Disability PhysicalBALANCENCT07157995
Phase 4 of Designed With You
A study testing BALANCE Building Active LIving and Addressing Needs for Caregiver Empowerment in people with Disability Physical, run by Johns Hopkins University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Disability Physical
- What is being tested?
- BALANCE Building Active LIving and Addressing Needs for Caregiver Empowerment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2026to 30 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Johns Hopkins School of Nursing
Baltimore, Maryland, 21205
Janiece Taylor, PhD, jwalke90@jhu.edu
Alicia Cooke, MS, acooke8@jhu.edu
About this study
Official title: Building Active Living and Addressing Needs for Caregiver Empowerment (BALANCE) Study - Phase 4 of Designed With You
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.
Read the 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
- Being tested
- BALANCE Building Active LIving and Addressing Needs for Caregiver Empowerment
- Keywords
- Caregivers, Disability, Sensory Disability, Mobility Disability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BALANCE Building Active LIving and Addressing Needs for Caregiver EmpowermentBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: BALANCE Building Active LIving and Addressing Needs for Caregiver Empowerment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perceived Stress Scale
Measurement of perceived stress. Scores can range from 0 to 40, with higher scores indicating worse levels of perceived stress.
Measured: 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.
Measured: 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
Measured: Baseline and post intervention at approximately 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2025
- Study start1 Jan 2026
- Primary completion30 May 2026
- Study completion30 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Disability PhysicalStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- feasibility study of the BALANCE intervention
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Disability, Independent Living, and Rehabilitation Research
- Responsible party
- Sponsor
- Investigators
- Janiece Taylor, PhD, RN, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07157995
- Sponsor's protocol ID
- IRB00388844
- Acronym
- BALANCE
- Status last verified
- Jun 2026
- First submitted
- 28 Aug 2025
- Last updated
- 2 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Building Active Living and Addressing Needs for Caregiver Empowerment (BALANCE) Study - Phase 4 of Designed With You
- ClinicalTrials.gov ID
- NCT07157995
- Acronym / sponsor ID
- BALANCE / IRB00388844
- Conditions
- Disability Physical
- Keywords
- Caregivers, Disability, Sensory Disability, Mobility Disability
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Institute on Disability, Independent Living, and Rehabilitation Research
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 30 May 2026 (actual)
- Study completion
- 30 Oct 2026 (estimated)
- First posted
- 5 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- feasibility study of the BALANCE intervention
| Arm | Type | Receives |
|---|---|---|
| Balance Intervention | Other | Behavioral: BALANCE Building Active LIving and Addressing Needs for Caregiver EmpowermentParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- have a terminal diagnosis (<1 year expected survival), and
- > severe cognitive impairment (5-7 errors) based on the Short Portable Mental Status Questionnaire (SPMQ)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BALANCE Building Active LIving and Addressing Needs for Caregiver EmpowermentThe 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. | Behavioural | Balance Intervention |
Primary outcome
Perceived Stress Scale
Time frame: Baseline and post intervention at approximately 10 weeks
Measurement of perceived stress. Scores can range from 0 to 40, with higher scores indicating worse levels of perceived stress.
Caregiver Burden Short Form
Time frame: Baseline and post intervention at approximately 10 weeks
Measure to address burdensome activities related to care giving experiences. Total score ranges from 0-48 wit higher scores indicating greater caregiver burden.
Depressive Symptoms (PHQ-9)
Time frame: Baseline and post intervention at approximately 10 weeks
Measure of depressive symptoms. Score range 0-27, higher values represent more depression symptoms
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Janiece Taylor, PhD, RN principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BALANCE Building Active LIving and Addressing Needs for Caregiver Empowerment in people with Disability Physical, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Janiece Taylor, PhD, RN (443-287-4503, jwalke90@jhu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perceived Stress Scale (time frame: Baseline and post intervention at approximately 10 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2026.