NCT07157995

Phase 4 of Designed With You

Building Active Living and Addressing Needs for Caregiver Empowerment (BALANCE) Study - Phase 4 of Designed With You

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Johns Hopkins University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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. Given 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).

Conditions

• Disability Physical

Interventions

Type	Name	Description
BEHAVIORAL	BALANCE Building Active LIving and Addressing Needs for Caregiver Empowerment	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.

Timeline

• Start date: 2026-01-01
• Primary completion: 2026-05-30
• Completion: 2026-10-30
• First posted: 2025-09-05
• Last updated: 2026-01-29

Locations

1 site across 1 country: United States