Keeley Tomkinson

Process evaluation of the Bristol girls dance project

BackgroundThe Bristol Girls Dance Project was a cluster randomised controlled trial that aimed to increase objectively measured moderate-to-vigorous physical activity (MVPA) levels of Year 7 (age 11–12) girls through a dance-based after-school intervention. The intervention was delivered in nine schools and consisted of up to forty after-school dance sessions. This paper reports on the main findings from the detailed process evaluation that was conducted.MethodsQuantitative and qualitative data were collected from intervention schools. Dose and fidelity were reported by dance instructors at every session. Intervention dose was defined as attending two thirds of sessions and was measured by attendance registers. Fidelity to the intervention manual was reported by dance instructors. On four randomly-selected occasions, participants reported their perceived level of exertion and enjoyment. Reasons for non-attendance were self-reported at the end of the intervention. Semi-structured interviews were conducted with all dance instructors who delivered the intervention (n = 10) and school contacts (n = 9) in intervention schools. A focus group was conducted with girls who participated in each intervention school (n = 9).ResultsThe study did not affect girls’ MVPA. An average of 31.7 girls participated in each school, with 9.1 per school receiving the intervention dose. Mean attendance and instructors’ fidelity to the intervention manual decreased over time. The decline in attendance was largely attributed to extraneous factors common to after-school activities. Qualitative data suggest that the training and intervention manual were helpful to most instructors. Participant ratings of session enjoyment were high but perceived exertion was low, however, girls found parts of the intervention challenging.ConclusionsThe intervention was enjoyed by participants. Attendance at the intervention sessions was low but typical of after-school activities. Participants reported that the intervention brought about numerous health and social benefits and improved their dance-based knowledge and skills. The intervention could be improved by reducing the number of girls allowed to participate in each school and providing longer and more in-depth training to those delivering the intervention.Trial registrationISRCTN52882523 Registered 25th April 2013.

Protocol for a randomised controlled trial for Reducing Arthritis Fatigue by clinical Teams (RAFT) using cognitive–behavioural approaches

Introduction Rheumatoid arthritis (RA) fatigue is distressing, leading to unmanageable physical and cognitive exhaustion impacting on health, leisure and work. Group cognitive–behavioural (CB) therapy delivered by a clinical psychologist demonstrated large improvements in fatigue impact. However, few rheumatology teams include a clinical psychologist, therefore, this study aims to examine whether conventional rheumatology teams can reproduce similar results, potentially widening intervention availability. Methods and analysis This is a multicentre, randomised, controlled trial of a group CB intervention for RA fatigue self-management, delivered by local rheumatology clinical teams. 7 centres will each recruit 4 consecutive cohorts of 10–16 patients with RA (fatigue severity ≥6/10). After consenting, patients will have baseline assessments, then usual care (fatigue self-management booklet, discussed for 5–6 min), then be randomised into control (no action) or intervention arms. The intervention, Reducing Arthritis Fatigue by clinical Teams (RAFT) will be cofacilitated by two local rheumatology clinicians (eg, nurse/occupational therapist), who will have had brief training in CB approaches, a RAFT manual and materials, and delivered an observed practice course. Groups of 5–8 patients will attend 6×2 h sessions (weeks 1–6) and a 1 hr consolidation session (week 14) addressing different self-management topics and behaviours. The primary outcome is fatigue impact (26 weeks); secondary outcomes are fatigue severity, coping and multidimensional impact, quality of life, clinical and mood status (to week 104). Statistical and health economic analyses will follow a predetermined plan to establish whether the intervention is clinically and cost-effective. Effects of teaching CB skills to clinicians will be evaluated qualitatively. Ethics and dissemination Approval was given by an NHS Research Ethics Committee, and participants will provide written informed consent. The copyrighted RAFT package will be freely available. Findings will be submitted to the National Institute for Health and Care Excellence, Clinical Commissioning Groups and all UK rheumatology departments. Trial registration number ISRCTN: 52709998; Protocol v3 09.02.2015.

AB1130-HPR Cognitive Therapy for Reducing The Impact of Rheumatoid Arthritis Fatigue: Sucessful Strategies for Meeting Targets in A Complex Health Care Intervention

Background Complex interventions are widely used in modern health care practice and are defined as those having potentially interacting components. Evaluation can be challenging due to difficulties in logistics, standardisation, delivery, recruiting to time and target (particularly in multi-centre studies) and minimising attrition and data loss. We report how the RAFT study (a 7-centre randomised controlled trial comparing a complex, group cognitive-behavioural intervention with standard care, for the reduction of fatigue impact in patients with rheumatoid arthritis) is implementing successful strategies to meet targets. The study requires patients to make a substantial commitment over a two year period and for the intervention to be delivered by routine clinical staff trained for this purpose. Objectives To recruit to time and target, ensure intervention delivery, minimise attrition and maximise retention. Methods Maximising recruitment: Funded research nurse time at all 7 sites, mailshot approach option, recruitment posters, flexible/pragmatic approach to session attendance, telephone, email and postal contact, newsletter and regular knowledge exchange between the central management team and sites, weekly recruitment review. Ensuring intervention delivery: Flexible course dates and times, regular discussions around foreseeable issues and preventative actions, provision of real-time clinical supervision and full-time telephone/email support. Minimising attrition and data loss: Primary outcome collected by telephone ensuring regular personal contact. Secondary data collected by postal questionnaire reducing the number of hospital visits. Telephone reminders, partial withdrawal options, personalised letters and thank you cards. Patient involvement: Acceptability and feasibility consultations with our 2 patient partners. Both have experience of attending the intervention, were co-applicants on the grant proposal and continue to provide the patient perspective as members of the trial management group. Results Recruitment: Target of 300 participants with no recent medication changes and a fatigue level of ≥6 (on a 1–10 scale where 10 is totally exhausted). During the 2 year recruitment phase 333 participants were randomised (11% over target). Intervention delivery: 28/28 programmes successfully delivered with 7/7 sites and 14/15 tutors remaining fully engaged with the study. Attrition and data loss: Retention at 6 months is currently 92.5% (sample size allows for 20% attrition). Data returned by those reaching the 6 month time point is 100% for the primary outcome and 97% for secondary outcomes. Conclusions Advanced planning and consistent application of these strategies has ensured success so far. A flexible and pragmatic approach, regular communication between local and central teams, personal contact with participants and extensive patient partner input are key components. Acknowledgement This work is funded by the NIHR HTA commissioned call [project number 11/112/01] Disclosure of Interest None declared