Phase 4 of Designed With You (BALANCE)

Johns Hopkins University

Status: Enrolling

Conditions: Disability Physical

Treatments: Behavioral: BALANCE Building Active LIving and Addressing Needs for Caregiver Empowerment

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT07157995

IRB00388844

Details and patient eligibility

About

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.

Full 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).

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18 years of age and older,
• Community dwelling in the state of Maryland,
• Self report of physical or sensory disability and
• self-report of serving as a family caregiver for a person for at least 10 hours/week.

Exclusion criteria

• have a terminal diagnosis (<1 year expected survival), and
• > severe cognitive impairment (5-7 errors) based on the Short Portable Mental Status Questionnaire (SPMQ)

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Balance Intervention

Other group

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.

Treatment:

Behavioral: BALANCE Building Active LIving and Addressing Needs for Caregiver Empowerment