Cost Effectiveness and Quality of Life in Heart Failure Patients With Diabetes (QUALITYHF-DM)

April 22, 2014 updated by: Sandra B. Dunbar, RN, Emory University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

141

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University School of Nursing

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HF-DM Self Care
educational counseling intervention about integrated HF-DM self care outcomes
Behavioral: HF DM self care
Education in monitoring signs and symptoms of Heart Failure and Diabetes as well as self care instruction
Other Names:
  • HF-DM Self Care
Behavioral: Usual Care
Educational materials on Heart Failure and diabetes at study enrollment. Full educational binder delivered at end of study.
No Intervention: Usual Care
Usual Care provided by providers

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Heart failure health related quality of life measures
Time Frame: 6 months
As measured by Minnesota Living with Heart Failure Questionnaire (MLHFQ).
6 months
Diabetes health related quality of life measures
Time Frame: 6 months
As measured by Audit of Diabetes - Dependent Quality of Life (ADDQOL).
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Heart Failure and Diabetes (HF-DM) physical outcomes
Time Frame: 6 months
BNP and HgA1c, and 6 minute walk test
6 months
Heart Failure Knowledge
Time Frame: 6 months
As measured by the Atlanta Heart Failure Knowledge Test (AHFKT)
6 months
Health resource use
Time Frame: 6 months
As measured by hospital and ED visits as well as contact with medical providers
6 months
Heart Failure (HF) self-efficacy
Time Frame: 6 months
As measured by Self Care in Heart Failure Inventory Self Efficacy Scale
6 months
Heart Failure and Diabetes(HF-DM) self-care behaviors
Time Frame: 6 months
As measured by activity calendars/logs, Self care in Heart failure Inventory subscales, and Summary of Diabetes Self Care Scale
6 months
Diabetes (DM) Knowledge
Time Frame: 6 months
Michigan Diabetes Knowledge Test (MDKT)
6 months
Diabetes (DM) self efficacy
Time Frame: 6 months
Measured by the Perceived Diabetes Self Management Scale (PDSMS)
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Emory University

Collaborators

National Institute of Nursing Research (NINR)
Atlanta VA Medical Center
Atlanta Clinical and Translational Science Institute

Investigators

  • Principal Investigator: Sandra B Dunbar, PhD, Nell Hodgson Woodruff School of Nursing
  • Study Director: Javed Butler, MD, Emory University
  • Study Director: Stephen Culler, MD, Emory University
  • Study Director: Rebecca A. Gary, PhD, Nell Hodgson Woodruff School of Nursing
  • Study Director: Carolyn M. Reilly, PhD, Nell Hodgson Woodruff School of Nursing

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (Actual)

September 1, 2013

Study Completion (Actual)

April 1, 2014

Study Registration Dates

First Submitted

May 14, 2012

First Submitted That Met QC Criteria

May 24, 2012

First Posted (Estimate)

May 25, 2012

Study Record Updates

Last Update Posted (Estimate)

April 24, 2014

Last Update Submitted That Met QC Criteria

April 22, 2014

Last Verified

September 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00026671
  • 1R01NR011888-01 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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