Research question/aim(s) | Objectives | Outcomes |
---|---|---|
Primary | To assess the acceptability and feasibility of the research trial, associated processes including the intervention, and assessments | Measured by: - Recruitment rates - Follow-up retention and questionnaire/outcome response rates - Attendance at sessions - Experience of involvement in the trial - Assessment of safety (SAEs) - Development of a manualised intervention |
Secondary | Physical Health: Body composition, blood pressure, cardiovascular fitness, health status Mental Health: Wellbeing, depression, anxiety, negative symptoms Behavioural: Physical activity, occupational functioning, diet, sleep | Physical health measures: - BMI - BP - Hip/waist/chest/neck circumference - Fitness test Mental health measures: - WEMWBS - HADS - SNS Behavioural measures: - SIMPAQ - MOHOST - 24-h diet recall - PROMIS SD Short-Form - PROMIS SRI Short Form Measures to support economic evaluation: - EQ-5D-5L - ReQoL - Engagement in care - LUNSERS - Ward activity |
Tertiary | Clarify training needs for delivering Motiv8 via a MDT care team, prior to the commencement of a definitive trial | - Qualitative interview - Adherence checklists - Feedback forms and interviews with facilitators - M-BacK Assessment and ESSEN-CES with clinical staff |