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

Heart Failure Clinical Trial

— QUALITYHF-DM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01606085
• Other study ID #: IRB00026671
• Secondary ID: 1R01NR011888-01
• Status: Completed
• Phase: N/A
• First received: May 14, 2012
• Last updated: April 22, 2014
• Start date: September 2009
• Est. completion date: April 2014

Study information

• Verified date: September 2013
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 141
• Est. completion date: April 2014
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Diabetes Mellitus
• Heart Failure

Intervention

Behavioral:
• HF DM self care
Education in monitoring signs and symptoms of Heart Failure and Diabetes as well as self care instruction
• Usual Care
Educational materials on Heart Failure and diabetes at study enrollment. Full educational binder delivered at end of study.

Locations

Country	Name	City	State
United States	Emory University School of Nursing	Atlanta	Georgia

Sponsors (4)

Lead Sponsor	Collaborator
Emory University	Atlanta Clinical and Translational Science Institute, Atlanta VA Medical Center, National Institute of Nursing Research (NINR)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Heart failure health related quality of life measures	As measured by Minnesota Living with Heart Failure Questionnaire (MLHFQ).	6 months	No
Primary	Diabetes health related quality of life measures	As measured by Audit of Diabetes - Dependent Quality of Life (ADDQOL).	6 months	No
Secondary	Heart Failure and Diabetes (HF-DM) physical outcomes	BNP and HgA1c, and 6 minute walk test	6 months	No
Secondary	Heart Failure Knowledge	As measured by the Atlanta Heart Failure Knowledge Test (AHFKT)	6 months	No
Secondary	Health resource use	As measured by hospital and ED visits as well as contact with medical providers	6 months	No
Secondary	Heart Failure (HF) self-efficacy	As measured by Self Care in Heart Failure Inventory Self Efficacy Scale	6 months	No
Secondary	Heart Failure and Diabetes(HF-DM) self-care behaviors	As measured by activity calendars/logs, Self care in Heart failure Inventory subscales, and Summary of Diabetes Self Care Scale	6 months	No
Secondary	Diabetes (DM) Knowledge	Michigan Diabetes Knowledge Test (MDKT)	6 months	No
Secondary	Diabetes (DM) self efficacy	Measured by the Perceived Diabetes Self Management Scale (PDSMS)	6 months	No

External Links

•   Research at Emory's School of Nursing