Cost Effectiveness and Quality of Life in Heart Failure Patients With Diabetes
Condition: Diabetes Mellitus; Heart Failure
MeSH terms: Heart Failure; Diabetes Mellitus
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): HF DM self care; Usual Care
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Education in monitoring signs and symptoms of Heart Failure and Diabetes as well as self care instruction; Educational materials on Heart Failure and diabetes at study enrollment. Full educational binder delivered at end of study.
Other intervention name(s): HF-DM Self Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Diabetes; Heart Failure; Quality of Life; Self Care