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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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04124744
Enrollment
100
Registered
2019-10-11
Start date
2020-04-02
Completion date
2022-05-30
Last updated
2020-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bipolar Disorder, Major Depressive Disorder, Schizophrenia

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.

Interventions

OTHERHealth Champions intervention

Health Champions are trained volunteers who will support service users with their physical health goals over 9 months, meeting once a week

OTHERControl group-treatment as usual

Participants will receive treatment as usual from their Community Mental Health Team

Sponsors

South London and Maudsley NHS Foundation Trust
CollaboratorOTHER
King's College London
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
EQ-5D-3LChange in outcome from baseline at 9 months and 15 monthsPhysical 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

MeasureTime frameDescription
Recovering Quality of Life Questionnaire-ReQOLChange in outcome from baseline at 9 months and 15 monthsMental 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 MeasureChange in outcome from baseline at 9 months and 15 monthsMeasure 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.
Multimorbidity Treatment Burden QuestionnaireChange in outcome from baseline at 9 months and 15 monthsBurden of illness with minimum score of 0 and maximum score of 50 with higher score indicating higher burden
De Jong Gierveld Loneliness ScaleChange in outcome from baseline at 9 months and 15 monthsMeasure 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
Health screenings in last 6 monthschange in number of health screenings from baseline at 9 months and 15 monthsNumber of health screenings in last 6 months

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 15, 2026