JASP-1 for Children Recently Diagnosed and Their Parents

Not Applicable

Completed

• Conditions: Support Program; Patient Satisfaction; JIA; Patient Outcome Assessment
• Interventions: Behavioral: JASP-1

• Registration Number: NCT06284616
• Lead Sponsor: Region Stockholm

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.

Study Timeline

• Study Start: 2019-08-15
• Primary Completion: 2023-04-15
• Study Completion: 2023-12-31
• Status Verified: 2024-02
• Study First Submitted: 2024-02-13
• Study First Submitted QC: 2024-02-21
• Study First Posted: 2024-02-29
• Last Update Submitted: 2024-03-04
• Last Update Posted: 2024-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 82

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
JASP-1 group	JASP-1	Participants were recruited from August 2019 to April 2022. The JASP-1 group consisted of children 0-16 years old who were diagnosed with JIA at their first visit to the PRC and their parents

Primary Outcome Measures

Name	Time	Method
Rate of Patient Reported Experienced Measures (PREM)	12 months	A study specific PREM questionnaire with 16 items. 5 point likert scale

Secondary Outcome Measures

Name	Time	Method
Rate of Overall perceived health	12 months	One item on a 5 point likert scale, range from "not good at all" to "totally good"
Number of active joints	12 months	Medical doctors assessment of the childs actice joints
Rate of Child Health Activity Questionnaire (CHAQ)	12 months	CHAQ assesses functional ability and assists in understanding the impact of the disease on the child´s daily life. On a Visual Analog Scale (VAS) ranging 0 to 10

Trial Locations

Locations (1)

Astrid Lindgren Children´s Hospital; 🇸🇪 Stockholm, Region Stockholm, Sweden