Coping in Heart Failure Partnership Intervention

NCT ID: NCT05337293

Last Updated: 2023-03-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 106 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-31
• Study Completion Date: 2016-08-31

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.

Conditions

Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

COPE-HF Partnership Intervention

Intervention Type: BEHAVIORAL

Participants were trained to use a 4-step problem-solving process based on the Theory of Social Problem-Solving (TSPS) to manage HF-related problems experienced in the home over 12-weeks. The core belief of TSPS is effective problem-solving requires a positive problem orientation (i.e., viewing problems as a challenge versus a threat) and elicits rational problem-solving versus avoidance or impulsivity/carelessness. Problem-solving follows from a positive problem orientation and involves accurate problem identification, generation of appropriate potential solutions, active decision-making, and solution implementation and evaluation. The goal of this intervention was to move HF patients toward a positive problem orientation and use of rational problem-solving strategies that support greater HF self-care and reduce depression. The COPE-HF Partnership Intervention consisted of 1 home visit and 7 follow-up telehealth sessions led by a registered nurse interventionist.

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.

Group Type: SHAM_COMPARATOR

Attention

Intervention Type: OTHER

Participants in the attention group received a sham intervention that consisted of scheduled telephone calls consistent with the timing of that received by the intervention group. During these calls, basic information was gathered on key areas of heart failure self-care management and the frequency of healthcare usage. No intervention or education was provided.

Usual Care

Participants in this arm received usual care from their healthcare providers and facility designated heart failure discharge education only.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

COPE-HF Partnership Intervention

Participants were trained to use a 4-step problem-solving process based on the Theory of Social Problem-Solving (TSPS) to manage HF-related problems experienced in the home over 12-weeks. The core belief of TSPS is effective problem-solving requires a positive problem orientation (i.e., viewing problems as a challenge versus a threat) and elicits rational problem-solving versus avoidance or impulsivity/carelessness. Problem-solving follows from a positive problem orientation and involves accurate problem identification, generation of appropriate potential solutions, active decision-making, and solution implementation and evaluation. The goal of this intervention was to move HF patients toward a positive problem orientation and use of rational problem-solving strategies that support greater HF self-care and reduce depression. The COPE-HF Partnership Intervention consisted of 1 home visit and 7 follow-up telehealth sessions led by a registered nurse interventionist.

Intervention Type: BEHAVIORAL

Attention

Participants in the attention group received a sham intervention that consisted of scheduled telephone calls consistent with the timing of that received by the intervention group. During these calls, basic information was gathered on key areas of heart failure self-care management and the frequency of healthcare usage. No intervention or education was provided.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

American Nurse Pracititioner Foundation (ANPF)

UNKNOWN

Sponsor Role: collaborator

Florida State University

OTHER

Sponsor Role: lead

Responsible Party

Lucinda Graven

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lucinda J Graven, PhD APRN

Role: PRINCIPAL_INVESTIGATOR

Florida State University

Locations

Capital Regional Medical Center

Tallahassee, Florida, United States

Tallahassee Memorial Hospital

Tallahassee, Florida, United States

Countries

United States

Other Identifiers

2015.14571

Identifier Type: -

Identifier Source: org_study_id