NCT02395588

Brief Summary

This study will test if standardized care helps patients feel better, if it can be implemented in rural hospitals, and find out which healthcare processes and outcomes are most important to heart failure patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2014

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

March 17, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 23, 2015

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

May 11, 2021

Status Verified

May 1, 2021

Enrollment Period

1.2 years

First QC Date

March 17, 2015

Last Update Submit

May 6, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Self-management

    Self-care of Heart Failure Index

    7 Days

Secondary Outcomes (1)

  • Readmission

    7 and 30 days post discharge

Study Arms (1)

Guideline based care

Prior to discharge. Survey data will include descriptive characteristics, depression, heart failure knowledge. After patient education is complete prior to discharge patients will complete a readiness for discharge scale and heart failure self-care survey. Phone call 48 hours after discharge. Discharge instructions will be reinforced. Phone call 7 days after discharge. Survey data will include self management, complications, and satisfaction care. Secondary data 30 days post discharge. The hospital electronic medical record system will be queried to determine if the patient has been readmitted within 30 days of discharge for heart failure or non-heart failure causes.

Other: Guideline based care

Interventions

Patient education using guideline based teaching guides

Guideline based care

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients admitted to participating rural hospitals with a diagnosis of heart failure.

You may qualify if:

  • Admitted to hospital with a diagnosis of heart failure
  • Age \> 20
  • Cognitively intact
  • English speaking
  • Plan for discharge to home, assisted living or intermediate care

You may not qualify if:

  • Patients with planned discharge to sub-acute or nursing home facilities
  • Patients enrolled in another research study to test interventions to improve heart failure knowledge, self-management or reduce readmission to the hospital within 30 days post discharge
  • Patients that are cognitively impaired
  • Patients that are transferred to another unit in the hospital, and will be discharged from that unit
  • Patients who undergo or have a planned surgical intervention during their hospital stay

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Riverside Shore Memorial Hospital

Nassawadox, Virginia, 23413, United States

Location

Riverside Tappahannock Hospital

Tappahannock, Virginia, 22560, United States

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Robin P Newhouse, PhD, RN

    University of Maryland, Baltimore

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 17, 2015

First Posted

March 23, 2015

Study Start

April 1, 2014

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

May 11, 2021

Record last verified: 2021-05

Locations