Problem-Solving for Rural Heart Failure Dyads

NCT04549181 | Completed

• 1 other identifier: 00001621
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 9

Brief Summary

This study will develop and test the effectiveness of a culturally-sensitive, telephone-based, tailored dyadic problem-solving intervention to improve self-care in rural heart failure (HF) dyads. The target population is rural-residing HF dyads (patient and family caregiver). Rural dyads will be recruited from the Florida State University Institute for Successful Longevity Participant Registry, outpatient HF/cardiac and rural healthcare clinics affiliated with the Tallahassee Memorial Hospital, Bond Community Health Clinic, via social medial and newspaper ads, and publicly available community sites (e.g., senior centers, post offices, grocery stores, etc.). Phase I (Arm I) will include a one-time telephone-based semi-structured interview. Dyads in Phase II (Arm II) will receive one telehealth (virtual or telephone) session, followed by 7 follow-up telephone sessions.

Conditions

Heart Failure

Keywords

heart failure; dyads; rural; problem-solving; self-care

Outcome Measures

Primary Outcomes (18)

• Self-Care Maintenance (HF patient)

  Self-care maintenance will be 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 (HF patient)

  Self-care maintenance will be 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 (HF patient)

  Self-care maintenance will be 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 (HF patient)

  Self-care management will be 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 (HF patient)

  Self-care management will be 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 (HF patient)

  Self-care management will be 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 (HF patient)

  Self-care confidence will be 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 (HF patient)

  Self-care confidence will be 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 (HF patient)

  Self-care confidence will be 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

• Caregiver Contribution to Self-Care Maintenance (caregiver)

  Caregiver contribution to self-care maintenance will be self-reported and measured using the Caregiver Contribution to Self-care of Heart Failure Index (SCHFI). Items pertain to one's contribution to treatment adherence and symptom monitoring. Scores are standardized (0-100), with higher scores suggesting higher contribution to self-care maintenance.

  Baseline, 5 weeks

• Caregiver Contribution to Self-Care Maintenance (caregiver)

  Caregiver contribution to self-care maintenance will be self-reported and measured using the Caregiver Contribution to Self-care of Heart Failure Index (SCHFI). Items pertain to one's contribution to treatment adherence and symptom monitoring. Scores are standardized (0-100), with higher scores suggesting higher contribution to self-care maintenance.

  Baseline, 9 weeks

• Caregiver Contribution to Self-Care Maintenance (caregiver)

  Caregiver contribution to self-care maintenance will be self-reported and measured using the Caregiver Contribution to Self-care of Heart Failure Index (SCHFI). Items pertain to one's contribution to treatment adherence and symptom monitoring. Scores are standardized (0-100), with higher scores suggesting higher contribution to self-care maintenance.

  Baseline, 13 weeks

• Caregiver Contribution to Self-Care Management (caregiver)

  Caregiver contribution to self-care management will be self-reported and measured using the Caregiver Contribution to Self-care of Heart Failure Index (SCHFI). Items pertain to one's contribution to symptom recognition and treatment and evaluation of treatment effectiveness. Scores are standardized (0-100), with higher scores suggesting higher contribution to self-care management.

  Baseline, 5 weeks

• Caregiver Contribution to Self-Care Management (caregiver)

  Caregiver contribution to self-care management will be self-reported and measured using the Caregiver Contribution to Self-care of Heart Failure Index (SCHFI). Items pertain to one's contribution to symptom recognition and treatment and evaluation of treatment effectiveness. Scores are standardized (0-100), with higher scores suggesting higher contribution to self-care management.

  Baseline, 9 weeks

• Caregiver Contribution to Self-Care Management (caregiver)

  Caregiver contribution to self-care management will be self-reported and measured using the Caregiver Contribution to Self-care of Heart Failure Index (SCHFI). Items pertain to one's contribution to symptom recognition and treatment and evaluation of treatment effectiveness. Scores are standardized (0-100), with higher scores suggesting higher contribution to self-care management.

  Baseline, 13 weeks

• Caregiver Contribution to Self-Care Confidence (caregiver)

  Caregiver contribution to self-care confidence will be self-reported and measured using the Caregiver Contribution to Self-care of Heart Failure Index (SCHFI). Items pertain to one's contribution to confidence in self-care ability. Scores are standardized (0-100), with higher scores suggesting higher contribution to self-care confidence.

  Baseline, 5 weeks

• Caregiver Contribution to Self-Care Confidence (caregiver)

  Caregiver contribution to self-care confidence will be self-reported and measured using the Caregiver Contribution to Self-care of Heart Failure Index (SCHFI). Items pertain to one's contribution to confidence in self-care ability. Scores are standardized (0-100), with higher scores suggesting higher contribution to self-care confidence.

  Baseline, 9 weeks

• Caregiver Contribution to Self-Care Confidence (caregiver)

  Caregiver contribution to self-care confidence will be self-reported and measured using the Caregiver Contribution to Self-care of Heart Failure Index (SCHFI). Items pertain to one's contribution to confidence in self-care ability. Scores are standardized (0-100), with higher scores suggesting higher contribution to self-care confidence.

  Baseline, 13 weeks

Secondary Outcomes (6)

• Healthcare Utilization (patient)

  baseline, 5 weeks

• Healthcare Utilization (patient)

  baseline, 9 weeks

• Healthcare Utilization (patient)

  baseline, 13 weeks

• Problem-Solving (HF patient and caregiver)

  baseline, 5 weeks

• Problem-Solving (HF patient and caregiver)

  baseline, 9 weeks

Other Outcomes (18)

• Depression (patient and caregiver)

  baseline, 5 weeks

• Depression (patient and caregiver)

  baseline, 9 weeks

• Depression (patient and caregiver)

  baseline, 13 weeks

Study Arms (2)

Phase I: Qualitative

NO INTERVENTION

Rural HF dyads will participate in a one-time telephone-based semi-structured interview to explore the types of HF-related problems that rural HF dyads experience and how these problems are managed.

Phase II: Problem-Solving for Rural HF Dyads

EXPERIMENTAL

The dyadic problem-solving intervention will be provided by a HF specialist nurse. The nurse will conduct the initial telehealth (virtual, telephone) session and provide dyads with an intervention booklet containing examples of common HF-related problems experienced by rural dyads and suggested management strategies tailored to the rural sociocultural context. The nurse will lead dyads in a card sorting task intended to help dyads prioritize current HF-related problems and will guide dyads in developing management strategies for the highest priority problem. Dyads will utilize these strategies until the next session at which time the nurse will guide dyads in evaluating the effectiveness of chosen strategies. The iterative process then begins again. Dyads will receive 7 follow-up telephone sessions with the nurse. In the intervention, the nurse will focus on problems related to self-care, including those specific to the rural population.

Behavioral: Phase II: Problem-Solving for Rural HF Dyads

Interventions

Phase II: Problem-Solving for Rural HF Dyads BEHAVIORAL

Participants in the Intervention Group will be trained to use a 4-step problem-solving process based on the Theory of Social Problem-Solving (TSPS) to manage HF-related problems collaboratively 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. Dyadic 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 dyadic intervention is to move HF dyads toward a positive problem orientation and use of rational problem-solving strategies that support greater patient and family caregiver-contributed HF self-care.

Phase II: Problem-Solving for Rural HF Dyads

Eligibility Criteria

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

You may qualify if:

• ≥ 18 years of age
• consist of a patient with New York Heart Association Class II- IV HF and their family caregiver
• live in a rural area
• read, write, and communicate verbally in English
• have access to a telephone with speaker capability
• family caregivers are defined as a spouse/partner or adult family member living in the same household and/or considered to be the primary caregiver and may be healthy

You may not qualify if:

• patient has HF due to a correctable cause or condition
• either dyad member exhibits cognition dysfunction (i.e., score ≤ 30 on the Telephone Interview for Cognitive Status \[TICS\])

Sponsors & Collaborators

• Florida State University: lead
• Florida Blue Center for Rural Research: collaborator

Study Sites (9)

Tallahassee Memorial Hospital Physician Partners - Blountstown Clinic

Blountstown, Florida, 32424, United States

Location

Tallahassee Memorial Hospital Physician Partners - Wakulla Clinic

Crawfordville, Florida, 32327, United States

Location

Talllahassee Memorial Physician Partners Cardiology - Marianna Clinic

Marianna, Florida, 32446, United States

Location

Tallahassee Memorial Hospital Physician Partners - Monticello Clinic

Monticello, Florida, 32344, United States

Location

Tallahassee Memorial Hospital Physician Partners - Perry Clinic

Perry, Florida, 32347, United States

Location

Tallahassee Memorial Hospital Physician Partners - Quincy Clinic

Quincy, Florida, 32351, United States

Location

Bond Community Health Center

Tallahassee, Florida, 32301, United States

Location

Tallahassee Memorial Hospital Physician Partners Cardiology Heart Failure Clinic

Tallahassee, Florida, 32308, United States

Location

HCA Capital Cardiology Associates

Tallahassee, Florida, 32324, United States

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Dyads (n = 60; 120 participants) will be trained to use a 4-step problem-solving process to collaboratively manage HF-related problems over 12 weeks.

Study Record Dates

• First Submitted: September 9, 2020
• First Posted: September 16, 2020
• Study Start: September 29, 2020
• Primary Completion: March 13, 2023
• Study Completion: March 13, 2023
• Last Updated: April 11, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (9)