Pulmonary DiseaseNCT06467162
Usage of Spacers and the Relationship With Symptoms Severity in COPD Elderly Patients
An observational study of Pulmonary Disease and Chronic Obstructive, run by Ai-Ling Chang at 1 site in Taiwan.
Trial summary
The goal of this observational study is to investigate the usage of spacers and their relationship with symptom severity in chronic obstructive pulmonary disease elderly patients. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- How many people
- 164 participants
- Where
- 1 siteTaiwan
- Study dates
- 6 Apr 2023to 30 Jun 2023
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Patients with chronic obstructive pulmonary disease aged 65 years or over at thoracic medicine outpatient clinics.
Who may be able to join
- Individuals aged 65 or above diagnosed with COPD by a pulmonologist.
- Clear consciousness and communication abilities in Mandarin or Taiwanese.
- Consent to participate in this study and sign the informed consent form.
Who cannot join
- Patients who are blind, deaf, unable to express themselves, and unable to understand the study explanation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Usage of Spacers and the Relationship With Symptoms Severity in Chronic Obstructive Pulmonary Disease Elderly Patients: A Correlational Study
The goal of this observational study is to investigate the usage of spacers and their relationship with symptom severity in chronic obstructive pulmonary disease elderly patients. Patients with chronic obstructive pulmonary disease aged 65 years or over at thoracic medicine outpatient clinics were recruited in this study. Research participants were interviewed using structured questionnaires, including demographic characteristics information, clinical characteristics information, and the chronic obstructive pulmonary disease assessment test.
Read the detailed description
The goal of this observational study is to investigate the usage of spacers and their relationship with symptom severity in chronic obstructive pulmonary disease elderly patients. A convenience sample was used to recruit patients with chronic obstructive pulmonary disease aged 65 years or over at thoracic medicine outpatient clinics from a teaching hospital in Taiwan. Research participants were interviewed using structured questionnaires, including demographic characteristics information, clinical characteristics information, and the chronic obstructive pulmonary disease assessment test.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Keywords
- Chronic Obstructive Pulmonary Disease, Spacer, Symptom severity
- Medical subject headings
- Lung Diseases, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| observational group | Research participants were interviewed using structured questionnaires, including demographic characteristics information, clinical characteristics information, and the chronic obstructive pulmonary disease assessment test. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptoms severity
The severity and impacts of the COPD symptoms were measured by using the chronic obstructive pulmonary disease assessment test
Measured: Immediately after the outpatient department visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2024
- Study start6 Apr 2023
- Primary completion30 Jun 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary DiseaseStudies 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 164 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ai-Ling Chang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ai-Ling Chang, Changhua Christian Hospital
- Investigators
- Wan-Ting Huang, PhD, Study chair, Da-Yeh University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06467162
- Sponsor's protocol ID
- 1110206
- Status last verified
- Jun 2024
- First submitted
- 14 Jun 2024
- Last updated
- 20 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Usage of Spacers and the Relationship With Symptoms Severity in Chronic Obstructive Pulmonary Disease Elderly Patients: A Correlational Study
- ClinicalTrials.gov ID
- NCT06467162
- Acronym / sponsor ID
- 1110206
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Keywords
- Chronic Obstructive Pulmonary Disease, Spacer, Symptom severity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 164 participants (actual)
- Lead sponsor
- Ai-Ling ChangUniversity, hospital or other
- Study start
- 6 Apr 2023 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 20 Jun 2024 (actual)
- 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.
The goal of this observational study is to investigate the usage of spacers and their relationship with symptom severity in chronic obstructive pulmonary disease elderly patients. Patients with chronic obstructive pulmonary disease aged 65 years or over at thoracic medicine outpatient clinics were recruited in this study. Research participants were interviewed using structured questionnaires, including demographic characteristics information, clinical characteristics information, and the chronic obstructive pulmonary disease assessment test.
Detailed description
The goal of this observational study is to investigate the usage of spacers and their relationship with symptom severity in chronic obstructive pulmonary disease elderly patients. A convenience sample was used to recruit patients with chronic obstructive pulmonary disease aged 65 years or over at thoracic medicine outpatient clinics from a teaching hospital in Taiwan. Research participants were interviewed using structured questionnaires, including demographic characteristics information, clinical characteristics information, and the chronic obstructive pulmonary disease assessment test.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| observational group | – | –Research participants were interviewed using structured questionnaires, including demographic characteristics information, clinical characteristics information, and the chronic obstructive pulmonary disease assessment test. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patients with chronic obstructive pulmonary disease aged 65 years or over at thoracic medicine outpatient clinics.
Key inclusion criteria (3 listed)
- Individuals aged 65 or above diagnosed with COPD by a pulmonologist.
- Clear consciousness and communication abilities in Mandarin or Taiwanese.
- Consent to participate in this study and sign the informed consent form.
Key exclusion criteria (1 listed)
- Patients who are blind, deaf, unable to express themselves, and unable to understand the study explanation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Symptoms severity
Time frame: Immediately after the outpatient department visit
The severity and impacts of the COPD symptoms were measured by using the chronic obstructive pulmonary disease assessment test
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 Jun 2024.
- Individual participant dataSharing planned: No
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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.
Wan-Ting Huang, PhD study chair
Da-Yeh University
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 Pulmonary Disease and Chronic Obstructive, run by Ai-Ling Chang at 1 site in Taiwan.
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 3 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 20 Jun 2024. 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 Taiwan. 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?
Symptoms severity (time frame: Immediately after the outpatient department visit). 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 Jun 2024.