DyspneaNCT02441868
Feasibility Testing of a Hospice Family Caregiver Intervention to Improve Patient Dyspnea Care
A study testing Shortness of breath recognition and treatment in people with Dyspnea, run by Wayne State University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dyspnea
- What is being tested?
- Shortness of breath recognition and treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Oct 2015to 30 Apr 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Patients with bulbar ALS or quadriplegia.
Trial locations and contacts
1 site in 1 country.
About this study
This study is a pilot test of an intervention to train family caregivers of home hospice patients about recognizing and treating shortness of breath.
Read the 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.
- Conditions
- Dyspnea
- Being tested
- Shortness of breath recognition and treatment
- Medical subject headings
- Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shortness of breath recognition and treatmentBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | all participants will receive the training Receives: Behavioral: Shortness of breath recognition and treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and up to four weeks until patient death
Secondary outcomes (1)
Family caregiver burden index
The Modified Caregiver Strain Index
Measured: Baseline and participants will be followed for an average of 4 weeks until date of death
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2015 (estimated)
- Study start15 Oct 2015
- Primary completion30 Apr 2018
- Study completion30 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyspneaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wayne State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Margaret Campbell, Wayne State University
- Investigators
- Margaret L. Campbell, PhD, Principal investigator, Wayne State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02441868
- Sponsor's protocol ID
- RDOS-Family
- Status last verified
- Apr 2018
- First submitted
- 30 Apr 2015
- Last updated
- 3 May 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Testing of a Hospice Family Caregiver Intervention to Improve Patient Dyspnea Care
- ClinicalTrials.gov ID
- NCT02441868
- Acronym / sponsor ID
- RDOS-Family
- Conditions
- Dyspnea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Wayne State UniversityUniversity, hospital or other
- Study start
- 15 Oct 2015 (actual)
- Primary completion
- 30 Apr 2018 (actual)
- Study completion
- 30 Apr 2018 (actual)
- First posted
- 12 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a pilot test of an intervention to train family caregivers of home hospice patients about recognizing and treating shortness of breath.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Shortness of breath recognition and treatmentall participants will receive the training |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- Patients with bulbar ALS or quadriplegia.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Shortness of breath recognition and treatmentHospice 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. | Behavioural | Intervention |
Primary outcome
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.
1 secondary outcome
Family caregiver burden index
Time frame: Baseline and participants will be followed for an average of 4 weeks until date of death
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Margaret L. Campbell, PhD principal investigator
Wayne State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Shortness of breath recognition and treatment in people with Dyspnea, run by Wayne State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in patient respiratory comfort (time frame: Baseline and up to four weeks until patient death). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2018.