Phase 4 of Designed With You
ConditionDisability Physical
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorJohns Hopkins University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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 design
Design model
Single group
Treatments tested in this trial
BALANCE Building Active LIving and Addressing Needs for Caregiver Empowerment
BehavioralThe 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.
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: Balance InterventionOther 1 intervention
Trial outcomes
Primary outcomes
1
Perceived Stress Scale
Measurement of perceived stress. Scores can range from 0 to 40, with higher scores indicating worse levels of perceived stress.
Time frame
Baseline and post intervention at approximately 10 weeks2
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.
Time frame
Baseline and post intervention at approximately 10 weeks3
Depressive Symptoms (PHQ-9)
Measure of depressive symptoms. Score range 0-27, higher values represent more depression symptoms
Time frame
Baseline and post intervention at approximately 10 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Johns Hopkins University
Lead sponsor
National Institute on Disability, Independent Living, and Rehabilitation Research
Collaborator
Source ClinicalTrials.gov