Pilot and Feasibility Studies
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Published By Springer (Biomed Central Ltd.)

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2022 ◽  
Vol 8 (1) ◽  
Author(s):  
Emmeline Lagunes-Cordoba ◽  
Ruth Alcala-Lozano ◽  
Roberto Lagunes-Cordoba ◽  
Ana Fresan-Orellana ◽  
Manuela Jarrett ◽  
...  

Abstract Background There is research evidence regarding the presence of stigmatising attitudes in psychiatrists towards people with mental illness, but a lack of studies and interventions focused on this issue in low and middle-income countries. Aims To assess the feasibility of implementing an anti-stigma intervention for Mexican psychiatric trainees, and its potential effects. Methods This study comprised a pre-post design with outcome measures compared between baseline and 3-month follow-up. Quantitative outcome measures were used to evaluate the potential effects of the intervention, whilst the process evaluation required the collection and analysis of both quantitative and qualitative data. Results Twenty-nine trainees (25% of those invited) participated in the intervention, of whom 18 also participated in the follow-up assessment. Outcome measures showed the intervention had moderately large effects on reducing stereotypes and the influence of other co-workers on trainees’ own attitudes. The main mechanisms of impact identified were recognition of negative attitudes in oneself and colleagues, self-reflection about the impact of stigma, one’s own negative attitudes and recognition of one’s ability to make change. Participants accepted and were satisfied with the intervention, which many considered should be part of their routine training. However, trainees’ work overload and lack of support from the host organisation were identified as barriers to implement the intervention. Conclusions A brief anti-stigma intervention for Mexican psychiatric trainees is feasible, potentially effective, well accepted and was considered necessary by participants. This study also suggests mechanisms of impact and mediators should be considered for developing further interventions, contributing to reducing the damaging effects that mental health-related stigma has on people’s lives.


2022 ◽  
Vol 8 (1) ◽  
Author(s):  
Kyongje Sung ◽  
Hanna Glazer ◽  
Jessica O’Grady ◽  
Mindy L. McEntee ◽  
Laura Bosley ◽  
...  

Abstract Background Although visual abnormalities are considered common in individuals with autism spectrum disorders, the associated electrophysiological markers have remained elusive. One impediment has been that methodological challenges often preclude testing individuals with low-functioning autism (LFA). Methods In this feasibility and pilot study, we tested a hybrid visual evoked potential paradigm tailored to individuals with LFA that combines passively presented visual stimuli to elicit scalp-recorded evoked responses with a behavioral paradigm to maintain visual attention. We conducted a pilot study to explore differences in visual evoked response patterns across three groups: individuals with LFA, with high-functioning autism (HFA), and with typical development. Results All participants with LFA met criteria for study feasibility by completing the recordings and producing measurable cortical evoked waveform responses. The LFA group had longer (delayed) cortical response latencies on average as compared with the HFA and typical development groups. We also observed group differences in visually induced alpha spectral power: the LFA group showed little to no prestimulus alpha activity in contrast to the HFA and typical development groups that showed increased prestimulus alpha activity. This observation was confirmed by the bootstrapped confidence intervals, suggesting that the absence of prestimulus alpha power may be a potential electrophysiological marker of LFA. Conclusion Our results confirm the utility of tailoring visual electrophysiology paradigms to individuals with LFA in order to facilitate inclusion of individuals across the autism spectrum in studies of visual processing.


2022 ◽  
Vol 8 (1) ◽  
Author(s):  
Stacie A. Salsbury ◽  
Elissa Twist ◽  
Robert B. Wallace ◽  
Robert D. Vining ◽  
Christine M. Goertz ◽  
...  

Abstract Background Low back pain (LBP) is common among military veterans seeking treatment in Department of Veterans Affairs (VA) healthcare facilities. As chiropractic services within VA expand, well-designed pragmatic trials and implementation studies are needed to assess clinical effectiveness and program uptake. This study evaluated veteran stakeholder perceptions of the feasibility and acceptability of care delivery and research processes in a pilot trial of multimodal chiropractic care for chronic LBP. Methods The qualitative study was completed within a mixed-method, single-arm, pragmatic, pilot clinical trial of chiropractic care for LBP conducted in VA chiropractic clinics. Study coordinators completed semi-structured, in person or telephone interviews with veterans near the end of the 10-week trial. Interviews were audiorecorded and transcribed verbatim. Qualitative content analysis using a directed approach explored salient themes related to trial implementation and delivery of chiropractic services. Results Of 40 participants, 24 completed interviews (60% response; 67% male gender; mean age 51.7 years). Overall, participants considered the trial protocol and procedures feasible and reported that the chiropractic care and recruitment methods were acceptable. Findings were organized into 4 domains, 10 themes, and 21 subthemes. Chiropractic service delivery domain encompassed 3 themes/8 subthemes: scheduling process (limited clinic hours, scheduling future appointments, attendance barriers); treatment frequency (treatment sufficient for LBP complaint, more/less frequent treatments); and chiropractic clinic considerations (hire more chiropractors, including female chiropractors; chiropractic clinic environment; patient-centered treatment visits). Outcome measures domain comprised 3 themes/4 subthemes: questionnaire burden (low burden vs. time-consuming or repetitive); relevance (items relevant for LBP study); and timing and individualization of measures (questionnaire timing relative to symptoms, personalized approach to outcomes measures). The online data collection domain included 2 themes/4 subthemes: user concerns (little difficulty vs. form challenges, required computer skills); and technology issues (computer/internet access, junk mail). Clinical trial planning domain included 2 themes/5 subthemes: participant recruitment (altruistic service by veterans, awareness of chiropractic availability, financial compensation); and communication methods (preferences, potential barriers). Conclusions This qualitative study highlighted veteran stakeholders’ perceptions of VA-based chiropractic services and offered important suggestions for conducting a full-scale, veteran-focused, randomized trial of multimodal chiropractic care for chronic LBP in this clinical setting. Trial registration ClinicalTrials.govNCT03254719


2022 ◽  
Vol 8 (1) ◽  
Author(s):  
Arlette Simo Fotso ◽  
Arsène Kouassi Kra ◽  
Mathieu Maheu-Giroux ◽  
Sokhna Boye ◽  
Marc d’Elbée ◽  
...  

Abstract Background Due to the discreet and private nature of HIV self-testing (HIVST), it is particularly challenging to monitor and assess the impacts of this testing strategy. To overcome this challenge, we conducted a study in Côte d’Ivoire to characterize the profile of end users of HIVST kits distributed through the ATLAS project (AutoTest VIH, Libre d’Accéder à la connaissance de son Statut). Feasibility was assessed using a pilot phone-based survey. Methods The ATLAS project aims to distribute 221300 HIVST kits in Côte d’Ivoire from 2019 to 2021 through both primary (e.g., direct distribution to primary users) and secondary distribution (e.g., for partner testing). The pilot survey used a passive recruitment strategy—whereby participants voluntarily called a toll-free survey phone number—to enrol participants. The survey was promoted through a sticker on the HIVST instruction leaflet and hotline invitations and informal promotion by HIVST kit-dispensing agents. Importantly, participation was not financially incentivized, even though surveys focussed on key populations usually use incentives in this context. Results After a 7-month period in which 25,000 HIVST kits were distributed, only 42 questionnaires were completed. Nevertheless, the survey collected data from users receiving HIVST kits via both primary and secondary distribution (69% and 31%, respectively). Conclusion This paper provides guidance on how to improve the design of future surveys of this type. It discusses the need to financial incentivize participation, to reorganize the questionnaire, the importance of better informing and training stakeholders involved in the distribution of HIVST, and the use of flyers to increase the enrolment of users reached through secondary distribution.


2022 ◽  
Vol 8 (1) ◽  
Author(s):  
Mairéad Conneely ◽  
Aoife Leahy ◽  
Margaret O’Connor ◽  
Louise Barry ◽  
Gillian Corey ◽  
...  

Abstract Background Older adults frequently attend the emergency department (ED) and experience high rates of adverse outcomes following ED presentation including functional decline, ED re-presentation and unplanned hospital admission. The development of effective interventions to prevent such outcomes is a key priority for research and service provision. This paper reports a protocol designed to evaluate the feasibility of conducting a three arm randomised controlled trial (RCT) within the ED setting and in the patient’s home. The interventions are comprehensive geriatric assessment (CGA), ED PLUS and usual care. Methods The ED PLUS pilot trial is designed as a feasibility RCT conducted in the ED and Acute Medical Assessment Unit of a university teaching hospital in the mid-west region of Ireland. We aim to recruit 30 patients, aged 65 years and over presenting to the ED with undifferentiated medical complaints and discharged within 72 h of index visit. Patients will be randomised by a computer in a ratio of 1:1:1 to deliver usual care, CGA or ED PLUS during a 6-month study period. A randomised algorithm is used to perform randomization. CGA will include a medical assessment, medication review, nursing assessment, falls assessment, assessment of mobility and stairs, transfers, personal care, activities of daily living (ADLs), social supports and baseline cognition. ED PLUS, a physiotherapist led, multidisciplinary intervention, aims to bridge the transition of care between the index visit to the ED and the community by initiating a CGA intervention in the ED and implementing a 6-week follow-up self-management programme in the patient’s own home following discharge from the ED. The outcomes will be parameters of the feasibility of the intervention and trial methods and will be assessed quantitatively and qualitatively. Discussion Rising ED visits and an ageing population with chronic health issues render ED interventions to reduce adverse outcomes in older adults a research priority. This feasibility RCT will generate data and experience to inform the conduct and delivery of a definite RCT. Trial registration The trial was registered in Clinical Trials Protocols and Results System as of 21st July 2021, with registration number NCT049836020.


2022 ◽  
Vol 8 (1) ◽  
Author(s):  
Katarzyna Kostyrka-Allchorne ◽  
Claire Ballard ◽  
Sarah Byford ◽  
Samuele Cortese ◽  
David Daley ◽  
...  

Abstract Background In the UK, children with high levels of hyperactivity, impulsivity and inattention referred to clinical services with possible attention-deficit/hyperactivity disorder (ADHD) often wait a long time for specialist diagnostic assessment. Parent training (PT) has the potential to support parents during this difficult period, especially regarding the management of challenging and disruptive behaviours that often accompany ADHD. However, traditional face-to-face PT is costly and difficult to organise in a timely way. We have created a low-cost, easily accessible PT programme delivered via a phone app, Structured E-Parenting Support (STEPS), to address this problem. The overall OPTIMA programme will evaluate the efficacy and cost-effectiveness of STEPS as a way of helping parents manage their children behaviour while on the waitlist. To ensure the timely and efficient evaluation of STEPS in OPTIMA, we have worked with children’s health services to implement a remote strategy for recruitment, screening and assessment of recently referred families. Part of this strategy is incorporated into routine clinical practice and part is OPTIMA specific. Here, we present the protocol for Phase 1 of OPTIMA—a study of the feasibility of this remote strategy, as a basis for a large-scale STEPS randomised controlled trial (RCT). Methods This is a single arm observational feasibility study. Participants will be parents of up to 100 children aged 5-11 years with high levels of hyperactivity/impulsivity, inattention and challenging behaviour who are waiting for assessment in one of five UK child and adolescent mental health or behavioural services. Recruitment, consenting and data collection will occur remotely. The primary outcome will be the rate at which the families, who meet inclusion criteria, agree in principle to take part in a full STEPS RCT. Secondary outcomes include acceptability of remote consenting and online data collection procedures; the feasibility of collecting teacher data remotely within the required timeframe, and technical difficulties with completing online questionnaires. All parents in the study will receive access to STEPS. Discussion Establishing the feasibility of our remote recruitment, consenting and assessment strategy is a pre-requisite for the full trial of OPTIMA. It can also provide a model for future trials conducted remotely.


2022 ◽  
Vol 8 (1) ◽  
Author(s):  
Bethan Pell ◽  
Jemma Hawkins ◽  
Rebecca Cannings-John ◽  
Joanna M. Charles ◽  
Britt Hallingberg ◽  
...  

Abstract Background In the UK, there is evidence that girls’ physical activity tends to decline to a greater extent than boys as they enter adolescence. ‘Role models’ could play a vital role in inspiring girls to become or remain physically active. The CHARMING Programme is a primary school-based community linked role-model programme, co-developed in 2016, with children, parents, schools and wider stakeholders. It involves different types of physical activity delivered for 1-h each week by a community provider and peer role models (e.g. older girls from secondary schools) joining in with the sessions. The programme ultimately aims to increase and sustain physical activity levels among 9–10-year-old girls. This study aims to assess the feasibility and acceptability of the CHARMING Programme and of evaluating it using a randomised trial. Methods This study is a feasibility cluster randomised controlled trial, with embedded process evaluation and health economic evaluation. Approximately 90 Year 5 (i.e. 9–10-year-old) girls will be recruited across six primary schools in Mid-South Wales. Participating schools will be allocated to the programme: control on a 2:1 basis; four intervention schools will run the CHARMING Programme and two will continue with usual practice. A survey and accelerometer will be administered at baseline and repeated at 12 months. Interviews and focus groups will be conducted post-intervention delivery. The primary aim is to assess feasibility of a future randomised trial via the recruitment of schools, participants and role models; randomisation; retention; reach; data collection completion rates; programme adherence; and programme fidelity, views on intervention acceptability and programme barriers and facilitators. Secondary aims are to evaluate established physical activity outcome measures for children plus additional health economic outcomes for inclusion in a future full-scale trial. Discussion The results of this study will inform decisions on whether and how to proceed to a full-scale evaluation of the effectiveness and cost-effectiveness of the CHARMING Programme to improve or sustain physical activity. Trial registration ClinicalTrials.gov ISRCTN36223327. Registered March 29, 2021


2021 ◽  
Vol 7 (1) ◽  
Author(s):  
Michelle Harvie ◽  
David P. French ◽  
Mary Pegington ◽  
Grace Cooper ◽  
Anthony Howell ◽  
...  

Abstract Background Excess weight and unhealthy behaviours (e.g. sedentariness, high alcohol) are common amongst women including those attending breast screening. These factors increase the risk of breast cancer and other diseases. We tested the feasibility and acceptability of a weight loss/behaviour change programme framed to reduce breast cancer risk (breast cancer prevention programme, BCPP) compared to one framed to reduce risk of breast cancer, cardiovascular disease (CVD) and diabetes (T2D) (multiple disease prevention programme, MDPP). Methods Women aged 47-73 years with overweight or obesity (n = 1356) in the NHS Breast Screening Programme (NHSBSP) were randomised (1:2) to be invited to join a BCPP or a MDPP. The BCPP included personalised information on breast cancer risk and a web and phone weight loss/behaviour change intervention. The MDPP also included an NHS Health Check (lipids, blood pressure, HbA1c and personalised feedback for risk of CVD [QRISK2] and T2D [QDiabetes and HbA1c]). Primary outcomes were uptake and retention and other feasibility outcomes which include intervention fidelity and prevalence of high CVD and T2D risk. Secondary outcomes included change in weight. Results The BCPP and MDPP had comparable rates of uptake: 45/508 (9%) vs. 81/848 (10%) and 12-month retention; 33/45 (73%) vs. 53/81 (65%). Both programmes had a high fidelity of delivery with receipt of mean (95% CI) 90 (88-98% of scheduled calls, 91 (86-95%) of scheduled e-mails and 89 (76-102) website entries per woman over the 12-month period. The MDPP identified 15% of women with a previously unknown 10-year CVD QRISK2 of ≥ 10% and 56% with 10-year Qdiabetes risk of ≥ 10%. Both groups experienced good comparable weight loss: BCPP 26/45 (58%) and MDPP 46/81 (57%) with greater than 5% weight loss at 12 months using baseline observation carried forward imputation. Conclusions Both programmes appeared feasible. The MDPP identified previously unknown CVD and T2D risk factors but does not appear to increase engagement with behaviour change beyond a standard BCPP amongst women attending breast screening. A future definitive effectiveness trial of BCPP is supported by acceptable uptake and retention, and good weight loss. Trial registration ISRCTN91372184, registered 28 September 2014.


2021 ◽  
Vol 7 (1) ◽  
Author(s):  
Veronika van der Wardt ◽  
Hannah Seipp ◽  
Annette Becker ◽  
Catharina Maulbecker-Armstrong ◽  
Rebecca Kraicker ◽  
...  

Abstract Background Long-term disability to work is a risk factor for a permanent reduction in income. Rehabilitation care can support people to return to work. In Germany, rehabilitation care to return to work is mostly provided in specialised clinics. The aim of the Rehapro-SERVE study is to reduce work disability days by facilitating rehabilitation care planning using a digital communication platform. To investigate the feasibility, we will test the implementation of the digital platform and evaluate the study procedures. The Rehapro-SERVE study is funded by the German Federal Ministry of Labour and Social Affairs (BMAS) (grant number: 661R0053K1). Method The feasibility study includes a two-armed unblinded block randomised controlled study (RCT) without follow-up assessments as well as an interview study. Participants for the RCT (n = 16) are primary care patients with a minimum of 4 weeks of absence from work due to musculoskeletal, oncological or psychological conditions and at high risk of early retirement. Eligibility criteria are age 40 to 60 years; minimum of 4 weeks continuous sick leave before recruitment due to musculoskeletal, mental health or oncological conditions; and being at high risk of early retirement. Patients will be recruited from 8 primary care practices in urban and rural areas in Hesse, Germany. Following baseline assessments, patients will be randomised to either digitalised care planning (treatment) or a control group. The digitalised care planning platform will include the patients’ primary care physicians, jobcentres and public health physicians to decide on a tailored return-to-work programme. The collaboration will be supported by a case administrator and, if considered beneficial, a social worker for the patient. An interview study will evaluate the acceptability of the study procedures and the intervention. Discussion The use of a digital communication platform enables stakeholders to exchange information and discuss rehabilitation care planning in a timely fashion. The results of the feasibility study will lead to the adaptation of study procedures for the main study. The results will support the design and conduct of similar studies including digital applications in primary care or across different healthcare settings. Trial registration DRKS- German Clinical Trials Register, DRKS00024207. Registered on 22 March 2021


2021 ◽  
Vol 7 (1) ◽  
Author(s):  
Kerri M. Winters-Stone ◽  
Karen S. Lyons ◽  
Tomasz M. Beer ◽  
Meghan B. Skiba ◽  
Arthur Hung

Abstract Introduction Prostate cancer can negatively impact the health of patients and their spouse, particularly early on in the cancer trajectory. Purpose To determine the feasibility and acceptability of dyadic exercises during radiation therapy and preliminary efficacy on physical, mental, and relational outcomes for men and their spouses. Exercising Together©, originally designed as a 6-month dyadic resistance training program for couples post-treatment, was adapted for the radiation setting. Methods We conducted a single-group pilot feasibility study of Exercising Together© in men scheduled for radiation therapy for prostate cancer and their spouse. Couples attended supervised exercise sessions thrice weekly throughout radiation treatment and were followed up 8 weeks later. Primary outcomes were feasibility and acceptability with secondary outcomes of changes in physical (physical functioning (short physical performance battery (sPPB)), gait speed (m/s), functional capacity (400-m walk (min), physical activity (min/week)), mental (depressive symptoms (CES-D), and anxiety (SCL-90 ANX)), and relationship (Dyadic Coping, Role Overload, and Physical Intimacy Behavior Scales) health outcomes for each partner. Participants completed an evaluation post-intervention. Results Ten couples enrolled and 8 completed the intervention, attending 83% of scheduled sessions. Couple satisfaction with the intervention was high (patients: mean difference (MD) = 9.4 ± 1.9 and spouses: MD = 10.0 ± 0.0, on a 1–10 scale). At post-intervention, gait speed (MD = 0.1; 95%CI: 0.1, 0.2; p = 0.003; d = 0.94) and functional capacity (MD = −0.6; 95%CI: −0.9, 0.3; p = 0.002; d = −0.42) improved in patients and sPPB in spouses (MD = 1.3; 95%CI: 0.3, 2.2; p = 0.02; d = 0.71). Total physical activity increased non-significantly for patients and significantly for spouses at post-intervention and decreased at follow-up (MD = 179.6; 95%CI: 55.4, 303.7; p = 0.01; d = 1.35 and MD = −139.9; 95%CI: −266.5, 13.3; p = 0.03; d=1.06). Among patients, anxiety and active engagement significantly improved post-intervention (MD = −2.3; 95%CI: −3.8, 0.7; p = 0.01; d = −0.43 and MD = 2.5; 95%CI: 0.7, 4.3; p = 0.01; d = 0.98, respectively). There were modest effects on other physical, mental, and relationship health domains in patients and spouses. Conclusion A modified version of Exercising Together© is a feasible and acceptable program during radiation therapy for prostate cancer and shows preliminary evidence for improvements on physical, mental, and relational health in both patient and spouse. A larger, fully powered randomized controlled trial is warranted and could help shift the landscape toward dyadically targeted interventions. Trial registration This study was registered on ClinicalTrials.gov on February 18th, 2018 (NCT03418025).


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