Chronic Obstructive Pulmonary DiseaseNCT05459740
Self-management Behaviors and Resilience Among Chronic Obstructive Pulmonary Disease Patients
An observational study of Chronic Obstructive Pulmonary Disease and Self-management Behavior, run by Shin Kong Wu Ho-Su Memorial Hospital at 1 site in Taiwan.
Trial summary
This study conducted an assessment of the influencing factors and correlations that affect self-management behaviors and resilience in the COPD population. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease, Self-management Behavior, Resilience
- How many people
- 112 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Feb 2020to 30 Jan 2021
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The age ranged from 39-90 years old for all the population. The proportions of BMI < 18.5 kg/m2, 18.5-24.9 kg/m2, and ≥ 24.9 kg/m2 were 8%, 58%, and 34%, respectively. Overall, only 14% of the COPD subjects were educated with a university degree or higher, which was associated with higher self-management scores compared to those educated with below university degree. Half of the subjects were former smokers.
Who may be able to join
- The recruited participants have been diagnosed with COPD for at least a month by thoracic physicians based on the guidelines of the Global Initiative for Chronic Obstructive Lung Disease (GOLD).
Who cannot join
- Participants who were diagnosed with serious mental disorders, cancer, terminal illness, or end-stage diseases were excluded from this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Relations of Resilience to Self-management Behaviors Among Patients With Chronic Obstructive Pulmonary Disease
This study conducted an assessment of the influencing factors and correlations that affect self-management behaviors and resilience in the COPD population.
Read the detailed description
A total of 100 participants with COPD from a medical center in Northern Taiwan were recruited from February 2020 to January 2021 in this cross-sectional study. Each subject completed self-reported questionnaires through face-to-face interviews, including 20-item COPD Self-Management Scale (CSMS-20) and a 25-item Connor-Davidson Resilience Scale (CD-RISC-25). A multiple linear regression model was used to examine the relationship between the levels of self-management behavior and resilience, controlling for sociodemographic and clinical factors.
- Keywords
- chronic obstructive pulmonary disease, self-management behavior, resilience
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What is being measured
The primary outcome is the main question the study is designed to answer.
Levels of COPD self-management behavior
Each subject completed the self-reported 20-item COPD Self-Management Scale (CSMS-20) questionnaire through face-to-face interviews. The range of scores is from 20 to 100, with a higher score indicating better self-management behaviors.
Measured: 2020-02-01 to 2021-01-30
Levels of COPD psychological resilience
Each subject completed the 25-item Connor-Davidson Resilience Scale (CD-RISC-25) questionnaire through face-to-face interviews. The range of scores is from 0 to 100, with a higher score indicating better psychological resilience.
Measured: 2020-02-01 to 2021-01-30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2022
- Study start1 Feb 2020
- Primary completion30 Jan 2021
- Study completion30 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive 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 crossover
- Time perspective
- Cross-sectional
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shin Kong Wu Ho-Su Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- EN-MING CHANG, master, Study chair, Respiratory therapist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05459740
- Sponsor's protocol ID
- 20191101R
- Status last verified
- Jul 2022
- First submitted
- 27 Jun 2022
- Last updated
- 15 Jul 2022
- Results posted
- 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 15 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relations of Resilience to Self-management Behaviors Among Patients With Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT05459740
- Acronym / sponsor ID
- 20191101R
- Keywords
- chronic obstructive pulmonary disease, self-management behavior, resilience
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Shin Kong Wu Ho-Su Memorial HospitalUniversity, hospital or other
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 30 Jan 2021 (actual)
- Study completion
- 30 Jan 2021 (actual)
- First posted
- 15 Jul 2022 (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.
This study conducted an assessment of the influencing factors and correlations that affect self-management behaviors and resilience in the COPD population.
Detailed description
A total of 100 participants with COPD from a medical center in Northern Taiwan were recruited from February 2020 to January 2021 in this cross-sectional study. Each subject completed self-reported questionnaires through face-to-face interviews, including 20-item COPD Self-Management Scale (CSMS-20) and a 25-item Connor-Davidson Resilience Scale (CD-RISC-25). A multiple linear regression model was used to examine the relationship between the levels of self-management behavior and resilience, controlling for sociodemographic and clinical factors.
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The age ranged from 39-90 years old for all the population. The proportions of BMI < 18.5 kg/m2, 18.5-24.9 kg/m2, and ≥ 24.9 kg/m2 were 8%, 58%, and 34%, respectively. Overall, only 14% of the COPD subjects were educated with a university degree or higher, which was associated with higher self-management scores compared to those educated with below university degree. Half of the subjects were former smokers.
Key inclusion criteria (1 listed)
- The recruited participants have been diagnosed with COPD for at least a month by thoracic physicians based on the guidelines of the Global Initiative for Chronic Obstructive Lung Disease (GOLD).
Key exclusion criteria (1 listed)
- Participants who were diagnosed with serious mental disorders, cancer, terminal illness, or end-stage diseases were excluded from this study.
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
Levels of COPD self-management behavior
Time frame: 2020-02-01 to 2021-01-30
Each subject completed the self-reported 20-item COPD Self-Management Scale (CSMS-20) questionnaire through face-to-face interviews. The range of scores is from 20 to 100, with a higher score indicating better self-management behaviors.
Levels of COPD psychological resilience
Time frame: 2020-02-01 to 2021-01-30
Each subject completed the 25-item Connor-Davidson Resilience Scale (CD-RISC-25) questionnaire through face-to-face interviews. The range of scores is from 0 to 100, with a higher score indicating better psychological resilience.
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 15 Jul 2022.
- 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.
EN-MING CHANG, master study chair
Respiratory therapist
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 and Self-management Behavior, run by Shin Kong Wu Ho-Su Memorial Hospital 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 1 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 15 Jul 2022. 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?
Levels of COPD self-management behavior (time frame: 2020-02-01 to 2021-01-30). The study lists 2 primary outcomes in all. 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 15 Jul 2022.