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

Dyspnea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02441868
• Other study ID #: RDOS-Family
• Status: Completed
• Phase: N/A
• Start date: October 15, 2015
• Est. completion date: April 30, 2018

Study information

• Verified date: April 2018
• Source: Wayne State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: April 30, 2018
• Est. primary completion date: April 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dyspnea

Intervention

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.

Locations

Country	Name	City	State
United States	Angela Hospice	Livonia	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Wayne State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.
Other	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
Other	Family depression questionnaire		Baseline and participants will be followed for an average of four weeks to end at time of death
Primary	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	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