- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07235839
The Impact of an Advance Care Planning Game on Life-Sustaining Treatment Preferences, Depression, and Hope in Older Adults With Stroke
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Background:
Stroke is the third leading cause of death worldwide and one of the most common causes of disability, accounting for approximately 10% of all deaths. One in four people experiences a stroke in their lifetime, and about 10% of stroke survivors face the risk of recurrent stroke within five years, often with more severe symptoms than the first episode. The one-year and five-year mortality rates after stroke are as high as 41% and 60%, respectively. Due to its high incidence, high recurrence rate, and high mortality, many stroke patients are unable to express their values and treatment preferences during the course of illness. This underscores the necessity of engaging in Advance Care Planning (ACP) discussions after stroke.
Purpose:
This study aims to explore the effects of an ACP game intervention on life-sustaining treatment preferences, depression, and hope among older adults with stroke.
Design:
A randomized controlled trial design was adopted.
Participants:
Using purposive sampling, we recruited subacute stroke patients aged 65-100 years from the neurology, neurosurgery, and rehabilitation wards of a regional teaching hospital in eastern Taiwan.
Measurement Tools:
The Life Support Preferences Questionnaire (LSPQ) was used as the primary outcome measure to assess differences in life-sustaining treatment preferences immediately after the intervention and at week 4 post-intervention. Secondary outcome measures included the Hospital Anxiety and Depression Scale (HADS) and the Herth Hope Index (HHI).
Intervention:
The intervention utilized the "LOHAS Journey" ACP block-based game developed for this study. The game incorporates travel-themed scenario guidance, allowing participants to express their medical preferences through the arrangement of blocks. "Hope blocks" were added to transform various stroke- and cancer-related scenarios, enhancing the participants' sense of hope. The game also includes companion option cards, emphasizing personal resources and potential future surrogate decision-makers. Beyond discussing life-sustaining treatment preferences, the game further encourages warm emotional expressions such as gratitude and affection.
Statistical Analysis:
Generalized Estimating Equations (GEE) were used to examine differences in life-sustaining treatment preferences, depression, and hope across repeated measurements, as well as to analyze time and group interaction effects.
If the effectiveness of the ACP block-based game on life-sustaining treatment preferences, depression, and hope among older adults with stroke is confirmed, it will support the promotion of ACP-related discussions in clinical stroke care.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
-
Yilan, Taiwan
- Lotong PohAi Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Older adults aged 65-100 years.
- Diagnosed with ischemic or hemorrhagic stroke confirmed by computer tomography (CT) or magnetic resonance imaging (MRI), and in the subacute stage 1-6 months after stroke onset.
- A National Institute of Health Stroke Scale (NIHSS) score ≤ 15, indicating mild to moderate stroke severity.
- Clear consciousness and able to communicate in Mandarin or Taiwanese.
Exclusion Criteria:
- Individuals diagnosed with chronic psychiatric disorders such as major depression, mania, or bipolar disorder.
- Older adults diagnosed with moderate to severe dementia.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: ACP Block Game Intervention
|
The "LOHAS Journey" Advance Care Planning (ACP) block game serves as an intervention.
This non-invasive intervention, themed around a game-like journey, guides participants through various scenarios, allowing them to express their healthcare preferences through the blocks.
The inclusion of "Hope Blocks" transforms several scenarios related to stroke and cancer, helping participants strengthen their hope for healthcare.
The game also provides support tabs highlighting personal resources and potential future healthcare decision-makers.
Beyond discussing life-sustaining treatment preferences, the game encourages expressing warm emotions such as gratitude and love.
|
|
No Intervention: Usual Care
Routine stroke care
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
life support preferences questionnaire; LSPQ
Time Frame: From enrollment to the end of treatment at 5 weeks
|
The questionnaire is designed to assess participants' preferences for various life-sustaining treatments across six medical scenarios and five treatment options.
The maximum possible score is 150 and the minimum is 25.
Higher scores indicate a greater willingness to receive life-sustaining medical treatments.
|
From enrollment to the end of treatment at 5 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
hospital anxiety and depression scale; HADS
Time Frame: From enrollment to the end of treatment at 5 weeks
|
This scale is used to screen for the prevalence of anxiety and depression among patients in medical settings who do not have psychiatric disorders.
It contains 14 items, with a total score ranging from 0 to 21. Scores of 0-7 are considered within the normal range; scores of 8-10 indicate borderline or potential anxiety or depressive symptoms; and scores of ≥11 suggest the possible presence of emotional disorders or underlying conditions.
Higher scores indicate more severe anxiety or depressive symptoms.
|
From enrollment to the end of treatment at 5 weeks
|
|
herth hope index; HHI
Time Frame: From enrollment to the end of treatment at 5 weeks
|
This scale is used to assess the level of hope among patients with acute, chronic, or terminal illnesses.
It consists of 12 items, with a total score ranging from 12 to 48.
Higher scores indicate a higher level of hope.
|
From enrollment to the end of treatment at 5 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB114-220-B
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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