- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04203407
Effects of a Culturally-sensitive Theory-driven Advance Care Planning (ACP) Game Among Chinese Older Adults
January 25, 2021 updated by: LIU Li, Chinese University of Hong Kong
Effects of a Culturally-sensitive Theory-driven Advance Care Planning (ACP) Game on Self-efficacy and ACP Behaviors Among Chinese Older Adults: a Mixed Method Study
This proposed study aims to examine the effects of a culturally-sensitive theory-driven advance care planning (ACP) game in increasing the self-efficacy and readiness of ACP behaviours among Chinese community-dwelling older adults.
This is a mixed methods study with the quantitative paradigm being the main research approached used.
The quantitative arm will be a randomized controlled trial (RCT).
The qualitative arm will adopt focus group interviews for data collection.
Recruited subjects from the community centres will be randomly allocated to the intervention and control group.
The older adults in the experimental group will receive an ACP board game delivered by trained facilitators, whereas the older adults in the control group will receive another board game about healthy lifestyle.
The outcome measures of the older adults will include the ACP Engagement scale, the Life-Support Preferences Questionnaire (LSPQ), a self-developed ACP knowledge questionnaire and those data will be collected at baseline (T0), immediately post-intervention(T1), at 1 month (T2), and 3 month (T3).
The qualitative arm of this study will contribute to the understanding of issues and effects of ACP game as an intervention.
Its finding will complement the results obtained from the RCT.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
144
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
-
-
Hunan
-
Changsha, Hunan, China
- Xihu community, guanshaling community
-
-
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
60 years to 100 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- aged 60 years or over;
- speak Chinese.
Exclusion Criteria:
- uncommunicable because of language barrier or sensory impairment;
- have been referred to the palliative care service at the time of recruitment.
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
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: ACP game
Participants in the intervention group will be divided into groups of 4 participants to play a 1-hour culturally-sensitive theory-driven ACP board game with 15-minute debriefing delivered by facilitators.
The ACP board game is developed by the principle investigator in a previous project.
|
Participants in the intervention group will be divided into groups of 4 participants to play a 1-hour culturally-sensitive theory-driven ACP board game with 15-minute debriefing delivered by facilitators.
The ACP board game is developed by the principle investigator in a previous project.
|
ACTIVE_COMPARATOR: Usual care
Participants in the control group will receive a 1-hour board game about health lifestyle.
|
Participants in the control group will receive a 1-hour board game about health lifestyle.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Advance Care Planning Engagement Scale
Time Frame: 3 months
|
Behaviour changes in ACP behaviours measured using Advance Care Planning Engagement Scale.
It is about different ACP behavior on a 5-point Likert scale.
The higher score means the higher level of self-efficacy and readiness for the behaviours.
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Certainty rate of end-of-life preferences toward medical care
Time Frame: 3 months
|
End-of-life preferences is measured by the Life-Support Preferences Questionnaire (LSPQ).
It describes one hypothetical terminally ill scenario.
Preferences regarding (i) three kinds of life-sustaining treatments (cardiopulmonary resuscitation, mechanical ventilator and tube feeding) based on three options (want to attempt, refuse or uncertain) and (ii) care goals (comfort-oriented, prolongation of life at all costs or uncertain) , will be asked.
|
3 months
|
Self-develped ACP knowledge questionnaire
Time Frame: 3 months
|
The questionnaire comprised 10 questions.
Response options for each of these questions were "yes" and "no".
Content validity was assessed within a palliative care expert team.
|
3 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change of emotional status
Time Frame: Immediate post-intervention
|
Emotional status is measured using the Chinese version of the 7-item Generalized Anxiety Disorder ( GAD-7) scale as process indicators.
The total score ranges from 0 to 21.
Higher scores indicate higher level of anxiety.
|
Immediate post-intervention
|
Experience of playing ACP game
Time Frame: Immediate post-intervention
|
Participants' experience of playing ACP game will be collected by focus group interviews.
|
Immediate post-intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Li LIU, 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)
August 8, 2020
Primary Completion (ACTUAL)
December 25, 2020
Study Completion (ACTUAL)
December 25, 2020
Study Registration Dates
First Submitted
December 15, 2019
First Submitted That Met QC Criteria
December 16, 2019
First Posted (ACTUAL)
December 18, 2019
Study Record Updates
Last Update Posted (ACTUAL)
January 27, 2021
Last Update Submitted That Met QC Criteria
January 25, 2021
Last Verified
January 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CREC2019428
- ChiCTR1900028190 (REGISTRY: Chinese Clinical Trial Registry, ChiCTR)
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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