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

NCT03971149 | Withdrawn

• 1 other identifier: RSRB00003400
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (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 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

Study Arms (1)

Behavorial intervention

EXPERIMENTAL

Behavioral: EMPOWER

Interventions

EMPOWER BEHAVIORAL

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.

Behavorial intervention

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Rochester: lead

Study Sites (1)

UR Medicine Home Care

Rochester, New York, 14580, United States

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Jinjiao Wang, PhD, RN

  University of Rochester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 29, 2019
• First Posted: June 3, 2019
• Study Start: January 1, 2021
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: April 20, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)