Emory University School of Nursing
Atlanta, Georgia, 30322, United States
NCT Number: NCT01606085
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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Notify Me21 year–80 year
All sexes
Interventional
Not applicable
Atlanta, Georgia, 30322, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Education in monitoring signs and symptoms of Heart Failure and Diabetes as well as self care instruction
Other names: HF-DM Self Care
Educational materials on Heart Failure and diabetes at study enrollment. Full educational binder delivered at end of study.
Time frame: 6 months
As measured by Minnesota Living with Heart Failure Questionnaire (MLHFQ).
Time frame: 6 months
As measured by Audit of Diabetes - Dependent Quality of Life (ADDQOL).
Time frame: 6 months
BNP and HgA1c, and 6 minute walk test
Time frame: 6 months
As measured by the Atlanta Heart Failure Knowledge Test (AHFKT)
Time frame: 6 months
As measured by hospital and ED visits as well as contact with medical providers
Time frame: 6 months
As measured by Self Care in Heart Failure Inventory Self Efficacy Scale
Time frame: 6 months
As measured by activity calendars/logs, Self care in Heart failure Inventory subscales, and Summary of Diabetes Self Care Scale
Time frame: 6 months
Michigan Diabetes Knowledge Test (MDKT)
Time frame: 6 months
Measured by the Perceived Diabetes Self Management Scale (PDSMS)
Emory University
Other
Acronym: QUALITYHF-DM
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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