Clinical trial NCT04549181: Problem-Solving for Rural Heart Failure Dyads
Official title: Enhancing Problem-Solving Skills in Underserved Rural Heart Failure Dyads
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Keywords: heart failure
dyads
rural
problem-solving
self-care
Lead sponsor: Florida State University
Sponsor class: OTHER
Collaborators: name: Florida Blue Center for Rural Research
First posted: 2020-09-16
Enrollment: 94
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: 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.
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: The long-term goal of this research is to reduce morbidity and improve HF self-care by enhancing family problem-solving and collaborative care management among rural HF dyads. The initial step in meeting this goal is to develop and pilot-test a culturally-sensitive, telephone-based, tailored dyadic problem-solving intervention to improve HF self-care in rural HF dyads. Using a multi-phase, sequential qualitative and quantitative approach, the following research aims are to: 1) identify the major dyadic HF-related problems dyads experience and how these problems are managed; 2) develop a telephone-based, tailored dyadic problem-solving intervention and determine its feasibility and acceptability for managing HF-related problems; and 3) evaluate the preliminary effects of the telephone-based, tailored dyadic problem-solving intervention on dyadic problem-solving and patient and family caregiver contributions to HF self-care. As an exploratory aim, we will also evaluate the effectiveness of the dyadic problem-solving intervention on caregiver burden, self-care, and life changes. In Phase I, qualitative inquiry will guide in-depth semi-structured dyad interviews (n = 12-20 dyads; 24-40 participants) to identify the dyadic HF-related problems experienced by rural HF dyads and associated management strategies (Aim 1). Phase II will be guided by qualitative and quantitative methods and include a repeated measures, single-group design to evaluate the feasibility, acceptability, and preliminary effectiveness of the 12-week dyadic problem-solving intervention in a sample of rural HF dyads (n = 60 dyads; 120 participants) (Aims 2, 3). Participants for this study will be recruited from from the Florida State University Institute for Successful Longevity Participant Registry, outpatient HF/cardiac and rural healthcare clinics affiliated with 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 1) will identify dyadic HF-related problems and management strategies using semi-structured interviews in a sample of rural-residing HF dyads (n = 12-20 dyads; 24-40 participants). Following consent, interviews will occur once and be approximately 45 minutes long. Qualitative data from Phase I will be analyzed using thematic analytic methods and NVivo11. Information gained in Phase I will be used to develop the telephone-based, tailored, dyadic problem-solving intervention for rural HF dyads tested in Phase II.

Phase II (Arm II) will be guided by qualitative and quantitative inquiry and include a single-group, repeated measures design with time and dyad-member as within-subject factors. A sample size of 60 dyads (120 participants) is desired based on a power analysis for repeated measures ANOVA with 4 time points, alpha level of .05, a medium effect size (f = 0.25), and 80% power, plus oversampling for potential attrition (20%). Following verbal informed consent via telephone, all dyads will be screened for cognitive impairment using the Telephone Interview for Cognitive Status (TICS) prior to baseline data collection, which will include a Sociodemographic and Clinical Survey, the Self-Care of HF Index (SCHFI; v. 6.2) (patients only), the Caregiver Contribution to the Self-Care of HF Index (CCSCHFI) (caregivers only), Healthcare Utilization Survey, the Social Problem-Solving Inventory Revised-Short (SPSIRS), the Center for Epidemiological Studies-Depression (CESD), the Global Family Function Subscale (GFF) of the Family Assessment Device Questionnaire, and the Interpersonal Support Evaluation List-12 (ISEL-12). Caregivers will also complete the Dutch Objective Burden Inventory (DOBI), Denyes Self-care Practice Instrument (DENYES), and the BAKAS Caregiving Outcomes Scale (BAKAS).

Using a single group design, all dyads will participate in a problem-solving training intervention over 12 weeks (Weeks 1-4, 6, 8, 10, 12), with follow-up data collection occurring at weeks 5, 9, 11, 13. Qualitative data will be collected at weeks 5 and 11 via semi-structured interviews with dyads. Quantitative data on study outcomes and covariates will be collected at weeks 5, 9, and 13 and consist of the SCHFI (patient), CCSCHFI (caregiver), healthcare utilization (patient), SPSIRS (dyad), REALM (dyad), CESD (dyad), GFF (dyad),ISEL-12 (dyad), DOBI (caregiver), Denyes (caregiver) and the BAKAS (caregiver). All data will be self-report and collected by a trained research assistant who will collect study data over the telephone and mark participants answers on a computerized data spreadsheet. Qualitative data will be analyzed using thematic analytic methods and NVivo11. Possible treatment effectiveness on dyadic problem-solving, patient and caregiver contributions to HF self-care, healthcare utilization, caregiver burden, caregiver self-care, caregiver life changes, and differences among subgroups (gender, relationship type) over the 13 weeks will be examined using multilevel modeling and dyadic Growth Curve Modeling (GCM).

Eligibility criteria: Inclusion Criteria:

* ≥ 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

Exclusion Criteria:

* 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 \[TICS\])

Primary outcomes:
measure: Self-Care Maintenance (HF patient)
timeFrame: Baseline, 5 weeks
measure: Self-Care Maintenance (HF patient)
timeFrame: Baseline, 9 weeks
measure: Self-Care Maintenance (HF patient)
timeFrame: Baseline, 13 weeks
measure: Self-Care Management (HF patient)
timeFrame: Baseline, 5 weeks
measure: Self-Care Management (HF patient)
timeFrame: Baseline, 9 weeks
measure: Self-Care Management (HF patient)
timeFrame: Baseline, 13 weeks
measure: Self-Care Confidence (HF patient)
timeFrame: Baseline, 5 weeks
measure: Self-Care Confidence (HF patient)
timeFrame: Baseline, 9 weeks
measure: Self-Care Confidence (HF patient)
timeFrame: Baseline, 13 weeks
measure: Caregiver Contribution to Self-Care Maintenance (caregiver)
timeFrame: Baseline, 5 weeks
measure: Caregiver Contribution to Self-Care Maintenance (caregiver)
timeFrame: Baseline, 9 weeks
measure: Caregiver Contribution to Self-Care Maintenance (caregiver)
timeFrame: Baseline, 13 weeks
measure: Caregiver Contribution to Self-Care Management (caregiver)
timeFrame: Baseline, 5 weeks
measure: Caregiver Contribution to Self-Care Management (caregiver)
timeFrame: Baseline, 9 weeks
measure: Caregiver Contribution to Self-Care Management (caregiver)
timeFrame: Baseline, 13 weeks
measure: Caregiver Contribution to Self-Care Confidence (caregiver)
timeFrame: Baseline, 5 weeks
measure: Caregiver Contribution to Self-Care Confidence (caregiver)
timeFrame: Baseline, 9 weeks
measure: Caregiver Contribution to Self-Care Confidence (caregiver)
timeFrame: Baseline, 13 weeks
Secondary outcomes:
measure: Healthcare Utilization (patient)
timeFrame: baseline, 5 weeks
measure: Healthcare Utilization (patient)
timeFrame: baseline, 9 weeks
measure: Healthcare Utilization (patient)
timeFrame: baseline, 13 weeks
measure: Problem-Solving (HF patient and caregiver)
timeFrame: baseline, 5 weeks
measure: Problem-Solving (HF patient and caregiver)
timeFrame: baseline, 9 weeks
measure: Problem-Solving (HF patient and caregiver)
timeFrame: baseline,13 weeks
Other outcomes:
measure: Depression (patient and caregiver)
timeFrame: baseline, 5 weeks
measure: Depression (patient and caregiver)
timeFrame: baseline, 9 weeks
measure: Depression (patient and caregiver)
timeFrame: baseline, 13 weeks
measure: Family Function (patient and caregiver)
timeFrame: baseline, 5 weeks
measure: Family Function (patient and caregiver)
timeFrame: baseline, 9 weeks
measure: Family Function (patient and caregiver)
timeFrame: baseline, 13 weeks
measure: Social Support (patient and caregiver)
timeFrame: baseline, 5 weeks
measure: Social Support (patient and caregiver)
timeFrame: baseline, 9 weeks
measure: Social Support (patient and caregiver)
timeFrame: baseline, 13 weeks
measure: Caregiver Burden (caregiver)
timeFrame: baseline, 5 weeks
measure: Caregiver Burden (caregiver)
timeFrame: baseline, 9 weeks
measure: Caregiver Burden (caregiver)
timeFrame: baseline, 13 weeks
measure: Caregiver Self-care (caregiver)
timeFrame: baseline, 5 weeks
measure: Caregiver Self-care (caregiver)
timeFrame: baseline, 9 weeks
measure: Caregiver Self-care (caregiver)
timeFrame: baseline, 13 weeks
measure: Life Changes (caregiver)
timeFrame: baseline, 5 weeks
measure: Life Changes (caregiver)
timeFrame: baseline, 9 weeks
measure: Life Changes (caregiver)
timeFrame: baseline, 13 weeks
Locations:
city: Blountstown
country: United States
facility: Tallahassee Memorial Hospital Physician Partners - Blountstown Clinic
state: Florida
city: Crawfordville
country: United States
facility: Tallahassee Memorial Hospital Physician Partners - Wakulla Clinic
state: Florida
city: Marianna
country: United States
facility: Talllahassee Memorial Physician Partners Cardiology - Marianna Clinic
state: Florida
city: Monticello
country: United States
facility: Tallahassee Memorial Hospital Physician Partners - Monticello Clinic
state: Florida
city: Perry
country: United States
facility: Tallahassee Memorial Hospital Physician Partners - Perry Clinic
state: Florida
city: Quincy
country: United States
facility: Tallahassee Memorial Hospital Physician Partners - Quincy Clinic
state: Florida
city: Tallahassee
country: United States
facility: Bond Community Health Center
state: Florida
city: Tallahassee
country: United States
facility: Tallahassee Memorial Hospital Physician Partners Cardiology Heart Failure Clinic
state: Florida
city: Tallahassee
country: United States
facility: HCA Capital Cardiology Associates
state: Florida
Study officials:
References: