A Pilot Randomised Controlled Trial of a Health Champion Intervention

Schizophrenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04124744
• Other study ID #: 270290
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 2, 2020
• Est. completion date: May 30, 2022

Study information

• Verified date: October 2019
• Source: King's College London
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: May 30, 2022
• Est. primary completion date: January 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bipolar Disorder
• Depressive Disorder
• Depressive Disorder, Major
• Disease
• Major Depressive Disorder
• Schizophrenia

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
• Control group-treatment as usual
Participants will receive treatment as usual from their Community Mental Health Team

Locations

Country	Name	City	State
United Kingdom	King's College London	London

Sponsors (2)

Lead Sponsor	Collaborator
King's College London	South London and Maudsley NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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