A Pilot Randomised Controlled Trial of a Health Champion Intervention

NCT ID: NCT04124744

Last Updated: 2020-02-20

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

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-02

Study Completion Date

2022-05-30

Brief Summary

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This study is a pilot RCT to evaluate the effectiveness and implementation challenges of an intervention using volunteer 'Health Champions' matched with service users to support service their physical health goals.

Detailed Description

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Conditions

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Schizophrenia Bipolar Disorder Major Depressive Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Intervention

Will receive the Health Champion intervention

Group Type EXPERIMENTAL

Health Champions intervention

Intervention Type OTHER

Health Champions are trained volunteers who will support service users with their physical health goals over 9 months, meeting once a week

Control

Treatment as usual

Group Type ACTIVE_COMPARATOR

Control group-treatment as usual

Intervention Type OTHER

Participants will receive treatment as usual from their Community Mental Health Team

Interventions

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Health Champions intervention

Health Champions are trained volunteers who will support service users with their physical health goals over 9 months, meeting once a week

Intervention Type OTHER

Control group-treatment as usual

Participants will receive treatment as usual from their Community Mental Health Team

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Older than 18 years old with a serious mental illness (Mood \[affective\] disorders \[F30-F39\], Schizophrenia, schizotypal, delusional, and other non-mood psychotic disorders \[F20-F29\]).
* Currently with a Community Mental Health Team (CMHT).
* Want to make changes to their physical health.
* Has capacity to give written informed consent to take part in the project.
* Able to provide a named Care Coordinator or Point of Contact reachable in the event of a health crisis.

Exclusion Criteria

* • Under 18 years of age

* Unable to give informed consent
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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South London and Maudsley NHS Foundation Trust

OTHER

Sponsor Role collaborator

King's College London

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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King's College London

London, , United Kingdom

Site Status

Countries

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United Kingdom

Facility Contacts

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Julie Williams

Role: primary

447920831414

Role: backup

References

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Williams J, Fairbairn E, McGrath R, Bakolis I, Healey A, Akpan U, Mdudu I, Gaughran F, Sadler E, Khadjesari Z, Lillywhite K, Sevdalis N. A feasibility hybrid II randomised controlled trial of volunteer 'Health Champions' supporting people with serious mental illness manage their physical health: study protocol. Pilot Feasibility Stud. 2021 May 31;7(1):116. doi: 10.1186/s40814-021-00854-8.

Reference Type DERIVED
PMID: 34059148 (View on PubMed)

Other Identifiers

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270290

Identifier Type: -

Identifier Source: org_study_id

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