A Pilot Randomised Controlled Trial of a Volunteer Health Champion Intervention to Support People With Severe Mental Illness to Improve Their Physical Health

King's College London1 site in 1 country100 target enrollmentApril 2, 2020

ConditionsSchizophrenia Bipolar Disorder Major Depressive Disorder

Overview

Phase: N/A
Intervention: Not specified
Conditions: Schizophrenia
Sponsor: King's College London
Enrollment: 100
Locations: 1
Primary Endpoint: EQ-5D-3L
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

April 2, 2020

End Date

May 30, 2022

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

King's College London

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

EQ-5D-3L

Time Frame: Change in outcome from baseline at 9 months and 15 months

Physical health related quality of life measure-The descriptive system element of the EQ-5D questionnaire produces a 5-digit health state profile that represents the level of reported problems on each of the five dimensions of health. A higher score indicates poorer health. into a single summary number.

Secondary Outcomes

Multimorbidity Treatment Burden Questionnaire(Change in outcome from baseline at 9 months and 15 months)
Health screenings in last 6 months(change in number of health screenings from baseline at 9 months and 15 months)
Recovering Quality of Life Questionnaire-ReQOL(Change in outcome from baseline at 9 months and 15 months)
Patient Activation Measure(Change in outcome from baseline at 9 months and 15 months)
De Jong Gierveld Loneliness Scale(Change in outcome from baseline at 9 months and 15 months)