Skip to main content
OpenTrials
Completed

NCT Number: NCT02441868

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Dyspnea Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Angela Hospice

Livonia, Michigan, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Shortness of breath recognition and treatment

Behavioral

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.

Primary outcomes

  1. Change in patient respiratory comfort

    Time frame: Baseline and up to four weeks until patient death

    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.

Secondary outcomes

  1. Family caregiver burden index

    Time frame: Baseline and participants will be followed for an average of 4 weeks until date of death

    The Modified Caregiver Strain Index

Other outcomes

  1. Family caregiver stress as measured by Salivary cortisol

    Time frame: Baseline and participants will be followed for an average of four weeks to end at time of death.

    Salivary cortisol

  2. Family anxiety questionnaire

    Time frame: Baseline and participants will be followed for an average of four weeks to end at time of death

    Promis anxiety Short form

  3. Family depression questionnaire

    Time frame: Baseline and participants will be followed for an average of four weeks to end at time of death

Sponsors and collaborators

Lead sponsor

Wayne State University

Other

Registry information

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
May 12, 2015
Registry last updated
May 3, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.