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

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.

Conditions

• Diabetes Mellitus
• Heart Failure

Interventions

BEHAVIORAL

HF DM self care

Education in monitoring signs and symptoms of Heart Failure and Diabetes as well as self care instruction

BEHAVIORAL

Usual Care

Educational materials on Heart Failure and diabetes at study enrollment. Full educational binder delivered at end of study.

Sponsors & Collaborators

• Atlanta VA Medical Center

  collaborator FED

• Atlanta Clinical and Translational Science Institute

  collaborator OTHER

• National Institute of Nursing Research (NINR)

  collaborator NIH

• Emory University

  lead OTHER

Principal Investigators

• Sandra B Dunbar, PhD · Nell Hodgson Woodruff School of Nursing

• Javed Butler, MD · Emory University

• Stephen Culler, MD · Emory University

• Rebecca A. Gary, PhD · Nell Hodgson Woodruff School of Nursing

• Carolyn M. Reilly, PhD · Nell Hodgson Woodruff School of Nursing

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

21 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2009-09-30

Primary Completion

2013-09-30

Completion

2014-04-30

Countries

• United States

Study Locations