- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04162912
Motivational Interviewing Tailored Programme for Promoting Advance Care Planning Behaviours
April 15, 2020 updated by: Dr. Helen YL Chan, Food and Health Bureau, Hong Kong
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
204
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Kwun Tong, Hong Kong
- United Christian Hospital
-
Tseung Kwan O, Hong Kong
- Haven of Hope Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- uncommunicable because of sensory impairment or language barrier
- cognitively impaired
- are receiving active psychiatric treatment
- already had signed an advance directive
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Experimental group
Participants in the experimental group will receive a MotivationaI Interviewing tailored ACP programme.
|
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.
|
No Intervention: Control group
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 the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Baseline, 1 month and 3 months follow up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Decisional conflict
Time Frame: Baseline, 1 month and 3 months follow up
|
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.
|
Baseline, 1 month and 3 months follow up
|
Perceived stress
Time Frame: Baseline, 1 month and 3 months follow up
|
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.
|
Baseline, 1 month and 3 months follow up
|
Quality of life
Time Frame: Baseline, 1 month and 3 months follow up
|
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.
|
Baseline, 1 month and 3 months follow up
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Helen N Chan, PhD, Chinese University of Hong Kong
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2018
Primary Completion (Actual)
December 31, 2019
Study Completion (Actual)
December 31, 2019
Study Registration Dates
First Submitted
November 11, 2019
First Submitted That Met QC Criteria
November 12, 2019
First Posted (Actual)
November 14, 2019
Study Record Updates
Last Update Posted (Actual)
April 17, 2020
Last Update Submitted That Met QC Criteria
April 15, 2020
Last Verified
April 1, 2020
More Information
Terms related to this study
Other Study ID Numbers
- 14168417
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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