JASP-1 for Children Recently Diagnosed and Their Parents (JASP-1)

Benefits of a Juvenile Arthritis Support Program (JASP-1) for Children Recently Diagnosed With Juvenile Idiopathic Arthritis (JIA) and Their Parents

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.

Study Overview

• Status: Completed
• Conditions: Patient Satisfaction; Patient Outcome Assessment; JIA; Support Program
• Intervention / Treatment: Behavioral: JASP-1

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 Type: Interventional
• Enrollment (Actual): 82
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Region Stockholm
    • Stockholm, Region Stockholm, Sweden, 17176
      • Astrid Lindgren Children´s Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: JASP-1 group; 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	Behavioral: JASP-1; patients following the Juvenile Arthritis Support Program at the Pediatric Rheumatology Clinic
No Intervention: Control group; The control group consisted of children 1-16 years old, who were diagnosed with JIA at their first visit at the PRC who were receiving standard care after the diagnosis, and their parents

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of Overall perceived health	One item on a 5 point likert scale, range from "not good at all" to "totally good"	12 months
Rate of Child Health Activity Questionnaire (CHAQ)	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	12 months
Number of active joints	Medical doctors assessment of the childs actice joints	12 months

Collaborators and Investigators

• Sponsor: Region Stockholm
• Investigators: Principal Investigator: Eva Broström, Professor, Supervisor

Study record dates

Study Major Dates

• Study Start (Actual): August 15, 2019
• Primary Completion (Actual): April 15, 2023
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: February 13, 2024
• First Submitted That Met QC Criteria: February 21, 2024
• First Posted (Actual): February 29, 2024

Study Record Updates

• Last Update Posted (Actual): March 6, 2024
• Last Update Submitted That Met QC Criteria: March 4, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: JIA; Patient outcome assessment; Patient Satisfaction; Support program
• Other Study ID Numbers: K2019-0392

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No