A Pilot Randomised Controlled Trial of a Health Champion Intervention

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

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.

Study Overview

• Status: Unknown
• Conditions: Schizophrenia; Bipolar Disorder; Major Depressive Disorder
• Intervention / Treatment: Other: Health Champions intervention; Other: Control group-treatment as usual

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, SE5 8AF
    • King's College London

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: HEALTH_SERVICES_RESEARCH
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Intervention; Will receive the Health Champion intervention	Other: 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
ACTIVE_COMPARATOR: Control; Treatment as usual	Other: Control group-treatment as usual; Participants will receive treatment as usual from their Community Mental Health Team

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
EQ-5D-3L	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.	Change in outcome from baseline at 9 months and 15 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recovering Quality of Life Questionnaire-ReQOL	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	Change in outcome from baseline at 9 months and 15 months
Patient Activation Measure	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.	Change in outcome from baseline at 9 months and 15 months
Multimorbidity Treatment Burden Questionnaire	Burden of illness with minimum score of 0 and maximum score of 50 with higher score indicating higher burden	Change in outcome from baseline at 9 months and 15 months
De Jong Gierveld Loneliness Scale	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	Change in outcome from baseline at 9 months and 15 months
Health screenings in last 6 months	Number of health screenings in last 6 months	change in number of health screenings from baseline at 9 months and 15 months

Collaborators and Investigators

• Sponsor: King's College London
• Collaborators: South London and Maudsley NHS Foundation Trust

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): April 2, 2020
• Primary Completion (ANTICIPATED): January 30, 2022
• Study Completion (ANTICIPATED): May 30, 2022

Study Registration Dates

• First Submitted: October 9, 2019
• First Submitted That Met QC Criteria: October 10, 2019
• First Posted (ACTUAL): October 11, 2019

Study Record Updates

• Last Update Posted (ACTUAL): February 20, 2020
• Last Update Submitted That Met QC Criteria: February 19, 2020
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Mood Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Bipolar and Related Disorders; Depressive Disorder; Schizophrenia; Disease; Bipolar Disorder; Depressive Disorder, Major
• Other Study ID Numbers: 270290

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Deidentified individual participant data for all primary and secondary outcome measures will be made available
• IPD Sharing Time Frame: Data will be available within 6 months of study completion
• IPD Sharing Access Criteria: Data requests will be reviewed by the team. Requestors will be required to sign a Data Access Agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

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