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Phase 4 of Designed With You

Phase 4 of Designed With You

Recruiting
18 years and older
All
Phase N/A

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Overview

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.

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).

Eligibility

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)

Study details
    Disability Physical

NCT07157995

Johns Hopkins University

1 February 2026

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FAQs

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A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

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Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

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The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

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