Coping in Heart Failure Partnership Intervention

NCT05337293 | Completed

• 1 other identifier: 2015.14571
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 2

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.

Conditions

Heart Failure

Keywords

heart failure; problem-solving; social support; self-care

Outcome Measures

Primary Outcomes (9)

• Self-care Maintenance

  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.

  baseline, 5 weeks

• Self-care Maintenance

  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.

  baseline, 9 weeks

• Self-care Maintenance

  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.

  baseline, 13 weeks

• Self-care Management

  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.

  baseline, 5 weeks

• Self-care Management

  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.

  baseline, 9 weeks

• Self-care Management

  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.

  baseline, 13 weeks

• Self-care Confidence

  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.

  baseline, 5 weeks

• Self-care Confidence

  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.

  baseline, 9 weeks

• Self-care Confidence

  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.

  baseline, 13 weeks

Secondary Outcomes (6)

• Depression

  baseline, 5 weeks

• Depression

  baseline, 9 weeks

• Depression

  baseline, 13 weeks

• Healthcare utilization

  baseline, 5 weeks

• Healthcare utilization

  baseline, 9 weeks

Other Outcomes (9)

• Heart Failure Symptoms

  baseline, 5 weeks

• Heart Failure Symptoms

  baseline, 9 weeks

• Heart Failure Symptoms

  baseline, 13 weeks

Study Arms (3)

COPE-HF Partnership Intervention

EXPERIMENTAL

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.

Behavioral: COPE-HF Partnership Intervention

Attention

SHAM COMPARATOR

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.

Other: Attention

Usual Care

NO INTERVENTION

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

Interventions

COPE-HF Partnership Intervention 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.

COPE-HF Partnership Intervention

Attention 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.

Attention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Florida State University: lead
• American Nurse Pracititioner Foundation (ANPF): collaborator

Study Sites (2)

Capital Regional Medical Center

Tallahassee, Florida, 32308, United States

Location

Tallahassee Memorial Hospital

Tallahassee, Florida, 32308, United States

Location

MeSH Terms

Conditions

Heart Failure

Interventions

Neuropsychological Tests

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Psychological Tests; Behavioral Disciplines and Activities

Study Officials

• Lucinda J Graven, PhD APRN

  Florida State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: All data were collected by a research assistant blinded to study group assignment and purpose of study. A second research assist blinded to study purpose and intervention conducted all participant contacts with the attention group.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: April 13, 2022
• First Posted: April 20, 2022
• Study Start: March 1, 2015
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: March 21, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)