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

NCT06008210 | Completed DMC

• 1 other identifier: 14118622
• Study Type: interventional
• Target: 226
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Chronic Obstructive Pulmonary Disease Severe

Keywords

Advance Care Planning; Decision making; End-of-life care

Outcome Measures

Primary Outcomes (3)

• Decisional conflict at T0

  Decisional conflict regarding EOL care measured using The SURE test. It includes four items to be rated on a dichotomous format, with 0 (no) or 1 (yes). The total score ranged from 0 to 4, with a higher score means less decisional conflict.

  Baseline

• Decisional conflict at T1

  Decisional conflict regarding EOL care measured using The SURE test. It includes four items to be rated on a dichotomous format, with 0 (no) or 1 (yes). The total score ranged from 0 to 4, with a higher score means less decisional conflict.

  1-month post allocation

• Decisional conflict at T2

  Decisional conflict regarding EOL care measured using The SURE test. It includes four items to be rated on a dichotomous format, with 0 (no) or 1 (yes). The total score ranged from 0 to 4, with a higher score means less decisional conflict.

  6-month post allocation

Secondary Outcomes (12)

• Self-efficacy for ACP at T0

  Baseline

• Self-efficacy for ACP at T1

  1-month post allocation

• Self-efficacy for ACP at T2

  6-month post allocation

• Readiness for ACP at T0

  Baseline

• Readiness for ACP at T1

  1-month post allocation

Study Arms (2)

Intervention Group

EXPERIMENTAL

Decision Support Intervention

Behavioral: Decision Support Intervention

Control Group

ACTIVE COMPARATOR

Health coaching

Behavioral: Health Coaching

Interventions

Decision Support Intervention BEHAVIORAL

The participants will receive two 60-minute consultation sessions delivered by a trained nurse in four weeks at home. Participant's family members will be encouraged to attend the sessions. In the first session, the nurse will explore the participant's understanding of the current health condition, introduce the concept of advance care planning and discuss their decisional needs for end-of-life care decision-making. In the second session, the nurse will ask the participants to complete a value clarification exercise individually.

Intervention Group

Health Coaching BEHAVIORAL

The participants will receive two 60-minute health coaching sessions delivered by a trained nurse in four weeks at home. This intervention will focus on lifestyle modification and self-care management unrelated to the tested intervention content or outcomes.

Control Group

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Food and Health Bureau, Hong Kong: lead
• Hospital Authority, Hong Kong: collaborator

Study Sites (2)

Prince of Wales Hospital

Hong Kong, China

Location

Tai Po Hospital

Hong Kong, China

Location

Study Officials

• Helen Chan, Ph.D.

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: A parallel two-arm single-blinded randomised controlled trial will be conducted.

Study Record Dates

• First Submitted: August 18, 2023
• First Posted: August 23, 2023
• Study Start: September 1, 2023
• Primary Completion: August 3, 2025
• Study Completion: August 31, 2025
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)