Cost Effectiveness and Quality of Life in Heart Failure Patients With Diabetes (QUALITYHF-DM)
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|ClinicalTrials.gov Identifier: NCT01606085|
Recruitment Status : Completed
First Posted : May 25, 2012
Last Update Posted : April 24, 2014
The purposes of this study are:
- 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.
- 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.
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus Heart Failure||Behavioral: HF DM self care Behavioral: Usual Care||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||141 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Cost Effectiveness and Quality of Life in Heart Failure Patients With Diabetes|
|Study Start Date :||September 2009|
|Actual Primary Completion Date :||September 2013|
|Actual Study Completion Date :||April 2014|
Experimental: HF-DM Self Care
educational counseling intervention about integrated HF-DM self care outcomes
Behavioral: HF DM self care
Education in monitoring signs and symptoms of Heart Failure and Diabetes as well as self care instruction
Other Name: HF-DM Self Care
Behavioral: Usual Care
Educational materials on Heart Failure and diabetes at study enrollment. Full educational binder delivered at end of study.
No Intervention: Usual Care
Usual Care provided by providers
- Heart failure health related quality of life measures [ Time Frame: 6 months ]As measured by Minnesota Living with Heart Failure Questionnaire (MLHFQ).
- Diabetes health related quality of life measures [ Time Frame: 6 months ]As measured by Audit of Diabetes - Dependent Quality of Life (ADDQOL).
- Heart Failure and Diabetes (HF-DM) physical outcomes [ Time Frame: 6 months ]BNP and HgA1c, and 6 minute walk test
- Heart Failure Knowledge [ Time Frame: 6 months ]As measured by the Atlanta Heart Failure Knowledge Test (AHFKT)
- Health resource use [ Time Frame: 6 months ]As measured by hospital and ED visits as well as contact with medical providers
- Heart Failure (HF) self-efficacy [ Time Frame: 6 months ]As measured by Self Care in Heart Failure Inventory Self Efficacy Scale
- 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
- Diabetes (DM) Knowledge [ Time Frame: 6 months ]Michigan Diabetes Knowledge Test (MDKT)
- Diabetes (DM) self efficacy [ Time Frame: 6 months ]Measured by the Perceived Diabetes Self Management Scale (PDSMS)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01606085
|United States, Georgia|
|Emory University School of Nursing|
|Atlanta, Georgia, United States, 30322|
|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|