Feasibility Testing of a Hospice Family Caregiver Intervention to Improve Patient Dyspnea Care

This study is a pilot test of an intervention to train family caregivers of home hospice patients about recognizing and treating shortness of breath.

Study Overview

• Status: Completed
• Conditions: Dyspnea
• Intervention / Treatment: Behavioral: Shortness of breath recognition and treatment

Detailed Description

Shortness of breath is a prevalent symptom causing distress among patients at the end of life. In home hospice care family caregivers are expected to assist their family member with symptom management. This is often accomplished with little or no training.

The investigators have developed a bundle of training materials targeted for family caregivers of home hospice patients at risk for shortness of breath. The investigators will pilot test the intervention in this clinical trial. A future randomized clinical trial is planned and the evidence from this pilot will enhance the planning of that future trial.

• Study Type: Interventional
• Enrollment (Actual): 7
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Livonia, Michigan, United States
      • Angela Hospice

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patient in home hospice care with an estimated survival of 3-4 weeks, at risk for dyspnea secondary to lung cancer, COPD, or heart failure.
• Family caregiver in patient's home must speak and read English.

Exclusion Criteria:

• Patients with bulbar ALS or quadriplegia.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• 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: Intervention; all participants will receive the training

Behavioral: Shortness of breath recognition and treatment; Hospice registered nurses will train family caregivers about how to recognize patient shortness of breath. This training will employ a guided learning tool the Respiratory Distress Observation Scale-Family. Training will be done with a DVD and return demonstration of the skills using the patient. In addition, the family will be taught the bundle of evidence-based interventions to treat shortness of breath.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in patient respiratory comfort	The Respiratory Distress Observation Scale will be used to measure patient respiratory comfort at enrollment (baseline), twice each week during the study until patient death.	Baseline and up to four weeks until patient death

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Family caregiver burden index	The Modified Caregiver Strain Index	Baseline and participants will be followed for an average of 4 weeks until date of death

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Family caregiver stress as measured by Salivary cortisol	Salivary cortisol	Baseline and participants will be followed for an average of four weeks to end at time of death.
Family anxiety questionnaire	Promis anxiety Short form	Baseline and participants will be followed for an average of four weeks to end at time of death
Family depression questionnaire		Baseline and participants will be followed for an average of four weeks to end at time of death

Collaborators and Investigators

• Sponsor: Wayne State University
• Investigators: Principal Investigator: Margaret L. Campbell, PhD, Wayne State University

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2015
• Primary Completion (Actual): April 30, 2018
• Study Completion (Actual): April 30, 2018

Study Registration Dates

• First Submitted: April 30, 2015
• First Submitted That Met QC Criteria: May 7, 2015
• First Posted (Estimate): May 12, 2015

Study Record Updates

• Last Update Posted (Actual): May 3, 2018
• Last Update Submitted That Met QC Criteria: April 30, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Dyspnea
• Other Study ID Numbers: RDOS-Family