Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 7:21 AM
Study NCT ID:
NCT07439393
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-02
First Post:
2026-02-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Using a Conversation Game to Engage Native American Washoe Tribe Members in Advance Care Planning: Preparation for a Clinical Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 108}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2028-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-26', 'studyFirstSubmitDate': '2026-02-23', 'studyFirstSubmitQcDate': '2026-02-23', 'lastUpdatePostDateStruct': {'date': '2026-03-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Arm 1: Qualitative themes describing Advance Care Planning needs, motivations, and challenges', 'timeFrame': 'During qualitative focus groups (up to 2 hours)', 'description': '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.'}, {'measure': 'Arm 2: Initial Enrollment Subject Numbers', 'timeFrame': 'RA Observed during participation in Hello game event (up to 1 hour)', 'description': 'Feasibility metric (Observed by Research Assistant) - How many participants actually enrolled.'}, {'measure': 'Arm 2: Retention at 3-month follow-up', 'timeFrame': 'RA Observed during 3-month follow-up event (up to 1 hour)', 'description': 'Feasibility metric (Observed by Research Assistant) - # of participants who attended the follow-up event.'}, {'measure': 'Arm 2: Acceptability Score', 'timeFrame': 'During participation in Hello Game Event (up to 1 hour)', 'description': '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.'}, {'measure': 'Arm 2: ACP engagement survey score Time 1', 'timeFrame': 'During participation in Hello Game Event (up to 1 hour)', 'description': '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)".'}, {'measure': 'Arm 2: ACP engagement survey score Time 2', 'timeFrame': '3-months post game attendance (up to 1 hour)', 'description': '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)".'}, {'measure': 'Arm 2: ACP Behavior completion', 'timeFrame': '3-months post game attendance (up to 1 hour)', 'description': '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'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Advance care planning', 'American Indian or Alaska Native', 'Gamification'], 'conditions': ['Advance Care Planning', 'American Indian or Alaska Native', 'Gamification']}, 'descriptionModule': {'briefSummary': '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:\n\nCan the Hello game be successfully adapted to reflect the cultural values, beliefs, and storytelling traditions of the Washoe Tribe?\n\nDoes playing the adapted Hello game increase ACP engagement and advance directive (AD) completion among Washoe Tribe members within 3 months?\n\nParticipants will:\n\n* 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\n* Complete brief questionnaires about their ACP attitudes and behaviors\n* Play the culturally adapted Hello game in a group setting\n* Complete follow-up measures of ACP engagement and advance directive completion 3 months after playing the game'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 years or older\n* Member of the Washoe American Indian Tribe\n* Able to attend in-person events\n* Speaks, reads, and writes in English\n* Able to provide informed consent\n\nExclusion Criteria:\n\n* Under 18 years of age\n* Non-Tribal member\n* Non-English speaking\n* Unable to provide informed consent'}, 'identificationModule': {'nctId': 'NCT07439393', 'briefTitle': 'Using a Conversation Game to Engage Native American Washoe Tribe Members in Advance Care Planning: Preparation for a Clinical Trial', 'organization': {'class': 'OTHER', 'fullName': 'Milton S. Hershey Medical Center'}, 'officialTitle': 'Using a Conversation Game to Engage Native American Washoe Tribe Members in Advance Care Planning: Preparation for a Clinical Trial', 'orgStudyIdInfo': {'id': 'STUDY00027799'}, 'secondaryIdInfos': [{'id': '1R34NR021940-01', 'link': 'https://reporter.nih.gov/quickSearch/1R34NR021940-01', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Advance Care Planning Talking Circles', 'interventionNames': ['Behavioral: Aim 1: Talking Circles']}, {'type': 'OTHER', 'label': 'Arm 2: Modified Hello Game Play', 'interventionNames': ['Behavioral: Aim 2: Play Modified Hello Game']}], 'interventions': [{'name': 'Aim 1: Talking Circles', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['Advance Care Planning Talking Circles']}, {'name': 'Aim 2: Play Modified Hello Game', 'type': 'BEHAVIORAL', 'description': "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.", 'armGroupLabels': ['Arm 2: Modified Hello Game Play']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Heather J Costigan, MPH', 'role': 'CONTACT', 'email': 'hcostigan@pennstatehealth.psu.edu', 'phone': '7175316499'}, {'name': 'Lauren J Van Scoy, MD', 'role': 'CONTACT', 'email': 'lvanscoy@pennstatehealth.psu.edu'}], 'overallOfficials': [{'name': 'Lauren J Van Scoy, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Penn State University - Hershey'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'ICF'], 'timeFrame': 'De-identified data will be made available upon request and written approval from the PI and Washoe Tribal Council following publication of research manuscripts and will remain available for the life of the repository (minimum 10 years for ScholarSphere; indefinitely for openICPSR), or for as long as contact can be made with the PI.', 'ipdSharing': 'YES', 'description': '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.', 'accessCriteria': 'Requests for de-identified individual participant data should be directed to the Principal Investigator. Access requires written approval from both the PI and the Washoe Tribal Council. Requestors should describe the purpose and proposed use of the data. Data will be provided in de-identified CSV format at no cost to the requestor.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Milton S. Hershey Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Nursing Research (NINR)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Lauren Van Scoy', 'investigatorAffiliation': 'Milton S. Hershey Medical Center'}}}}