Self-management Adherence in Heart Failure Patients

NCT01964053 | Completed DMC

• 1 other identifier: 0228-13-EP
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 2

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.

Conditions

Heart Failure

Keywords

Self-management adherence; post acute care; critical access hospitals; patient activation; hospital readmission

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in self-management adherence at 3 and 6 months

  Primary outcome of self-management adherence refers to the adherence to self-care behaviors

  3 and 6 months following intervention

Secondary Outcomes (1)

• Change from Baseline in re-hospitalization rate at 30-day, 3 and 6 months

  30 day after intervention

Study Arms (2)

PATCH Intervention

EXPERIMENTAL

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

Usual Care

ACTIVE COMPARATOR

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

Interventions

PATCH intervention BEHAVIORAL

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.

PATCH Intervention

Usual care BEHAVIORAL

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.

Usual Care

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Nebraska: lead

Study Sites (2)

Beatrice Community Hospital & Health Center

Beatrice, Nebraska, 68310, United States

Location

Jefferson Community Health Center

Fairbury, Nebraska, 68352, United States

Location

Related Publications (2)

• Young L, Hertzog M, Barnason S. Effects of a home-based activation intervention on self-management adherence and readmission in rural heart failure patients: the PATCH randomized controlled trial. BMC Cardiovasc Disord. 2016 Sep 8;16(1):176. doi: 10.1186/s12872-016-0339-7.

  PMID: 27608624 DERIVED

• Young L, Barnason S, Do V. Promoting self-management through adherence among heart failure patients discharged from rural hospitals: a study protocol. F1000Res. 2014 Dec 30;3:317. doi: 10.12688/f1000research.5998.2. eCollection 2014.

  PMID: 25844160 DERIVED

MeSH Terms

Conditions

Heart Failure; Patient Participation

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Lufei Young, PhD

  University of Nebraska

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2013
• First Posted: October 17, 2013
• Study Start: October 1, 2013
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: September 6, 2023

Record last verified: 2023-08

Locations

US (2)