Use of Involvement Matrix in Cerebral Palsy Into Spain and Brazil

NCT ID: NCT05214352

Last Updated: 2022-01-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

24 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-02-01

Study Completion Date

2022-09-30

Brief Summary

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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

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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 ".

Conditions

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Public and Patient Involvement Patient Participation Family Research Participation

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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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.

co-design in the intervention manual elaboration to increase the participation in the community

Intervention Type OTHER

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.

Interventions

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co-design in the intervention manual elaboration to increase the participation in the community

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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
Minimum Eligible Age

12 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Castilla-La Mancha

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of Castilla-La Mancha

Toledo, , Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Rocío Palomo-Carrión, PhD

Role: CONTACT

+34606417213

Facility Contacts

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Rocío C Palomo-Carrión

Role: primary

+34606417213

References

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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.

Reference Type RESULT
PMID: 29440127 (View on PubMed)

Alderson 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.

Reference Type RESULT
PMID: 31115138 (View on PubMed)

Forsyth 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.

Reference Type RESULT
PMID: 30915233 (View on PubMed)

Costello 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.

Reference Type RESULT
PMID: 31625656 (View on PubMed)

Boland 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.

Reference Type RESULT
PMID: 30658670 (View on PubMed)

Smits 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.

Reference Type RESULT
PMID: 32550002 (View on PubMed)

van 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.

Reference Type RESULT
PMID: 33005440 (View on PubMed)

Other Identifiers

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Rpalomo02

Identifier Type: -

Identifier Source: org_study_id

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