Cost Effectiveness and Quality of Life in Heart Failure Patients With Diabetes
QUALITYHF-DM
2 other identifiers
interventional
141
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable diabetes-mellitus
Started Sep 2009
Longer than P75 for not_applicable diabetes-mellitus
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2009
CompletedFirst Submitted
Initial submission to the registry
May 14, 2012
CompletedFirst Posted
Study publicly available on registry
May 25, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2014
CompletedApril 24, 2014
September 1, 2013
4 years
May 14, 2012
April 22, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Heart failure health related quality of life measures
As measured by Minnesota Living with Heart Failure Questionnaire (MLHFQ).
6 months
Diabetes health related quality of life measures
As measured by Audit of Diabetes - Dependent Quality of Life (ADDQOL).
6 months
Secondary Outcomes (7)
Heart Failure and Diabetes (HF-DM) physical outcomes
6 months
Heart Failure Knowledge
6 months
Health resource use
6 months
Heart Failure (HF) self-efficacy
6 months
Heart Failure and Diabetes(HF-DM) self-care behaviors
6 months
- +2 more secondary outcomes
Study Arms (2)
HF-DM Self Care
EXPERIMENTALeducational counseling intervention about integrated HF-DM self care outcomes
Usual Care
NO INTERVENTIONUsual Care provided by providers
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Emory Universitylead
- Atlanta VA Medical Centercollaborator
- Atlanta Clinical and Translational Science Institutecollaborator
- National Institute of Nursing Research (NINR)collaborator
Study Sites (1)
Emory University School of Nursing
Atlanta, Georgia, 30322, United States
Related Publications (2)
Reilly CM, Butler J, Culler SD, Gary RA, Higgins M, Schindler P, Butts B, Dunbar SB. An economic evaluation of a self-care intervention in persons with heart failure and diabetes. J Card Fail. 2015 Sep;21(9):730-7. doi: 10.1016/j.cardfail.2015.06.382. Epub 2015 Jul 8.
PMID: 26164214DERIVEDDunbar SB, Reilly CM, Gary R, Higgins MK, Culler S, Butts B, Butler J. Randomized clinical trial of an integrated self-care intervention for persons with heart failure and diabetes: quality of life and physical functioning outcomes. J Card Fail. 2015 Sep;21(9):719-29. doi: 10.1016/j.cardfail.2015.05.012. Epub 2015 May 29.
PMID: 26028261DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor and Associate Dean of Academic Advancement
Study Record Dates
First Submitted
May 14, 2012
First Posted
May 25, 2012
Study Start
September 1, 2009
Primary Completion
September 1, 2013
Study Completion
April 1, 2014
Last Updated
April 24, 2014
Record last verified: 2013-09