EMPOWER Study, a Personalized Home Care Intervention for Older Heart Failure Patients

Examining the Feasibility of EMPOWER - A Personalized Adherence Enhancement Intervention for Older Post-discharge Heart Failure Patients

The purpose of this study is to see how investigators may best improve treatment adherence and disease management for heart failure after hospital discharge. This is because the period after hospital discharge is critical to long-term recovery, overall quality of life, and prevention of future hospitalizations. In this study, a trained nurse interventionist will work with the participants to develop a personalized adherence enhancement strategy for heart failure diagnosis. The personalized adherence enhancement strategy is called EMPOWER.

Study Overview

• Status: Withdrawn
• Conditions: Heart Failure
• Intervention / Treatment: Behavioral: EMPOWER

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Rochester, New York, United States, 14580
      • UR Medicine Home Care

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• diagnosis of moderate/severe heart failure at hospital admission, defined by ICD codes (ICD-9 428 or ICD-10 150), New York Heart Association class III/IV, and left ventricular ejection fraction less than or equal to 40% (i.e., echocardiography)
• discharge from heart failure-led hospitalization to home health care in approximately the previous week
• intact or mildly impaired cognitive function (Montreal Cognitive Assessment eligibility scores greater than or equal to 18)
• primary residence in four counties within 30 minutes distance to the University of Rochester

Exclusion Criteria:

• end-of-life prognosis in the following 6 months that make it difficult to examine the changes in heart failure outcomes
• currently receiving hospice care
• conditions that impact the receipt of the intervention such as active suicidal ideation that is identified at baseline using the Geriatric Depression Scale and the Geriatric Suicide Ideation Scale
• being non-English speaking
• having serious visual and or hearing impairment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Behavorial intervention	Behavioral: EMPOWER; EMPOWER includes 4 weekly home visit and 4 follow up booster phone calls every other week for the following 8 weeks. The trained nurse interventionist will address identified adherence barriers related to knowledge deficits about heart failure and its treatment including psycho-social barriers and logistic barriers with their primary care physician if necessary.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean change in medication adherence	Adherence will be calculated either by manual pill counting or by the Medication Event Monitoring System, a microelectronic monitoring device on the cap of medication containers.	week 1 to week 4
Mean change in medication adherence	Adherence will be calculated either by manual pill counting or by the Medication Event Monitoring System, a microelectronic monitoring device on the cap of medication containers.	week 1 to 3 months
mean change in adherence to low-sodium diet	Adherence to low sodium diet will be assessed by the Dietary Sodium Restriction Questionnaire (DSRQ). The DSRQ is composed of 3 subscales: 1) attitude toward the behavior, 2) subjective norm, and 3) perceived behavioral control. Attitude. There are 6 items in the Attitude subscale. The scores on this subscale ranged from 6 to 30, where a higher score indicates correct attitudes (better knowledge) about following a low-sodium diet. Subjective norm. There are 3 items in the Subjective Norm subscale. The scores on this subscale ranged from 3 to 15, where a higher score indicates heavier influence of subjective norm of social contacts on one's adherence to low-sodium diet. Perceived behavioral control. There are 7 items in the Perceived Behavioral Control subscale. The scores on this subscale ranged from 7 to 35, a higher score indicates a higher likelihood for each item to be a barrier in adherence to low-sodium diet.	week 1 to week 4
mean change in adherence to low-sodium diet	Adherence to low sodium diet will be assessed by the Dietary Sodium Restriction Questionnaire (DSRQ). The DSRQ is composed of 3 subscales: 1) attitude toward the behavior, 2) subjective norm, and 3) perceived behavioral control. Attitude. There are 6 items in the Attitude subscale. The scores on this subscale ranged from 6 to 30, where a higher score indicates correct attitudes (better knowledge) about following a low-sodium diet. Subjective norm. There are 3 items in the Subjective Norm subscale. The scores on this subscale ranged from 3 to 15, where a higher score indicates heavier influence of subjective norm of social contacts on one's adherence to low-sodium diet. Perceived behavioral control. There are 7 items in the Perceived Behavioral Control subscale. The scores on this subscale ranged from 7 to 35, a higher score indicates a higher likelihood for each item to be a barrier in adherence to low-sodium diet.	week 1 to 3 months

Collaborators and Investigators

• Sponsor: University of Rochester
• Investigators: Principal Investigator: Jinjiao Wang, PhD, RN, University of Rochester

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2021
• Primary Completion (Anticipated): December 31, 2021
• Study Completion (Anticipated): December 31, 2021

Study Registration Dates

• First Submitted: May 29, 2019
• First Submitted That Met QC Criteria: May 29, 2019
• First Posted (Actual): June 3, 2019

Study Record Updates

• Last Update Posted (Actual): April 20, 2021
• Last Update Submitted That Met QC Criteria: April 17, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: RSRB00003400

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No