Heart Failure Clinical Trial

Coping in Heart Failure Partnership Intervention

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.

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Full 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.

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Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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 is for people with:

Heart Failure

Estimated Enrollment:

106

Study ID:

NCT05337293

Recruitment Status:

Completed

Sponsor:

Florida State University

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There is 1 Location for this study

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Capital Regional Medical Center
Tallahassee Florida, 32308, United States
Tallahassee Memorial Hospital
Tallahassee Florida, 32308, United States

How clear is this clinincal trial information?

Study is for people with:

Heart Failure

Estimated Enrollment:

106

Study ID:

NCT05337293

Recruitment Status:

Completed

Sponsor:


Florida State University

How clear is this clinincal trial information?

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