Advance Care PlanningNCT07439393
Using a Conversation Game to Engage Native American Washoe Tribe Members in Advance Care Planning: Preparation for a Clinical Trial
A study testing Aim 1: Talking Circles and Aim 2: Play Modified Hello Game in people with Advance Care Planning and American Indian or Alaska Native, run by Milton S. Hershey Medical Center.
Trial summary
The goal of this study is to learn if a culturally adapted version of the Hello game, an advance care planning (ACP) conversation tool, is feasible and acceptable for use with members of the Washoe Tribe. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Advance Care Planning, American Indian or Alaska Native, Gamification
- What is being tested?
- Aim 1: Talking Circles and Aim 2: Play Modified Hello Game
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- No sites listed yet
- Study dates
- 10 Nov 2026to Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18 years or older
- Member of the Washoe American Indian Tribe
- Able to attend in-person events
- Speaks, reads, and writes in English
- Able to provide informed consent
Who cannot join
- Under 18 years of age
- Non-Tribal member
- Non-English speaking
- Unable to provide informed consent
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Lauren J Van Scoy, MD contact
About this study
The goal of this study is to learn if a culturally adapted version of the Hello game, an advance care planning (ACP) conversation tool, is feasible and acceptable for use with members of the Washoe Tribe. The main questions it aims to answer are:
Can the Hello game be successfully adapted to reflect the cultural values, beliefs, and storytelling traditions of the Washoe Tribe?
Read more
Does playing the adapted Hello game increase ACP engagement and advance directive (AD) completion among Washoe Tribe members within 3 months?
Participants will:
- Take part in talking circles at one of four Washoe reservations to share their beliefs, motivations, and experiences related to end-of-life care and advance care planning
- Complete brief questionnaires about their ACP attitudes and behaviors
- Play the culturally adapted Hello game in a group setting
- Complete follow-up measures of ACP engagement and advance directive completion 3 months after playing the game
- Being tested
- Aim 1: Talking Circles, Aim 2: Play Modified Hello Game
- Keywords
- Advance care planning, American Indian or Alaska Native, Gamification
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aim 1: Talking CirclesBehavioural
To expand study partnership with the Washoe tribe to further explore the needs, motivations, and barriers related to ACP and end-of-life decision-making for Tribal members and explore how findings converge or diverge from Western culture and across Washoe reservations. 2 talking circles (qualitative focus groups) will be conducted at each of the 4 Washoe reservations (n=8 groups, 48 individuals) along with brief questionnaires to: 1) explore beliefs about and motivations for ACP; 2) determine if and how storytelling plays a role in ACP; and 3) define meaningful and culturally appropriate ACP outcomes for the Washoe tribe.
Aim 2: Play Modified Hello GameBehavioural
Adapt and pilot test the Hello conversation game for use by the Washoe Tribe while establishing procedures for measuring the game's impact on ACP engagement. This objective includes: a) incorporating tribal recommendations to culturally adapt the game based on findings from objective 1, and b) conducting a feasibility and acceptability study of the modified game with 60 Washoe tribal members (15 from each reservation) using convergent mixed methods to assess preliminary outcomes and refine procedures for the future clinical trial.
| Study group | Role | What they receive |
|---|---|---|
| Advance Care Planning Talking Circles | Other | Not described Receives: Behavioral: Aim 1: Talking Circles |
| Arm 2: Modified Hello Game Play | Other | Not described Receives: Behavioral: Aim 2: Play Modified Hello Game |
What is being measured
The primary outcome is the main question the study is designed to answer.
Arm 1: Qualitative themes describing Advance Care Planning needs, motivations, and challenges
Participants will take part in qualitative focus groups, where they will verbally answer questions in a conversational format. These conversations will be audio recorded and qualitatively analyzed. Demographic information will be collected along with contact information. No validated survey measures will be used to collect data at this time point. Only qualitative data, demographics and contact information.
Measured: During qualitative focus groups (up to 2 hours)
Arm 2: Initial Enrollment Subject Numbers
Feasibility metric (Observed by Research Assistant) - How many participants actually enrolled.
Measured: RA Observed during participation in Hello game event (up to 1 hour)
Arm 2: Retention at 3-month follow-up
Feasibility metric (Observed by Research Assistant) - # of participants who attended the follow-up event.
Measured: RA Observed during 3-month follow-up event (up to 1 hour)
Arm 2: Acceptability Score
Feasibility metric; participants will fill out Conversation Acceptability measure to determine acceptability of playing the Hello game. The Acceptability measure consists of 3 items; 2 items on a Likert scale from 1-7 with 1 being Strongly Agree and 7 being Strongly Disagree, and 1 item indicating likelihood of recommending conversation activity to others on a scale of 0-10 with 0 being not likely at all and 10 being extremely likely.
Measured: During participation in Hello Game Event (up to 1 hour)
Arm 2: ACP engagement survey score Time 1
Participants will be asked to fill out the validated ACP engagement survey to determine engagement and readiness levels for ACP actions. The ACP engagement survey consists of 4 items asking questions related to readiness for ACP behaviors. 2 items are on a scale of 1-5 with 1 being "I have never thought about it" and 5 being "I already have done it". The other 2 items are on a scale of 1-6 with 1 being "I have never thought about it" and 6 being "I have already done it (more than 5 years ago)".
Measured: During participation in Hello Game Event (up to 1 hour)
Arm 2: ACP engagement survey score Time 2
Participants will be asked to fill out the validated ACP engagement survey to determine engagement and readiness levels for ACP actions. The ACP engagement survey consists of 4 items asking questions related to readiness for ACP behaviors. 2 items are on a scale of 1-5 with 1 being "I have never thought about it" and 5 being "I already have done it". The other 2 items are on a scale of 1-6 with 1 being "I have never thought about it" and 6 being "I have already done it (more than 5 years ago)".
Measured: 3-months post game attendance (up to 1 hour)
Arm 2: ACP Behavior completion
Participants will be asked to fill out the questions related to ACP behaviors. 6-items will be asked with 1 having options of yes/no/not sure/did not answer; 2 being yes/no/N/A/did not answer; 2 with options yes/no/did not answer and 1 with options nursing home/long-term care/insurance/hospice or palliative/funeral planning/other/did not report/did not answer
Measured: 3-months post game attendance (up to 1 hour)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start10 Nov 2026 (estimated)
- Primary completionSep 2028 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advance Care PlanningStudies of the same condition, open and under way.
- More trials run by Milton S. Hershey Medical CenterThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Principal investigator, Lauren Van Scoy, Milton S. Hershey Medical Center
- Investigators
- Lauren J Van Scoy, MD, Principal investigator, Penn State University - Hershey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07439393
- Sponsor's protocol ID
- STUDY00027799
- Other IDs
- 1R34NR021940-01
- Status last verified
- Oct 2026
- First submitted
- 23 Feb 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) collected during the study will be made available upon request following publication of research manuscripts. Data will include quantitative measures (demographics, social determinants of health, ACP engagement, intervention acceptability, and conversation satisfaction) and associated documentation. In alignment with Washoe Tribal sovereignty, all data sharing decisions require written approval from both the Principal Investigator and the Washoe Tribal Council, who retain ultimate authority over data access and reuse. Linkage sheets will not be shared and will be returned to the Washoe Tribe or destroyed upon study completion. Only de-identified data (identified by study ID only) will be shared in accordance with Penn State and NIH policies.
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using a Conversation Game to Engage Native American Washoe Tribe Members in Advance Care Planning: Preparation for a Clinical Trial
- ClinicalTrials.gov ID
- NCT07439393
- Acronym / sponsor ID
- STUDY00027799
- Keywords
- Advance care planning, American Indian or Alaska Native, Gamification
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- 10 Nov 2026 (estimated)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 27 Feb 2026 (actual)
- 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 goal of this study is to learn if a culturally adapted version of the Hello game, an advance care planning (ACP) conversation tool, is feasible and acceptable for use with members of the Washoe Tribe. The main questions it aims to answer are:
Can the Hello game be successfully adapted to reflect the cultural values, beliefs, and storytelling traditions of the Washoe Tribe?
Does playing the adapted Hello game increase ACP engagement and advance directive (AD) completion among Washoe Tribe members within 3 months?
Participants will:
- Take part in talking circles at one of four Washoe reservations to share their beliefs, motivations, and experiences related to end-of-life care and advance care planning
- Complete brief questionnaires about their ACP attitudes and behaviors
- Play the culturally adapted Hello game in a group setting
- Complete follow-up measures of ACP engagement and advance directive completion 3 months after playing the game
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Advance Care Planning Talking Circles | Other | Behavioral: Aim 1: Talking Circles |
| Arm 2: Modified Hello Game Play | Other | Behavioral: Aim 2: Play Modified Hello Game |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18 years or older
- Member of the Washoe American Indian Tribe
- Able to attend in-person events
- Speaks, reads, and writes in English
- Able to provide informed consent
Key exclusion criteria (4 listed)
- Under 18 years of age
- Non-Tribal member
- Non-English speaking
- Unable to provide informed consent
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 |
|---|---|---|
| Aim 1: Talking CirclesTo expand study partnership with the Washoe tribe to further explore the needs, motivations, and barriers related to ACP and end-of-life decision-making for Tribal members and explore how findings converge or diverge from Western culture and across Washoe reservations. 2 talking circles (qualitative focus groups) will be conducted at each of the 4 Washoe reservations (n=8 groups, 48 individuals) along with brief questionnaires to: 1) explore beliefs about and motivations for ACP; 2) determine if and how storytelling plays a role in ACP; and 3) define meaningful and culturally appropriate ACP outcomes for the Washoe tribe. | Behavioural | Advance Care Planning Talking Circles |
| Aim 2: Play Modified Hello GameAdapt and pilot test the Hello conversation game for use by the Washoe Tribe while establishing procedures for measuring the game's impact on ACP engagement. This objective includes: a) incorporating tribal recommendations to culturally adapt the game based on findings from objective 1, and b) conducting a feasibility and acceptability study of the modified game with 60 Washoe tribal members (15 from each reservation) using convergent mixed methods to assess preliminary outcomes and refine procedures for the future clinical trial. | Behavioural | Arm 2: Modified Hello Game Play |
Primary outcome
Arm 1: Qualitative themes describing Advance Care Planning needs, motivations, and challenges
Time frame: During qualitative focus groups (up to 2 hours)
Participants will take part in qualitative focus groups, where they will verbally answer questions in a conversational format. These conversations will be audio recorded and qualitatively analyzed. Demographic information will be collected along with contact information. No validated survey measures will be used to collect data at this time point. Only qualitative data, demographics and contact information.
Arm 2: Initial Enrollment Subject Numbers
Time frame: RA Observed during participation in Hello game event (up to 1 hour)
Feasibility metric (Observed by Research Assistant) - How many participants actually enrolled.
Arm 2: Retention at 3-month follow-up
Time frame: RA Observed during 3-month follow-up event (up to 1 hour)
Feasibility metric (Observed by Research Assistant) - # of participants who attended the follow-up event.
Arm 2: Acceptability Score
Time frame: During participation in Hello Game Event (up to 1 hour)
Feasibility metric; participants will fill out Conversation Acceptability measure to determine acceptability of playing the Hello game. The Acceptability measure consists of 3 items; 2 items on a Likert scale from 1-7 with 1 being Strongly Agree and 7 being Strongly Disagree, and 1 item indicating likelihood of recommending conversation activity to others on a scale of 0-10 with 0 being not likely at all and 10 being extremely likely.
Arm 2: ACP engagement survey score Time 1
Time frame: During participation in Hello Game Event (up to 1 hour)
Participants will be asked to fill out the validated ACP engagement survey to determine engagement and readiness levels for ACP actions. The ACP engagement survey consists of 4 items asking questions related to readiness for ACP behaviors. 2 items are on a scale of 1-5 with 1 being "I have never thought about it" and 5 being "I already have done it". The other 2 items are on a scale of 1-6 with 1 being "I have never thought about it" and 6 being "I have already done it (more than 5 years ago)".
Arm 2: ACP engagement survey score Time 2
Time frame: 3-months post game attendance (up to 1 hour)
Participants will be asked to fill out the validated ACP engagement survey to determine engagement and readiness levels for ACP actions. The ACP engagement survey consists of 4 items asking questions related to readiness for ACP behaviors. 2 items are on a scale of 1-5 with 1 being "I have never thought about it" and 5 being "I already have done it". The other 2 items are on a scale of 1-6 with 1 being "I have never thought about it" and 6 being "I have already done it (more than 5 years ago)".
Arm 2: ACP Behavior completion
Time frame: 3-months post game attendance (up to 1 hour)
Participants will be asked to fill out the questions related to ACP behaviors. 6-items will be asked with 1 having options of yes/no/not sure/did not answer; 2 being yes/no/N/A/did not answer; 2 with options yes/no/did not answer and 1 with options nursing home/long-term care/insurance/hospice or palliative/funeral planning/other/did not report/did not answer
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) collected during the study will be made available upon request following publication of research manuscripts. Data will include quantitative measures (demographics, social determinants of health, ACP engagement, intervention acceptability, and conversation satisfaction) and associated documentation. In alignment with Washoe Tribal sovereignty, all data sharing decisions require written approval from both the Principal Investigator and the Washoe Tribal Council, who retain ultimate authority over data access and reuse. Linkage sheets will not be shared and will be returned to the Washoe Tribe or destroyed upon study completion. Only de-identified data (identified by study ID only) will be shared in accordance with Penn State and NIH policies.
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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.
Lauren J Van Scoy, MD contact
Lauren J Van Scoy, MD principal investigator
Penn State University - Hershey
Questions about this trial
What is this clinical trial studying?
A study testing Aim 1: Talking Circles and Aim 2: Play Modified Hello Game in people with Advance Care Planning and American Indian or Alaska Native, run by Milton S. Hershey Medical Center.
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 5 inclusion and 4 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: opening soon, as of the sponsor's last update on 20 Oct 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Heather J Costigan, MPH (7175316499, hcostigan@pennstatehealth.psu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Arm 1: Qualitative themes describing Advance Care Planning needs, motivations, and challenges (time frame: During qualitative focus groups (up to 2 hours)). The study lists 7 primary outcomes in all. 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 20 Oct 2026.