Clinical trial NCT01606085: Cost Effectiveness and Quality of Life in Heart Failure Patients With Diabetes
Official title: Cost Effectiveness and Quality of Life in Heart Failure Patients With Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Heart Failure
Keywords: Diabetes
Heart Failure
Quality of Life
Self Care
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: Atlanta VA Medical Center
name: Atlanta Clinical and Translational Science Institute
name: National Institute of Nursing Research (NINR)
First posted: 2012-05-25
Enrollment: 141
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility 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

Primary outcomes:
measure: Heart failure health related quality of life measures
timeFrame: 6 months
measure: Diabetes health related quality of life measures
timeFrame: 6 months
Secondary outcomes:
measure: Heart Failure and Diabetes (HF-DM) physical outcomes
timeFrame: 6 months
measure: Heart Failure Knowledge
timeFrame: 6 months
measure: Health resource use
timeFrame: 6 months
measure: Heart Failure (HF) self-efficacy
timeFrame: 6 months
measure: Heart Failure and Diabetes(HF-DM) self-care behaviors
timeFrame: 6 months
measure: Diabetes (DM) Knowledge
timeFrame: 6 months
measure: Diabetes (DM) self efficacy
timeFrame: 6 months
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University School of Nursing
state: Georgia
Study officials:
affiliation: Nell Hodgson Woodruff School of Nursing
name: Sandra B Dunbar, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Emory University
name: Javed Butler, MD
role: STUDY_DIRECTOR
affiliation: Emory University
name: Stephen Culler, MD
role: STUDY_DIRECTOR
affiliation: Nell Hodgson Woodruff School of Nursing
name: Rebecca A. Gary, PhD
role: STUDY_DIRECTOR
affiliation: Nell Hodgson Woodruff School of Nursing
name: Carolyn M. Reilly, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: Dunbar 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.