Back to resultsA Pilot Randomised Controlled Trial of a Health Champion Intervention
Primary Purpose
Schizophrenia, Bipolar Disorder, Major Depressive Disorder
Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Health Champions intervention
Control group-treatment as usual
Sponsored by
About this trial
This is an interventional health services research trial for Schizophrenia
Eligibility Criteria
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
Sites / Locations
- King's College London
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Intervention
Control
Arm Description
Will receive the Health Champion intervention
Treatment as usual
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
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.
Multimorbidity Treatment Burden Questionnaire
Burden of illness with minimum score of 0 and maximum score of 50 with higher score indicating higher burden
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
Health screenings in last 6 months
Number of health screenings in last 6 months
Full Information
NCT ID
NCT04124744
First Posted
October 9, 2019
Last Updated
February 19, 2020
Sponsor
King's College London
Collaborators
South London and Maudsley NHS Foundation Trust
1. Study Identification
Unique Protocol Identification Number
NCT04124744
Brief Title
A Pilot Randomised Controlled Trial of a Health Champion Intervention
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Unknown status
Study Start Date
April 2, 2020 (Anticipated)
Primary Completion Date
January 30, 2022 (Anticipated)
Study Completion Date
May 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
King's College London
Collaborators
South London and Maudsley NHS Foundation Trust
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Bipolar Disorder, Major Depressive Disorder
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Will receive the Health Champion intervention
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Treatment as usual
Intervention Type
Other
Intervention Name(s)
Health Champions intervention
Intervention Description
Health Champions are trained volunteers who will support service users with their physical health goals over 9 months, meeting once a week
Intervention Type
Other
Intervention Name(s)
Control group-treatment as usual
Intervention Description
Participants will receive treatment as usual from their Community Mental Health Team
Primary Outcome Measure Information:
Title
EQ-5D-3L
Description
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.
Time Frame
Change in outcome from baseline at 9 months and 15 months
Secondary Outcome Measure Information:
Title
Recovering Quality of Life Questionnaire-ReQOL
Description
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
Time Frame
Change in outcome from baseline at 9 months and 15 months
Title
Patient Activation Measure
Description
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.
Time Frame
Change in outcome from baseline at 9 months and 15 months
Title
Multimorbidity Treatment Burden Questionnaire
Description
Burden of illness with minimum score of 0 and maximum score of 50 with higher score indicating higher burden
Time Frame
Change in outcome from baseline at 9 months and 15 months
Title
De Jong Gierveld Loneliness Scale
Description
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
Time Frame
Change in outcome from baseline at 9 months and 15 months
Title
Health screenings in last 6 months
Description
Number of health screenings in last 6 months
Time Frame
change in number of health screenings from baseline at 9 months and 15 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
King's College London
City
London
ZIP/Postal Code
SE5 8AF
Country
United Kingdom
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julie Williams
Phone
447920831414
Email
julie.williams@kcl.ac.uk
Email
julie.williams@kcl.ac.uk
First Name & Middle Initial & Last Name & Degree
Julie Williams
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
Citations:
PubMed Identifier
34059148
Citation
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.
Results Reference
derived
Learn more about this trial
A Pilot Randomised Controlled Trial of a Health Champion Intervention
We'll reach out to this number within 24 hrs