Ignite Creation Date:
2025-12-24 @ 4:58 PM
Ignite Modification Date:
2026-01-19 @ 7:33 PM
Study NCT ID:
NCT07280650
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-12
First Post:
2025-12-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Feasibility and Acceptability of Earkick for Family Caregivers: Evaluation Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'The study will recruit approximately 20 care partners of individuals with TBI, 20 care partners of individuals with dementia, and 20 care partners of individuals with Huntington Disease'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-02', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2027-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-01', 'studyFirstSubmitDate': '2025-12-01', 'studyFirstSubmitQcDate': '2025-12-01', 'lastUpdatePostDateStruct': {'date': '2025-12-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-05-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Feasibility and Acceptability as measured by the Feasibility Questionnaire', 'timeFrame': '8 weeks (post intervention)', 'description': 'Feasibility Questionnaire (items are scaled from 1 to 5 to indicate level of agreement, where "1" indicates "strong disagreement" and "5" indicates "strong agreement"). Feasibility and Acceptability as measured by ≥80% of participants indicating that care partners either "Agree" or "Strongly Agree" that the different study elements are feasible and acceptable.'}], 'secondaryOutcomes': [{'measure': 'Attrition as measured by the percent of participants completing the study', 'timeFrame': 'Baseline to post intervention interview (approximately 8-12 weeks)', 'description': 'The study team expects ≥80% of participants to complete the study.'}, {'measure': 'Adherence as measured by the percentage of missing data over the course of the study', 'timeFrame': 'Baseline to 8 weeks', 'description': 'Percent missing data of total expected data for each person and on average will also be calculated to characterize the feasibility of this approach (i.e., the study team expects ≥80% completion rates for the midpoint and end-of-study assessments).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Caregivers for adults with Traumatic Brain Injury (TBI)', 'Caregivers for adults with dementia', 'Caregivers for adults with Huntington disease', 'Artificial intelligence (AI) mobile application', 'Chatbot', 'Surveys'], 'conditions': ['Caregivers']}, 'descriptionModule': {'briefSummary': 'This study evaluates the feasibility and acceptability of using the artificial intelligence (AI) chatbot mobile application (called Earkick) to support the well-being of informal care partners of individuals with traumatic brain injury (TBI), dementia, or Huntington disease (HD). Over an 8-week intervention period, up to 60 care partners will engage with the application (app), spending four weeks focusing on physical health and four weeks focusing on mental health. Participants will complete surveys at the midpoint and end of the intervention period. Participants will also complete a semi-structured interview to discuss participants experience using the Earkick app.\n\nThe study team hypothesizes that care partners will find the chatbot acceptable and feasible to use in daily life, and that there will be low attrition and high completion rates of the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria (care partner)\n\n* Age 18 years or older\n* Able to independently provide informed consent\n* Able to read, speak, and understand English\n* Have an Apple (iOS) smartphone, tablet, or laptop, have access to the internet and text messages, and be willing to use these resources for the study, including downloading and using the AI chatbot app (Earkick)\n* Be caring for and adult with a medically documented diagnosis of TBI, dementia or Huntington disease (HD)\n* Provide emotional, physical, and/or financial support/assistance to the individual with the TBI, dementia, or HD, indicating a response per protocol\n* Indicate high levels of caregiver burden, confirmed using the 12-item Zarit Burden questionnaire (scores must be ≥20)\n* Willing to complete all study assessments for the duration of their study participation\n\nInclusion Criteria (care recipient):\n\n* Age 18 years or older\n* Have a medically documented diagnosis of TBI, dementia or Huntington disease as noted per protocol\n\nExclusion Criteria (care partner)\n\n* Anyone not meeting inclusion criteria above\n* Professional, paid caregivers\n* Anyone at the discretion of the Principal investigator (PI) that would be a preclusion of safe or meaningful participation\n\nExclusion Criteria (care recipient):\n\n* Anyone not meeting inclusion criteria\n* Lives in a care facility (assisted living, nursing home) or is bedbound'}, 'identificationModule': {'nctId': 'NCT07280650', 'briefTitle': 'Feasibility and Acceptability of Earkick for Family Caregivers: Evaluation Study', 'organization': {'class': 'OTHER', 'fullName': 'University of Michigan'}, 'officialTitle': 'Feasibility and Acceptability of Earkick for Family Caregivers: Evaluation Study', 'orgStudyIdInfo': {'id': 'HUM00265379'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Earkick app', 'interventionNames': ['Other: Earkick app']}], 'interventions': [{'name': 'Earkick app', 'type': 'OTHER', 'description': 'Participants will download the app with the study team\'s help and set it up. The participants will select topics of interest to focus on during the 8-week use of the Earkick app. Participants will choose one mental health related topic to focus on from weeks 1-4 and one physical health related topic to focus on from weeks 5-8. During these 4 week cycles the participants will be guided to engage with the app\'s "Chat" feature, which offers conversational support through interactions with the chatbot. Additionally, participants will complete surveys at baseline, the midpoint, and end of the 8-week intervention period. Participants will also complete a semi-structured interview to discuss their experience using the Earkick app.', 'armGroupLabels': ['Earkick app']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'contacts': [{'name': 'Christopher Graves', 'role': 'CONTACT', 'email': 'gravesch@med.umich.edu', 'phone': '734-764-7004'}, {'name': 'Noelle Carlozzi, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Michigan', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}], 'centralContacts': [{'name': 'Christopher Graves', 'role': 'CONTACT', 'email': 'gravesch@med.umich.edu', 'phone': '734-764-7004'}], 'overallOfficials': [{'name': 'Noelle Carlozzi, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Michigan'}]}, 'ipdSharingStatementModule': {'timeFrame': 'The data will be available after the acceptance for publication of the main findings from the final dataset.', 'ipdSharing': 'YES', 'description': 'Participant data collected during the trial, after de-identification, will be available for sharing with individuals in the scientific community, upon request, at the discretion of the Principal Investigator. The data will be available after the acceptance for publication of the main findings from the final dataset. The University of Michigan project manager will coordinate requests for data and maintain documentation for requests and distributions. An institutional data use agreement will be required before data is shared.', 'accessCriteria': 'Data is available upon request to the project manager. Requests for data sharing should be emailed to PMR-CODALab@med.umich.edu'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Michigan', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Noelle E Carlozzi', 'investigatorAffiliation': 'University of Michigan'}}}}