JIAJASP-1NCT06284616
JASP-1 for Children Recently Diagnosed and Their Parents
A study testing JASP-1 in people with JIA and Support Program, run by Region Stockholm at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 16 years
- Conditions the study is for
- JIA, Support Program, Patient Satisfaction
- What is being tested?
- JASP-1
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteSweden
- Study dates
- 15 Aug 2019to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children 1-16 years old
- Diagnosed with JIA at their first visit to the PRC
Who cannot join
- Children that did not fulfil the criteria for JIA
- Children/parents who could not understand the Swedish language.
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Astrid Lindgren Children´s Hospital
Stockholm, Region Stockholm, 17176
About this study
Official title: 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.
Read the 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.
- Conditions
- JIA, Support Program, Patient Satisfaction, Patient Outcome Assessment
- Being tested
- JASP-1
- Keywords
- JIA, Support program, Patient Satisfaction, Patient outcome assessment
- Medical subject headings
- Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JASP-1Behavioural
patients following the Juvenile Arthritis Support Program at the Pediatric Rheumatology Clinic
| Study group | Role | What they receive |
|---|---|---|
| JASP-1 group | Experimental | 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 Receives: Behavioral: JASP-1 |
| Control group | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
Rate of Patient Reported Experienced Measures (PREM)
A study specific PREM questionnaire with 16 items. 5 point likert scale
Measured: 12 months
Secondary outcomes (3)
Rate of Overall perceived health
One item on a 5 point likert scale, range from "not good at all" to "totally good"
Measured: 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
Measured: 12 months
Number of active joints
Medical doctors assessment of the childs actice joints
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2024
- Study start15 Aug 2019
- Primary completion15 Apr 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for JIAStudies of the same condition, open and under way.
- More trials run by Region StockholmThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- The study is a non-randomized intervention study with 2 groups receiving either a Support program (JASP-1) or standard care
- Masking
- None (open label)
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Stockholm
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Eva Broström, Professor, Principal investigator, Supervisor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06284616
- Sponsor's protocol ID
- K2019-0392
- Acronym
- JASP-1
- Status last verified
- Feb 2024
- First submitted
- 13 Feb 2024
- Last updated
- 6 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mordrup K, Jungner JG, Brostrom E, Palmblad K, Bartholdson C. Benefits of a Juvenile Arthritis Support Program (JASP-1) for children recently diagnosed with Juvenile Idiopathic Arthritis and their parents. BMC Rheumatol. 2024 Aug 15;8(1):35. doi: 10.1186/s41927-024-00404-8.
PubMed 39143588
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Benefits of a Juvenile Arthritis Support Program (JASP-1) for Children Recently Diagnosed With Juvenile Idiopathic Arthritis (JIA) and Their Parents
- ClinicalTrials.gov ID
- NCT06284616
- Acronym / sponsor ID
- JASP-1 / K2019-0392
- Conditions
- JIA, Support Program, Patient Satisfaction, Patient Outcome Assessment
- Keywords
- JIA, Support program, Patient Satisfaction, Patient outcome assessment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Region StockholmOther government
- Study start
- 15 Aug 2019 (actual)
- Primary completion
- 15 Apr 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 29 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study is a non-randomized intervention study with 2 groups receiving either a Support program (JASP-1) or standard care
| Arm | Type | Receives |
|---|---|---|
| JASP-1 group | Experimental | Behavioral: JASP-1Participants 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 |
| Control group | No intervention | –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 |
Who may qualify
- Ages
- 1 year to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children 1-16 years old
- Diagnosed with JIA at their first visit to the PRC
Key exclusion criteria (2 listed)
- Children that did not fulfil the criteria for JIA
- Children/parents who could not understand the Swedish language.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JASP-1patients following the Juvenile Arthritis Support Program at the Pediatric Rheumatology Clinic | Behavioural | JASP-1 group |
Primary outcome
Rate of Patient Reported Experienced Measures (PREM)
Time frame: 12 months
A study specific PREM questionnaire with 16 items. 5 point likert scale
3 secondary outcomes
Rate of Overall perceived health
Time frame: 12 months
Rate of Child Health Activity Questionnaire (CHAQ)
Time frame: 12 months
Number of active joints
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2024.
- Derived from this study: PubMed 39143588Mordrup K, Jungner JG, Brostrom E, Palmblad K, Bartholdson C. Benefits of a Juvenile Arthritis Support Program (JASP-1) for children recently diagnosed with Juvenile Idiopathic Arthritis and their parents. BMC Rheumatol. 2024 Aug 15;8(1):35. doi: 10.1186/s41927-024-00404-8.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eva Broström, Professor principal investigator
Supervisor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing JASP-1 in people with JIA and Support Program, run by Region Stockholm at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Patient Reported Experienced Measures (PREM) (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06284616, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2024.