Ignite Creation Date:
2025-12-24 @ 1:58 PM
Ignite Modification Date:
2025-12-29 @ 8:43 PM
Study NCT ID:
NCT07157995
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-10-22
First Post:
2025-08-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase 4 of Designed With You
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': 'OTHER', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'feasibility study of the BALANCE intervention'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2026-10-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-21', 'studyFirstSubmitDate': '2025-08-28', 'studyFirstSubmitQcDate': '2025-08-28', 'lastUpdatePostDateStruct': {'date': '2025-10-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-05-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Perceived Stress Scale', 'timeFrame': 'Baseline and post intervention at approximately 10 weeks', 'description': 'Measurement of perceived stress. Scores can range from 0 to 40, with higher scores indicating worse levels of perceived stress.'}, {'measure': 'Caregiver Burden Short Form', 'timeFrame': 'Baseline and post intervention at approximately 10 weeks', 'description': 'Measure to address burdensome activities related to care giving experiences. Total score ranges from 0-48 wit higher scores indicating greater caregiver burden.'}, {'measure': 'Depressive Symptoms (PHQ-9)', 'timeFrame': 'Baseline and post intervention at approximately 10 weeks', 'description': 'Measure of depressive symptoms. Score range 0-27, higher values represent more depression symptoms'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Caregivers', 'Disability', 'Sensory Disability', 'Mobility Disability'], 'conditions': ['Disability Physical']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to provide evaluate the feasibility of a structured 8-10-week, multi-component intervention that integrates individualized resource navigation, personalized self-care planning, emergency and end of life (EOL) preparedness, and peer support to improve the well-being, resource access and social connectedness of caregivers with disabilities. For this study we are interested in caregivers over the age of 18 who have some form (e.g. mobility or sensory) disability and are caring for a person with a disability and/or a chronic illness.', 'detailedDescription': 'The BALANCE is a feasibility study of the BALANCE intervention and will be delivered over 8-10 weeks. The proposed study is a Phase 1 feasibility trial designed to assess the feasibility and acceptability of a novel intervention aimed at \\[briefly describe intervention\\]. The primary objectives are to evaluate the practicality of implementing the intervention, participant engagement, and the appropriateness of study procedures.\n\nGiven the early-stage nature of this research, a control group is not required. Phase 1 feasibility studies are not intended to assess efficacy or comparative outcomes, but rather to refine the intervention and study logistics. According to guidance from the Office of Research Integrity (ORI), "Phase I trials are feasibility trials focused on developing and pretesting the acceptability, feasibility, and safety of the intervention components of Balance. "No control condition is needed."14 This approach aligns with best practices in early intervention development and allows for iterative refinement before proceeding to more rigorous testing in later phases (e.g., randomized controlled trials).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years of age and older,\n* Community dwelling in the state of Maryland,\n* Self report of physical or sensory disability and\n* self-report of serving as a family caregiver for a person for at least 10 hours/week.\n\nExclusion Criteria:\n\n* have a terminal diagnosis (\\<1 year expected survival), and\n* \\> severe cognitive impairment (5-7 errors) based on the Short Portable Mental Status Questionnaire (SPMQ)'}, 'identificationModule': {'nctId': 'NCT07157995', 'acronym': 'BALANCE', 'briefTitle': 'Phase 4 of Designed With You', 'organization': {'class': 'OTHER', 'fullName': 'Johns Hopkins University'}, 'officialTitle': 'Building Active Living and Addressing Needs for Caregiver Empowerment (BALANCE) Study - Phase 4 of Designed With You', 'orgStudyIdInfo': {'id': 'IRB00388844'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Balance Intervention', 'description': 'Participants will receive the intervention. BALANCE is a feasibility study of the BALANCE intervention that is testing feasibility and acceptability of a intervention that includes individual and group sessions with a caregiver navigator. The focus of the intervention is the unmet needs of caregivers with disabilities.', 'interventionNames': ['Behavioral: BALANCE Building Active LIving and Addressing Needs for Caregiver Empowerment']}], 'interventions': [{'name': 'BALANCE Building Active LIving and Addressing Needs for Caregiver Empowerment', 'type': 'BEHAVIORAL', 'description': 'The Balance intervention will include individual visits by a Caregiver Navigator and group sessions with other participants, led by the caregiver navigator. The focus will be on future planning, resources for unmet needs and support and socialization.', 'armGroupLabels': ['Balance Intervention']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Janiece Taylor, PhD, RN', 'role': 'CONTACT', 'email': 'jwalke90@jhu.edu', 'phone': '443-287-4503'}, {'name': 'Alicia Cooke', 'role': 'CONTACT', 'email': 'acooke8@jhu.edu', 'phone': '4109559954'}], 'overallOfficials': [{'name': 'Janiece Taylor, PhD, RN', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Johns Hopkins University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johns Hopkins University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Disability, Independent Living, and Rehabilitation Research', 'class': 'FED'}], 'responsibleParty': {'type': 'SPONSOR'}}}}