Feasibility Testing of a Hospice Family Caregiver Intervention to Improve Patient Dyspnea Care
1 other identifier
interventional
7
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2015
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 30, 2015
CompletedFirst Posted
Study publicly available on registry
May 12, 2015
CompletedStudy Start
First participant enrolled
October 15, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2018
CompletedMay 3, 2018
April 1, 2018
2.5 years
April 30, 2015
April 30, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Family caregiver burden index
Baseline and participants will be followed for an average of 4 weeks until date of death
Other Outcomes (3)
Family caregiver stress as measured by Salivary cortisol
Baseline and participants will be followed for an average of four weeks to end at time of death.
Family anxiety questionnaire
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
Study Arms (1)
Intervention
EXPERIMENTALall participants will receive the training
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Patients with bulbar ALS or quadriplegia.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Angela Hospice
Livonia, Michigan, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Margaret L. Campbell, PhD
Wayne State University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
April 30, 2015
First Posted
May 12, 2015
Study Start
October 15, 2015
Primary Completion
April 30, 2018
Study Completion
April 30, 2018
Last Updated
May 3, 2018
Record last verified: 2018-04