CClinicalTrials.gg
Not yet recruitingNCT064342854PiQUpdated May 30, 2024

A 4Pi Questionnaire for Service User and Carer Involvement Experience

An observational study in Mental Health, sponsored by King's College London. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-05-30.

Sponsored by King's College London · Observational

From the registry’s dates

  • Primary completion was expected by Sep 2024, 2 years ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
8
Ages
18 Years and older
Sex
All
01

Study summary

Service user (SU) and carer involvement in planning healthcare services and improving their quality is crucial and required by the NHS. Research has shown that SUs and carers can greatly benefit healthcare; however, effective involvement can be challenging due to barriers such as language, lack of training or support, and undervaluing the input of patients and the public compared to that of professionals.

The 4Pi framework sets out standards for good involvement practices by focusing on principles such as respect and inclusivity, shared purposes, diversity, accurate planning, and ensuring involvement leads to improvements in people's lives.

This study, funded by King's Health Partners, aims to take the 4Pi framework a step further by developing a questionnaire to evaluate how well patients and carers are involved in improving mental health services. The researchers will work closely with SUs and carers to create this questionnaire, with the ultimate goal to ensure that involvement in healthcare leads to real, positive changes for everyone involved.

The research questions for the study is: to what extent, from SUs and carers' perspectives, is the questionnaire understandable and successful in capturing the meaning of 4Pi domains?

To be eligible for the study, participants need to be at least 18 years old and have experience of involvement activities/projects in SLaM. Researchers, SUs, and carers will define the questionnaire to ensure it is understandable, comprehensive, and feasible; this will be done via virtual (or in person at Denmark Hill/King's College London campus depending on participants' preferences) group interviews. The questionnaire will then be piloted on a small sample of individuals, and the final questionnaire refined based on any potential additional feedback from them.

This study is part of the King's Improvement Science programme's research portfolio that is funded by King's Health Partners.

02

Conditions studied

  • Mental Health
03

In context

Lead sponsor

King's College London is the lead sponsor of 506 studies on the registry; 125 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Service users and carers with experience in service involvement activities.

Inclusion criteria

  1. be at least 18 years old;
  2. have experience of being involved in service involvement activities in SLaM NHS Foundation Trust.

Exclusion criteria

Exclusion Criteria:

a) No experience of being involved in service improvement activities.

05

Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
8 participants (estimated)
Patient registry
No

Interventions

  • OtherQuestionnaire development

    Cognitive interviewing group will be run to inform questionnaire development.

06

What researchers measure

Primary outcomes

  1. Questionnaire

    Time frame: Day 1

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 30, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06434285
Lead sponsor
King's College London
Collaborators
South London and Maudsley NHS Foundation Trust
Responsible party
Sponsor
First posted
May 30, 2024
Start date
Jun 24, 2024 (estimated)
Primary completion
Sep 30, 2024 (estimated)
Completion
Sep 30, 2024 (estimated)
Last update
May 30, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in May 2024. You cannot join it, but the record below documents what was studied.

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