Phase 4 of Designed With You
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: BALANCE Building Active LIving and Addressing Needs for Caregiver Empowerment.
- Who it may be relevant to
- Registry conditions: Disability Physical. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Building Active Living and Addressing Needs for Caregiver Empowerment (BALANCE) Study - Phase 4 of Designed With You
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.
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).
Interventions
- 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.
Primary outcome measures
- Perceived Stress Scale [Time frame: Baseline and post intervention at approximately 10 weeks]
- Caregiver Burden Short Form [Time frame: Baseline and post intervention at approximately 10 weeks]
- Depressive Symptoms (PHQ-9) [Time frame: Baseline and post intervention at approximately 10 weeks]
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
United States · 1 center
- Johns Hopkins School of Nursing — Baltimore
Identifiers
NCT: NCT07157995 · IRB00388844