NCT05459740

Brief Summary

This study conducted an assessment of the influencing factors and correlations that affect self-management behaviors and resilience in the COPD population.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
112

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2020

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2021

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

June 27, 2022

Completed
18 days until next milestone

First Posted

Study publicly available on registry

July 15, 2022

Completed
Last Updated

July 15, 2022

Status Verified

July 1, 2022

Enrollment Period

12 months

First QC Date

June 27, 2022

Last Update Submit

July 12, 2022

Conditions

Keywords

chronic obstructive pulmonary diseaseself-management behaviorresilience

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    2020-02-01 to 2021-01-30

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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.

You may qualify if:

  • 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).

You may not qualify if:

  • Participants who were diagnosed with serious mental disorders, cancer, terminal illness, or end-stage diseases were excluded from this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shin Kong Wu Ho-Su Memorial Hospital

Taipei, Taiwan

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • EN-MING CHANG, master

    Respiratory therapist

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 27, 2022

First Posted

July 15, 2022

Study Start

February 1, 2020

Primary Completion

January 30, 2021

Study Completion

January 30, 2021

Last Updated

July 15, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations