrame: baseline, 9 weeks
measure: Heart Failure Symptoms
timeFrame: baseline, 13 weeks
measure: Social Problem-Solving
timeFrame: baseline, 5 weeks
measure: Social Problem-Solving
timeFrame: baseline, 9 weeks
measure: Social Problem-Solving
timeFrame: baseline, 13 weeks
measure: Social Support
timeFrame: baseline, 5 weeks
measure: Social Support
timeFrame: baseline, 9 weeks
measure: Social Support
timeFrame: baseline, 13 weeks
Locations:
city: Tallahassee
country: United States
facility: Capital Regional Medical Center
state: Florida
city: Tallahassee
country: United States
facility: Tallahassee Memorial Hospital
state: Florida
Study officials:
affiliation: Florida State University
name: Lucinda J Graven, PhD APRN
role: PRINCIPAL_INVESTIGATOR
References: