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Completed

NCT Number: NCT01606085

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

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.

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Key information

Age range

21 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Emory University School of Nursing

Atlanta, Georgia, 30322, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HF DM self care

Behavioral

Education in monitoring signs and symptoms of Heart Failure and Diabetes as well as self care instruction

Other names: HF-DM Self Care

Usual Care

Behavioral

Educational materials on Heart Failure and diabetes at study enrollment. Full educational binder delivered at end of study.

Primary outcomes

  1. Heart failure health related quality of life measures

    Time frame: 6 months

    As measured by Minnesota Living with Heart Failure Questionnaire (MLHFQ).

  2. Diabetes health related quality of life measures

    Time frame: 6 months

    As measured by Audit of Diabetes - Dependent Quality of Life (ADDQOL).

Secondary outcomes

  1. Heart Failure and Diabetes (HF-DM) physical outcomes

    Time frame: 6 months

    BNP and HgA1c, and 6 minute walk test

  2. Heart Failure Knowledge

    Time frame: 6 months

    As measured by the Atlanta Heart Failure Knowledge Test (AHFKT)

  3. Health resource use

    Time frame: 6 months

    As measured by hospital and ED visits as well as contact with medical providers

  4. Heart Failure (HF) self-efficacy

    Time frame: 6 months

    As measured by Self Care in Heart Failure Inventory Self Efficacy Scale

  5. Heart Failure and Diabetes(HF-DM) self-care behaviors

    Time frame: 6 months

    As measured by activity calendars/logs, Self care in Heart failure Inventory subscales, and Summary of Diabetes Self Care Scale

  6. Diabetes (DM) Knowledge

    Time frame: 6 months

    Michigan Diabetes Knowledge Test (MDKT)

  7. Diabetes (DM) self efficacy

    Time frame: 6 months

    Measured by the Perceived Diabetes Self Management Scale (PDSMS)

Sponsors and collaborators

Lead sponsor

Emory University

Other

Collaborators

  • Atlanta Clinical and Translational Science Institute
  • Atlanta VA Medical Center
  • National Institute of Nursing Research (NINR)

Registry information

Acronym: QUALITYHF-DM

Important dates

Study start
2009
Primary completion
2013
Study completion
2014
First posted
May 25, 2012
Registry last updated
Apr 24, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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