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

NCT ID: NCT06008210

Last Updated: 2024-05-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

226 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-01

Study Completion Date

2025-05-31

Brief Summary

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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.

Detailed Description

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Chronic Obstructive Pulmonary Disease (COPD) is a progressive life-limiting condition. However, patients with advanced COPD and their family members generally are unprepared for end-of-life (EOL) situations. The Ottawa Decision Support Framework model is adopted to address the patients' decisional needs for the difficult decisions in EOL care. The participants will be randomly allocated to either the intervention group to receive the decision support intervention or the control group to receive general health coaching. Outcomes will be measured at baseline and 1- and 6-month post-allocation. Subsequently, a descriptive qualitative study will be conducted with a subsample of 30 dyads to explore how the intervention influenced the study outcomes.

Conditions

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Chronic Obstructive Pulmonary Disease Severe

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A parallel two-arm single-blinded randomised controlled trial will be conducted.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Intervention Group

Decision Support Intervention

Group Type EXPERIMENTAL

Decision Support Intervention

Intervention Type 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.

Control Group

Health coaching

Group Type ACTIVE_COMPARATOR

Health Coaching

Intervention Type 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.

Interventions

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Decision Support Intervention

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 Type BEHAVIORAL

Health Coaching

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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.

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.
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital Authority, Hong Kong

OTHER_GOV

Sponsor Role collaborator

Food and Health Bureau, Hong Kong

OTHER_GOV

Sponsor Role lead

Responsible Party

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Helen YL Chan

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Helen Chan, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Chinese University of Hong Kong

Locations

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Prince of Wales Hospital

Hong Kong, , China

Site Status RECRUITING

Tai Po Hospital

Hong Kong, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Helen Chan, Ph.D.

Role: CONTACT

Facility Contacts

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Helen Chan, Ph.D.

Role: primary

Helen Chan, Ph.D.

Role: primary

Other Identifiers

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14118622

Identifier Type: -

Identifier Source: org_study_id

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