Fidelity Of Intervention Delivery Research Articles

Why do we continue to exclude the most vulnerable in our society in diabetes research and education? Addressing the challenges presented by people with intellectual disability

Abstract People with an intellectual disability are more likely to develop diabetes compared to their non‐disabled peers. There has been a history of exclusion of people with an intellectual disability from diabetes research and education: we must now challenge this from a human rights perspective. In challenging these perceptions, we must identify the ethical and methodological reasons for exclusion and offer practical solutions to these challenges.These barriers to inclusion focus on three core areas. Firstly, individual factors concerning the person with the disability (can the person give their own informed consent, can the person read/write, completion of self‐report measures?). Secondly, factors concerning the methodology and design of the research study (can studies recruit the numbers needed, can people with intellectual disability understand/accept randomisation?). And, thirdly, system/organisational factors pertaining to the enablers/barriers to engaging in and completing research studies (buy‐in from senior managers, staff acting as gatekeepers, maternalistic attitudes held by gatekeepers, fidelity of intervention delivery).This Janet Kinson paper will explore these intentional and unintentional exclusion criteria that are so often applied to people with an intellectual disability in research trial studies. This paper will dispel the myths and offer solutions for including people with an intellectual disability in diabetes research and education. Using the UK national diabetes structured education programme, DESMOND, this paper will highlight the types of reasonable adjustments that can be made to adapt this programme suitable for adults with an intellectual disability: called DESMOND‐ID. This paper will demonstrate how, with reasonable adjustments, this newly‐adapted DESMOND‐ID education programme then can be tested within a National Institute for Health and Care Research clinical randomised control trial across the UK investigating the programme's clinical and cost‐effectiveness. Copyright © 2024 John Wiley & Sons.

Personalised Exercise-Rehabilitation FOR people with Multiple long-term conditions (PERFORM): protocol for a randomised feasibility trial

IntroductionPersonalised Exercise-Rehabilitation FOR people with Multiple long-term conditions (PERFORM) is a research programme that seeks to develop and evaluate a comprehensive exercise-based rehabilitation intervention designed for people with multimorbidity, the...

Exploring critical intervention features and trial processes in the evaluation of sensory integration therapy for autistic children

BackgroundWe evaluated the clinical and cost-effectiveness of manualised sensory integration therapy (SIT) for autistic children with sensory processing difficulties in a two-arm randomised controlled trial. Trial processes and contextual factors which may have affected intervention outcomes were explored within a nested process evaluation. This paper details the process evaluation methods and results. We also discuss implications for evaluation of individual level, tailored interventions in similar populations.MethodsThe process evaluation was conducted in line with Medical Research Council guidance. Recruitment, demographics, retention, adherence, and adverse effects are reported using descriptive statistics. Fidelity of intervention delivery is reported according to the intervention scoring manual. Qualitative interviews with therapists and carers were undertaken to explore the acceptability of the intervention and trial processes. Qualitative interviews with carers explored potential contamination.ResultsRecruitment, reach and retention within the trial met expected thresholds. One hundred thirty-eight children and carers were recruited (92% of those screened and 53.5% of those who expressed an interest) with 77.5% retained at 6 months and 69.9% at 12 months post-randomisation. The intervention was delivered with structural and process fidelity with the majority (78.3%) receiving a ‘sufficient dose’ of intervention. However, there was considerable individual variability in the receipt of sessions. Carers and therapists reported that trial processes were generally acceptable though logistical challenges such as appointment times, travel and COVID restrictions were frequent barriers to receiving the intervention. No adverse effects were reported.ConclusionsThe process evaluation was highly valuable in identifying contextual factors that could impact the effectiveness of this individualised intervention. Rigorous evaluations of interventions for autistic children are important, especially given the limitations such as limited sample sizes and short-term follow-up as faced by previous research. One of the challenges lies in the variability of outcomes considered important by caregivers, as each autistic child faces unique challenges. It is crucial to consider the role of parents or other caregivers in facilitating access to these interventions and how this may impact effectiveness.Trial registrationThis trial is registered as ISRCTN14716440. August 11, 2016.

Evaluating an intervention to improve the safety and experience of transitions from hospital to home for older people (Your Care Needs You): a protocol for a cluster randomised controlled trial and process evaluation

BackgroundOlder patients often experience safety issues when transitioning from hospital to home. The ‘Your Care Needs You’ (YCNY) intervention aims to support older people to ‘know more’ and ‘do more’ whilst in hospital so that they are better prepared for managing at home.MethodsA multi-centre cluster randomised controlled trial (cRCT) will evaluate the effectiveness and cost-effectiveness of the YCNY intervention.Forty acute hospital wards (clusters) in England from varying medical specialities will be randomised to deliver YCNY or care-as-usual on a 1:1 basis. The primary outcome will be unplanned hospital readmission rates within 30 days of discharge. This will be extracted from routinely collected data of at least 5440 patients (aged 75 years and older) discharged to their own homes during the 4- to 5-month YCNY intervention period. A nested cohort of up to 1000 patients will be recruited to the study to collect secondary outcomes via follow-up questionnaires at 5-, 30- and 90-day post-discharge. These will include measures of patient experience of transitions, patient-reported safety events, quality of life and healthcare resource use. Unplanned hospital readmission rates at 60 and 90 days of discharge will be collected from routine data.A process evaluation (primarily interviews and observations with patients, carers and staff) will be conducted to understand the implementation of the intervention and the contextual factors that shape this, as well as the intervention’s underlying mechanisms of action. Fidelity of intervention delivery will also be assessed across all intervention wards.DiscussionThis study will establish the effectiveness and cost-effectiveness of the YCNY intervention which aims to improve patient safety and experience for older people during transitions of care. The process evaluation will generate insights about how the YCNY intervention was implemented, what elements of the intervention work and for whom, and how to optimise its implementation so that it can be delivered with high fidelity in routine service contexts.Trial registrationUK Clinical Research Network Portfolio: 44559; ISTCRN: ISRCTN17062524. Registered on 11/02/2020.

Manchester Intermittent and Daily diet Type 1 Diabetes App Study (MIDDAS-Type 1): protocol for a randomised feasibility trial of an intermittent and continuous low-energy diet in patients with type 1 diabetes and overweight and obesity

IntroductionRising levels of overweight and obesity among people with type 1 diabetes (T1D) contribute to insulin resistance, dyslipidaemia, retinopathy, cardiometabolic complications and psychological morbidity. Continuous low-energy diets (CLED) providing approximately...

Preliminary effectiveness and implementation outcomes of the IMARA-South Africa sexual health intervention on adolescent girls and young women: A pilot randomized trial.

Family-based interventions may help reduce the risk of HIV and other sexually transmitted infections (STI) among adolescent girls and young women (AGYW) in sub-Saharan Africa but few have been tested. We examined the preliminary effectiveness and implementation outcomes of Informed, Motivated, Aware, and Responsible Adolescents and Adults-South Africa (IMARA-SA), an evidence-based intervention for South African AGYW (15-19 years) and their female caregivers. We piloted IMARA-SA in the Western Cape using an individually randomized experimental design and average follow-up at 11 months. Primary outcomes were HIV Testing and Counselling (HTC) uptake, STI incidence (gonorrhea, chlamydia), and pre-exposure prophylaxis (PrEP) uptake. Secondary outcomes were self-reported sexual risk behavior (condom use at last sex, consistency of condom use, substance use during sex, and number of sexual partners) and PrEP adherence. We examined four implementation outcomes: reach, feasibility, acceptability, and fidelity. Data from 59 AGYW (mean = 17.2 years) were analyzed at baseline (n = 29 from IMARA-SA, 30 from a health promotion control group). At follow-up, 51 (86%) completed surveys and 39 (66%) presented for HTC, STI testing, and/or PrEP. Compared to controls, fewer IMARA-SA participants tested positive for an STI (22% versus 38%), more IMARA-SA participants took up PrEP (68% versus 45%), and four of five secondary outcomes favored the IMARA-SA group at follow-up. These differences did not reach statistical significance. HTC uptake at follow-up was 100% in both groups. All AGYW-FC dyads agreed to participate in the study (reach). In the IMARA-SA group, 76% of dyads completed the intervention (feasibility), and over 76% of acceptability ratings from AGYW and their FC had the highest Likert rating. Fidelity of intervention delivery was 95%. IMARA-SA is a promising strategy for reducing HIV/STI risk among South African AGYW. We found strong evidence of reach, feasibility, acceptability, and fidelity. A fully powered randomized controlled trial is warranted. Trial registration: Clinical trials.gov registration number: NCT05504954.

Systematic development and feasibility testing of a multibehavioural digital prehabilitation intervention for patients approaching major surgery (iPREPWELL): A study protocol.

Improving outcomes for people undergoing major surgery, specifically reducing perioperative morbidity and mortality remains a global health challenge. Prehabilitation involves the active preparation of patients prior to surgery, including support to tackle risk behaviours that mediate and undermine physical and mental health and wellbeing. The majority of prehabilitation interventions are delivered in person, however many patients express a preference for remotely-delivered interventions that provide them with tailored support and the flexibility. Digital prehabilitation interventions offer scalability and have the potential to benefit perioperative healthcare systems, however there is a lack of robustly developed and evaluated digital programmes for use in routine clinical care. We aim to systematically develop and test the feasibility of an evidence and theory-informed multibehavioural digital prehabilitation intervention 'iPREPWELL' designed to prepare patients for major surgery. The intervention will be developed with reference to the Behaviour Change Wheel, COM-B model, and the Theoretical Domains Framework. Codesign methodology will be used to develop a patient intervention and accompanying training intervention for healthcare professionals. Training will be designed to enable healthcare professionals to promote, support and facilitate delivery of the intervention as part of routine clinical care. Patients preparing for major surgery and healthcare professionals involved with their clinical care from two UK National Health Service centres will be recruited to stage 1 (systematic development) and stage 2 (feasibility testing of the intervention). Participants recruited at stage 1 will be asked to complete a COM-B questionnaire and to take part in a qualitative interview study and co-design workshops. Participants recruited at stage 2 (up to twenty healthcare professionals and forty participants) will be asked to take part in a single group intervention study where the primary outcomes will include feasibility, acceptability, and fidelity of intervention delivery, receipt, and enactment. Healthcare professionals will be trained to promote and support use of the intervention by patients, and the training intervention will be evaluated qualitatively and quantitatively. The multifaceted and systematically developed intervention will be the first of its kind and will provide a foundation for further refinement prior to formal efficacy testing.

Brief education supported psychological treatment for adolescent borderline personality disorder: the BEST feasibility RCT

BackgroundBorderline personality disorder is a severe mental health condition characterised by a pattern of emotional instability, interpersonal dysfunction, disturbed self-image and impulsive behaviour, including self-harm. Symptoms of borderline personality disorder typically emerge during adolescence. Although there is compelling evidence in support of early intervention for borderline personality disorder, current evidence-based interventions are resource intensive, with the result that few young people access timely treatment. Therefore, there is an urgent need for accessible interventions to facilitate early intervention for adolescents with borderline personality disorder symptoms.ObjectivesThe first objective was to adapt a brief psychological treatment for adolescent borderline personality disorder that had previously been delivered within secondary mental health services for co-delivery within schools and colleges. The second objective was to assess the feasibility of evaluating the clinical effectiveness and cost-effectiveness of this intervention in a future randomised controlled trial.DesignWe first conducted a rapid evidence synthesis of barriers to and facilitators of the implementation of indicated mental health interventions for adolescents within educational settings and piloted the prototype intervention with three schools/colleges. Based on the findings of the evidence synthesis and pilot, we refined the intervention and study procedures in preparation for a feasibility randomised controlled trial. The feasibility randomised controlled trial involved 12 schools and colleges, whose pastoral staff members received training to deliver the intervention alongside a mental health practitioner. Participants were randomised in a 1 : 1 ratio to receive either the BEST (Brief Education Supported Treatment) intervention plus treatment as usual or treatment as usual alone. Participants were assessed pre randomisation (baseline) and at 12 and 24 weeks post randomisation. Mixed-methods process data were collected to understand how the intervention was implemented, to assess acceptability and to monitor contamination of the control arm.ParticipantsYoung people eligible to participate were aged 13–18 years, reported symptoms of borderline personality disorder above an established threshold and had a history of repeated self-harm.ResultsThe intervention was refined based on findings of the rapid evidence synthesis, which included 50 studies, feedback from staff participants in the pilot and analysis of session recordings. In the feasibility randomised controlled trial, we randomised 32 participants prior to the premature closure of recruitment. The rate of recruitment was slower than anticipated but would probably have narrowly surpassed our progression criterion over the full recruitment window. Participant retention was high (89.5% at 12 weeks and 73.7% at 24 weeks) and the performance of the proposed outcome measures was satisfactory. We did not find any evidence that participants allocated to the treatment-as-usual arm received the BEST intervention or its components. Fidelity of intervention delivery was high (93.5% of recordings rated as adherent) and the intervention was viewed as offering benefits for individual participants, practitioners involved in co-delivery and the wider school/college.LimitationsThe feasibility randomised controlled trial was disrupted by the closure of schools and colleges in response to the COVID-19 pandemic. This reduced the window for participant recruitment and limited the data that could be collected.ConclusionsThe refined BEST intervention was able to be delivered successfully within schools and colleges and was found to be acceptable to staff and young people. The findings provide support for continuing this programme of research and would inform the design of a future trial.Trial registrationThis trial is registered as ISRCTN16862589.FundingThis project was funded by the National Institute for Health and Care Research (NIHR) Health and Social Care Delivery Research programme and will be published in full inHealth and Social Care Delivery Research; Vol. 10, No. 37. See the NIHR Journals Library website for further project information.

Feasibility of an Audit and Feedback Intervention to Facilitate Journal Policy Change Towards Greater Promotion of Transparency and Openness in Sports Science Research

ObjectivesTo evaluate (1) the feasibility of an audit-feedback intervention to facilitate sports science journal policy change, (2) the reliability of the Transparency of Research Underpinning Social Intervention Tiers (TRUST) policy evaluation form, and (3) the extent to which policies of sports science journals support transparent and open research practices.MethodsWe conducted a cross-sectional, audit-feedback, feasibility study of transparency and openness standards of the top 38 sports science journals by impact factor. The TRUST form was used to evaluate journal policies support for transparent and open research practices. Feedback was provided to journal editors in the format of a tailored letter. Inter-rater reliability and agreement of the TRUST form was assessed using intraclass correlation coefficients and the standard error of measurement, respectively. Time-based criteria, fidelity of intervention delivery and qualitative feedback were used to determine feasibility.ResultsThe audit-feedback intervention was feasible based on the time taken to rate journals and provide tailored feedback. The mean (SD) score on the TRUST form (range 0–27) was 2.05 (1.99), reflecting low engagement with transparent and open practices. Inter-rater reliability of the overall score of the TRUST form was moderate [ICC (2,1) = 0.68 (95% CI 0.55–0.79)], with standard error of measurement of 1.17. However, some individual items had poor reliability.ConclusionPolicies of the top 38 sports science journals have potential for improved support for transparent and open research practices. The feasible audit-feedback intervention developed here warrants large-scale evaluation as a means to facilitate change in journal policies.Registration: OSF (https://osf.io/d2t4s/).

Peer-led family-centred problem management plus for immigrants (PMP-I) for mental health promotion among immigrants in USA: protocol for a pilot, randomised controlled feasibility trial

IntroductionResearch is needed to investigate preventive strategies to reduce mental health burden and assess effective implementation among immigrants. Problem management plus (PMP) is a low-intensity multicomponent psychological intervention developed by...

A feasibility RCT comparing TRAK-ACL digital rehabilitation intervention plus TAU versus TAU for knee anterior cruciate ligament reconstruction patients

Keywords: Digital health; Anterior cruciate ligament; Behaviour change Purpose: To evaluate the feasibility of TRAK-ACL, a digital health intervention that provides health information, personalised exercise plans and remote clinical support combined with treatment as usual (TAU), for people following anterior cruciate ligament (ACL) reconstruction. Methods: The study design was a two-arm parallel randomised control trial (RCT). Eligible participants were adults, English speakers, had undergone ACL reconstruction within the last 12 weeks, had access to the internet and could provide informed consent. Recruitment took place at 3 sites in the UK. TRAK-ACL intervention was an interactive website informed by behaviour change technique combined with TAU. The comparator was TAU. Outcomes were: recruitment and retention, completeness of outcome measures at follow-up, fidelity of intervention delivery, and engagement with the TRAK-ACL website. Individuals were randomised using a computer-generated random number sequence. Blinded assessors allocated groups and collected outcome measures. Results: Fifty-nine people were assessed for eligibility and 51 were randomised, 26 were allocated to TRAK-ACL and 25 to TAU. Retention was 44 and 40 at 3 and 6 months. All eligible participants were identified at two of the participating sites. All outcome measures were completed fully at 6 months except the Client Service Receipt Inventory. Two patients in each arm did not receive the treatment they were randomised to. Engagement with TRAK-ACL intervention was a median of 5 logins (Inter Quartile Range 3-13), over 18 weeks (Standard Deviation 12.2). Conclusion(s): The feasibility of TRAK-ACL has been demonstrated and would be suitable for evaluation of effectiveness in a fully powered RCT. Further investment in the intervention would be required. Impact: This research provides an evidence-based digital health intervention that reflects the expertise of physiotherapy led ACL rehabilitation. TRAK ACL, could go some way to overcoming the variations in care at a national level and improving access to the information, exercises and benchmarks that are needed at all stages of ACL rehabilitation. TRAK ACL has the potential to improve access to optimal care across the NHS. Technical work to increase its functionality will be a part of its ongoing impact. Funding acknowledgements: NIHR Clinical Doctoral Research Fellowship.

ASHA-Led Community-Based Groups to Support Control of Hypertension in Rural India Are Feasible and Potentially Scalable.

Background: To improve the control of hypertension in low- and middle-income countries, we trialed a community-based group program co-designed with local policy makers to fit within the framework of India's health system. Trained accredited social health activists (ASHAs), delivered the program, in three economically and developmentally diverse settings in rural India. We evaluated the program's implementation and scalability.Methods: Our mixed methods process evaluation was guided by the United Kingdom Medical Research Council guidelines for complex interventions. Meeting attendance reports, as well as blood pressure and weight measures of attendees and adherence to meeting content and use of meeting tools were used to evaluate the implementation process. Thematic analysis of separate focus group discussions with participants and ASHAs as well as meeting reports and participant evaluation were used to investigate the mechanisms of impact.Results: Fifteen ASHAs led 32 community-based groups in three rural settings in the states of Kerala and Andhra Pradesh, Southern India. Overall, the fidelity of intervention delivery was high. Six meetings were delivered over a 3-month period to each of the intervention groups. The mean number of meetings attended by participants at each site varied significantly, with participants in Rishi Valley attending fewer meetings [mean (SD) = 2.83 (1.68)] than participants in West Godavari (Tukeys test, p = 0.009) and Trivandrum (Tukeys test, p < 0.001) and participants in West Godavari [mean (SD) = 3.48 (1.72)] attending significantly fewer meetings than participants in Trivandrum [mean (SD) = 4.29 (1.76), Tukeys test, p < 0.001]. Culturally appropriate intervention resources and the training of ASHAs, and supportive supervision of them during the program were critical enablers to program implementation. Although highly motivated during the implementation of the program ASHA reported historical issues with timely remuneration and lack of supportive supervision.Conclusions: Culturally appropriate community-based group programs run by trained and supported ASHAs are a successful and potentially scalable model for improving the control of hypertension in rural India. However, consideration of issues related to unreliable/insufficient remuneration for ASHAs, supportive supervision and their formal role in the wider health workforce in India will be important to address in future program scale up.Trial Registration: Clinical Trial Registry of India [CTRI/2016/02/006678, Registered prospectively].

A Mobile Health Salt Reduction Intervention for People With Hypertension: Results of a Feasibility Randomized Controlled Trial.

BackgroundA high-salt diet is a risk factor for hypertension and cardiovascular disease; therefore, reducing dietary salt intake is a key part of prevention strategies. There are few effective salt reduction interventions suitable for delivery in the primary care setting, where the majority of the management and diagnosis of hypertension occurs.ObjectiveThe aim of this study is to assess the feasibility of a complex behavioral intervention to lower salt intake in people with elevated blood pressure and test the trial procedures for a randomized controlled trial to investigate the intervention’s effectiveness.MethodsThis feasibility study was an unblinded, randomized controlled trial of a mobile health intervention for salt reduction versus an advice leaflet (control). The intervention was developed using the Behavior Change Wheel and comprised individualized, brief advice from a health care professional with the use of the SaltSwap app. Participants with an elevated blood pressure recorded in the clinic were recruited through primary care practices in the United Kingdom. Primary outcomes assessed the feasibility of progression to a larger trial, including follow-up attendance, fidelity of intervention delivery, and app use. Secondary outcomes were objectively assessed using changes in salt intake (measured via 24-hour urine collection), salt content of purchased foods, and blood pressure. Qualitative outcomes were assessed using the think-aloud method, and the process outcomes were evaluated.ResultsA total of 47 participants were randomized. All progression criteria were met: follow-up attendance (45/47, 96%), intervention fidelity (25/31, 81%), and app use (27/31, 87%). There was no evidence that the intervention significantly reduced the salt content of purchased foods, salt intake, or blood pressure; however, this feasibility study was not powered to detect changes in secondary outcomes. Process and qualitative outcomes demonstrated that the trial design was feasible and the intervention was acceptable to both individuals and practitioners and positively influenced salt intake behaviors.ConclusionsThe intervention was acceptable and feasible to deliver within primary care; the trial procedures were practicable, and there was sufficient signal of potential efficacy to change salt intake. With some improvements to the intervention app, a larger trial to assess intervention effectiveness for reducing salt intake and blood pressure is warranted.Trial RegistrationInternational Standard Randomized Controlled Trial Number (ISRCTN): 20910962; https://www.isrctn.com/ISRCTN20910962

An intervention to support adherence to inhaled medication in adults with cystic fibrosis: the ACtiF research programme including RCT

An intervention to support adherence to inhaled medication in adults with cystic fibrosis: the ACtiF research programme including RCT

Healthy Parent Carers: feasibility randomised controlled trial of a peer-led group-based health promotion intervention for parent carers of disabled children

BackgroundParent carers of children with special educational needs or disability are at higher risk of poor mental and physical health. The need for a tailored, peer-led group programme was raised by parent carers, who co-developed the Healthy Parent Carers programme with researchers. This study aimed to test the feasibility of programme delivery in community settings, and the feasibility and acceptability of a randomised controlled trial design.MethodsParticipants were individually randomised with concealed allocation to a structured group programme and access to online resources (intervention), or access to the online resources only (control). Measures of wellbeing and secondary and economic outcomes were collected before randomisation, immediately post-intervention, and 6 months post-intervention. Descriptive statistics on recruitment and attrition, demographics, attendance, and fidelity of intervention delivery were analysed with feedback on the acceptability of the trial design.ResultsOne hundred and ninety-three parent carers expressed an interest in taking part. Ninety-two participants recruited from across six sites were randomised (47 intervention, 45 control). Lead and assistant facilitators were trained and delivered the group sessions. Sixteen (34%) participants in the intervention arm did not attend any sessions, and attendance varied across sites and sessions. One participant withdrew post-randomisation, and 83 (90%) participants completed outcome measures at the six-month follow-up.ConclusionsThe study demonstrated that it was feasible to deliver the programme in community settings. The number of parent carers who expressed interest signifies the need for such a programme and the feasibility of recruiting to a definitive trial. Loss to follow-up was low. Further research is needed to explore ways to reduce barriers to participation in person and assess the feasibility and acceptability of programme content and delivery for more ethnically diverse groups, and potentially using interpreters. Given the Covid-19 pandemic and delivery format feedback, there is also a need to investigate remote or blended delivery strategies. Although the results indicate that a definitive trial is feasible, programme impact would be strengthened through exploration of these uncertainties.Trial registrationISRCTN, ISRCTN15144652, registered on 25 October 2018, ClinicalTrials.gov, NCT03705221, registered on 15 October 2018.

Social Network Research contribution to evaluating process in a feasibility study of a peer-led and school-based sexual health intervention

There is growing interest in social network-based programmes to improve health, but rigorous methods using Social Network research to evaluate the process of these interventions is less well developed. Using data from the “STis And Sexual Health” (STASH) feasibility trial of a school-based, peer-led intervention on sexual health prevention, we illustrate how network data analysis results can address key components of process evaluations for complex interventions—implementation, mechanisms of impacts, and context. STASH trained students as Peer Supporters (PS) to diffuse sexual health messages though face-to-face interactions and online Facebook (FB) groups. We applied a Multilevel Exponential Random Graph modelling approach to analyse the interdependence between offline friendship relationships and online FB ties and how these different relationships align. Our results suggest that the creation of online FB communities mirrored offline adolescent groups, demonstrating fidelity of intervention delivery. Data on informal friendship networks related to student’s individual characteristics (i.e., demographics, sexual health knowledge and adherence to norms, which were included for STASH), contributed to an understanding of the social relational ‘building’ mechanisms that sustain tie-formation. This knowledge could assist the selection of opinion leaders, improving identification of influential peers situated in optimal network positions. This work provides a novel contribution to understanding how to integrate network research with the process evaluation of a network intervention.

Feasibility randomised controlled trial comparing TRAK-ACL digital rehabilitation intervention plus treatment as usual versus treatment as usual for patients following anterior cruciate ligament reconstruction

ObjectivesTo evaluate the feasibility of trialling taxonomy for the rehabilitation of knee conditions—ACL (TRAK-ACL), a digital health intervention that provides health information, personalised exercise plans and remote clinical support combined...

Promoting physical activity in primary care: a systematic review and meta-analysis.

BackgroundPromoting physical activity is an important part of patient care in primary care and has been investigated in many studies with a wide range of intervention characteristics, often including external support. It is unclear, however, if promoting physical activity is effective.AimTo investigate the effectiveness of behaviour change interventions to promote physical activity in primary care.Design and settingThis is a systematic review and meta-analysis to evaluate physical activity promotion in a primary care setting.MethodEMBASE, MEDLINE, PsycInfo, and the Joanna Briggs Institute Database were searched for ‘physical activity’, ‘interview’, ‘motivation’, ‘primary care’, and equivalent words to identify randomised controlled trials with physical activity as the outcome at patient level.ResultsThe review identified 25 eligible studies. The quality appraisal showed that most studies reported insufficient details regarding randomisation, group allocation, blinding, and fidelity of intervention delivery. The included studies reported a wide range of interventions with varying numbers of follow-up visits or phone calls. The overall effect size for interventions with a 6-month follow-up interval was 0.04 (95% confidence interval [CI] = −0.06 to 0.14), and for interventions with a 12-month follow-up interval it was 0.19 (95% CI = 0.03 to 0.36). Only one intervention based on three motivational interviewing sessions achieved a moderate effect.ConclusionCounselling to promote physical activity in primary care has a limited effect on patients’ behaviour and it might not, on its own, be enough to change physical activity behaviour.

Risk\u2010of\u2010falling related outcomes improved in community\u2010dwelling older adults after a 6-week sideways walking intervention: a feasibility and pilot study

BackgroundAging increases fall risk and alters gait mechanics and control. Our previous work has identified sideways walking as a potential training regimen to decrease fall risk by improving frontal plane control in older adults’ gait. The purposes of this pilot study were to test the feasibility of sideways walking as an exercise intervention and to explore its preliminary effects on risk-of-falling related outcomes.MethodsWe conducted a 6-week single-arm intervention pilot study. Participants were community-dwelling older adults ≥ 65 years old with walking ability. Key exclusion criteria were neuromusculoskeletal and cardiovascular disorders that affect gait. Because initial recruitment rate through University of Nebraska at Omaha and Omaha community was slower than expected (3 participants∙week− 1), we expanded the recruitment pool through the Mind & Brain Health Labs registry of the University of Nebraska Medical Center. Individualized sideways walking intervention carried out under close supervision in a 200 m indoor walking track (3 days∙week− 1). Recruitment and retention capability, safety, and fidelity of intervention delivery were recorded. We also collected (open-label) walking speed, gait variability, self-reported and performance-based functional measures to assess participants’ risk-of-falling at baseline and post-intervention: immediate, and 6 weeks after the completion of the intervention.ResultsOver a 7-month period, 42 individuals expressed interest, 21 assessed for eligibility (21/42), and 15 consented to participate (15/21). Most of the potential participants were reluctant to commit to a 6-week intervention. Desired recruitment rate was achieved after revising the recruitment strategy. One participant dropped out (1/15). Remaining participants demonstrated excellent adherence to the protocol. Participants improved on most outcomes and the effects remained at follow-up. No serious adverse events were recorded during the intervention.ConclusionsOur 6-week sideways walking training was feasible to deliver and demonstrated strong potential as an exercise intervention to improve risk-of-falling outcomes in community-dwelling older adults. In a future trial, alternative clinical tools should be considered to minimize the presence of ceiling/floor effects. A future large trial is needed to confirm sideways walking as a fall prevention intervention.Trial registrationClinicalTrials.gov identifier: NCT04505527. Retrospectively registered 10 August 2020.

Brief behavioral activation intervention for depressive symptoms: Patient satisfaction, acceptability, engagement, and treatment response.

Depressive symptoms are the most common reason for referral to integrated behavioral health providers in primary care. Although evidence-based brief psychotherapies for depression in primary care exist, treatment duration is a significant barrier to implementation. In this open trial, we examined the patient experience of receiving a brief behavioral activation intervention designed for use in primary care (BA-PC), which comprised 2 30-min appointments and 2 boosters spaced 2-3 weeks apart across 12 weeks, and its impact on depression symptoms. Participants were 22 patients recruited from primary care who reported at least moderate depressive symptoms (score ≥ 10 on the Patient Health Questionnaire-9 [PHQ-9]). Patient experiences were examined through assessing patient engagement, satisfaction, acceptability, and treatment response. Fidelity of intervention delivery in delivering the BA-PC within a 12-week period was also assessed. Participants reported a high level of satisfaction with and acceptability of the BA-PC intervention, materials, and format. Within-subject t tests revealed a significant reduction in depressive symptoms from baseline at the 12-week assessment, based on PHQ-9 total score, t(21) = 3.80, p = .001. Evidence of fidelity included 81% of patients completing the 2 BA-PC appointments, average appointment lengths of approximately 30 min, and high content fidelity within each appointment. These preliminary findings suggest that overall experience of a brief BA-PC intervention was positive, with high patient satisfaction, patient acceptability, and treatment fidelity as well as positive patient treatment response. (PsycInfo Database Record (c) 2020 APA, all rights reserved).