Enhancing Problem-Solving Skills in Underserved Rural Heart Failure Dyads
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- Heart Failure
- 发起方
- Florida State University
- 入组人数
- 94
- 试验地点
- 9
- 主要终点
- Self-Care Confidence (HF patient)
- 状态
- 已完成
- 最后更新
- 3年前
概览
简要总结
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.
详细描述
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).
研究者
Lucinda Graven
Associate Professor
Florida State University
入排标准
入选标准
- •≥ 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
排除标准
- •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 \[TICS\])
结局指标
主要结局
Self-Care Confidence (HF patient)
时间窗: Baseline, 13 weeks
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.
Caregiver Contribution to Self-Care Maintenance (caregiver)
时间窗: Baseline, 13 weeks
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.
Caregiver Contribution to Self-Care Management (caregiver)
时间窗: Baseline, 13 weeks
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.
Caregiver Contribution to Self-Care Confidence (caregiver)
时间窗: Baseline, 13 weeks
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.
Self-Care Maintenance (HF patient)
时间窗: Baseline, 13 weeks
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.
Self-Care Management (HF patient)
时间窗: Baseline, 13 weeks
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.
次要结局
- Healthcare Utilization (patient)(baseline, 13 weeks)
- Problem-Solving (HF patient and caregiver)(baseline,13 weeks)