Public and Patient InvolvementInMatrix-CPNCT05214352
Use of Involvement Matrix in Cerebral Palsy Into Spain and Brazil
An observational study of Public and Patient Involvement and Patient Participation, run by University of Castilla-La Mancha at 1 site in Spain.
Trial summary
Application of Involvement Matrix in young people with Cerebral Palsy (GMFCS levels IV and V) from 12 to 17 years old with the purpose of improving the participation of this group in community leisure activities Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Public and Patient Involvement, Patient Participation, Family Research
- What is being tested?
- co-design in the intervention manual elaboration to increase the participation in the community
- How many people
- 24 participants
- Where
- 1 siteSpain
- Study dates
- 1 Feb 2022to 30 Sep 2022
- 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 12 to 17 years
- All sexes
- Child
Study population: The research will be carried out remotely (online) with 9 young people from 12 to 17 years old with cerebral palsy, GMFCS IV and V, their families and 6 healthcare professionals (physiotherapists and occupational therapists).
Who may be able to join
- young people diagnosed with Cerebral Palsy (CP) from 12 to 17 years old, levels IV-V within the Gross Motor Function Classification System (GMFCS)
- preserved cognitive status
- families willing to cooperate with the research, as well as the physiotherapists and occupational therapists that accept to participate in the study.
Who cannot join
- young people with an inadequate cognitive level (CI <70) to answer questions and collaborate, with other problems or diseases not associated with CP
- non-cooperative families, and physiotherapists and occupational therapists who do not agree to sign the informed consent form for inclusion in the study
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
University of Castilla-La Mancha
Toledo, 45071
Rocío C Palomo-Carrión, +34606417213, Rocio.Palomo@uclm.es
About this study
Official title: Using the Involvement Matrix for the Implication of Young People With Cerebral Palsy in the Elaboration of an Intervention Program to Encourage Participation in the Community.
Application of Involvement Matrix in young people with Cerebral Palsy (GMFCS levels IV and V) from 12 to 17 years old with the purpose of improving the participation of this group in community leisure activities
Read the detailed description
The "Involvement Matrix" is a tool, which was built with organizations of patients, patients, parents, educators, doctors, and researchers, and supports the conversation and discussion about roles and expectations, aiming at authentic and sustainable alliances in research. It includes five participation roles: Listener, Co-thinker, Advisor, Partner and Decision-maker in three main phases of the research project: Preparation, Execution, and Implementation. The Involvement Matrix aims to be a guide for the project leader or researcher to dialogue with patients (public). Using the Matrix, agreements are made about the roles that the patient wishes to acquire and how they are involved in each phase. In this way, the empty cells in the Matrix are filled with specific activities.
Using the Involvement Matrix before and during the different phases of a project has the potential to help researchers and patients reach clear agreements about research and their participation. The tool can be used prospectively, to discuss the possible roles of patients in the different phases of the projects, and retrospectively to discuss whether the roles have been satisfactorily performed. It is known that some studies with PPI had children and young people with the most severe disabilities as active participants and with non-verbal communication, thus, the most effective ways to collaborate with this group should be developed and enhanced to encourage their involvement in research. Although periodicals on the PPI are increasing rapidly, a solid evidence base of the impact of the PPI on research is still lacking, as many publications relate to the PPI process in general and without addressing the real impact of the PPI on the research.
In this sense, the goal of this project is "to develop (co-production) an intervention program for young people with Cerebral Palsy (GMFCS levels IV and V) from 12 to 17 years old with the purpose of improving the participation of this group in community leisure activities and assess the viability of public involvement in the research project through the use of the Involvement Matrix ".
- Being tested
- co-design in the intervention manual elaboration to increase the participation in the community
- Keywords
- family, research project, co-design
- Medical subject headings
- Patient Participation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
co-design in the intervention manual elaboration to increase the participation in the communityOther
It will co-design an intervention manual between all participants (families, young people with cerebral palsy and therapists) and researchers, using the involvement matrix to increase the participation of young people in the community.
Different focus grous will be created to work together and various online meetings, masterclass, workshops to increase the knowlodge in all groups.
| Study group | Role | What they receive |
|---|---|---|
| young population with cerebral palsy-Families-Therapist and researchers | The principal group is designed by all people who composed the research and who will work together in the intervention manual elaboration on the participation in the community. Receives: Other: co-design in the intervention manual elaboration to increase the participation in the community |
What is being measured
The primary outcome is the main question the study is designed to answer.
open questions and surveries
to obtain the experiences from young people with cerebral palsy, families and therapist.
These questionnaires will be designed by patients and therapist to introduce the correct information
Measured: 12 weeks
The PEM-CY: Participation and Environment Measure - Children and Youth
is a measure that evaluates participation in the home, at school, and in the community, alongside environmental factors within each of these settings.
Measured: At baseline to know how is the participation in young people to increase it in the works groups.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2022
- Study start1 Feb 2022 (estimated)
- Primary completion30 May 2022 (estimated)
- Study completion30 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Public and Patient InvolvementStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Castilla-La Mancha
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05214352
- Sponsor's protocol ID
- Rpalomo02
- Acronym
- InMatrix-CP
- Status last verified
- Jan 2022
- First submitted
- 5 Dec 2021
- Last updated
- 28 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The protocol study will be shared with other researchers
Publications
Mitchell SJ, Slowther AM, Coad J, Akhtar S, Hyde E, Khan D, Dale J. Ethics and patient and public involvement with children and young people. Arch Dis Child Educ Pract Ed. 2019 Aug;104(4):195-200. doi: 10.1136/archdischild-2017-313480. Epub 2018 Feb 9.
PubMed 29440127Alderson H, Brown R, Smart D, Lingam R, Dovey-Pearce G. 'You've come to children that are in care and given us the opportunity to get our voices heard': The journey of looked after children and researchers in developing a Patient and Public Involvement group. Health Expect. 2019 Aug;22(4):657-665. doi: 10.1111/hex.12904. Epub 2019 May 21.
PubMed 31115138Forsyth F, Saunders C, Elmer A, Badger S. 'A group of totally awesome people who do stuff' - a qualitative descriptive study of a children and young people's patient and public involvement endeavour. Res Involv Engagem. 2019 Mar 12;5:13. doi: 10.1186/s40900-019-0148-0. eCollection 2019.
PubMed 30915233Costello W, Dorris E. Laying the groundwork: Building relationships for public and patient involvement in pre-clinical paediatric research. Health Expect. 2020 Feb;23(1):96-105. doi: 10.1111/hex.12972. Epub 2019 Oct 18.
PubMed 31625656Boland L, Graham ID, Legare F, Lewis K, Jull J, Shephard A, Lawson ML, Davis A, Yameogo A, Stacey D. Barriers and facilitators of pediatric shared decision-making: a systematic review. Implement Sci. 2019 Jan 18;14(1):7. doi: 10.1186/s13012-018-0851-5.
PubMed 30658670Smits DW, van Meeteren K, Klem M, Alsem M, Ketelaar M. Designing a tool to support patient and public involvement in research projects: the Involvement Matrix. Res Involv Engagem. 2020 Jun 16;6:30. doi: 10.1186/s40900-020-00188-4. eCollection 2020.
PubMed 32550002van Schelven F, van der Meulen E, Kroeze N, Ketelaar M, Boeije H. Patient and public involvement of young people with a chronic condition: lessons learned and practical tips from a large participatory program. Res Involv Engagem. 2020 Sep 30;6:59. doi: 10.1186/s40900-020-00234-1. eCollection 2020.
PubMed 33005440
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using the Involvement Matrix for the Implication of Young People With Cerebral Palsy in the Elaboration of an Intervention Program to Encourage Participation in the Community.
- ClinicalTrials.gov ID
- NCT05214352
- Acronym / sponsor ID
- InMatrix-CP / Rpalomo02
- Keywords
- family, research project, co-design
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- University of Castilla-La ManchaUniversity, hospital or other
- Study start
- 1 Feb 2022 (estimated)
- Primary completion
- 30 May 2022 (estimated)
- Study completion
- 30 Sep 2022 (estimated)
- First posted
- 28 Jan 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.
Application of Involvement Matrix in young people with Cerebral Palsy (GMFCS levels IV and V) from 12 to 17 years old with the purpose of improving the participation of this group in community leisure activities
Detailed description
The "Involvement Matrix" is a tool, which was built with organizations of patients, patients, parents, educators, doctors, and researchers, and supports the conversation and discussion about roles and expectations, aiming at authentic and sustainable alliances in research. It includes five participation roles: Listener, Co-thinker, Advisor, Partner and Decision-maker in three main phases of the research project: Preparation, Execution, and Implementation. The Involvement Matrix aims to be a guide for the project leader or researcher to dialogue with patients (public). Using the Matrix, agreements are made about the roles that the patient wishes to acquire and how they are involved in each phase. In this way, the empty cells in the Matrix are filled with specific activities.
Using the Involvement Matrix before and during the different phases of a project has the potential to help researchers and patients reach clear agreements about research and their participation. The tool can be used prospectively, to discuss the possible roles of patients in the different phases of the projects, and retrospectively to discuss whether the roles have been satisfactorily performed. It is known that some studies with PPI had children and young people with the most severe disabilities as active participants and with non-verbal communication, thus, the most effective ways to collaborate with this group should be developed and enhanced to encourage their involvement in research. Although periodicals on the PPI are increasing rapidly, a solid evidence base of the impact of the PPI on research is still lacking, as many publications relate to the PPI process in general and without addressing the real impact of the PPI on the research.
In this sense, the goal of this project is "to develop (co-production) an intervention program for young people with Cerebral Palsy (GMFCS levels IV and V) from 12 to 17 years old with the purpose of improving the participation of this group in community leisure activities and assess the viability of public involvement in the research project through the use of the Involvement Matrix ".
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| young population with cerebral palsy-Families-Therapist and researchers | – | Other: co-design in the intervention manual elaboration to increase the participation in the communityThe principal group is designed by all people who composed the research and who will work together in the intervention manual elaboration on the participation in the community. |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Age groups
- Child
- Study population
- The research will be carried out remotely (online) with 9 young people from 12 to 17 years old with cerebral palsy, GMFCS IV and V, their families and 6 healthcare professionals (physiotherapists and occupational therapists).
Key inclusion criteria (3 listed)
- young people diagnosed with Cerebral Palsy (CP) from 12 to 17 years old, levels IV-V within the Gross Motor Function Classification System (GMFCS)
- preserved cognitive status
- families willing to cooperate with the research, as well as the physiotherapists and occupational therapists that accept to participate in the study.
Key exclusion criteria (2 listed)
- young people with an inadequate cognitive level (CI <70) to answer questions and collaborate, with other problems or diseases not associated with CP
- non-cooperative families, and physiotherapists and occupational therapists who do not agree to sign the informed consent form for inclusion in the study
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 |
|---|---|---|
| co-design in the intervention manual elaboration to increase the participation in the communityIt will co-design an intervention manual between all participants (families, young people with cerebral palsy and therapists) and researchers, using the involvement matrix to increase the participation of young people in the community. Different focus grous will be created to work together and various online meetings, masterclass, workshops to increase the knowlodge in all groups. | Other | young population with cerebral palsy-Families-Therapist and researchers |
Primary outcome
open questions and surveries
Time frame: 12 weeks
to obtain the experiences from young people with cerebral palsy, families and therapist. These questionnaires will be designed by patients and therapist to introduce the correct information
The PEM-CY: Participation and Environment Measure - Children and Youth
Time frame: At baseline to know how is the participation in young people to increase it in the works groups.
is a measure that evaluates participation in the home, at school, and in the community, alongside environmental factors within each of these settings.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2022.
- Results publication: PubMed 29440127Mitchell SJ, Slowther AM, Coad J, Akhtar S, Hyde E, Khan D, Dale J. Ethics and patient and public involvement with children and young people. Arch Dis Child Educ Pract Ed. 2019 Aug;104(4):195-200. doi: 10.1136/archdischild-2017-313480. Epub 2018 Feb 9.
- Results publication: PubMed 31115138Alderson H, Brown R, Smart D, Lingam R, Dovey-Pearce G. 'You've come to children that are in care and given us the opportunity to get our voices heard': The journey of looked after children and researchers in developing a Patient and Public Involvement group. Health Expect. 2019 Aug;22(4):657-665. doi: 10.1111/hex.12904. Epub 2019 May 21.
- Results publication: PubMed 30915233Forsyth F, Saunders C, Elmer A, Badger S. 'A group of totally awesome people who do stuff' - a qualitative descriptive study of a children and young people's patient and public involvement endeavour. Res Involv Engagem. 2019 Mar 12;5:13. doi: 10.1186/s40900-019-0148-0. eCollection 2019.
- Results publication: PubMed 31625656Costello W, Dorris E. Laying the groundwork: Building relationships for public and patient involvement in pre-clinical paediatric research. Health Expect. 2020 Feb;23(1):96-105. doi: 10.1111/hex.12972. Epub 2019 Oct 18.
- Results publication: PubMed 30658670Boland L, Graham ID, Legare F, Lewis K, Jull J, Shephard A, Lawson ML, Davis A, Yameogo A, Stacey D. Barriers and facilitators of pediatric shared decision-making: a systematic review. Implement Sci. 2019 Jan 18;14(1):7. doi: 10.1186/s13012-018-0851-5.
- Results publication: PubMed 32550002Smits DW, van Meeteren K, Klem M, Alsem M, Ketelaar M. Designing a tool to support patient and public involvement in research projects: the Involvement Matrix. Res Involv Engagem. 2020 Jun 16;6:30. doi: 10.1186/s40900-020-00188-4. eCollection 2020.
- Results publication: PubMed 33005440van Schelven F, van der Meulen E, Kroeze N, Ketelaar M, Boeije H. Patient and public involvement of young people with a chronic condition: lessons learned and practical tips from a large participatory program. Res Involv Engagem. 2020 Sep 30;6:59. doi: 10.1186/s40900-020-00234-1. eCollection 2020.
- Individual participant dataSharing planned: No. The protocol study will be shared with other researchers
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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.
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 Public and Patient Involvement and Patient Participation, run by University of Castilla-La Mancha at 1 site in Spain.
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 3 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: status not confirmed, as of the sponsor's last update on 28 Jan 2022. 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 Spain. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rocío Palomo-Carrión, PhD (+34606417213, Rocio.Palomo@uclm.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
open questions and surveries (time frame: 12 weeks). The study lists 2 primary outcomes in all. 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 NCT05214352, which also lists 7 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 28 Jan 2022.