Phase 4 of Designed With You

NCT ID: NCT07157995

Last Updated: 2026-01-29

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-01
• Study Completion Date: 2026-10-30

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Balance Intervention

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.

Group Type: OTHER

BALANCE Building Active LIving and Addressing Needs for Caregiver Empowerment

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Disability, Independent Living, and Rehabilitation Research

FED

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janiece Taylor, PhD, RN

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Johns Hopkins School of Nursing

Baltimore, Maryland, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Janiece Taylor, PhD, RN

Role: CONTACT

jwalke90@jhu.edu

443-287-4503

Alicia Cooke

Role: CONTACT

acooke8@jhu.edu

4109559954

Facility Contacts

Janiece Taylor, PhD

Role: primary

jwalke90@jhu.edu

Alicia Cooke, MS

Role: backup

acooke8@jhu.edu

Other Identifiers

IRB00388844

Identifier Type: -

Identifier Source: org_study_id