Self-management Adherence in Heart Failure Patients (PATCH)

August 30, 2023 updated by: University of Nebraska

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
105

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Nebraska
      • Beatrice, Nebraska, United States, 68310
        • Beatrice Community Hospital & Health Center
      • Fairbury, Nebraska, United States, 68352
        • Jefferson Community Health Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
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.
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.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
3 and 6 months following intervention

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
30 day after intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Nebraska

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Lufei Young, PhD, University of Nebraska

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 10, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 13, 2013

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 17, 2013

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 6, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 30, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 0228-13-EP

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