Use of Involvement Matrix in Cerebral Palsy Into Spain and Brazil (InMatrix-CP)

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

Study Overview

• Status: Recruiting
• Conditions: Patient Participation; Family Research; Public and Patient Involvement; Participation
• Intervention / Treatment: Other: co-design in the intervention manual elaboration to increase the participation in the community

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 Type: Observational
• Enrollment (Anticipated): 24

Contacts and Locations

• Study Contact: Name: Rocío Palomo-Carrión, PhD; Phone Number: +34606417213; Email: Rocio.Palomo@uclm.es

Study Locations

• Spain
  • Toledo, Spain, 45071
    • Recruiting
    • University of Castilla-La Mancha
    • Contact: Rocío C Palomo-Carrión; Phone Number: +34606417213; Email: Rocio.Palomo@uclm.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 17 years (Child)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

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).

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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.

Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	At baseline to know how is the participation in young people to increase it in the works groups.

Collaborators and Investigators

• Sponsor: University of Castilla-La Mancha

Publications and helpful links

General 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): February 1, 2022
• Primary Completion (Anticipated): May 30, 2022
• Study Completion (Anticipated): September 30, 2022

Study Registration Dates

• First Submitted: December 5, 2021
• First Submitted That Met QC Criteria: January 17, 2022
• First Posted (Actual): January 28, 2022

Study Record Updates

• Last Update Posted (Actual): January 28, 2022
• Last Update Submitted That Met QC Criteria: January 17, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: family; research project; co-design
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Damage, Chronic; Cerebral Palsy
• Other Study ID Numbers: Rpalomo02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: The protocol study will be shared with other researchers

Drug and device information, study documents

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