Andy
Retired committee member
Funded study in progress. My bolding.
Abstract:
Background Inflammatory arthritis refers to a group of auto-immune rheumatic conditions, most commonly rheumatoid arthritis (RA). In the UK, approximately 690,000 adults have RA. Around three quarters of people diagnosed are of working age, and there are 20,000 new cases every year. Fatigue is a distressing symptom, present on most days for most patients with inflammatory arthritis, with >70% reporting levels similar to Chronic Fatigue Syndrome. However, rheumatology nurses and occupational therapists (OTs) working with this patient group have reported that they do not know how to provide appropriate support. Our team has developed an intervention called FREE-IA (Fatigue - Reducing its Effects through individualised support Episodes in Inflammatory Arthritis) to reduce the impact of fatigue. FREE-IA is a brief, pragmatic intervention, delivered by rheumatology nurses/OTs using cognitive techniques. FREE-IA comprises two core sessions plus up to two optional sessions.
Aims Our long-term aim is to test the clinical and cost-effectiveness of FREE-IA. However, we first need to answer the question of whether it is feasible to conduct a definitive randomised controlled trial (RCT) of FREE-IA. To address this question, our feasibility study has two main aims: To design and deliver the FREE-IA training package to rheumatology nurses/OTs; To explore and resolve key uncertainties to allow the final development of a definitive RCT of FREE-IA.
Plan of investigation The feasibility study will be conducted in four phases: In Phase 1, we will develop and deliver FREE-IA training to approximately 6-8 rheumatology nurses/OTs from four sites. Training will be delivered face-to-face in a central location over two days. We will also prepare study documentation and gain ethics and other necessary approvals for the feasibility study.
In Phase 2, we will recruit 50-60 patients from across the four sites, and collect their baseline data. Rheumatology nurses/OTs who have received the training will then deliver FREE-IA to participants at the end of their routine consultations. The two core sessions will be delivered face-to-face. The additional, optional, two sessions can be delivered face-to-face, by telephone, or by Skype, depending on participant preference.
In Phase 3, we will collect quantitative outcome data at two time points to determine follow-up rates and completion rates of outcome measures from participants who have received the intervention. Our proposed clinical outcome measures include fatigue impact (the planned primary outcome), fatigue severity and importance, impact of disease, and disability. Our proposed measures of therapeutic mechanisms include participants self-efficacy, health competency, and support for autonomy. We will also collect data to inform the design of a health economics evaluation alongside a future definitive RCT.
In Phase 3, we will also conduct a qualitative evaluation to determine the acceptability of FREE-IA to participants, and to gain insight into the experiences of nurses/OTs who have delivered the intervention. Data will be generated in one-to-one semi-structured interviews.
In Phase 4, we will refine the intervention and prepare a grant preparation for a definitive RCT, if supported by evidence from Phase 3. The decision will be informed by recruitment rates, uptake and delivery of the intervention, completion rates of outcome measures, and acceptability of FREE-IA to participants.
Potential benefits to patients and the NHS Short-term, this study will inform us whether we can design a definitive RCT to test the clinical and cost-effectiveness of FREE-IA. If, following the definitive trial, we find that FREE-IA is effective, it has the potential to benefit patients by offering flexible, accessible support for a symptom that causes high levels of distress. There is the potential to benefit the NHS by providing rheumatology nurses/OTs with additional [sic]
https://fundingawards.nihr.ac.uk/award/PB-PG-1216-20014
Abstract:
Background Inflammatory arthritis refers to a group of auto-immune rheumatic conditions, most commonly rheumatoid arthritis (RA). In the UK, approximately 690,000 adults have RA. Around three quarters of people diagnosed are of working age, and there are 20,000 new cases every year. Fatigue is a distressing symptom, present on most days for most patients with inflammatory arthritis, with >70% reporting levels similar to Chronic Fatigue Syndrome. However, rheumatology nurses and occupational therapists (OTs) working with this patient group have reported that they do not know how to provide appropriate support. Our team has developed an intervention called FREE-IA (Fatigue - Reducing its Effects through individualised support Episodes in Inflammatory Arthritis) to reduce the impact of fatigue. FREE-IA is a brief, pragmatic intervention, delivered by rheumatology nurses/OTs using cognitive techniques. FREE-IA comprises two core sessions plus up to two optional sessions.
Aims Our long-term aim is to test the clinical and cost-effectiveness of FREE-IA. However, we first need to answer the question of whether it is feasible to conduct a definitive randomised controlled trial (RCT) of FREE-IA. To address this question, our feasibility study has two main aims: To design and deliver the FREE-IA training package to rheumatology nurses/OTs; To explore and resolve key uncertainties to allow the final development of a definitive RCT of FREE-IA.
Plan of investigation The feasibility study will be conducted in four phases: In Phase 1, we will develop and deliver FREE-IA training to approximately 6-8 rheumatology nurses/OTs from four sites. Training will be delivered face-to-face in a central location over two days. We will also prepare study documentation and gain ethics and other necessary approvals for the feasibility study.
In Phase 2, we will recruit 50-60 patients from across the four sites, and collect their baseline data. Rheumatology nurses/OTs who have received the training will then deliver FREE-IA to participants at the end of their routine consultations. The two core sessions will be delivered face-to-face. The additional, optional, two sessions can be delivered face-to-face, by telephone, or by Skype, depending on participant preference.
In Phase 3, we will collect quantitative outcome data at two time points to determine follow-up rates and completion rates of outcome measures from participants who have received the intervention. Our proposed clinical outcome measures include fatigue impact (the planned primary outcome), fatigue severity and importance, impact of disease, and disability. Our proposed measures of therapeutic mechanisms include participants self-efficacy, health competency, and support for autonomy. We will also collect data to inform the design of a health economics evaluation alongside a future definitive RCT.
In Phase 3, we will also conduct a qualitative evaluation to determine the acceptability of FREE-IA to participants, and to gain insight into the experiences of nurses/OTs who have delivered the intervention. Data will be generated in one-to-one semi-structured interviews.
In Phase 4, we will refine the intervention and prepare a grant preparation for a definitive RCT, if supported by evidence from Phase 3. The decision will be informed by recruitment rates, uptake and delivery of the intervention, completion rates of outcome measures, and acceptability of FREE-IA to participants.
Potential benefits to patients and the NHS Short-term, this study will inform us whether we can design a definitive RCT to test the clinical and cost-effectiveness of FREE-IA. If, following the definitive trial, we find that FREE-IA is effective, it has the potential to benefit patients by offering flexible, accessible support for a symptom that causes high levels of distress. There is the potential to benefit the NHS by providing rheumatology nurses/OTs with additional [sic]
https://fundingawards.nihr.ac.uk/award/PB-PG-1216-20014