Self-management Adherence in Heart Failure Patients



Status:Active, not recruiting
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:21 - Any
Updated:4/21/2016
Start Date:October 2013
End Date:March 2016

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Promoting Self-management Through Adherence Among Heart Failure Patients

Non-adherence to self-management behaviors is prevalent and accounts for hospital
readmissions in heart failure (HF) patients 65 years of age and older. The mechanism to
activate and engage HF patients in managing their own care is uncertain. Yet post-acute care
service that is vital to improve HF patients' self-management adherence and HF outcomes is
suboptimal in rural hospitals (primarily critical access hospitals). The investigators
central hypothesis is that patients with higher activation level will have significantly
better self-management adherence. This study will test whether Patient AcTivated Care at
Home (PATCH) will improve self-management adherence and health outcome (reduced hospital
readmissions), as well as the feasibility to translate the research findings to a home based
post-acute care service in rural communities.

Heart failure (HF) is among the most prevalent chronic conditions and leading cause of
hospital readmission in adults 65 years of age and older. HF patients discharged from rural
critical access hospitals (CAHs) had higher 30-day readmission rates compared to patients
discharged from urban hospitals. Adhering to recommended self-management behaviors improves
HF patients' health outcomes and reduces readmissions; however, the prevalence of adherence
is low in HF patients. In rural communities, low adherence can be attributed to the fact
that rural HF patients received less information about managing their chronic condition
based on the investigators preliminary study. Previous studies reported inconsistent
findings regarding the effectiveness of interventions designed to improve self-management
adherence. The feasibility of these interventions in rural settings is unknown. Therefore,
innovative programs are needed to identify the intervention to enhance self-management
adherence in HF patients living in rural communities. The purpose of this prospective,
two-group, repeated measures, randomized control trial is to test the efficacy and
feasibility of a 12-week activation-enhancing intervention (Patient AcTivated Care at Home
[PATCH]) on self-management adherence and health outcome (readmission rates) in HF patients
discharged from rural hospitals (critical access hospitals). A sample size of 96 subjects
with heart failure will be recruited over 14 month period. Both intervention and control
groups will receive usual care. The intervention group will additionally receive 2-phase
PATCH intervention: the in-hospital discharge education session (Phase I) and 12-week
post-discharge education sessions delivered by telephone (Phase II). The tailored strategies
are developed to activate patients engaging in self-management behaviors based on their
baseline activation level. The investigators central hypothesis, based upon their
preliminary data, is that patients with higher activation level will have significantly
better self-management adherence. The investigators will test their hypothesis with the
following Specific Aims: To evaluate the effects of the patient activation intervention on
self-management adherence (Aim 1) and hospital readmissions (Aim 2) over time. To evaluate
the mechanism of the patient activation intervention (Aim 3). To evaluate the feasibility of
the PATCH intervention (Aim 4). The PATCH intervention is innovative because: 1) it
translates patient activation theory into intervention strategies to improve self-management
in a vulnerable population (rural heart failure patients living in rural community), 2) it
tests the mechanism of patient activation on self-management adherence; 3) it uses the rural
nursing theory to guide developing a sustainable intervention program in rural communities;
and 4) it evaluates a biomarker collected by a single urine test as the indicator of
self-management adherence in HF patients. This study will impact the management of heart
failure by adding knowledge about the mechanism to improve self-management adherence in
heart failure patient living in rural communities. Long term adherence to the recommended
self-management behaviors is the foundation to realize health benefit and reduce burden on
patients, their family and the healthcare system.

Inclusion Criteria:

- have HF as one of their discharge diagnoses;

- have New York Heart Association (NYHA) class II to IV symptoms or have NYHA class I
symptoms

- have had at least one other HF-related hospitalization or emergency department visit
in the previous year;

- are discharged to home;

- pass a mini-cog screen

- understand English;

- have access to a phone.

Exclusion Criteria:

- Have scheduled procedures and/or surgeries during hospitalization;

- Have depressive symptoms (receive a score of 3 or above on the Patient Health
Questionnaire-2 (PHQ-2) have documented medical diagnosis or diagnostic evidence of
liver cirrhosis;

- Have renal failure (serum creatinine greater than 2.0mg/dl)
We found this trial at
2
sites
Fairbury, Nebraska 68352
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mi
from
Fairbury, NE
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from
Beatrice, NE
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