Promoting Health-Related Quality of Life in Pediatric Lupus Patients: Development and Implementation of a Tailored Brain Health Intervention
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Andrea Knight
- Enrollment
- 60
- Primary Endpoint
- Number of participants recruited
Overview
Brief Summary
This project will work closely with patients to design and test a new program that supports brain health in children and youth with childhood-onset lupus (cSLE). The investigators will see how practical and helpful the program is for patients.
Detailed Description
The proposed project will use a patient-informed participatory action approach to develop and assess preliminary feasibility and acceptability of an intervention tailored to address the specific brain health needs of cSLE patients.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 13 Years to 18 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Receive subject-informed consent;
- •Have a current diagnosis of cSLE that meets the 1997 American College of Rheumatology (ACR) or System Lupus International Collaborating Clinics (SLICC) classification criteria
- •Aged 13-18 years old
Exclusion Criteria
- •Conditions that significantly affect cognition (e.g., intellectual disability diagnosis, active psychosis), hearing loss or vision problems precluding participation in group
- •Non-English speaking
- •Lack of access to technology that would allow them to participate in the virtual intervention (e.g., phone, tablet, computer, etc.)
Outcomes
Primary Outcomes
Number of participants recruited
Time Frame: 1 year
Feasibility will be assessed by rates of participant recruitment.
Number of intervention sessions attended
Time Frame: through study completion, an average of 1 year
Feasibility will be assessed by rates of participant session attendance.
Number of participants completing the intervention
Time Frame: through study completion, an average of 1 year
Feasibility will be assessed by rates of participant intervention completion.
Acceptability ratings
Time Frame: 0-2 weeks post-intervention
Participant acceptability will be determined ratings of their satisfaction with aspects of the program on a brief survey using 5-point Likert scales (ranging from "dissatisfied" to "extremely satisfied").
Qualitative feedback on feasibility and acceptability of the intervention
Time Frame: 0-2 weeks post-intervention
Semi- structured interviews administered to participants post-intervention will also assess intervention feasibility and acceptability.
Secondary Outcomes
- Depressive symptoms(Baseline and 10 weeks)
- Anxiety symptoms(Baseline and 10 weeks)
- Executive function(Baseline and 10 weeks)
- Self-efficacy(Baseline and 10 weeks)
- Social engagement(Baseline and 10 weeks)
- Medication adherence(Baseline and 10 weeks)
- Health-related quality of life(Baseline and 10 weeks)
Investigators
Andrea Knight
Clinical Investigator
The Hospital for Sick Children