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| Name | Class |
|---|---|
| South London and Maudsley NHS Foundation Trust | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Will receive the Health Champion intervention |
|
| Control | Active Comparator | Treatment as usual |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Health Champions intervention | Other | Health Champions are trained volunteers who will support service users with their physical health goals over 9 months, meeting once a week |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
• Under 18 years of age
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| King's College London | London | SE5 8AF | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34059148 | Derived | 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. |
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Deidentified individual participant data for all primary and secondary outcome measures will be made available
Data will be available within 6 months of study completion
Data requests will be reviewed by the team. Requestors will be required to sign a Data Access Agreement.
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| D001714 | Bipolar Disorder |
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
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| Control group-treatment as usual | Other | Participants will receive treatment as usual from their Community Mental Health Team |
|
| 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 |
| D003866 | Depressive Disorder |