A Pilot Randomised Controlled Trial of a Health Champion Intervention

Study Overview
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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.

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

Conditions
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Schizophrenia, Bipolar Disorder, Major Depressive Disorder

Intervention / Treatment
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* Other: Health Champions intervention
* Other: Control group-treatment as usual


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Will receive the Health Champion intervention | Other: Health Champions intervention<br>* Health Champions are trained volunteers who will support service users with their physical health goals over 9 months, meeting once a week<br>|
| Active Comparator: Control<br>Treatment as usual | Other: Control group-treatment as usual<br>* Participants will receive treatment as usual from their Community Mental Health Team<br>|

What is the study measuring?
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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 |