Children with Chronic ConditionPITChREHABNCT05547958
Parents InformaTion in Child REHABilitation
An observational study of Children with Chronic Condition, run by Fondation Ildys at 1 site in France.
Trial summary
In France, approximaly 3 million children have a chronic disease and require regular care such as paediatric rehabilitation. These cares are provided over long periods of time, most often throughout childhood and often into adulthood. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Children with Chronic Condition
- What is being tested?
- Focus group and online survey
- How many people
- 300 participants
- Where
- 1 siteFrance
- Study dates
- 24 Jun 2022to 31 Dec 2023
- Phase
- Observational
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Parents of a child (0-18 years) with a chronic condition and with a rehabilitation follow up will be invited by physicians in three pediatric rehabilitation centers to participate to the focus groups. The survey will be adressed nationally to the parents of children with a chronic condition and with a rehabilitation follow up.
Who may be able to join
- parents of a child (0-18 years) with a chronic condition and with a rehabiilitation follow up
Who cannot join
- parents who do not speak french
- parents with an intellectual disability (for the first part : focus group)
Trial locations and contacts
1 site in 1 country.
About this study
In France, approximaly 3 million children have a chronic disease and require regular care such as paediatric rehabilitation. These cares are provided over long periods of time, most often throughout childhood and often into adulthood. Paediatric rehabilitation care involves multidisciplinary team working closely with families. During follow-up rehabilitation, communication between the children, families and the professionals is essential. To this end, digital health solutions can be helpful.
Digital health solutions are rapidly emerging in the field of paediatric rehabilitation. In this context of emergence of digital health solutions, it is essential to identify the needs and expectations of families of children with a chronic disease.
This project aims to identify the key points in terms of information exchange on rehabilitation monitoring. To identify these needs, a mixed study will be carried out from June 2022 to June 2023 involving focus groups to gather qualitative informations on parent's needs in terms of information exchange through digital apps and quantitative research with a survey that will allow to prioritise these needs.
Read the detailed description
For the first part of the study, the researchers will conduct focus groups and interview parents about their experiences and perceptions of information exchange with rehabilitation professionals. All the participants will be parents of a child with a chronic disease, aged between 0 and 18 years and receiving paediatric rehabilitation care. The objective of this first part is to collect qualitative information on the needs of parents in terms of information exchange through digital applications.
With the analysis of the focus group, the researchers will define the hypothesis.
Then, a survey will be built and shared online in France during 3 months (2nd semester 2022).
With this survey, the objective is to identify the key points for the development of paediatric rehabilitation apps in terms of information exchange.
Quantitative data will be described with frequency, mean and standard deviation.
- Conditions
- Children with Chronic Condition
- Being tested
- Focus group and online survey
- Keywords
- m-health, mobile apps, chronic disease, informations, parents, pediatric, rehabilitation, communication
- Medical subject headings
- Chronic Disease, Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Focus group and online surveyOther
Focus group with parents of children with disabilities or chronic condition will be organized to identify hypotheses regarding their needs in terms of informations exchange with pediatric rehabilitation professionals about the rehabilitation care of their children.
Then, an online survey will be proposed to parents of children with disabilities or chronic condition in France to identify their needs regarding the development of apps that offer the feature to share informations with rehabilitation professionals.
What is being measured
The primary outcome is the main question the study is designed to answer.
key elements desired by parents in the apps aiming to share informations with rehabilitation professionals
The aim is to identify the key priority elements for parents in the design of mobile apps for information exchange with rehabilitation professionals.
Measured: june 2022 - june 2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2022
- Study start24 Jun 2022
- Primary completion31 Mar 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Children with Chronic ConditionStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Family based
- Time perspective
- Cross-sectional
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Ildys
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Brest
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05547958
- Sponsor's protocol ID
- IS-C4-2022-009
- Acronym
- PITChREHAB
- Status last verified
- Mar 2025
- First submitted
- 16 Sep 2022
- Last updated
- 12 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Nussbaum R, Kelly C, Quinby E, Mac A, Parmanto B, Dicianno BE. Systematic Review of Mobile Health Applications in Rehabilitation. Arch Phys Med Rehabil. 2019 Jan;100(1):115-127. doi: 10.1016/j.apmr.2018.07.439. Epub 2018 Aug 29.
PubMed 30171827Maguire M. Methods to support human-centred design. International Journal of Human-Computer Studies. 1 oct 2001;55(4):587-634.
O'Cathain A, Murphy E, Nicholl J. Three techniques for integrating data in mixed methods studies. BMJ. 2010 Sep 17;341:c4587. doi: 10.1136/bmj.c4587. No abstract available.
PubMed 20851841de Jongh T, Gurol-Urganci I, Vodopivec-Jamsek V, Car J, Atun R. Mobile phone messaging for facilitating self-management of long-term illnesses. Cochrane Database Syst Rev. 2012 Dec 12;12(12):CD007459. doi: 10.1002/14651858.CD007459.pub2.
PubMed 23235644
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parents InformaTion in Child REHABilitation
- ClinicalTrials.gov ID
- NCT05547958
- Acronym / sponsor ID
- PITChREHAB / IS-C4-2022-009
- Conditions
- Children with Chronic Condition
- Keywords
- m-health, mobile apps, chronic disease, informations, parents, pediatric, rehabilitation, communication
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Fondation IldysUniversity, hospital or other
- Collaborators
- University Hospital, Brest
- Study start
- 24 Jun 2022 (actual)
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 21 Sep 2022 (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.
In France, approximaly 3 million children have a chronic disease and require regular care such as paediatric rehabilitation. These cares are provided over long periods of time, most often throughout childhood and often into adulthood. Paediatric rehabilitation care involves multidisciplinary team working closely with families. During follow-up rehabilitation, communication between the children, families and the professionals is essential. To this end, digital health solutions can be helpful.
Digital health solutions are rapidly emerging in the field of paediatric rehabilitation. In this context of emergence of digital health solutions, it is essential to identify the needs and expectations of families of children with a chronic disease.
This project aims to identify the key points in terms of information exchange on rehabilitation monitoring. To identify these needs, a mixed study will be carried out from June 2022 to June 2023 involving focus groups to gather qualitative informations on parent's needs in terms of information exchange through digital apps and quantitative research with a survey that will allow to prioritise these needs.
Detailed description
For the first part of the study, the researchers will conduct focus groups and interview parents about their experiences and perceptions of information exchange with rehabilitation professionals. All the participants will be parents of a child with a chronic disease, aged between 0 and 18 years and receiving paediatric rehabilitation care. The objective of this first part is to collect qualitative information on the needs of parents in terms of information exchange through digital applications.
With the analysis of the focus group, the researchers will define the hypothesis.
Then, a survey will be built and shared online in France during 3 months (2nd semester 2022).
With this survey, the objective is to identify the key points for the development of paediatric rehabilitation apps in terms of information exchange.
Quantitative data will be described with frequency, mean and standard deviation.
Study design
- Observational model
- Family based
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Parents of a child (0-18 years) with a chronic condition and with a rehabilitation follow up will be invited by physicians in three pediatric rehabilitation centers to participate to the focus groups. The survey will be adressed nationally to the parents of children with a chronic condition and with a rehabilitation follow up.
Key inclusion criteria (1 listed)
- parents of a child (0-18 years) with a chronic condition and with a rehabiilitation follow up
Key exclusion criteria (2 listed)
- parents who do not speak french
- parents with an intellectual disability (for the first part : focus group)
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 |
|---|---|---|
| Focus group and online surveyFocus group with parents of children with disabilities or chronic condition will be organized to identify hypotheses regarding their needs in terms of informations exchange with pediatric rehabilitation professionals about the rehabilitation care of their children. Then, an online survey will be proposed to parents of children with disabilities or chronic condition in France to identify their needs regarding the development of apps that offer the feature to share informations with rehabilitation professionals. | Other | – |
Primary outcome
key elements desired by parents in the apps aiming to share informations with rehabilitation professionals
Time frame: june 2022 - june 2023
The aim is to identify the key priority elements for parents in the design of mobile apps for information exchange with rehabilitation professionals.
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 12 Mar 2025.
- Background: PubMed 30171827Nussbaum R, Kelly C, Quinby E, Mac A, Parmanto B, Dicianno BE. Systematic Review of Mobile Health Applications in Rehabilitation. Arch Phys Med Rehabil. 2019 Jan;100(1):115-127. doi: 10.1016/j.apmr.2018.07.439. Epub 2018 Aug 29.
- BackgroundMaguire M. Methods to support human-centred design. International Journal of Human-Computer Studies. 1 oct 2001;55(4):587-634.
- Background: PubMed 20851841O'Cathain A, Murphy E, Nicholl J. Three techniques for integrating data in mixed methods studies. BMJ. 2010 Sep 17;341:c4587. doi: 10.1136/bmj.c4587. No abstract available.
- Background: PubMed 23235644de Jongh T, Gurol-Urganci I, Vodopivec-Jamsek V, Car J, Atun R. Mobile phone messaging for facilitating self-management of long-term illnesses. Cochrane Database Syst Rev. 2012 Dec 12;12(12):CD007459. doi: 10.1002/14651858.CD007459.pub2.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Children with Chronic Condition, run by Fondation Ildys at 1 site in France.
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 1 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 12 Mar 2025. 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 France. 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?
key elements desired by parents in the apps aiming to share informations with rehabilitation professionals (time frame: june 2022 - june 2023). 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 NCT05547958, which also lists 4 linked publications.
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 12 Mar 2025.