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Self-management Adherence in Heart Failure Patients (PATCH)

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ClinicalTrials.gov Identifier: NCT01964053
Recruitment Status : Completed
First Posted : October 17, 2013
Last Update Posted : May 24, 2016
Sponsor:
Information provided by (Responsible Party):
Lufei Young, PhD, ACNP, University of Nebraska

Tracking Information
First Submitted Date  ICMJE October 10, 2013
First Posted Date  ICMJE October 17, 2013
Last Update Posted Date May 24, 2016
Study Start Date  ICMJE October 2013
Actual Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 18, 2015)
Change from Baseline in self-management adherence at 3 and 6 months [ Time Frame: 3 and 6 months following intervention ]
Primary outcome of self-management adherence refers to the adherence to self-care behaviors
Original Primary Outcome Measures  ICMJE
 (submitted: October 13, 2013)
  • self-management adherence [ Time Frame: 3 months following intervention ]
    Primary outcome of self-management adherence refers to the adherence to self-care behaviors, such as monitoring daily weight, following sodium restriction diet, taking medications as prescribed, exercise regularly and keeping follow-up appointment). The adherence to heart failure self-management is also assessed by the clinical biomarkers (B-type natriuretic peptide [BNP] and urine sodium/creatinine ratio [Na/Cr]), and its health outcome (i.e., hospital readmissions).
  • self-management adherence [ Time Frame: 6 months following intervention ]
    Primary outcome of self-management adherence refers to the adherence to self-care behaviors, such as monitoring daily weight, following sodium restriction diet, taking medications as prescribed, exercise regularly and keeping follow-up appointment). The adherence to heart failure self-management is also assessed by the clinical biomarkers (B-type natriuretic peptide [BNP] and urine sodium/creatinine ratio [Na/Cr]), and its health outcome (i.e., hospital readmissions).
Change History Complete list of historical versions of study NCT01964053 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 18, 2015)
Change from Baseline in re-hospitalization rate at 30-day, 3 and 6 months [ Time Frame: 30 day after intervention ]
Evaluate the immediate and extended effects of the patient activation intervention on the re-hospitalization rate in heart failure patients
Original Secondary Outcome Measures  ICMJE
 (submitted: October 13, 2013)
  • re-hospitalization rate [ Time Frame: 30 day after intervention ]
    Evaluate the immediate and extended effects of the patient activation intervention on the re-hospitalization rate in heart failure patients
  • re-hospitalization rate [ Time Frame: 3 months following intervention ]
    Evaluate the immediate and extended effects of the patient activation intervention on the re-hospitalization rate in heart failure patients
  • re-hospitalization rate [ Time Frame: 6 months following intervention ]
    Evaluate the immediate and extended effects of the patient activation intervention on the re-hospitalization rate in heart failure patients
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Self-management Adherence in Heart Failure Patients
Official Title  ICMJE Promoting Self-management Through Adherence Among Heart Failure Patients
Brief Summary 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.
Detailed Description 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Heart Failure
Intervention  ICMJE
  • Behavioral: PATCH intervention
    The intervention group will receive usual care and the PATCH intervention. The intervention is comprised of two phases in which the in-hospital discharge education session is followed by 12 weeks of post-discharge education sessions delivered by telephone. The focus of this study is to test the mechanism of the proposed patient activation intervention on HF self-management adherence and associated health outcomes.
  • Behavioral: Usual care
    Usual care refers to the standardized discharge written information and scheduled doctor appointments. Standardized discharge instruction, as recommended by CMS and the Joint Commission, includes: activity level, diet, discharge medications, follow-up doctor appointment, weight monitoring, and what to do if symptoms worsen.113 No further follow-ups are routinely done by the hospital and patients are told to see their primary care provider if problems occur.
Study Arms  ICMJE
  • Experimental: PATCH Intervention
    The intervention group will receive usual care and the PATCH intervention. The intervention is comprised of two phases in which the in-hospital discharge education session is followed by 12 weeks of post-discharge education sessions delivered by telephone. The focus of this study is to test the mechanism of the proposed patient activation intervention on HF self-management adherence and associated health outcomes.
    Intervention: Behavioral: PATCH intervention
  • Active Comparator: Usual Care
    The usual care group will receive standardized discharge written information and scheduled doctor appointments. Standardized discharge instruction, as recommended by CMS and the Joint Commission, includes: activity level, diet, discharge medications, follow-up doctor appointment, weight monitoring, and what to do if symptoms worsen. No further follow-ups are routinely done by the hospital and patients are told to see their primary care provider if problems occur.
    Intervention: Behavioral: Usual care
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: January 18, 2015)
98
Original Estimated Enrollment  ICMJE
 (submitted: October 13, 2013)
96
Actual Study Completion Date  ICMJE March 2016
Actual Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01964053
Other Study ID Numbers  ICMJE 228-13-EP
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Lufei Young, PhD, ACNP, University of Nebraska
Study Sponsor  ICMJE University of Nebraska
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Lufei Young, PhD University of Nebraska
PRS Account University of Nebraska
Verification Date May 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP