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

Not Applicable

Completed

• Conditions: Diabetes Mellitus; Heart Failure
• Interventions: Behavioral: HF DM self care; Behavioral: Usual Care

• Registration Number: NCT01606085
• Lead Sponsor: Emory University

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.

Study Timeline

• Study Start: 2009-09
• Study First Submitted: 2012-05-14
• Study First Submitted QC: 2012-05-24
• Study First Posted: 2012-05-25
• Status Verified: 2013-09
• Primary Completion: 2013-09
• Study Completion: 2014-04
• Last Update Submitted: 2014-04-22
• Last Update Posted: 2014-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 141

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HF-DM Self Care	HF DM self care	educational counseling intervention about integrated HF-DM self care outcomes
HF-DM Self Care	Usual Care	educational counseling intervention about integrated HF-DM self care outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Emory University School of Nursing; 🇺🇸 Atlanta, Georgia, United States