SchizophreniaNCT04124744
A Pilot Randomised Controlled Trial of a Health Champion Intervention
A study testing Health Champions intervention in people with Schizophrenia and Bipolar Disorder, run by King's College London at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Schizophrenia, Bipolar Disorder, Major Depressive Disorder
- What is being tested?
- Health Champions intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 2 Apr 2020to 30 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- • Under 18 years of age
- Unable to give informed consent
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
King's College London
London, SE5 8AF
Julie Williams, 447920831414, julie.williams@kcl.ac.uk
julie.williams@kcl.ac.uk
About this study
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
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.
- Conditions
- Schizophrenia, Bipolar Disorder, Major Depressive Disorder
- Being tested
- Health Champions intervention, Control group-treatment as usual
- Medical subject headings
- Schizophrenia, Bipolar Disorder, Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health Champions interventionOther
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 usualOther
Participants will receive treatment as usual from their Community Mental Health Team
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Will receive the Health Champion intervention Receives: Other: Health Champions intervention |
| Control | Active comparator | Treatment as usual Receives: Other: Control group-treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change in outcome from baseline at 9 months and 15 months
Secondary outcomes (5)
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
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: change in number of health screenings from baseline at 9 months and 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2019
- Study start2 Apr 2020 (estimated)
- Primary completion30 Jan 2022 (estimated)
- Study completion30 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by King's College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Collaborators
- South London and Maudsley NHS Foundation Trust
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04124744
- Sponsor's protocol ID
- 270290
- Status last verified
- Oct 2019
- First submitted
- 9 Oct 2019
- Last updated
- 20 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified individual participant data for all primary and secondary outcome measures will be made available
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.
PubMed 34059148
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04124744
- Acronym / sponsor ID
- 270290
- Conditions
- Schizophrenia, Bipolar Disorder, Major Depressive Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Collaborators
- South London and Maudsley NHS Foundation Trust
- Study start
- 2 Apr 2020 (estimated)
- Primary completion
- 30 Jan 2022 (estimated)
- Study completion
- 30 May 2022 (estimated)
- First posted
- 11 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Health Champions interventionWill receive the Health Champion intervention |
| Control | Active comparator | Other: Control group-treatment as usualTreatment as usual |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- • Under 18 years of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Health Champions interventionHealth Champions are trained volunteers who will support service users with their physical health goals over 9 months, meeting once a week | Other | Intervention |
| Control group-treatment as usualParticipants will receive treatment as usual from their Community Mental Health Team | Other | Control |
Primary outcome
EQ-5D-3L
Time frame: 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.
5 secondary outcomes
Recovering Quality of Life Questionnaire-ReQOL
Time frame: Change in outcome from baseline at 9 months and 15 months
Patient Activation Measure
Time frame: Change in outcome from baseline at 9 months and 15 months
Multimorbidity Treatment Burden Questionnaire
Time frame: Change in outcome from baseline at 9 months and 15 months
De Jong Gierveld Loneliness Scale
Time frame: Change in outcome from baseline at 9 months and 15 months
Health screenings in last 6 months
Time frame: change in number of health screenings from baseline at 9 months and 15 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2020.
- Derived from this study: PubMed 34059148Williams 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.
- Individual participant dataSharing planned: Yes. Deidentified individual participant data for all primary and secondary outcome measures will be made available
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health Champions intervention in people with Schizophrenia and Bipolar Disorder, run by King's College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EQ-5D-3L (time frame: Change in outcome from baseline at 9 months and 15 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04124744, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2020.