Chronic DiseaseNCT02619370
Evaluation of an Advance Care Planning Activity: Feasibility Testing for a Randomized Controlled Trial
A study testing Conversation card game in people with Chronic Disease and Caregivers, run by Lauren Van Scoy.
Trial summary
The overarching goal of this project is to facilitate engagement of individuals in effective advance care planning (ACP). Our specific objective is to conduct a randomized, controlled trial to determine whether playing a structured conversation game will increase the likelihood that participants will complete advance… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Disease, Caregivers
- What is being tested?
- Conversation card game
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- No sites listed yet
- Study dates
- Jan 2016to Sep 2016
- 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
None listed.
Who cannot join
- Do not fall into one of the above 3 categories
- Are <18 years of age
- Non-English speaking
- Cognitively impaired by self-report or score less than 21 on the MoCA screening tool
- Do not have a chronic illness (lacking one of the diseases from Iezonni's ICD-9 codes in chronic illness categories, described above)
- Have completed an advance directive within the last 18 months
Show all 9Show fewer
- Do not provide informed consent or unable to provide informed consent
- Carry a diagnosis of dementia
- Unable to complete a 3 hour study session in one sitting (by self-report)
About this study
The overarching goal of this project is to facilitate engagement of individuals in effective advance care planning (ACP). Our specific objective is to conduct a randomized, controlled trial to determine whether playing a structured conversation game will increase the likelihood that participants will complete advance directives and perform other ACP behaviors compared to those who are provided with only standard ACP educational materials.
Read the detailed description
Our central hypothesis is that having ACP conversations in a non-threatening and enjoyable game format will stimulate participants to engage in additional ACP behaviors including completion of ADs. We will use the ACP Engagement Survey to measure readiness to perform ACP, which includes measures of the "stage of change" for performing ACP behaviors.
The proposed study has two specific aims:
Aim 1. To determine whether individuals who play a conversation game are more likely to subsequently complete an online AD (called 'Making Your Wishes Known'; MYWK) compared to individuals who receive standard information about ACP. Our hypothesis is that playing a conversation game will result in a higher AD completion rate (compared to control) in the three months following the intervention.
Aim 2. To identify which participant and/or conversation-related factors influence movement along the stages of change continuum with respect to ACP behaviors (discussing end-of-life wishes with families or clinicians and then completing ADs). Our hypotheses are that: H1) the game intervention will lead to higher quality conversations than the control; and H2) participants whose conversations consist of high-quality ACP discussions will be more likely to progress toward enacting ACP behaviors (as measured by the ACP Engagement Survey score) than those participants whose conversations consist of low-quality discussions.
- Conditions
- Chronic Disease, Caregivers
- Being tested
- Conversation card game, Active Control
- Keywords
- advance care planning, advance directive, caregiving
- Medical subject headings
- Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conversation card gameBehavioural
Active ControlBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Play 'My Gift of Grace,' a conversation card game for 4-6 players (the game consists of 20 question cards that prompt players to identify and articulate their values and beliefs related to dying and end-of-life issues); all game sessions will be audio recorded and transcribed. Receives: Behavioral: Conversation card game |
| Control | Active comparator | Review and discuss a brochure on ACP called "Advance Care Planning: Tips from the National Institute of Aging". Discussion will be prompted by the researcher asking participants to discuss the information they've just read with the group. However, there will not be a formal structure to this discussion. Receives: Behavioral: Active Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Completion of an online advance directive
Measured: 3 months
Secondary outcomes (2)
Advance Care Planning Engagement Survey
This survey includes information about stage of readiness to perform advance care planning, self-efficacy, and other measures of behavioral change
Measured: 3 months
Advance Care Planning Behaviors
Open-ended interviews will ascertain additional advance care planning behaviors performed
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2015 (estimated)
- Study startJan 2016
- Primary completionJun 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic 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
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lauren Van Scoy
- Sponsor type
- University, hospital or other
- Collaborators
- University of Kentucky, Francis Family Foundation, Penn State University
- Responsible party
- Sponsor-investigator, Lauren Van Scoy, Milton S. Hershey Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02619370
- Sponsor's protocol ID
- STUDY00002634
- Status last verified
- Mar 2017
- First submitted
- 30 Nov 2015
- Last updated
- 22 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of an Advance Care Planning Activity: Feasibility Testing for a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02619370
- Acronym / sponsor ID
- STUDY00002634
- Conditions
- Chronic Disease, Caregivers
- Keywords
- advance care planning, advance directive, caregiving
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Lauren Van ScoyUniversity, hospital or other
- Collaborators
- University of Kentucky, Francis Family Foundation, Penn State University
- Study start
- Jan 2016 (actual)
- Primary completion
- Jun 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 2 Dec 2015 (estimated)
- 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.
The overarching goal of this project is to facilitate engagement of individuals in effective advance care planning (ACP). Our specific objective is to conduct a randomized, controlled trial to determine whether playing a structured conversation game will increase the likelihood that participants will complete advance directives and perform other ACP behaviors compared to those who are provided with only standard ACP educational materials.
Detailed description
Our central hypothesis is that having ACP conversations in a non-threatening and enjoyable game format will stimulate participants to engage in additional ACP behaviors including completion of ADs. We will use the ACP Engagement Survey to measure readiness to perform ACP, which includes measures of the "stage of change" for performing ACP behaviors.
The proposed study has two specific aims:
Aim 1. To determine whether individuals who play a conversation game are more likely to subsequently complete an online AD (called 'Making Your Wishes Known'; MYWK) compared to individuals who receive standard information about ACP. Our hypothesis is that playing a conversation game will result in a higher AD completion rate (compared to control) in the three months following the intervention.
Aim 2. To identify which participant and/or conversation-related factors influence movement along the stages of change continuum with respect to ACP behaviors (discussing end-of-life wishes with families or clinicians and then completing ADs). Our hypotheses are that: H1) the game intervention will lead to higher quality conversations than the control; and H2) participants whose conversations consist of high-quality ACP discussions will be more likely to progress toward enacting ACP behaviors (as measured by the ACP Engagement Survey score) than those participants whose conversations consist of low-quality discussions.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Conversation card gamePlay 'My Gift of Grace,' a conversation card game for 4-6 players (the game consists of 20 question cards that prompt players to identify and articulate their values and beliefs related to dying and end-of-life issues); all game sessions will be audio recorded and transcribed. |
| Control | Active comparator | Behavioral: Active ControlReview and discuss a brochure on ACP called "Advance Care Planning: Tips from the National Institute of Aging". Discussion will be prompted by the researcher asking participants to discuss the information they've just read with the group. However, there will not be a formal structure to this discussion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (9 listed)
- Do not fall into one of the above 3 categories
- Are <18 years of age
- Non-English speaking
- Cognitively impaired by self-report or score less than 21 on the MoCA screening tool
- Do not have a chronic illness (lacking one of the diseases from Iezonni's ICD-9 codes in chronic illness categories, described above)
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 |
|---|---|---|
| Conversation card game | Behavioural | Intervention |
| Active Control | Behavioural | Control |
Primary outcome
Completion of an online advance directive
Time frame: 3 months
2 secondary outcomes
Advance Care Planning Engagement Survey
Time frame: 3 months
Advance Care Planning Behaviors
Time frame: 3 months
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 22 Mar 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Conversation card game in people with Chronic Disease and Caregivers, run by Lauren Van Scoy.
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 0 inclusion and 9 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 22 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Completion of an online advance directive (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Mar 2017.