Chronic Obstructive Pulmonary Disease (COPD)RTQOLNCT02078622
Use of Respiratory Therapists (RTs) to Improve Outcomes and Quality of Life in Patients With COPD
An observational study of Chronic Obstructive Pulmonary Disease (COPD), run by StratiHealth at 1 site in United States.
Trial summary
Evaluate subjects in an prospective randomized controlled trial in which subjects will be administered scientifically validated questionnaires to determine the effect of the education and case management by Respiratory Therapists (RTs) on improvements in: health outcomes and quality of life as primary endpoints… Read more about this study
- Who is it for?
- Ages 55 to 80 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD)
- What is being tested?
- Respiratory Therapist Education and Case Management
- How many people
- 114 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2014to Apr 2016
- How long will I take part?
- 24 Weeks
- Phase
- Observational
- 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 55 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who are diagnosed with COPD
Who may be able to join
- Diagnosis of COPD
- Cognitive ability to retain education and training
- Resides in a stable residence or home, apartment
- Managed by primary care physician (family practice)
Who cannot join
- Lacks cognitive ability to retain education and training
- Not managed by primary care physician (family practice)
- No stable residence or is homeless
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Randomized Controlled Trial to Evaluate the Use of Respiratory Therapists (RTs) to Improve Outcomes and Quality of Life in Patients Diagnosed With COPD
Evaluate subjects in an prospective randomized controlled trial in which subjects will be administered scientifically validated questionnaires to determine the effect of the education and case management by Respiratory Therapists (RTs) on improvements in: health outcomes and quality of life as primary endpoints
Utilize: Chronic Respiratory Disease Questionnaire (CRQ)
The secondary endpoints will be: Rate of exacerbation's, Health care utilization (emergency room encounters, hospital admissions)
Read the detailed description
Evaluate subjects in an prospective randomized controlled trial in which subjects will be screened and administered scientifically validated questionnaires at study entry and during the observation period at specified intervals to determine the effect of the education and case management by Respiratory Therapists (RTs) on improvements in health outcomes and quality of life as primary endpoints, utilizing the Chronic Respiratory Disease Questionnaire (CRQ). The secondary endpoints will be rate of exacerbation's and health care utilization (emergency room encounters, hospital admissions).
- Being tested
- Respiratory Therapist Education and Case Management
- Keywords
- COPD, Respiratory Therapist, Case Management, Education
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Respiratory Therapist Education and Case ManagementOther
Respiratory Therapists will conduct home care visits over a period of one-year at two-week intervals
| Study group | Role | What they receive |
|---|---|---|
| COPD, Education and Case Management | Respiratory Therapist Education and Case Management Receives: Other: Respiratory Therapist Education and Case Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Life Using Chronic Respiratory Disease Questionnaire
Using the CRQ Evaluate Health Outcomes and QOL
Measured: Measure Dyspnea at baseline upon study entry and change from baseline every two weeks up to three months; Numerical, 7-point modified Likert Scale; Total score and subscores on categories; higher scores indicate better health-related quality of life
Secondary outcomes (1)
Healthcare Utilization
Hospital Admission, Emergency Room Encounters
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2014 (estimated)
- Study startMar 2014
- Primary completionMar 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 114 participants (actual)
- Target duration
- 24 Weeks
Sponsor and investigators
- Lead sponsor
- StratiHealth
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ISABEL PEREIRA, MD, Principal investigator, StratiHealthVERNON R PERTELLE, RRT, Study director, StratiHealth
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02078622
- Sponsor's protocol ID
- 20140101S
- Other IDs
- SH20140101S
- Acronym
- RTQOL
- Status last verified
- Aug 2018
- First submitted
- 1 Mar 2014
- Last updated
- 20 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Controlled Trial to Evaluate the Use of Respiratory Therapists (RTs) to Improve Outcomes and Quality of Life in Patients Diagnosed With COPD
- ClinicalTrials.gov ID
- NCT02078622
- Acronym / sponsor ID
- RTQOL / 20140101S
- Keywords
- COPD, Respiratory Therapist, Case Management, Education
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- StratiHealthIndustry (pharma, biotech, devices)
- Study start
- Mar 2014
- Primary completion
- Mar 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 5 Mar 2014 (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.
Evaluate subjects in an prospective randomized controlled trial in which subjects will be administered scientifically validated questionnaires to determine the effect of the education and case management by Respiratory Therapists (RTs) on improvements in: health outcomes and quality of life as primary endpoints
Utilize: Chronic Respiratory Disease Questionnaire (CRQ)
The secondary endpoints will be: Rate of exacerbation's, Health care utilization (emergency room encounters, hospital admissions)
Detailed description
Evaluate subjects in an prospective randomized controlled trial in which subjects will be screened and administered scientifically validated questionnaires at study entry and during the observation period at specified intervals to determine the effect of the education and case management by Respiratory Therapists (RTs) on improvements in health outcomes and quality of life as primary endpoints, utilizing the Chronic Respiratory Disease Questionnaire (CRQ). The secondary endpoints will be rate of exacerbation's and health care utilization (emergency room encounters, hospital admissions).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 24 Weeks
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| COPD, Education and Case Management | – | Other: Respiratory Therapist Education and Case ManagementRespiratory Therapist Education and Case Management |
Who may qualify
- Ages
- 55 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who are diagnosed with COPD
Key inclusion criteria (4 listed)
- Diagnosis of COPD
- Cognitive ability to retain education and training
- Resides in a stable residence or home, apartment
- Managed by primary care physician (family practice)
Key exclusion criteria (3 listed)
- Lacks cognitive ability to retain education and training
- Not managed by primary care physician (family practice)
- No stable residence or is homeless
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 |
|---|---|---|
| Respiratory Therapist Education and Case ManagementRespiratory Therapists will conduct home care visits over a period of one-year at two-week intervals | Other | COPD, Education and Case Management |
Primary outcome
Quality of Life Using Chronic Respiratory Disease Questionnaire
Time frame: Measure Dyspnea at baseline upon study entry and change from baseline every two weeks up to three months; Numerical, 7-point modified Likert Scale; Total score and subscores on categories; higher scores indicate better health-related quality of life
Using the CRQ Evaluate Health Outcomes and QOL
1 secondary outcome
Healthcare Utilization
Time frame: 1 year
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 20 Aug 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.
ISABEL PEREIRA, MD principal investigator
StratiHealth
VERNON R PERTELLE, RRT study director
StratiHealth
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Obstructive Pulmonary Disease (COPD), run by StratiHealth 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 4 inclusion and 3 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 20 Aug 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?
Quality of Life Using Chronic Respiratory Disease Questionnaire (time frame: Measure Dyspnea at baseline upon study entry and change from baseline every two weeks up to three months; Numerical, 7-point modified Likert Scale; Total score and subscores on categories; higher scores indicate better health-related quality of life). 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 20 Aug 2018.