Phase 4 of Designed With You

NCT07157995 | Recruiting

• 1 other identifier: IRB00388844
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Disability Physical

Keywords

Caregivers; Disability; Sensory Disability; Mobility Disability

Outcome Measures

Primary Outcomes (3)

• Perceived Stress Scale

  Measurement of perceived stress. Scores can range from 0 to 40, with higher scores indicating worse levels of perceived stress.

  Baseline and post intervention at approximately 10 weeks

• Caregiver Burden Short Form

  Measure to address burdensome activities related to care giving experiences. Total score ranges from 0-48 wit higher scores indicating greater caregiver burden.

  Baseline and post intervention at approximately 10 weeks

• Depressive Symptoms (PHQ-9)

  Measure of depressive symptoms. Score range 0-27, higher values represent more depression symptoms

  Baseline and post intervention at approximately 10 weeks

Study Arms (1)

Balance Intervention

OTHER

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.

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

Interventions

BALANCE Building Active LIving and Addressing Needs for Caregiver Empowerment 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.

Balance Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Johns Hopkins University: lead
• National Institute on Disability, Independent Living, and Rehabilitation Research: collaborator

Study Sites (1)

Johns Hopkins School of Nursing

Baltimore, Maryland, 21205, United States

RECRUITING

Study Officials

• Janiece Taylor, PhD, RN

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Janiece Taylor, PhD, RN

CONTACT

443-287-4503; jwalke90@jhu.edu

Alicia Cooke

CONTACT

4109559954; acooke8@jhu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: feasibility study of the BALANCE intervention

Study Record Dates

• First Submitted: August 28, 2025
• First Posted: September 5, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): October 30, 2026
• Last Updated: January 29, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)