A Pilot Hybrid Effectiveness-Implementation Trial for the Conversations Helpful for Awareness of Illness Trajectory (CHAT) Intervention
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Mean Change from Baseline on the Self-Care of Heart Failure Index (SCHFI) Summary Score at 90 Days
研究概览
简要总结
The researchers are studying whether an intervention that involves video-based educational content and a health coach is acceptable, feasible, and effective for people with Heart Failure with Preserved Ejection Fraction (HFpEF).
详细描述
This is a pilot randomized controlled trial of 50 subjects that will compare the CHAT intervention (video-based educational content and a health coach) with usual care. Video-based educational content was developed based on Adult Learning Theory and Social Cognitive Theory. Key content areas covered by the videos and health coach will include: HFpEF Overview, Signs and Symptoms of HFpEF, Medication Management, Physical Activity and Diet with HFpEF, and Planning for the Future (Advance Care Planning).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or Female ≥ 60 years old
- •Documentation of HFpEF according to clinical practice guidelines
排除标准
- •Previously referred to hospice care
- •Prior completion of advance directives; forms uploaded to the EMR in the past 3 years
- •Moderate-severe dementia or psychiatric disorder precluding informed consent.
研究组 & 干预措施
Standard of Care Group
Subjects randomized to the standard of care group will receive usual care (and will not receive the CHAT intervention).
干预措施: Standard of Care (SOC) (Behavioral)
CHAT Intervention Group
The group randomized to the CHAT intervention will be instructed to watch 7 short patient-facing videos and participate in four biweekly sessions with a trained health coach.
干预措施: Conversations Helpful for Awareness of Illness Trajectory (CHAT) Intervention (Behavioral)
结局指标
主要结局
Mean Change from Baseline on the Self-Care of Heart Failure Index (SCHFI) Summary Score at 90 Days
时间窗: Baseline, 90 days
This measure uses the SCHFI, a 29-item survey that evaluates three subscales: Symptom Perception, Self-Care Management, and Self-Care Maintenance, with the lowest possible score of 0 and the highest possible score of 100. Higher scores indicate better self-care. Standardized scoring will assess changes from baseline.
次要结局
- Scores on the Feasibility of Intervention Measure (FIM) at 90 Days(90 days)
- Scores on the Intervention Appropriateness Measure (IAM) at 90 Days(90 days)
- Scores on the Acceptability of Intervention Measure (AIM) at 90 Days(90 days)
- Mean Change from Baseline on the Advance Care Planning Engagement Survey at 90 Days(Baseline, 90 days)
- Mean Change from Baseline on the Advance Care Planning Readiness Scale at 90 Days(Baseline, 90 days)
- Mean Change from Baseline for Percentage of Participants Completing a Health Care Proxy Form at 90 days(Baseline, 90 days)
- Mean Change from Baseline for Percentage of Participants Completing a Living Will Form at 90 days(Baseline, 90 days)
- Mean Change from Baseline on the Perceived Health Competency Scale (PHCS) at 90 Days(Baseline, 90 days)
- Mean Change from Baseline on the Patient Activation Measure (PAM) at 90 Days(Baseline, 90 days)
- Mean Change from Baseline on The Human Connection (THC) Scale at 90 Days(Baseline, 90 days)
- Mean Change from Baseline on the Basic Psychological Need Satisfaction and Frustration Scale (BPNSF) Relatedness Subscale at 90 Days(Baseline, 90 days)