End Stage DiseaseNCT04162912
Motivational Interviewing Tailored Programme for Promoting Advance Care Planning Behaviours
A study testing Motivational Interviewing tailored Advance Care Planning in people with End Stage Disease, run by Food and Health Bureau, Hong Kong at 2 sites in Hong Kong.
Trial summary
This proposed study is designed to test the effects of motivational interviewing (MI) in increasing the uptake of ACP behaviours among patients with palliative care needs. A randomised controlled trial with repeated blinded outcome assessment will be conducted to assess the effects of a MI-tailored ACP (MI-ACP)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End Stage Disease
- What is being tested?
- Motivational Interviewing tailored Advance Care Planning
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 204 participants
- Where
- 2 sitesHong Kong
- Study dates
- 1 Jan 2018to 31 Dec 2019
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or over
- newly referred to palliative care services
- with a palliative performance scale (PPS) score of 60 or above; and
- with full level of consciousness
Who cannot join
- uncommunicable because of sensory impairment or language barrier
- cognitively impaired
- are receiving active psychiatric treatment
- already had signed an advance directive
Trial locations and contacts
2 sites in 1 country.
Hong Kong2 sites
United Christian Hospital
Kwun Tong
Haven of Hope Hospital
Tseung Kwan O
About this study
Official title: Effects of a Motivational Interviewing Tailored Programme for Promoting Advance Care Planning Behaviours Among Patients With Palliative Care Needs: A Randomised Controlled Trial
This proposed study is designed to test the effects of motivational interviewing (MI) in increasing the uptake of ACP behaviours among patients with palliative care needs. A randomised controlled trial with repeated blinded outcome assessment will be conducted to assess the effects of a MI-tailored ACP (MI-ACP) programme on palliative care patients recruited from the outpatient palliative care clinics and home palliative care services of two hospitals. A total of 204 patients will be recruited and randomly assigned to experimental and control groups. The patients in the experimental group will receive a MI-ACP programme facilitated by a trained nurse, whereas the patients in the control group will receive usual care. Primary outcome is the behavioural changes in ACP. Secondary outcomes are perceived stress, decisional conflict and quality of life. Study outcomes will be measured at baseline, 1 month and 3 months after enrolment.
- Conditions
- End Stage Disease
- Being tested
- Motivational Interviewing tailored Advance Care Planning
- Keywords
- Advance Care Planning, Motivational Interviewing, Pallative Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational Interviewing tailored Advance Care PlanningBehavioural
The trained interventionist who is experienced in MI techniques will explore their illness experiences, emotions and beliefs about their health conditions and future care in an empathetic manner and explore their ambivalence for ACP behaviours.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Participants in the experimental group will receive a MotivationaI Interviewing tailored ACP programme. Receives: Behavioral: Motivational Interviewing tailored Advance Care Planning |
| Control group | No intervention | The participants in the control group will receive usual care offered by the palliative care team under study and its affiliated day care centres, home care team and outpatient clinics. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Advance Care Planning Behaviour
Behaviour changes in ACP behaviours measured using a questionnaire. It included 4 items about different ACP behavior on a 5-point Likert scale. The higher score means the higher level of readiness for the behaviours.
Measured: Baseline, 1 month and 3 months follow up
Secondary outcomes (3)
Decisional conflict
Decisional conflict regarding end-of-life care is measured by the SURE test, a questionnaire with 4-item on knowledge and support for medical decision making. The higher score means the less decisional conflict.
Measured: Baseline, 1 month and 3 months follow up
Perceived stress
Perceived stress is measured by a 10-item Perceived Stress Scale, a questionnaire, using a 5-point Likert scale. The higher score means the higher level of stress.
Measured: Baseline, 1 month and 3 months follow up
Quality of life
Quality of life is measured by using a 23-item modified Quality of Life Concerns in the End of Life Questionnaire. The 23 items are rated on a 4-point Likert scale. The higher score means the better quality of life.
Measured: Baseline, 1 month and 3 months follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2019
- Study start1 Jan 2018
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for End Stage 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 204 participants (actual)
Sponsor and investigators
- Lead sponsor
- Food and Health Bureau, Hong Kong
- Sponsor type
- Other government
- Collaborators
- Haven of Hope Hospital, United Christian Hospital
- Responsible party
- Principal investigator, Dr. Helen YL Chan, Chinese University of Hong Kong
- Investigators
- Helen N Chan, PhD, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04162912
- Sponsor's protocol ID
- 14168417
- Status last verified
- Apr 2020
- First submitted
- 11 Nov 2019
- Last updated
- 17 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chan HY, Leung DY, Lam PT, Ko PP, Lam RW, Chan KS. Effect of motivational interviewing to promote advance care planning among palliative care patients in ambulatory care setting: a randomized controlled trial. BMC Palliat Care. 2025 Jan 31;24(1):31. doi: 10.1186/s12904-025-01667-9.
PubMed 39891169
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Motivational Interviewing Tailored Programme for Promoting Advance Care Planning Behaviours Among Patients With Palliative Care Needs: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT04162912
- Acronym / sponsor ID
- 14168417
- Conditions
- End Stage Disease
- Keywords
- Advance Care Planning, Motivational Interviewing, Pallative Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 204 participants (actual)
- Lead sponsor
- Food and Health Bureau, Hong KongOther government
- Collaborators
- Haven of Hope Hospital, United Christian Hospital
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 14 Nov 2019 (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 proposed study is designed to test the effects of motivational interviewing (MI) in increasing the uptake of ACP behaviours among patients with palliative care needs. A randomised controlled trial with repeated blinded outcome assessment will be conducted to assess the effects of a MI-tailored ACP (MI-ACP) programme on palliative care patients recruited from the outpatient palliative care clinics and home palliative care services of two hospitals. A total of 204 patients will be recruited and randomly assigned to experimental and control groups. The patients in the experimental group will receive a MI-ACP programme facilitated by a trained nurse, whereas the patients in the control group will receive usual care. Primary outcome is the behavioural changes in ACP. Secondary outcomes are perceived stress, decisional conflict and quality of life. Study outcomes will be measured at baseline, 1 month and 3 months after enrolment.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Behavioral: Motivational Interviewing tailored Advance Care PlanningParticipants in the experimental group will receive a MotivationaI Interviewing tailored ACP programme. |
| Control group | No intervention | –The participants in the control group will receive usual care offered by the palliative care team under study and its affiliated day care centres, home care team and outpatient clinics. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years of age or over
- newly referred to palliative care services
- with a palliative performance scale (PPS) score of 60 or above; and
- with full level of consciousness
Key exclusion criteria (4 listed)
- uncommunicable because of sensory impairment or language barrier
- cognitively impaired
- are receiving active psychiatric treatment
- already had signed an advance directive
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Motivational Interviewing tailored Advance Care PlanningThe trained interventionist who is experienced in MI techniques will explore their illness experiences, emotions and beliefs about their health conditions and future care in an empathetic manner and explore their ambivalence for ACP behaviours. | Behavioural | Experimental group |
Primary outcome
Advance Care Planning Behaviour
Time frame: Baseline, 1 month and 3 months follow up
Behaviour changes in ACP behaviours measured using a questionnaire. It included 4 items about different ACP behavior on a 5-point Likert scale. The higher score means the higher level of readiness for the behaviours.
3 secondary outcomes
Decisional conflict
Time frame: Baseline, 1 month and 3 months follow up
Perceived stress
Time frame: Baseline, 1 month and 3 months follow up
Quality of life
Time frame: Baseline, 1 month and 3 months follow up
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 17 Apr 2020.
- Derived from this study: PubMed 39891169Chan HY, Leung DY, Lam PT, Ko PP, Lam RW, Chan KS. Effect of motivational interviewing to promote advance care planning among palliative care patients in ambulatory care setting: a randomized controlled trial. BMC Palliat Care. 2025 Jan 31;24(1):31. doi: 10.1186/s12904-025-01667-9.
- 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.
Helen N Chan, PhD principal investigator
Chinese University of Hong Kong
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motivational Interviewing tailored Advance Care Planning in people with End Stage Disease, run by Food and Health Bureau, Hong Kong at 2 sites in Hong Kong.
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 4 inclusion and 4 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 17 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Hong Kong. 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?
Advance Care Planning Behaviour (time frame: Baseline, 1 month and 3 months follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04162912, which also lists 1 linked publication.
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 17 Apr 2020.