A Pilot Randomised Controlled Trial of a Health Champion Intervention

Not Applicable

• Conditions: Major Depressive Disorder; Schizophrenia; Bipolar Disorder
• Interventions: Other: Health Champions intervention; Other: Control group-treatment as usual

• Registration Number: NCT04124744
• Lead Sponsor: King's College London

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2019-10
• Study First Submitted: 2019-10-09
• Study First Submitted QC: 2019-10-10
• Study First Posted: 2019-10-11
• Last Update Submitted: 2020-02-19
• Last Update Posted: 2020-02-20
• Study Start: 2020-04-02
• Primary Completion: 2022-01-30
• Study Completion: 2022-05-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Health Champions intervention	Will receive the Health Champion intervention
Control	Control group-treatment as usual	Treatment as usual

Primary Outcome Measures

Name	Time	Method
EQ-5D-3L	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 Outcome Measures

Name	Time	Method
Multimorbidity Treatment Burden Questionnaire	Change in outcome from baseline at 9 months and 15 months	Burden of illness with minimum score of 0 and maximum score of 50 with higher score indicating higher burden
Health screenings in last 6 months	change in number of health screenings from baseline at 9 months and 15 months	Number of health screenings in last 6 months
Recovering Quality of Life Questionnaire-ReQOL	Change in outcome from baseline at 9 months and 15 months	Mental health related quality of life with minimum score of 0 and maximum of 40 The minimum score is 0 and the maximum is 40, where 0 indicates poorest quality of life and 40 indicates the highest quality of life
Patient Activation Measure	Change in outcome from baseline at 9 months and 15 months	Measure of self management The responses match the respondents to one of four levels of 'activation', each of which reveals insight into a range of health-related characteristics, including behaviours and outcomes.
De Jong Gierveld Loneliness Scale	Change in outcome from baseline at 9 months and 15 months	Measure of loneliness. There are negatively (1-3) and positively (4-6) worded items. On the negatively worded items, the neutral and positive answers are scored as "1". Therefore, on questions 1-3 score Yes=1, More or less=1, and No=0. On the positively worded items, the neutral and negative answers are scored as "1". Therefore, on questions 4-6, score Yes=0, More or less=1, and No=1. This gives a possible range of scores from 0 to 6, which can be read as follows: (Least lonely) 0 - (Most lonely) 6

Trial Locations

Locations (1)

King's College London; 🇬🇧 London, United Kingdom