Clinical trial NCT06284616: JASP-1 for Children Recently Diagnosed and Their Parents
Official title: Benefits of a Juvenile Arthritis Support Program (JASP-1) for Children Recently Diagnosed With Juvenile Idiopathic Arthritis (JIA) and Their Parents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: JIA
Support Program
Patient Satisfaction
Patient Outcome Assessment
Keywords: JIA
Support program
Patient Satisfaction
Patient outcome assessment
Lead sponsor: Region Stockholm
Sponsor class: OTHER_GOV
First posted: 2024-02-29
Enrollment: 82
Sex: ALL
Minimum age (years): 1
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study is a non-randomized intervention study with 2 groups receiving either a Support program (JASP-1) or standard care
Primary purpose: SUPPORTIVE_CARE

Brief summary: To implement and evaluate a patient-and family-centered Juvenile Arthritis Support Program during one year (JASP-1) for children recently diagnosed with JIA and their parents and after 12 months compare satistaction with care and health outcomes with a control group receiving standard care.

Detailed description: Children diagnosed with JIA (n=50) and their parents were offered the opportunity to participate in the JASP-1 from the time of diagnosis and the following year. One year after the JIA diagnosis, the children and/or their parents were invited to answer a study-specific questionnaire comprising 16 questions. The questionnaire assessed their experiences with the information, communication, participation, and emotional support they had received during the first year with JIA. In order to compare outcomes, the questionnaire was answered by both participants in JASP-1 and patients and parents receiving standard care (n=25).

One example of a question is; If you asked questions to the health care professionals, did you get answers that you understood? Response alternatives range from "No, not at all" to "Yes, Completely" ona 5-point Likert scale.

In Swedish Pediatric Rheumatology Quality Register (PedSRQ) information about treatment, disease- and joint activity (registered by Medical doctor), and Patient Reported Outcome Measures (PROM), are measured. The total Child Health Activity Questionnaire (CHAQ-score), as well as active joints and treatment at 12 months was registered in the PedSRQ and analyzed.

The study specific questionnaire measuring patient satisfaction has been developed in collaboration with the Swedish Municipalities and County councils.

Experimental and descriptive analyses will be performed using software for statistical analysis, SPSS. Distributions of responses will be calculated in percentage. Differences in proportions between groups will be determined by performing chi-square tests.

Eligibility criteria: Inclusion Criteria:

* Children 1-16 years old
* Diagnosed with JIA at their first visit to the PRC

Exclusion Criteria:

* Children that did not fulfil the criteria for JIA
* Children/parents who could not understand the Swedish language.

Primary outcomes:
measure: Rate of Patient Reported Experienced Measures (PREM)
timeFrame: 12 months
Secondary outcomes:
measure: Rate of Overall perceived health
timeFrame: 12 months
measure: Rate of Child Health Activity Questionnaire (CHAQ)
timeFrame: 12 months
measure: Number of active joints
timeFrame: 12 months
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Astrid Lindgren Children´s Hospital
state: Region Stockholm
Study officials:
affiliation: Supervisor
name: Eva Broström, Professor
role: PRINCIPAL_INVESTIGATOR
References: