Mixed Methods Feasibility Study Research Articles

Using Artificial Intelligence-informed Experience-Based Co-Design (AI-EBCD) to create a virtual reality-based mindfulness application to reduce diabetes distress: protocol for a mixed-methods feasibility study

IntroductionPeople with type 2 diabetes can experience diabetes distress which can negatively affect health outcomes. Non-pharmacological interventions such as mindfulness can help address diabetes distress. However, face-to-face programmes can be...

A virtual reality-based self-guided training on identification of negative automatic thoughts in healthy adults: a mixed-methods feasibility study

BackgroundCognitive restructuring (CR) is an evidence-based psychological technique for depression. However, face-to-face CR is not easily accessible. Digital CR interventions often overlook the difficulties individuals experiencing depression encounter in identifying their negative automatic thoughts (NAT), leading to suboptimal outcomes. Virtual Reality (VR) has potential advantages in assisting the identification of NAT in CR intervention.ObjectiveThe aim of this preliminary feasibility study is to assess the efficacy, acceptability and safety of a VR-based self-guided training on the identification of negative automatic thoughts (VR-STINAT) for depression, as well as to evaluate the user experience.MethodsIn a mixed methods study, 20 healthy participants underwent VR-STINAT and completed a semi-structured interview, followed by post-training homework. The VR-STINAT includes three modules: psychological education, NAT identification training in VR scenarios, and practice in personally experienced scenarios. Effectiveness was measured via Thought Record Skills Assessment (TRSA) of homework and Cognitive Therapy Awareness Scale (CTAS). Acceptability was measured using an adapted Technology Acceptance Model and duration of training. Safety was measured via Simulator Sickness Questionnaire and self-reported negative emotions. Qualitative material was analyzed using thematic analysis.ResultsThe VR-STINAT was acceptable, with an average rating of 80.68%. The accuracy of NAT identification in TRSA reached 84.55%, and CTAS correctness reached 76.67%. The majority of participants experienced minimal or no side effects, although a few (10%, 2/20) reported relatively severe fatigue and craniofacial pain. Thematic analysis reviewed four themes: effectiveness, acceptability, advantages of VR, difficulties in use and suggestions for improvement. Most participants indicated that they’ve learned how to identify their NAT through VR-STINAT (85%, 17/20), which was engaging (90%, 18/20) and easy to use (60%, 12/20).ConclusionThis study provides preliminary evidence that self-guided training for the identification of negative automatic thoughts related to depression using VR is feasible. Future studies are needed to compare the efficacy of VR with other intervention modalities in people with depression.

A Tailored De-Implementation Strategy to Reduce Low-Value Home-Based Nursing Care: A Mixed-Methods Feasibility Study.

To facilitate the delivery of appropriate care, the aim was to test if a tailored, multifaceted de-implementation strategy (RENEW) (1) would lead to less low-value nursing care and (2) was acceptable, implementable, cost effective and scalable in the home-based nursing care context. A mixed-methods design. The RENEW strategy with components on education, persuasion, enablement, incentives and training was introduced in seven teams from two organisations in the Netherlands. To estimate the effect size, data were collected at baseline (T0) and follow-up measurement (T1), on the volume of care in both frequency and time in minutes per week and independent samples t-tests were performed. A qualitative evaluation was conducted to understand feasibility aspects, see how the strategy works and identify influencing factors and used document analyses and semi-structured interviews. Deductive coding was used to analyse the results. The time spent on low-value nursing care (mean, minutes per week per client) in seven teams for 210 clients in T1 compared to 222 clients in T0 reduced statistically significant. The difference between T0 and T1 equals 17.94%. The frequency of delivered low-value nursing care (mean per week) reduced but not statistically significant. From the transcripts of eight semi-structured interviews and documents, a list of 79 influencing factors were identified. Practical implementation tools, workplace coaching and sharing experiences within and between teams were considered as the most contributing elements. The results showed that for the seven home-healthcare teams in this study, the RENEW strategy (1) leads to a reduction in low-value care and (2) is-conditional upon minor modifications-acceptable, implementable, cost effective and scalable. Standards for Reporting Implementation Studies (StaRI) guidelines. No Patient or Public Contribution.

“Optimizing Wellness and Neurorehabilitation with Mindfulness (OWNMindfulness)”: feasibility of a novel mindfulness-based rehabilitation intervention for Persisting Symptoms after Concussion

Background Persisting Symptoms after Concussion (PSaC) are common and difficult to treat. Mindfulness-based interventions can support recovery but are rarely included in rehabilitative care. We developed OWNMindfulness, an eight-week live-video mindfulness-based group for PSaC. Purpose To assess feasibility and preliminary clinical effects of OWNMindfulness. Methods Fourteen individuals with PSaC enrolled in this mixed-methods single-arm feasibility study. We assessed enrollment/retention, adherence, fidelity, instrument completion, safety, and satisfaction. We evaluated preliminary trends in the impact of the intervention on mindfulness (CAMS-R), concussion symptoms (PCSS), and QOL (WHOQOL-BREF). Qualitative analysis of exit interviews explored participants’ perceptions of the effects of the intervention, and framework analysis assessed adequacy of the quantitative measures to capture perceived effects. Results Feasibility results met a priori benchmarks. Mindfulness, concussion symptoms, and QOL scores improved (CAMS-R: adjusted p = 0.01, large effect size; PCSS: adjusted p = 0.03, moderate effect size; WHOQOL-BREF: not significant, small effect size). Qualitative analysis of interview data found benefits including validation, compassion, self-awareness, self-efficacy, concussion symptoms, resilience, life participation, social relationships, and QOL. Framework analysis demonstrated that quantitative tools captured change in concussion symptoms but did not comprehensively assess the other benefits identified through qualitative methods. Conclusions OWNMindfulness shows preliminary feasibility and promise for improving clinical outcomes. Results suggest the need for additional quantitative tools for comprehensive measurement of the effects and may point to potential mechanisms of action.

Feasibility of a custom-tailored, evidence-based, theory-informed, intervention to prevent burnout and reduce stress for healthcare professionals: protocol for a single-arm trial

BackgroundHealthcare professionals face high levels of occupational stress, time pressure, workload, and poor organizational support. This makes them particularly vulnerable to burnout. The COVID-19 pandemic has further exacerbated this situation. This single-arm, multicenter, mixed-methods feasibility study pilots the LAGOM program: A tailored, evidence-based intervention to prevent burnout and reduce stress among healthcare professionals.MethodsParticipants will include healthcare professionals (N = 30) working at Charité–Universitätsmedizin Berlin and Immanuel Hospital, Berlin. LAGOM focuses on support for individual behavior change and personal resources and also addresses the organizational level. The intervention´s feasibility will be evaluated through a non-randomized feasibility trial with a mixed methods process evaluation. The exploratory primary study aims are to assess the acceptability and feasibility of the (1) evaluation procedures and of the (2) intervention content and structure using study records, standardized questionnaires, protocol checklists, and diaries. Exploratory effectiveness analysis will take place as well. Further, semi-structured interviews (n = 3 to 6) and electrophysiological measurements (n = 20) will be conducted.DiscussionCustom-tailored, well-implemented multi-level interventions are needed to prevent burnout and reduce stress among healthcare professionals. Long-term strategies are warranted to sustainably implement effective programs. This feasibility study helps to refine trial procedures and content of the LAGOM program for a randomized controlled trial to evaluate the intervention’s effectiveness.Trial registrationGerman Clinical Trials Register: DRKS00032014, registered 17th October 2023.

Applying an osteopathic intervention to improve mild to moderate mental health symptoms: a mixed-methods feasibility randomised trial.

The increasing prevalence of mental health disorders in the United Kingdom necessitates the exploration of novel treatment modalities. This study aimed to assess the feasibility and acceptability of conducting a randomised controlled trial (RCT) evaluating the efficacy of four osteopathic interventions on psychophysiological and mental health outcomes. A mixed-methods feasibility study with an explanatory sequential design was implemented. The quantitative phase involved randomising 42 participants into four intervention groups: (1) high-velocity and articulation techniques (HVAT), (2) soft-tissue massage (STM), (3) craniosacral therapy (CST), and (4) a combination approach. Primary outcome measures encompassed recruitment rate, assessment duration, questionnaire completion, intervention attrition, and adverse events. Secondary outcomes included validated assessments of depression, anxiety, stress, psychological flexibility, heart rate variability (HRV), and interoception, administered pre- and post-intervention. Analysis of variance (ANOVA) was employed to evaluate pre-post intervention changes. The qualitative phase comprised semi-structured interviews analysed using thematic analysis. The study achieved a recruitment rate of 21 eligible participants per month, with 54.8% of respondents meeting eligibility criteria. All 33 participants who completed the study underwent interventions and assessments within the allocated one-hour timeframe, with full questionnaire completion. The attrition rate was 21%. No adverse events were reported. Qualitative analysis revealed positive participant experiences, with themes highlighting good practitioner communication, intervention accessibility, and increased bodily awareness. Some participants found the questionnaire battery burdensome. Exploratory quantitative analyses showed variations in effects across interventions for heart rate variability, interoceptive accuracy, and mental health measures, but these results should be interpreted cautiously due to the small sample size. This study provides evidence supporting the feasibility and acceptability of a larger-scale RCT investigating osteopathic interventions for individuals presenting with mild psychological symptoms. The preliminary findings suggest potential efficacy in improving mental health outcomes, warranting further investigation. Trial registration NCT05674071, registered 06/01/2023.

Improving recovery after bowel cancer surgery: mixed methods feasibility study of a co-produced information intervention (Recover Together).

Recovery after surgery for colorectal cancer is a complex process, involving numerous physiological, emotional, social and economic challenges. Good information is a key factor for enabling patients to recover well, but there is a paucity of evidence to guide how this should be done. A new information intervention (Recover Together) comprising a booklet, an online video and an inpatient goal board has been developed. This study explores its feasibility, as well as the feasibility of key study methods, during its first use in the United Kingdom National Health Service (NHS). This is a mixed methods, multi-centre, feasibility study of a complex intervention. A total of 105 participants undergoing oncological colorectal surgery will be recruited across three to four study sites in the UK. Participants will receive each component of the Recover Together intervention at defined timepoints before and during hospital admission. A series of patient-centred outcome instruments will be administered in hospital and during follow-up at 30 days and 6 months. Outcomes of feasibility will comprise the time taken to establish the intervention at participating sites, assessments of intervention fidelity and acceptability, as well as return rates of key clinical outcome instruments. The mixed methods design will comprise interviews and focus groups with patients and health professionals, non-participant observation in ward areas and clinics, user-specific video analytics and daily photographs of the goal boards. The findings of this study will provide a feasibility assessment of the Recover Together intervention when used for the first time in NHS practice. If shown to be feasible, this will guide the development of a future definitive study to explore the clinical and cost effectiveness of the Recover Together intervention to improve recovery after surgery. ISRCTN62430915.

Video Game-Based Trunk Exercises for Rehabilitation in Chronic Stroke Survivors: A Mixed-Methods Feasibility Study.

Aim: To assess the feasibility of video game-based trunk exercises using the Valedo® system in a chronic stroke population. Method: Ten chronic stroke survivors (eight males and two females, mean age 63 ± 15 years) were asked to complete 18 intervention sessions, each lasting 45 min., over 6-8 weeks. Feasibility was evaluated quantitatively using the Psychosocial Impact of Assistive Devices Scale (PIADS) as well as through recruitment, retention, adherence, and safety measures. Qualitative data on feasibility were collected through post-intervention semi-structured interviews. Descriptive analysis was used to summarize participant characteristics, recruitment, retention, and adherence. Qualitative data were analyzed using thematic analysis of the interviews. Results: Twelve stroke survivors were recruited from Southampton (United Kingdom) and Riyadh (Kingdom of Saudi Arabia), with two participants dropping out after the baseline assessment session. The remaining ten participants completed the study with a mean adherence of 96.11% to the planned sessions. No serious adverse effects were reported, however, four participants did experience trunk muscle tightness and fatigue. Post-intervention interviews revealed that participants encountered some physical and cognitive challenges while playing the Valedo video games. However, they felt that the implementation of trunk exercises using video games was safe, as the exercises were performed in a secure environment and in safe positions. Conclusions: The findings suggest that the Valedo system is feasible for delivering trunk exercises to chronic stroke survivors. Several factors should be considered when implementing this type of intervention in the future.

Combining music and dance movement therapy for people with dementia living in the community: A mixed methods feasibility study

Dementia is affecting an increasing number of people world-wide and presents a need to find more evidence-based therapies that can improve quality of life and care. Music therapy and dance movement therapy are two forms of arts therapies that share an active, embodied and improvisatory approach, however, maximising the benefits of combining music and dance movement therapy has not been researched with this population. In this feasibility study a convergent mixed methods design was used to evaluate the feasibility of using an intervention that combined music and dance movement therapy drawing on a systematic literature review. A dance movement therapist and a music therapist ran two session blocks involving eight participants in total. The Cornell Scale for Depression in Dementia was used at three assessment points (baseline, 5 weeks and 10 weeks) indicating an overall reduction in scores. Qualitative methods included multiple forms of data (video, reflective tool, journal) and focused on significant moments of connection between thoughts, feelings and physical sensations. It generated three main themes in the therapeutic process: making connections, acknowledging grief and loss, and growth and empowerment. This study contributes original knowledge to arts therapies research in the development of a research-based treatment approach involving a collaborative model of practice, an exploration of new arts-based data collection tools and testing this intervention in a community setting.

Implementing vocational rehabilitation for people with multiple sclerosis in the UK National Health Service: a mixed-methods feasibility study

Purpose To implement a job retention vocational rehabilitation (VR) intervention (MSVR) for people with multiple sclerosis (MS) and their employers in the UK National Health Service (NHS). Methods Multicentre, single-arm feasibility study with post-intervention interviews. MSVR was delivered by an occupational therapist (OT). Feasibility was assessed by recruitment rates, compliance, and practicality of delivery. Acceptability was assessed with post-intervention interviews. A survey assessed change in eight vocational outcomes (e.g., vocational goals, work instability) immediately post-intervention and at 3-month follow-up. Results Recruitment and training an OT was challenging. Twenty participants with MS, three employers, and three healthcare professionals were recruited. All participants but one completed the intervention. Factors affecting intervention adherence included annual leave and family responsibilities. MSVR was associated with improved vocational goal attainment post-intervention (t(18) = 7.41, p = <0.001) and at follow-up (t(17) = 6.01, p = <0.001). There was no change to the remaining outcomes. Interviews identified six themes: intervention impact, accessibility of support, the OT’s role, readiness for support, workplace supportiveness, and barriers to NHS delivery. Conclusion Challenges with recruitment, identifying newly diagnosed MS participants, and understanding the OT’s training needs to deliver the intervention were identified. The intervention demonstrated acceptability, but participants wanted it to continue for longer to address further needs.

Student-Led Mobility Interventions for Hospitalized Adults: A Mixed-Methods Feasibility and Acceptability Study.

Inactivity in hospitalized patients often leads to functional decline. We created an undergraduate course to promote mobilization, provide hands-on learning, and address staff shortages. To assess the feasibility and acceptability of undergraduate students providing mobility-focused interventions for hospitalized adults. This mixed-methods study was conducted at a level 1 trauma academic center. We analyzed program feasibility and acceptability using quantitative data and thematic analysis of interviews and focus groups. In total 47 individuals (n=14 students, n =9 patients, and n =24 clinicians) were included. Students averaged 4.1 mobility sessions per 4-hour shift. All stakeholders agreed the program is acceptable, and 98.6% affirmed the program is feasible. The themes identified included positive impacts on patient care, enhanced student professional development, and practical implementation challenges. Student-led mobility interventions can be an acceptable strategy to mitigate immobility harm in hospitalized patients. The integration of students enhances patient care and provides valuable educational experiences.

Social Gaming to Decrease Loneliness in Older Adults: Recruitment Challenges and Attrition Analysis in a Digital Mixed Methods Feasibility Study.

Digital mental health interventions could sustainably and scalably prevent and reduce loneliness in older adults. We designed an app containing 29 text-based games and a questionnaire-administering chatbot to stimulate intergenerational contact. This study aims to evaluate the feasibility of a social gaming app in reducing loneliness among older adults by evaluating recruitment strategies, data collection procedures, and gameplay activity. This mixed methods study recruited participants via newsletters, articles, and a social media campaign. We used semistructured interviews and descriptive analysis of questionnaire answers and game data to assess feasibility. Key measures included recruitment reach and efficiency, participant demographics, in-app activity, and app usability and engagement feedback. The social media campaign reached 192,641 potential participants, resulting in 1363 game downloads. A total of 155 participants (aged 65 years and older: n=34, 21.9% and aged less than 65 years: n=121, 78.1%) provided informed consent, yielding a conversion rate of 0.08%. The recruitment campaign focusing on distanced playful interaction had a significantly (P<.001) higher click-through rate (1.98%) than a campaign focusing on research participation (click-through rate=0.51%; P<.001). The overall conversion rate from advertisement exposure to research participation was 0.08%. Participants had a mean age of 48 (SD 16) years. The 65 years and older group averaged 70 (SD 5) years, while the less 65 years group averaged 42 (SD 12) years. Additionally, 45.2% (57/126) reported at least moderate levels of loneliness at baseline. Of the initial 554 players, 91 (16.4%) remained active after the first week, and 32 (5.8%) remained active for more than 90 days. Active participants tended to interact with those within their own age group, as indicated by a Pearson correlation of r=0.31 between the ages of the message sender and receiver. Interviews with 12 (48%) participants (aged 65-79 years; female: n=12, 83%) revealed barriers such as excessive chatbot questions and a mismatch between the target group and app design focus. Questionnaire completion rates dropped from 46% at baseline to 10% at follow-up. These findings underscore the challenges of recruitment and retention for older adults in a fully digital social gaming intervention. Effective recruitment strategies and targeted app design are crucial for engagement. Based on these insights, future interventions should focus on simplified interfaces, clear guidance for gameplay, and addressing the specific needs and preferences of older adults, thereby enhancing the effectiveness of digital mental health interventions.

The CO-produced Psychosocial INtervention delivered by GPs to young people after self-harm (COPING): protocol for a feasibility study.

Self-harm in young people is a growing concern and reducing rates a global priority. Rates of self-harm documented in general practice have been increasing for young people in the UK in the last two decades, especially in 13-16-year-olds. General practitioners (GPs) can intervene early after self-harm but there are no effective treatments presently available. We developed the GP-led COPING intervention, in partnership with young people with lived experience and GPs, to be delivered to young people 16-25 years across two consultations. This study aims to examine the feasibility and acceptability of conducting a fully powered effectiveness trial of the COPING intervention in NHS general practice. This will be a mixed-methods external non-randomised before-after single arm feasibility study in NHS general practices in the West Midlands, England. Patients aged 16-25 years who have self-harmed in the last 12 months will be eligible to receive COPING. Feasibility outcomes will be recruitment rates, intervention delivery, retention rates, and completion of follow-up outcome measures. All participants will receive COPING with a target sample of 31 with final follow-up data collection at six months from baseline. Clinical data such as self-harm repetition will be collected. A nested qualitative study and national survey of GPs will explore COPING acceptability, deliverability, implementation, and likelihood of contamination. Brief GP-led interventions for young people after self-harm are needed to address national guideline and policy recommendations. This study of the COPING intervention will assess whether a main trial is feasible. ISRCTN (ISRCTN16572400; 28.11.2023).

Recommendations for implementing digital alcohol interventions in primary care: lessons learned from a Norwegian feasibility study.

Excessive alcohol consumption is a leading global risk factor for ill-health and premature death. Digital alcohol interventions can be effective at reducing alcohol consumption, but their widespread adoption is lagging behind. This study aimed to identify factors promoting or inhibiting the implementation of a digital alcohol intervention in Norwegian primary care, by using Normalization Process Theory (NPT). A mixed methods feasibility study combining quantitative and qualitative methods. A digital alcohol intervention called "Endre" was implemented across four GP practices in Stavanger and Oslo. Usage of the intervention was logged on the digital platform. General practitioners (GPs) reported their perceived uptake of the intervention via a web-based survey. The Normalization MeAsure Development (NoMAD) survey was used to measure support staff's perceived normalization of the intervention. Qualitative data were analyzed using the NPT framework, with quantitative data analyzed descriptively and using χ 2 and Wilcoxon signed-rank test for differences in current and future normalization. Thirty-seven GPs worked in the clinics and could recruit patients for the digital intervention. Thirty-six patients registered for the intervention. Nine patients dropped out early and 25 completed the intervention as intended. Low normalization scores at follow-up (n = 27) indicated that Endre did not become fully embedded in and across practices. Nonetheless, staff felt somewhat confident about their use of Endre and thought it may become a more integral part of their work in the future. Findings from six semi-structured group interviews suggested that limited implementation success may have been due to a lack of tailored implementation support, staff's lack of involvement, their diminished trust in Endre, and a lack of feedback on intervention usage. The outbreak of the Covid-19 pandemic further limited opportunities for GPs to use Endre. This study investigated the real-world challenges of implementing a digital alcohol intervention in routine clinical practice. Future research should involve support staff in both the development and implementation of digital solutions to maximize compatibility with professional workflows and needs. Integration of digital solutions may further be improved by including features such as dashboards that enable clinicians to access and monitor patient progress and self-reported outcomes.

A Novel Cognitive Behavioral Therapy-Based Generative AI Tool (Socrates 2.0) to Facilitate Socratic Dialogue: Protocol for a Mixed Methods Feasibility Study.

Digital mental health tools, designed to augment traditional mental health treatments, are becoming increasingly important due to a wide range of barriers to accessing mental health care, including a growing shortage of clinicians. Most existing tools use rule-based algorithms, often leading to interactions that feel unnatural compared with human therapists. Large language models (LLMs) offer a solution for the development of more natural, engaging digital tools. In this paper, we detail the development of Socrates 2.0, which was designed to engage users in Socratic dialogue surrounding unrealistic or unhelpful beliefs, a core technique in cognitive behavioral therapies. The multiagent LLM-based tool features an artificial intelligence (AI) therapist, Socrates, which receives automated feedback from an AI supervisor and an AI rater. The combination of multiple agents appeared to help address common LLM issues such as looping, and it improved the overall dialogue experience. Initial user feedback from individuals with lived experiences of mental health problems as well as cognitive behavioral therapists has been positive. Moreover, tests in approximately 500 scenarios showed that Socrates 2.0 engaged in harmful responses in under 1% of cases, with the AI supervisor promptly correcting the dialogue each time. However, formal feasibility studies with potential end users are needed. This mixed methods study examines the feasibility of Socrates 2.0. On the basis of the initial data, we devised a formal feasibility study of Socrates 2.0 to gather qualitative and quantitative data about users' and clinicians' experience of interacting with the tool. Using a mixed method approach, the goal is to gather feasibility and acceptability data from 100 users and 50 clinicians to inform the eventual implementation of generative AI tools, such as Socrates 2.0, in mental health treatment. We designed this study to better understand how users and clinicians interact with the tool, including the frequency, length, and time of interactions, users' satisfaction with the tool overall, quality of each dialogue and individual responses, as well as ways in which the tool should be improved before it is used in efficacy trials. Descriptive and inferential analyses will be performed on data from validated usability measures. Thematic analysis will be performed on the qualitative data. Recruitment will begin in February 2024 and is expected to conclude by February 2025. As of September 25, 2024, overall, 55 participants have been recruited. The development of Socrates 2.0 and the outlined feasibility study are important first steps in applying generative AI to mental health treatment delivery and lay the foundation for formal feasibility studies. DERR1-10.2196/58195.

Exercise-based telerehabilitation for the management of chronic pain in people with severe haemophilia: a mixed-methods feasibility study

BackgroundChronic pain is reported by between 30 and 71% of people with haemophilia (PWH). Exercise is shown to be effective for pain management in other arthritides, but it remains unclear if such an approach is effective or acceptable to PWH. The aim of this study was to evaluate the feasibility and acceptability of a telerehabilitation exercise intervention for PWH living with chronic pain.MethodsThis was a multisite, non-randomised, pre-post feasibility design, with a nested qualitative study. People with severe haemophilia > 18 years, living with chronic pain, were recruited. The intervention comprised 12 low-impact/moderate intensity, individualised exercise sessions and 3 knowledge-sharing and discussion sessions. Primary objectives assessed according to predefined progression criteria were as follows: (a) recruitment rate (5 participants enrolled per site over 8 weeks), (b) adherence (≥ 75% participants would adhere to ≥ 75% of sessions), (c) follow-up rate (≥ 75% completion of self-reported measures), (d) fidelity (intervention delivered as described in protocol) and (e) safety (≤ 30% participants would report adverse events). Acceptability was evaluated from thematic analysis of post-intervention participant interviews. Preliminary evaluation of self-reported pain, function and quality of life (QoL) was a secondary objective. Results were reported using descriptive statistics integrated with qualitative findings.ResultsTen PWH were recruited and completed the intervention. Nine agreed to be interviewed post intervention. Attendance at individual sessions was 84.5% compared to 52.1% for the group sessions. Outcome measures were successfully completed for 100% at baseline, 70% at intervention end and 60% at 3-month follow-up. No serious adverse events were recorded. Group median values in outcome measures (pain, function, QoL) showed minimal change post intervention. Participant interviews highlighted high levels of enjoyment, confidence in continuing exercises independently and positive views of virtual delivery and condition-specific exercise.ConclusionsRecruitment rate and safety met the predefined progression criteria. Fidelity partially met the progression criteria, but the follow-up rate for self-reported measures did not. The study was acceptable to both participants and physiotherapists. Further intervention development is needed to review approaches to outcome measure collection and refine the usefulness of the knowledge-sharing sessions.Trial registrationThe study was prospectively registered on 9 July 2021: International Standard Randomised Controlled Trial Number ISRCTN 17454597.

CONTACT: a non-randomised feasibility study of bluetooth-enabled wearables for contact tracing in UK care homes during the COVID-19 pandemic

BackgroundThe need for effective non-pharmaceutical infection prevention measures such as contact tracing in pandemics remains in care homes, but traditional approaches to contact tracing are not feasible in care homes. The CONTACT intervention introduces Bluetooth-enabled wearable devices (BLE wearables) as a potential solution for automated contact tracing. Using structured reports and reports triggered by positive COVID-19 cases in homes, we fed contact patterns and trends back to homes to support better-informed infection prevention decisions and reduce blanket application of restrictive measures. This paper reports on the evaluation of feasibility and acceptability of the intervention prior to a planned definitive cluster randomised trial of the CONTACT BLE wearable intervention.MethodsCONTACT was a non-randomised mixed-method feasibility study over 2 months in four English care homes. Recruitment was via care home research networks, with individual consent. Data collection methods included routine data from the devices, case report forms, qualitative interviews (with staff and residents), field observation of care, and an adapted version of the NoMaD survey instrument to explore implementation using Normalisation Process Theory. Quantitative data were analysed using descriptive statistical methods. Qualitative data were thematically analysed using a framework approach and Normalisation Process Theory. Intervention and study delivery were evaluated against predefined progression criteria.ResultsOf 156 eligible residents, 105 agreed to wear a device, with 102 (97%) starting the intervention. Of 225 eligible staff, 82% (n = 178) participated. Device loss and damage were significant: 11% of resident devices were lost or damaged, ~ 50% were replaced. Staff lost fewer devices, just 6%, but less than 10% were replaced. Fob wearables needed more battery changes than card-type devices (15% vs. 0%). Structured and reactive feedback was variably understood by homes but unlikely to be acted on. Researcher support for interpreting reports was valued. Homes found information useful when it confirmed rather than challenged preconceived contact patterns. Staff privacy concerns were a barrier to adoption. Study procedures added to existing work, making participation burdensome. Study participation benefits did not outweigh perceived burden and were amplified by the pandemic context. CONTACT did not meet its quantitative or qualitative progression criteria.ConclusionCONTACT found a large-scale definitive trial of BLE wearables for contact tracing and feedback-informed IPC in care homes unfeasible and unacceptable — at least in the context of shifting COVID-19 pandemic demands. Future research should co-design interventions and studies with care homes, focusing on successful intervention implementation as well as technical effectiveness.Trial registrationISRCTN registration: 11204126 registered 17/02/2021.

Key considerations for digital decentralised clinical trials from a feasibility study assessing pacing interventions for long COVID

Post COVID-19 condition or long COVID is highly prevalent and often debilitating, with key symptoms including fatigue, breathlessness, and brain fog. There is currently a lack of evidence-based treatments for this highly complex syndrome. There is a need for clinical trial platforms to rapidly evaluate nonpharmacological treatments to support affected individuals with symptom management. We co-produced a mixed methods feasibility study to evaluate a multi-arm digital decentralised clinical trial (DCT) platform to assess non-pharmacological interventions for Long COVID, using pacing interventions as an exemplar. The study demonstrated that the platform was able to successfully e-consent participants, randomise them into one of four intervention arms, capture baseline data, and capture outcomes relevant to a health economic evaluation. The study also highlighted several challenges, including difficulties with recruitment, imposter participants, and high attrition rates. We highlight how these challenges can potentially be mitigated to make a fully powered DCT more feasible.

Occupational Therapy for Adults With Acute Hand Conditions: A Mixed-Methods Feasibility Study.

Hand injuries account for up to one third of acute hospital presentations. Current guidelines and standards of care recommend patients with hand trauma are seen by hand therapists, typically occupational therapists. This study explored the feasibility of implementing an occupational therapy-led hand therapy service for adults presenting acutely with a hand condition, using the RE-AIM framework. Purposeful sampling was used to recruit adult participants (n = 13). Outcome measures assessing function, health-related quality of life, pain, and occupational value and competence were completed. Focus groups were completed with patients and health care professionals. Data analysis revealed improvements in outcome measures post intervention and at 6-month follow-up. Participants were receptive of therapy-led services, and barriers and facilitators to service integration were identified using the RE-AIM framework. Occupational therapy-led hand therapy clinics show potential in treating people with acute hand conditions at emergency department settings, based on RE-AIM evaluation.

Introducing a self-managed early communication resource for parents – A mixed methods feasibility study of the Swedish “ComAlong online”

Background Web-based programmes offer parents of children with communication difficulties promising access to parent-mediated, early interventions. However, empirical evaluations of such programmes are limited. This study focused on parents and used mixed methods to examine the feasibility of ComAlong online. Methods ComAlong online is a Swedish, self-managed web-resource teaching parents supportive strategies to promote child communication. Data of different types were collected from a total of 71 parents: ten individual parent interviews, 21 pre-questionnaires and 10 post-questionnaires, and finally 50 anonymous digital evaluation surveys. Descriptive statistics and deductive qualitative content analysis were used. Results Findings indicate that parents perceived improved child communication and own competence after using the ComAlong online. The most valued parts included podcasts with experts and videos of parent-child interaction. Parents reported that the resource was easy to use, but they wanted to have gained access to the resource when the child was younger. Suggestions for changes included adding a chat function with experts, a parent net forum, and the possibility of creating personalised playlists of videos and podcasts. Evaluation of the research process revealed difficulties in recruiting parents from local child healthcare services and parents of children not yet with a diagnosis. Conclusions This study supports the potential for self-managed, web-based resources to disseminate evidence-based parent training for supporting early communication development. Importantly, parents lack individual guidance from experts and contact with other parents. Also, measures need to be made to disseminate the resources within local child healthcare services.