Cost Effectiveness and Quality of Life in Heart Failure Patients With Diabetes

Completed · Not applicable

Conditions studied: Diabetes Mellitus, Heart Failure

In brief

The purposes of this study are: 1. 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. 2. 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.

Key facts

Study ID

NCT01606085

Run by

Emory University

People needed

141

Starts

2009-09-01

Expected to finish

2014-04-01

Last updated by the study team

2014-04-24

Who can join

Age: 21 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Emory University School of Nursing — Atlanta, Georgia, United States

Full record on ClinicalTrials.gov

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