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

This study has been completed.
Sponsor:
Collaborators:
Atlanta VA Medical Center
Atlanta Clinical and Translational Science Institute
Information provided by (Responsible Party):
Sandra B. Dunbar, RN, Emory University
ClinicalTrials.gov Identifier:
NCT01606085
First received: May 14, 2012
Last updated: April 22, 2014
Last verified: September 2013
  Purpose

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.


Condition Intervention
Diabetes Mellitus
Heart Failure
Behavioral: HF DM self care
Behavioral: Usual Care

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Cost Effectiveness and Quality of Life in Heart Failure Patients With Diabetes

Resource links provided by NLM:


Further study details as provided by Emory University:

Primary Outcome Measures:
  • Heart failure health related quality of life measures [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    As measured by Minnesota Living with Heart Failure Questionnaire (MLHFQ).

  • Diabetes health related quality of life measures [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    As measured by Audit of Diabetes - Dependent Quality of Life (ADDQOL).


Secondary Outcome Measures:
  • Heart Failure and Diabetes (HF-DM) physical outcomes [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    BNP and HgA1c, and 6 minute walk test

  • Heart Failure Knowledge [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    As measured by the Atlanta Heart Failure Knowledge Test (AHFKT)

  • Health resource use [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    As measured by hospital and ED visits as well as contact with medical providers

  • Heart Failure (HF) self-efficacy [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    As measured by Self Care in Heart Failure Inventory Self Efficacy Scale

  • Heart Failure and Diabetes(HF-DM) self-care behaviors [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    As measured by activity calendars/logs, Self care in Heart failure Inventory subscales, and Summary of Diabetes Self Care Scale

  • Diabetes (DM) Knowledge [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Michigan Diabetes Knowledge Test (MDKT)

  • Diabetes (DM) self efficacy [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Measured by the Perceived Diabetes Self Management Scale (PDSMS)


Enrollment: 141
Study Start Date: September 2009
Study Completion Date: April 2014
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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.
Other Name: Usual Care
No Intervention: Usual Care
Usual Care provided by providers

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.

  Eligibility

Ages Eligible for Study:   21 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01606085

Locations
United States, Georgia
Emory University School of Nursing
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
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
  More Information

Additional Information:
No publications provided

Responsible Party: Sandra B. Dunbar, RN, Professor and Associate Dean of Academic Advancement, Emory University
ClinicalTrials.gov Identifier: NCT01606085     History of Changes
Other Study ID Numbers: IRB00026671, 1R01NR011888-01
Study First Received: May 14, 2012
Last Updated: April 22, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Emory University:
Diabetes
Heart Failure
Quality of Life
Self Care

Additional relevant MeSH terms:
Diabetes Mellitus
Heart Failure
Cardiovascular Diseases
Endocrine System Diseases
Glucose Metabolism Disorders
Heart Diseases
Metabolic Diseases

ClinicalTrials.gov processed this record on October 23, 2014