CompletedNot Applicable

A Decision Aid on End-of-life Care for Patients With Advanced COPD and Their Family

China226 participantsStarted 2023-09-01

Plain-language summary

This study aims to support EOL decision-making in patients with advanced COPD and their family members. A parallel two-arm single-blinded randomised controlled trial will be conducted to evaluate the effects of a specific decision support intervention. A total of 226 patients with advanced COPD and their designated family members will be recruited from hospital wards and outpatient clinics.

Who can participate

Age range

50 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria of patients: * are aged 50 years or over * have been diagnosed with COPD * are cognitively sound (scored \> 5 on the validated Abbreviated Mental Test (Hong Kong version) \[AMT-HK\]) * meet at least two of the six specific clinical indicators related to advanced COPD in the Gold Standards Framework (GSF) Proactive Identification Guidance, 6th Edition * can nominate a family member who would take part in their healthcare decision- making. Inclusion Criteria of patients' family members: * are aged 18 years or over, * can communicate in Cantonese, * have at least one personal contact per week with the patient in the past 6 months and * are willing to join the study. Family members will be excluded if they score \< 6 on the AMT-HK or are expecting to leave Hong Kong within the next 6 months. Exclusion Criteria: * non-communicable due to a severe hearing impairment, dysphasia or a language barrier; * are receiving palliative care services or * have already completed ACP or an advance directive.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Decisional conflict at T0

Timeframe: Baseline

Decisional conflict at T1

Timeframe: 1-month post allocation

Decisional conflict at T2

Timeframe: 6-month post allocation

Trial details

NCT IDNCT06008210

SponsorFood and Health Bureau, Hong Kong

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2025-08-03

View on ClinicalTrials.gov More Chronic Obstructive Pulmonary Disease Severe trials