Medical Research Council Guidance Research Articles

426 - FindMyApps: Protocol for a randomized controlled trial with community-dwelling people with dementia, evaluating the effectiveness and cost-effectiveness of an intervention to improve self-management and social participation

Background: For the rising number of people living with dementia, cost-effective community-based interventions to support psychosocial care are needed. The FindMyApps program helps people with dementia and their caregivers learn to use tablet computers and find user-friendly apps that facilitate self-management and engagement in meaningful activities. This definitive trial builds on previous feasibility pilot trials of FindMyApps and further evaluates cost-effectiveness.Method: This is a protocol for a non-blinded randomized controlled trial (RCT) with two arms (intervention and usual care). 150 dyads (person with dementia and their carer) will be recruited. Participants must be resident in the community, with a diagnosis of Mild Cognitive Impairment or mild dementia (Mini Mental-State Examination 17-26, or Global Deterioration Scale 3-4. Dyads will be randomly assigned in equal proportions to receive either the FindMyApps intervention (experimental arm) or usual care (control arm). Primary outcomes measured at 3 months will be: patient self-management and social participation; caregiver sense of competence. Data will be collected through questionnaires filled in by the researcher (patient outcomes) or participants themselves (carer outcomes). In addition to a main effect analysis, a cost-effectiveness analysis will take place. In line with Medical Research Council (MRC) guidance for the evaluation of complex interventions, a process analysis will be undertaken, to identify factors that may influence trial outcomes. Semi-structured interviews and remotely collected data regarding use of the FindMyApps app will support the process analysis.Result: Results of this study are expected in 2022. The study will be adequately powered to detect at least a moderate effect size of the intervention with respect to the primary outcomes.Conclusion: This study will investigate the effectiveness and cost-effectiveness of the FindMyApps intervention. The results of the study will provide strong evidence to support or oppose scaling up implementation of the intervention. This is also an example of how the MRC framework for the evaluation of complex interventions can be implemented in practice. In a field which is often criticized for a lack of high quality evidence, randomized controlled trials should be applied more frequently designed for the robust and transparent evaluation of digital tools and technologies.

Process Evaluation of a Participative Organizational Intervention as a Stress Preventive Intervention for Employees in Swedish Primary Health Care.

This study is a process evaluation of a trial examining the effects of an organizational intervention (Productivity Measurement and Enhancement System or ProMES) on employee stress. The aims were to explore the implementation process and fidelity to the intervention guidelines, examine the influence of contextual factors (hindrances and facilitators) and explore participants’ experience of working with ProMES. We used the UK Medical Research Council (MRC) guidance to guide the process evaluation. The recruitment, reach and dose delivered were satisfactory and participation high. The employees felt ProMES clarified priorities, gave control and increased participation in decision-making. However, difficulty in obtaining statistical productivity data from the central administration office (a central feature of the intervention) hindered full implementation and regular feedback meetings. Staffing shortages interfered with the implementation process, while having seven design teams and one consultant prevented all occupational groups from working simultaneously. A detailed examination of access to necessary organizational data should be undertaken before implementing ProMES. We recommend a better introduction for new employees, more work on design and packaging and giving employees more training in how to use the software program. The study contributes to our understanding of process evaluations in research into organizational stress management interventions.

Patterns of behaviour in nursing staff actioning the afferent limb of the rapid response system (RRS): A focused ethnography.

To improve understanding of afferent limb behaviour in acute hospital ward settings, to define and specify who needs to do what differently and to report what afferent limb behaviours should be targeted in a subsequent multi-phase, theory-based, intervention development process. Focused ethnography was used including direct observation of nursing staff enacting afferent limb behaviours and review of vital signs charts. An observation guide focused observation on "key moments" of the afferent limb. Descriptions of observations from between 7 January 2019-18 December 2019 were recorded in a field journal alongside reflexive notes. Vital signs and early warning scores from charts were reviewed and recorded. Field notes were analysed using structured content analysis. Observed behaviour was compared with expected (policy-specified) behaviour. Observation was conducted for 300hr. Four hundred and ninety-nine items of data (e.g., an episode of observation or a set of vital signs) were collected. Two hundred and eighty-nine (58%) items of data were associated with expected (i.e. policy-specified) afferent limb behaviour; 210 (42%) items of data were associated with unexpected afferent limb behaviour (i.e. alternative behaviour or no behaviour). Ten specific behaviours were identified where the behaviour observed deviated (negatively) from policy or where no action was taken when it should have been. One further behaviour was seen to expedite the assessment of a deteriorating patient by an appropriate responder and was therefore considered a positive deviance. Afferent limb failure has been described as a problem of inconsistent staff behaviour. Eleven potential target behaviours for change are reported and specified using a published framework. Clear specification of target behaviour will allow further enquiry into the determinants of these behaviours and the development of a theory-based intervention that is more likely to result in behaviour change and can be tested empirically in future research.

Advance care planning with people with dementia: a process evaluation of an educational intervention for general practitioners

BackgroundGeneral practitioners (GPs) are advised to offer advance care planning (ACP) to people with dementia (PWD). In a randomized controlled trial, an educational intervention for GPs aimed at initiating and optimizing ACP proved to be effective. During the intervention most GPs were accompanied by their practice nurse (PN). To provide insights into the intervention’s successful components and what could be improved, we conducted a process evaluation and explored implementation, mechanisms of impact and contextual factors.MethodsWe used the Medical Research Council guidance for process evaluations. Implementation was explored identifying reach and acceptability. We performed descriptive analyses of participants’ characteristics; selection, inclusion and intervention attendance; a GP post-intervention survey on initiating ACP; a post intervention focus group with trainers of the intervention.Mechanisms of impact were explored identifying adoption and appropriateness. We used: participants’ intervention ratings; a GP post-intervention survey on conducting ACP; ACP documentation in PWD’s medical files; post-intervention interviews with PWD/FC dyads. All data was used to identify contextual factors.ResultsThe intervention was implemented by a small percentage of the total Dutch GP population invited, who mostly included motivated PWD/FC dyads with relatively little burden, and PWD with limited cognitive decline. The mechanisms of impact for GPs were: interactively learning to initiate ACP with training actors with a heterogeneous group of GPs and PNs. For PWD/FCs dyads, discussing non-medical preferences was most essential regarding their SDM experience and QoL. Some dyads however found ACP stressful and not feasible. Younger female GPs more often initiated ACP. Male PWD and those with mild dementia more often had had ACP. These characteristics and the safe and intimate training setting, were important contextual facilitators.ConclusionWe recommend Interventions aimed at improving ACP initiation with PWD by GPs to include interactive components and discussion of non-medical preferences. A safe environment and a heterogeneous group of participants facilitates such interventions. However, in practice not all FC/PWD dyads will be ready to start. Therefore, it is necessary to check their willingness when ACP is offered.

Process evaluation of the FindMyApps program trial among people with dementia or MCI and their caregivers based on the MRC guidance

Background: People with dementia can improve their wellbeing by using touchscreen technology. FindMyApps is a program comprising of a web-based selection-tool and an errorless learning training to help people with dementia and their caregivers find suitable apps which can improve their self-management and engagement in meaningful activities. This process evaluation was conducted as part of an exploratory pilot trial into Find-MyApps and involved a sample of the participants in this trial. Objective: To evaluate which factors might influence the trial outcomes, according to the Medical Research Council (MRC) guidance. Contextual, implementation, and mechanisms of impact factors that may have influenced trial outcomes were evaluated. Method: Quantitative and qualitative data were collected from semi-structured interviews (SSIs) with participants from both trial arms and other stakeholders. The SSI designed for this study comprised closed and open questions, based on the MRC process evaluation guidance. Twenty people with mild dementia or Mild Cognitive Impairment (MCI) and their caregivers were recruited in the Netherlands. Exclusion criteria were severe sight problems or moderate to severe dementia. All participants received a tablet computer for three months. Dyads in the experimental group were taught to use the tablet and Find-MyApps tool by the ‘errorless learning’ method, to help them find apps for self-management and meaningful activities. Dyads in the control group received general instruction in tablet use and a list of websites with potentially useful apps. Results: Important themes identified included participants experiencing technical problems and variable quality of training in the use of the FindMyApps selection-tool. Dyads did not use FindMyApps-tool regularly, but frequently used the apps they found through FindMyApps and experienced them as useful and enjoyable. Conclusion: The tablet-based FindMyApps intervention is experienced as user-friendly and useful by people with dementia/MCI and their informal caregivers. Several adaptations to the trial protocol are recommended, to ensure robust outcomes of a definitive effectiveness trial of FindMyApps.

Process evaluation of the FindMyApps program trial among people with dementia or MCI and their caregivers based on the MRC guidance

Background: People with dementia can improve their wellbeing by using touchscreen technology. FindMyApps is a program comprising of a web-based selection-tool and an errorless learning training to help people with dementia and their caregivers find suitable apps which can improve their self-management and engagement in meaningful activities. This process evaluation was conducted as part of an exploratory pilot trial into FindMyApps and involved a sample of the participants in this trial. Objective: To evaluate which factors might influence the trial outcomes, according to the Medical Research Council (MRC) guidance. Contextual, implementation, and mechanisms of impact factors that may have influenced trial outcomes were evaluated. Method: Quantitative and qualitative data were collected from semi-structured interviews (SSIs) with participants from both trial arms and other stakeholders. The SSI designed for this study comprised closed and open questions, based on the MRC process evaluation guidance. Twenty people with mild dementia or Mild Cognitive Impairment (MCI) and their caregivers were recruited in the Netherlands. Exclusion criteria were severe sight problems or moderate to severe dementia. All participants received a tablet computer for three months. Dyads in the experimental group were taught to use the tablet and FindMyApps tool by the ‘errorless learning’ method, to help them find apps for self-management and meaningful activities. Dyads in the control group received general instruction in tablet use and a list of websites with potentially useful apps. Results: Important themes identified included participants experiencing technical problems and variable quality of training in the use of the FindMyApps selection-tool. Dyads did not use FindMyApps-tool regularly, but frequently used the apps they found through FindMyApps and experienced them as useful and enjoyable. Conclusion: The tablet-based FindMyApps intervention is experienced as user-friendly and useful by people with dementia/MCI and their informal caregivers. Several adaptations to the trial protocol are recommended, to ensure robust outcomes of a definitive effectiveness trial of FindMyApps.

Improving Primary Care After Stroke (IPCAS) randomised controlled trial: protocol for a multidimensional process evaluation

IntroductionPrimary care interventions are often multicomponent, with several targets (eg, patients and healthcare professionals). Improving Primary Care After Stroke (IPCAS) is a novel primary care-based model of long-term stroke care...

Midterm Evaluation of Malaysia’s National Salt Reduction Strategy – Lessons Learned on Adapting Salt Reduction ‘Best Buys’ to the Local Context

Abstract Objectives To evaluate the implementation progress and contextual influences of Malaysia's five-year national salt reduction program at midpoint, with a view to generating lessons on adapting the World Health Organization's salt reduction ‘best buys’ to suit the local context. Methods The Malaysian Government's multi-faceted strategy includes three of four salt-related ‘best buys’; reduce salt intake through 1) behavior change communication, 2) reformulation of food products to contain less salt and 3) implementation of front-of-pack labeling, as well as a strategy to monitor population salt intake and sodium levels in foods. Based on the UK Medical Research Council's guidance on process evaluation, routinely-collected administrative data, 12 semi-structured interviews and public information were used and synthesized in NVivo to evaluate the reach, dose, adoption, fidelity and contextual influences of implementation. This was supplemented with data from three focus groups (43 participants) conducted using the nominal group technique to understand the priority barriers and facilitators of lowering salt intake in Malaysia. Results In the first 3 years, there was high progress in accurately monitoring population salt intake and developing culturally-specific education resources. However, a major barrier to implementing the other interventions was the absence of mandatory sodium content declaration on packaged foods. A lack of packaged foods with sodium content labeling hindered the program implementers' ability to identify and engage high-salt food producers in reformulation, identify low-salt foods eligible for the Healthy Choice Logo front-of-pack label, educate consumers to identify high or lower-salt foods and monitor the sodium content of packaged foods. This aligns with the perceived challenges of reducing salt consumption in Malaysia being poor consumer knowledge and attitudes around salt reduction, and the absence of low-salt alternatives. Conclusions Countries without mandatory sodium or salt labeling on packaged foods should prioritize this regulation to enable effective implementation of the salt reduction ‘best buys’. Interim process evaluations are useful for identifying necessary intervention adaptations. Funding Sources The World Health Organization.

A blended learning training programme for health information providers to enhance implementation of the Guideline Evidence-based Health Information: development and qualitative pilot study

BackgroundThe Guideline Evidence-based Health Information was published in 2017 and addresses health information providers. The long-term goal of the guideline is to improve the quality of health information. Evidence-based health information represents a prerequisite for informed decision-making. Health information providers lack competences in evidence-based medicine. Therefore, our aim was to develop and pilot-test a blended learning training programme for health information providers to enhance application of the guideline.MethodsDevelopment:We developed the training programme according to the Medical Research Council guidance for developing and evaluating complex interventions. The training programme was planned on the basis of problem-based learning. It aims to impart competences in evidence-based medicine. Furthermore, it comprises the application of criteria for evidence-based health information.Pilot testing:We conducted a qualitative pilot study focusing on the acceptability and feasibility of the training programme. Health information providers were recruited and in-house training sessions were offered.Feasibility and acceptability were explored by structured class observations and in semi-structured focus group interviews with the participants after the training sessions. The transcripts and documentations were analysed using qualitative content analysis according to Mayring. The training was revised iteratively according to the results.ResultsWe conducted two training courses with 17 participants between November 2018 and March 2019. The adequacy of the training for the target group was identified as a major issue. There was significant heterogeneity concerning previous knowledge. Some wished to delve deeper while others seemed to be overwhelmed. In general, the work tasks were understandable. However, the participants asked for a more detailed theoretical introduction in advance. The practical relevance of the evidence-based medicine contents was rated rather low compared to the content about evidence-based health information. Based on these results, we revised the programme.ConclusionsOverall, the training proved to be feasible for implementation. Meeting the needs of all the participants was a challenge, since they were heterogeneous. Not all of them will be able or intend to implement the training contents into their working routine to the full extent. The implementation will be evaluated in a randomised controlled trial.

How Theory Can Influence Hearing Aid Use

How Theory Can Influence Hearing Aid Use

Engaging hospitalised patients in their nutrition care using technology: development of the NUTRI-TEC intervention

BackgroundNutrition is vital for health and recovery during hospitalisation, however most patients fail to meet minimum dietary requirements and up to 50% of patients are malnourished in hospital. When patients participate in nutrition care, their dietary intakes are improved. Advances in health information technology (HIT) have broadened the ways by which patients can participate in care. Our team has developed an innovative, HIT-based intervention (called NUTRI-TEC; engaging patients in their nutrition care using technology), facilitating patient participation in their nutrition care in hospital. This paper aims to describe the systematic and iterative process by which the intervention was developed.MethodsNUTRI-TEC development was informed by the Medical Research Council guidance for developing complex interventions and underpinned by theoretical frameworks and concepts (i.e. integrated knowledge translation and patient participation in care), existing evidence and a rigorous program of research. The intervention was co-developed by the multidisciplinary research team and stakeholders, including health consumers (patients), health professionals and industry partners. We used an iterative development and evaluation cycle and regularly tested the intervention with hospital patients and clinicians.ResultsThe NUTRI-TEC intervention involves active patient participation in their nutrition care during hospitalisation. It has two components: 1) Patient education and training; and 2) Guided nutrition goal setting and patient-generated dietary intake tracking. The first component includes brief education on the importance of meeting energy/protein requirements in hospital; and training on how to use the hospital’s electronic foodservice system, accessed via bedside computer screens. The second component involves patients recording their food intake after each meal on their bedside computer and tracking their intakes relative to their goals. This is supported with brief, daily goal-setting sessions with a health care professional.ConclusionsNUTRI-TEC is a HIT intervention designed to enable patient participation in their nutrition care in hospital. As research on HIT interventions to engage patients in health care in the hospital setting is in its infancy, and as gaps and inconsistencies in the development of such interventions exist, this paper will inform future development of HIT-based interventions in the hospital setting.

Process evaluation of complex cardiovascular interventions: How to interpret the results of my trial?

Complex interventions of varying degrees of complexity are commonly used and evaluated in cardiovascular nursing and allied professions. Such interventions are increasingly tested using randomized trial designs. However, process evaluations are seldom used to better understand the results of these trials. Process evaluation aims to understand how complex interventions create change by evaluating implementation, mechanisms of impact, and the surrounding context when delivering an intervention. As such, this method can illuminate important mechanisms and clarify variation in results. In this article, process evaluation is described according to the Medical Research Council guidance and its use exemplified through a randomized controlled trial evaluating the effectiveness of a transition program for adolescents with chronic conditions.

N02 The IBD-BOOST programme: developing a digital self-management intervention for symptoms of fatigue, pain and urgency in inflammatory bowel disease

Abstract Background Fatigue, pain and urgency are among the most commonly reported and burdensome symptoms of inflammatory bowel disease (IBD). A disconnect between symptoms and inflammation has been documented and medical management does not always adequately resolve symptoms. Extensive research shows the relationship between IBD symptoms and psychosocial factors. This poster describes the development of a facilitator-supported, theory-driven, tailored web-based intervention for fatigue, pain and urgency in IBD. Methods The Medical Research Council (MRC) guidance and the person-based approach were used to guide intervention development. Literature reviews of psychosocial factors related to fatigue, pain and urgency in IBD and trials of behavioural interventions were used to create a cognitive-behavioural model of symptom perpetuation and impact. The model was tested and refined in large cross-sectional and qualitative studies to understand patients’ experiences of these symptoms and intervention needs. The refined model was mapped onto an intervention logic model to define the psychosocial processes to target in intervention techniques. Patient feedback on the logic model and session content was obtained. Usability of the website was assessed using think-aloud methods and survey data were collected on session content, design and functionality. Results 87 people with IBD and 68 IBD nurses participated in Patient and Public Involvement activities for intervention development. Five interviews were carried out to develop guiding principles and two focus groups provided feedback on a logic model and session plan. 54 people with IBD and 45 IBD nurses completed an initial discovery online survey. Results indicated preferences to receive facilitator support via email/online-messages rather than telephone. Five focus groups included 68 IBD-nurses to assess barriers/facilitators in supporting the intervention. Desirable functionalities included diagrams/aids, email reminders and links to external resources. 31 people with IBD were included in feasibility and acceptability testing. The final intervention includes 8 core sessions with tasks and 4 symptom-specific sessions, and facilitator support of one 30-minute call and in-site messaging. Core to all sessions is understanding and ‘breaking’ personal ‘vicious cycles’ of symptom interference. Conclusion We have used a person-based approach and systematic application of theory, evidence and stakeholder involvement to guide intervention development. BOOST is the first web-based intervention with the primary aim of targeting fatigue, pain and urgency and improving the quality of life of people with IBD. This is now being tested in a large randomised controlled trial.

Barriers to the Implementation of the Ward-Based Outreach Team Program in Mpumalanga Province: Results From Process Evaluation.

Background:South Africa adopted the ward-based outreach team (WBOT) program as one aspect of the three-stream approach to primary health care (PHC) re-engineering. PHC re-engineering seeks to modify the hospicentric and curative approach into a more preventive and promotive approach to improve health outcomes. There has not been an evaluation of the implementation of the WBOTs in Nkangala District since its inception in 2012.Methods:A process evaluation approach using qualitative methods was used to examine and describe the contextual, organizational, health provider, and program-related barriers considered to affect the implementation of the WBOTs 3 sub-districts in one of the health districts in Mpumalanga Province, South Africa. The framework for this evaluation was informed by the logic model framework developed by the Center for Disease Control as well as the 3 domains of evaluation recommended by the Medical Research Council Guidance on process evaluation. Data were collected through in-depth interviews with multiple data sources directly involved in the implementation of the WBOTs. A thematic analysis was done using NVivo 11.Results:The key critical barriers identified by the evaluation include the inadequate provision of resources, the lack of supervision, the heavy workload for outreach teams, the inadequate and irregular payment of stipends, threats to the safety of the CHWs, and the cultural beliefs and practices of the communities who are to receive the services. The lack of adequate financial resources was the main challenge, and will continue to pose a risk to the successful implementation of the WBOTs.Conclusions:Although the barriers are being reported as separate contextual factors, the internal and external contexts are interdependent, interact with one each other, and should not be considered in isolation. The need to improve stakeholder engagement on the WBOT program underscores the importance of the external context in the successful implementation of WBOTs.

Process evaluation of a randomised controlled trial of PBS-based staff training for challenging behaviour in adults with intellectual disability.

BackgroundPositive Behaviour Support (PBS) for challenging behaviour is a complex intervention. Process evaluation is pivotal in fully understanding the mechanisms and contextual factors that impact on participant outcomes.AimsTo conduct a process evaluation of a national clinical trial investigating the impact of PBS-based staff training on the level of challenging behaviour in adults with intellectual disability.MethodThe Medical Research Council guidance for process evaluation of complex interventions was followed. Semi-structured interviews with 62 stakeholders from the intervention arm (service users, family and paid carers, service managers, staff who delivered the intervention and PBS trainers), quantitative data from the study database and an external evaluation of the quality of the PBS plans were used.ResultsTwenty-one health staff volunteered to be trained in delivering PBS. Available log data from 17 therapists revealed that they worked with 63 participants a median of 11.50 hours (IQR 8–32). Only 33 out of 108 reports had included all elements of the intervention. Another 47 reports had some elements of the intervention. All PBS plans were rated weak, indicating insufficient quality to impact challenging behaviour. Stakeholders reported an appreciation of PBS and its potential to impact quality of care and engagement with the participant. However, they also identified important challenges including managing PBS-related caseloads, paid carer turnover and service commitment to the delivery of PBS.ConclusionsPBS-based staff training was well received, but therapists found it difficult to undertake all the elements of the intervention in routine care. Implementing a workforce training strategy is important to better define the active components of PBS, and resource implications if the intervention is no better than usual care.

Process evaluations of primary care interventions addressing chronic disease: a systematic review

ObjectiveProcess evaluations (PEs) alongside randomised controlled trials of complex interventions are valuable because they address questions of for whom, how and why interventions had an impact. We synthesised the methods...

Process evaluation of a cluster randomised intervention in Swedish primary care: using care managers in collaborative care to improve care quality for patients with depression

BackgroundThe collaborative care model with a care manager has previously generated beneficial results for patients with depression in terms of decreased burden of depression symptoms. A care manager function has been tested in Sweden in the PRIM-CARE RCT with successful results. The aim of the present study was to evaluate the process of implementing care managers in collaborative care for patients with depression in Swedish primary health care in the PRIM-CARE RCT.MethodsThe study followed UK Medical Research Council guidance for process evaluation.Field notes from the implementation of the PRIM - CARE RCT were used, as well as data collected from five focus group discussions with General Practitioners (n = 29) and three focus group discussions with care managers (n = 11). Data were analysed with content analysis.ResultsTraining sessions, careful preparation and extensive initial support to the care manager and staff at the Primary Care Centres were important ingredients in the implementation. The close access to facilitators, the recurrent peer support meetings, and the weekly newsletter strengthened the care manager function.ConclusionsA complex intervention adapted to the Swedish primary care context focusing on a care manager function for patients with depression could be performed through a stepwise implementation process. Financial support from the health care regions included in the study helped to reduce the impact of identified barriers. This process evaluation has revealed new and important knowledge for primary care development concerning infrastructure and organization building, knowledge sharing, and facilitating factors and barriers.Trial registrationNCT02378272 Care Manager – Coordinating Care for Person Centered Management of Depression in Primary Care (PRIM – CARE). Registered March 4 2015. Retrospectively registered.

Exercise referral schemes enhanced by self-management strategies to reduce sedentary behaviour and increase physical activity among community-dwelling older adults from four European countries: protocol for the process evaluation of the SITLESS randomised controlled trial

IntroductionSITLESS is a randomised controlled trial determining whether exercise referral schemes can be enhanced by self-management strategies to reduce sedentary behaviour and increase physical activity in the long term, in...

What\u2019s in it for me? A process evaluation of the implementation of a mobile phone-supported intervention after stroke in Uganda

BackgroundThe prevalence of stroke in Uganda is increasing. In stroke rehabilitation, information and communication technology has been shown to have potential in improving service delivery in high-income countries but there is limited knowledge of its use and impact in low-income countries.The aim of the study was to evaluate the implementation process of a mobile phone-supported family-centred rehabilitation intervention and to gain knowledge on the mechanisms of impact as well as the contextual factors that might have affected the implementation process and its outcome.MethodThis was a single-case study design using the integrated Promoting Action on Research Implementation in Health Services framework and the Medical Research Council guidance as frameworks. Quantitative process data was derived from 14 log books used by occupational therapists during the implementation. Qualitative semi-structured interviews were conducted with 12 implementers in different professions, 12 months into the implementation, in order to obtain the primary data. Secondary data was derived from six semi-structured interviews conducted directly after pre-intervention workshops and 6 months later. The framework method was used in the data analysis.ResultsIn 11 out of 14 cases, the clients were compliant with the intervention. Yet, challenges such as technical problems were reported. The target of conducting 16 phone calls for each client was achieved to 74%. Eight categories emerged from the qualitative analysis of the interviews including: 1) perceptions on facilitation, 2) using scientific and experience-based knowledge, 3) tailoring the intervention, 4) supportive working culture, 5) barriers to the service delivery, 6) implementers’ interaction with the intervention, 7) perceptions on motivations and values, and 8) improving the model and enabling sustainability. Mechanisms contributing to the implementation of the intervention included engaged facilitators and motivated participants. Challenges in the client recruitment and poor information dissemination were some of the mechanisms impeding the implementation.ConclusionsThe intervention was partially delivered in accordance with the logic model for the project, where the implementation process was influenced by several barriers in the context such as technical setbacks. However, there were also several mediators in the process driving the project forward, including strong facilitation and motivated participants.

Developing a group intervention to manage fatigue in rheumatoid arthritis through modifying physical activity

BackgroundFatigue is a major symptom of rheumatoid arthritis (RA). There is some evidence that physical activity (PA) may be effective in reducing RA fatigue. However, few PA interventions have been designed to manage fatigue and there is limited evidence of end-user input into intervention development. The aim of this research was to co-design an intervention to support self-management of RA fatigue through modifying PA.MethodsA series of studies used mixed methodological approaches to co-design a fatigue management intervention focused on modifying PA based on UK Medical Research Council guidance, and informed by the Behaviour Change Wheel theoretical framework. Development was based on existing evidence, preferences of RA patients and rheumatology healthcare professionals, and practical issues regarding intervention format, content and implementation.ResultsThe resulting group-based intervention consists of seven sessions delivered by a physiotherapist over 12 weeks. Each session includes an education and discussion session followed by supervised PA chosen by the participant. The intervention is designed to support modification and maintenance of PA as a means of managing fatigue. This is underpinned by evidence-based behaviour change techniques that might support changes in PA behaviour. Intervention delivery is interactive and aims to enhance capability, opportunity and motivation for PA.ConclusionThis study outlines stages in the systematic development of a theory-based intervention designed through consultation with RA patients and healthcare professionals to reduce the impact of RA fatigue. The feasibility of future evaluation of the intervention should now be determined.