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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04203407
Other study ID # CREC2019428
Secondary ID ChiCTR1900028190
Status Completed
Phase N/A
First received
Last updated
Start date August 8, 2020
Est. completion date December 25, 2020

Study information

Verified date January 2021
Source Chinese University of Hong Kong
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 144
Est. completion date December 25, 2020
Est. primary completion date December 25, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 60 Years to 100 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
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.
Usual care
Participants in the control group will receive a 1-hour board game about health lifestyle.

Locations

Country Name City State
China Xihu community, guanshaling community Changsha Hunan

Sponsors (3)

Lead Sponsor Collaborator
Chinese University of Hong Kong Guanshaling community healthcare service centre, Xihu community healthcare service centre

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Other Change of emotional status 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
Other Experience of playing ACP game Participants' experience of playing ACP game will be collected by focus group interviews. Immediate post-intervention
Primary Advance Care Planning Engagement Scale 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 Certainty rate of end-of-life preferences toward medical care 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
Secondary Self-develped ACP knowledge questionnaire 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
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