Cost Effectiveness and Quality of Life in Heart Failure Patients With Diabetes
Cost Effectiveness and Quality of Life in Heart Failure Patients With Diabetes
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.
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.
Inclusion Criteria:

 -  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

 Exclusion Criteria:

 -  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