Cost Effectiveness and Quality of Life in Heart Failure Patients With Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 141
- 试验地点
- 2
- 主要终点
- Heart failure health related quality of life measures
研究概览
简要总结
The purposes of this study are:
- to develop and test an integrated self care intervention for Heart Failure (HF)patients with Diabetes (DM) for its effects on patient outcomes including health related quality of life (HRQOL), physical function and health resource utilization.
- to assess the costs and cost effectiveness of the intervention.
The intervention is designed to go beyond usual care of providing separate Heart Failure (HF) and Diabetes (DM) patient education by educating HF-DM patients on integrated self care and self management related to a HF-DM diet, HF-DM medication-taking behaviors, physical activity, and HF-DM symptom monitoring and management. An integrated self care intervention will compare HF-DM patients who receive the intervention with those who receive usual care-attention control for effects on patient outcomes,self care process measures, and health care utilization. If effective, the intervention will lead to improved self care, improved quality of life, and reduced health care resource use and costs. This study will facilitate greater understanding of self care within the context of two chronic illnesses and will lead directly to improved clinical practice and future research on comorbid self care in Heart Failure.
详细描述
The investigators hypothesize that participants receiving the Heart Failure and Diabetes (HF-DM) self-care intervention will report greater Health Related Quality of Life (HRQOL) on the Minnesota Living with HF Questionnaire (MLHFQ), the Audit of Diabetes-dependent Quality of Life (ADDQoL), and the EuroQol (EQ5D) than the Usual Care (UC-AC) group at 6 months when controlling for age, gender, and NYHA Class.
Secondly, that participants receiving the Heart Failure and Diabetes (HF-DM) self-care intervention will demonstrate improved physical function indicators (BNP levels, HgA1c, and 6MWT) at 6 months over the UC-AC group when controlling for age, gender, BMI, and NYHA Class and comorbid conditions.
Thirdly, that participants receiving the Heart Failure and Diabetes (HF-DM) self-care intervention will exhibit greater improvement in: HF knowledge and DM knowledge than UC-AC at 6 months. Participants receiving the integrated HF-DM self-care intervention will report greater improvements in HF self-efficacy and DM self-efficacy over UC-AC at 6 months. HF-DM patients randomized to the integrated self-care intervention will exhibit greater improvements in overall HF and DM self-care behaviors and HF-DM diet and physical activity over UC-AC at 6 months.
Lastly, that HF-DM patients who receive the integrated self-care intervention will exhibit less health resource use and associated costs(direct health care costs of provider visits, hospitalizations, ED visits, length of stay, and direct non-health care costs associated with the HRU and intervention) over the 6 months than those who receive UC-AC controlling for comorbidity and insurance status.
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
- None
入排标准
- 年龄范围
- 21 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •hospital admission with a diagnosis of Heart Failure (HF) with Left Ventricular Systolic Dysfunction (LVSD) or diastolic dysfunction and concomitant Diabetes (DM) type II
- •planned discharge from hospital to home setting
- •NYHA Class II-IV
- •On optimal HF regimen of care including ACE-Inhibitors or ARBs beta blocking agents, and diuretics if indicated by patient fluid status
- •ambulatory
- •able to read and write English
- •acceptable cognitive screening test
排除标准
- •planned discharge to long term acute care
- •presence of an insulin pump
- •active foot ulcer
- •presence of hemodynamically significant angina pectoris
- •renal failure with hemodialysis
- •planned cardiac surgery
- •impaired cognition due to neurological comorbidity
- •psychiatric diagnosis
- •uncorrected visual or hearing problem
- •uncorrected hearing or vision problems
- •moderately severe depressive symptoms
- •UNOS/ A status or ventricular assist device
- •lack of telephone access
结局指标
主要结局
Heart failure health related quality of life measures
时间窗: 6 months
As measured by Minnesota Living with Heart Failure Questionnaire (MLHFQ).
Diabetes health related quality of life measures
时间窗: 6 months
As measured by Audit of Diabetes - Dependent Quality of Life (ADDQOL).
次要结局
- Diabetes (DM) self efficacy(6 months)
- Heart Failure and Diabetes (HF-DM) physical outcomes(6 months)
- Heart Failure Knowledge(6 months)
- Health resource use(6 months)
- Heart Failure (HF) self-efficacy(6 months)
- Heart Failure and Diabetes(HF-DM) self-care behaviors(6 months)
- Diabetes (DM) Knowledge(6 months)
研究者
Sandra B. Dunbar, RN
Professor and Associate Dean of Academic Advancement
Emory University