Specialty: Stroke, Primary sub-specialty: Rehabilitation
Conditions
Interventions
Participating sites will be randomised on a 1:1 basis to one of two study arms
Control arm: Participants receive standard care as provided by their treating clinician.
Sponsors
Bradford Teaching Hospitals NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 05/07/2017: Stroke Service Inclusion Criteria: 1. Encompasses primary and secondary care over a defined geographical area within the United Kingdom (UK) 2. Includes a stroke unit which fulfils the RCP guidelines definition of a stroke unit 3. Agree to try and establish a robust mechanism to identify all stroke survivors at four to six months post stroke. 4. Have the facilities and capacity to deliver the New Start intervention 5. Fully supportive of time required for New Start training, including two face to face away days and online training 6. Agreement to be involved via signed model Non-Commercial Agreement (mNCA) and local management approval Stroke survivor inclusion criteria: 1. At least four months and not more than six months since confirmed primary diagnosis of new stroke 2. Are residing in the community (i.e. not in a nursing or residential care home 3. Provide informed consent or consultee assent Carer inclusion criteria (participation optional): 1. Identified by the stroke survivor, as the main informal caregiver who provides the stroke survivor with support a minimum of once per week 2. Provided informed consent (i.e. implied via return of completed baseline questionnaire) Previous inclusion criteria: Stroke Service Inclusion Criteria: 1. Encompasses primary and secondary care over a defined geographical area within the United Kingdom (UK) 2. Includes a stroke unit which fulfils the RCP guidelines definition of a stroke unit 3. Agree to try and establish a robust mechanism to identify all stroke survivors at four to seven months post stroke. 4. Have the facilities and capacity to deliver the Moving Forward intervention 5. Fully supportive of time required for Moving Forward training, including two face to face away days and online training 6. Agreement to be involved via signed model Non-Commercial Agreement (mNCA) and local management approval Stroke survivor inclusion criteria: 1. At least four months and not more than seven months since confirmed primary diagnosis of new stroke 2. Are residing in the community (i.e. not in a nursing or residential care home 3. Provide written informed consent or consultee assent Carer inclusion criteria (participation optional): 1. Identified by the stroke survivor, as the main informal caregiver who provides the stroke survivor with support a minimum of once per week 2. Provided informed consent (i.e. implied via return of completed baseline questionnaire)
Exclusion criteria
Exclusion criteria: Current inclusion criteria: Stroke services exclusion criteria: 1. Previously participated in the development of the intervention; as part of this programme of research or are intending to implement the New Start intervention within the proposed duration of the study will not be eligible because these sites might be expected to have enhanced skills or knowledge about the New Start intervention 2. Stroke services that are currently delivering or planning to deliver a similar supported self-management intervention Stroke survivors exclusion criteria: It is unknown whether the Moving Forward intervention can be delivered to Stroke Survivors with other (specific) co-morbidities. Therefore, no exclusion criteria will be applied and reasons for not receiving care at 6 months post-stroke will be documented and used to inform eligibility criteria for a definitive trial. Carer exclusion criteria: Their stroke survivor does not consent for carer involvement. Previous exclusion criteria: Stroke services exclusion criteria: 1. Previously participated in the development of the intervention; as part of this programme of research or are intending to implement the Moving Forward intervention within the proposed duration of the study will not be eligible because these sites might be expected to have enhanced skills or knowledge about the Moving Forward intervention 2. Stroke services that are currently delivering or planning to deliver a similar supported self-management intervention Stroke survivors exclusion criteria: 1. Main requirement is palliative care 2. Have concurrent major illness which is likely to predominately determine care (e.g. in receipt of consistent medical input from a specialist other than stroke/neurologist) 3. Stroke survivors not resident within the geographical area covered by the stroke service Carer exclusion criteria: Their stroke survivor does not consent for carer involvement.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Acceptability of recruitment methods for sites is determined using site feasibility questionnaires and face to face/telephone discussions with site teams collected prior to trial opening 2. Acceptability of recruitment methods for participants is measured using screening data and face to face/telephone discussions with site teams throughout the recruitment period 3. Acceptability of implementation and delivery of the intervention is measured by collecting training records, collecting data on competency assessment, treatment records and data collected as part of a detailed process evaluation throughout the training recruitment and follow up period 4. Acceptability of collecting questionnaires at baseline, 3, 6 and 9 months is determined through number of patients who completed the questionnaires at baseline, 3, 6 and 9 months 5. Routinely offered services (usual care) is defined through feasibility questionnaires and face to face/telephone discussions with site teams, collected throughout the trial 6. Safety is measured by collecting adverse events continuously throughout the trial 7. Health economics analysis is conducted using the health economics resource use questionnaire, the EQ5D and the ICECAP-A at baseline, 3, 6 and 9 months | — |
Secondary
| Measure | Time frame |
|---|---|
| No secondary outcome measures | — |
Countries
England, United Kingdom, Wales
Contacts
Public ContactAnne Forster
Outcome results
None listed