Two-arm Randomised Controlled Trial Research Articles

The SAInT study: a protocol for a randomized controlled trial of steroid injection for subacromial pain syndrome using the anterolateral versus posterior approach.

Steroid injections are used for subacromial pain syndrome and can be administered via the anterolateral or posterior approach to the subacromial space. It is not currently known which approach is superior in terms of improving clinical symptoms and function. This is the protocol for a randomized controlled trial (RCT) to compare the clinical effectiveness of a steroid injection given via the anterolateral or the posterior approach to the subacromial space. The Subacromial Approach Injection Trial (SAInT) study is a single-centre, parallel, two-arm RCT. Participants will be allocated on a 1:1 basis to a subacromial steroid injection via either the anterolateral or the posterior approach to the subacromial space. Participants in both trial arms will then receive physiotherapy as standard of care for subacromial pain syndrome. The primary analysis will compare the change in Oxford Shoulder Score (OSS) at three months after injection. Secondary outcomes include the change in OSS at six and 12 months, as well as the Pain Numeric Rating Scale (0 = no pain, 10 = worst pain), Disabilities of Arm, Shoulder and Hand questionnaire (DASH), and 36-Item Short-Form Health Survey (SF-36) (RAND) at three months, six months, and one year after injection. Assessment of pain experienced during the injection will also be determined. A minimum of 86 patients will be recruited to obtain an 80% power to detect a minimally important difference of six points on the OSS change between the groups at three months after injection. The results of this trial will demonstrate if there is a difference in shoulder pain and function after a subacromial space steroid injection between the anterolateral versus posterior approach in patients with subacromial pain syndrome. This will help to guide treatment for patients with subacromial pain syndrome.

Randomized controlled trial of a text-based smokeless tobacco cessation intervention for rural and medically underserved communities.

Smokeless tobacco use remains prevalent in rural and medically underserved populations, leading to increased rates of tobacco-related cancers and chronic disease. While access to effective cessation programs is limited, text-based interventions may offer a delivery approach with broad reach. This two-armed randomized control trial (RCT) assessed the efficacy of #EnufSnuff.TXT, a text-based smokeless tobacco cessation intervention, in rural and medically underserved communities. We conducted a two-arm RCT assessing #EnufSnuff.TXT, a text-based scheduled reduction intervention paired with text-based cessation support messages compared with the modified Enough Snuff intervention comprised of a cessation education booklet and bi-weekly motivational text messages. We recruited participants via social media and surveyed participants at three and six months post-randomization. The primary outcome was self-reported seven-day point prevalence abstinence at six months. We recruited and randomized 532 participants. At three months post randomization, the quit rate was significantly higher in #EnufSnuff.TXT arm compared to the Enough Snuff arm for intent-to-treat (ITT) cases (29.2% vs 19.0%, OR=1.75, p=0.0066). The quit rate at six months post randomization remained higher in #EnufSNuff.TXT compared to Enough Snuff for ITT cases (23.1% vs 20.9%, OR=1.14, p=0.5384), although no longer significantly different. This is the first large-scale text-based cessation clinical trial for individuals in underserved areas who use smokeless tobacco. The #EnufSnuff.TXT intervention performed better in the short term, however both interventions yielded similar quit-rates at 6-months post randomization. Future research should focus on improving long-term abstinence in the #EnufSNuff.TXT intervention. Text-based cessation approaches have the potential to increase access to cessation interventions in rural and medically underserved areas and reduce tobacco-related chronic disease morbidity and mortality. Our study shows short-term efficacy from the first ever randomized controlled trial of a smokeless tobacco cessation intervention, #EnufSnuff.TXT, for rural and medically underserved residents in the United States. Our #EnufSnuff.TXT Intervention offers a scalable solution to reach and provide much needed access to cessation interventions in medically underserved, rural communities in the United States. This work provides the foundation for further inquiry on augmented text-based approaches to increase cessation in this at-risk group.

Comparison of the efficacy, safety and quality of life of pegylated liposomal doxorubicin-cyclophosphamide versus epirubicin-cyclophosphamide in patients with early stage HER2-negative breast cancer: A prospective, randomized, multicenter, Phase II study.

This multicenter, phase II randomized, non-inferiority study reports from the first prospective two-armed randomized control trial that compared the efficacy, safety and quality-of-life of pegylated liposomal doxorubicin (PLD)-based and epirubicin-based as adjuvant chemotherapy for stage I-II Human Epidermal Growth Factor Receptor 2 (HER2)-negative breast cancer. Patients with stage I/II HER2-negative breast cancer received PLD (37.5mg/m2, Q3W, 5 cycles, LC arm) plus cyclophosphamide (600mg/m2) or epirubicin (90mg/m2, Q3W, 4 cycles, EC arm) plus cyclophosphamide (600mg/m2). Randomization was stratified by lymph node, ER and PR status. The primary endpoint was disease-free survival (DFS), and secondary endpoints were overall survival (OS), safety profiles, and quality of life (QoL). QoL was assessed using the EORTC QLQ-C30 and QLQ-BR23 questionnaires. A total of 256 patients were assigned to LC (n=148) and EC (n=108). There was no difference in 5-year DFS and OS rate between two groups. LC-based adjuvant regimens had significantly less alopecia, less grade 3-4 hematologic adverse events (AEs). Significantly improved QoL was observed in the LC arm during and after treatment for symptoms including fatigue, nausea and vomiting, and systemic therapy side effects. Comparable efficacy and safety between adjuvant PLD and epirubicin for stage I-II HER2-negative breast cancer was observed. There was no difference in 5-year DFS and OS rate between the two treatment arms. However, less grade 3-4 AEs and a trend of favorable QoL symptom scales were observed in the LC arm, suggesting that PLD-containing regimen could become a new standard treatment for early stage HER2-negative breast cancer patients.

The effectiveness of the WHO school mental health package in promoting mental health literacy among secondary school teachers in Qatar: a randomized controlled trial

Teachers’ mental health literacy (MHL) is fundamental for recognizing and assisting students with mental disorders. The aim of this study was to assess the effectiveness of the World Health Organization School Mental Health Program (WHO-SMHP) in promoting MHL among secondary schools’ teachers in Qatar. We conducted a two-arm randomized control trial. Teachers working in governmental secondary schools were eligible for selection. A total of 16 schools (8 intervention, 8 control) randomly selected and stratified by gender then randomly assigned (1:1). Participants and study team were aware of group assignment. Assessment of teachers’ MHL was at day 0, 3 then 3 months afterward. Bivariat analysis and Generalized Estimating Equations were used in analysis. The primary outcome was teachers MHL. Secondary outcome was the influence of sociodemographic characteristics on the level of MHL. Between October 30, 2018 and March 21, 2019, we randomly assigned 195 teachers from 16 schools to attend training workshop on WHO-SMHP (n = 95) or usual practice (n = 100). Compared with controls, teachers from intervention group demonstrated a significant improvement in the level of MHL at day three (mean difference = 19.1, 95% CI = 17.0–21.2, Cohen’s d = 2.63; p < 0.001).) and after three months (mean difference 16.61, 95% CI = 13.96–19.26, Cohen’s d = 1.86; p < 001). There were no significant differences related to influence of other variables on MHL. To our knowledge, this is the first trial to prove the effectiveness of the (WHO-SMHP) in promoting teachers MHL, which can be successfully implemented in a wider scale.

P-532 Preimplantation genetic testing versus morphology as selection criteria for single embryo transfer in women aged 35-42: results of a pilot randomized controlled trial

Abstract Study question To assess the feasibility of running a large randomised controlled trial (RCT) evaluating the benefit of preimplantation genetic testing for aneuploidy (PGT-A) for embryo selection. Summary answer Running a PGT-A RCT is feasible. Considerations include participant recruitment, seven-day biopsy-embryologist availability and logistical complexities. What is known already Critics question the effectiveness of PGT-A leading to concerns about false positives and negatives, unnecessary embryo discarding and clinical effectiveness. Past studies have been criticised for only performing biopsy on top quality embryos, their criteria for randomization and the age of the population being assessed. Given these uncertainties there is a need for a rigorous RCT evaluating the role of PGT-A using current methodologies and biopsy techniques in women most affected by aneuploidy. Our pilot study is the first study where all embryos generated will undergo biopsy and ranked in terms in implantation potential prior to transfer. Study design, size, duration In this prospective, concealed allocation two-arm parallel RCT, our goal was to randomise 100 women with ≥3 good quality embryos on day 3 post egg collection into two groups: embryos screened using next-generation sequencing (NGS)-based PGT-A or selection-based on morphology alone. PGT-A patients underwent a trophectoderm biopsy on day 5/6/7 following egg collection. Biopsied embryos were frozen and subsequently transferred. Euploid and embryos described as being low mosaic (&amp;lt;30% abnormal cells) were prioritised for transfer. Participants/materials, setting, methods Women aged between 35–42 years undergoing IVF±ICSI were included, with those undergoing PGT for inherited genetic disorders, gamete donation cycles, untreated hydrosalpinges or untreated uterine abnormalities excluded. Primary objective during the pilot phase was to assess the ability to recruit, randomise, adherence to the study protocol and plan for a full study. Secondary outcomes were clinical pregnancy rate per embryo transferred, clinical pregnancy rate per couple randomised, miscarriage rate and time to pregnancy. Main results and the role of chance Out of 247 eligible women,100 were randomised, and 94 received the assigned treatment. The recruitment rate was 70.18%(173/247, 95%CI 61.65%-78.70%). An average of 6 participants were randomised each month. All randomised participants completed the follow-up. Our main recruitment challenges included 19% of eligible patients choosing to have PGT-A privately and 6% withdrawing their consent choosing to have a fresh transfer. Lack of biopsy-embryologist also meant patients whose potential biopsy would have been on a weekend had to be excluded in the first 4 months of our recruitment process. Baseline characteristics including age, BMI and cause of infertility were comparable in both arms and a total of 56 euploid, 53 aneuploid and 3 low mosaic embryos were identified. There was no statistically difference in CPR (23/50 vs 21/50, RR 1.09 95%CI:0.83-1.15, p-value&amp;gt;0.23) and miscarriage rate (3/50 vs 2/50, RR 1.5 95%CI:0.84-1.75, p-value: 0.15) per single embryo transfer or per woman randomised (23/46 vs 21/48, RR 1.14 95%CI 0.78-1.27, p-value:0.24 and 3/46 vs 2/48, RR 0.72 95%CI 0.58-1.17 p-value: 0.17) in either arm of the study. We cannot yet confirm the clinical benefit of PGT-A owing to the insufficient sample size in this pilot study. No low mosaic embryos were transferred. Limitations, reasons for caution The study was conducted in a single centre. If future definitive trials are conducted in multiple centres, the criteria for recruitment, randomisation, intervention, and follow-up still need to be unified. Many women aged above 40 failed to reach randomization due to challenges in producing three good-quality embryos. Wider implications of the findings The pilot study found that the eligibility rate is adequate however researchers should consider reviewing the conditions for randomisation in main study such as reducing the number of good embryos required to two. In addition, stratified randomization should be used in order to better balance female age within each group. Trial registration number NCT05009745

Biofeedback combined with percutaneous electrical pudendal nerve stimulation for the treatment of low anterior rectal resection syndrome: a study protocol for a randomized controlled trial

BackgroundLow anterior resection syndrome (LARS) is a distressing condition that affects approximately 25–80% of patients following surgery for rectal cancer. LARS is characterized by debilitating bowel dysfunction symptoms, including fecal incontinence, urgent bowel movements, and increased frequency of bowel movements. Although biofeedback therapy has demonstrated effectiveness in improving postoperative rectal control, the research results have not fulfilled expectations. Recent research has highlighted that stimulating the pudendal perineal nerves has a superior impact on enhancing pelvic floor muscle function than biofeedback alone. Hence, this study aims to evaluate the efficacy of a combined approach integrating biofeedback with percutaneous electrical pudendal nerve stimulation (B-PEPNS) in patients with LARS through a randomized controlled trial (RCT).Methods and analysisIn this two-armed multicenter RCT, 242 participants with LARS after rectal surgery will be randomly assigned to undergo B-PEPNS (intervention group) or biofeedback (control group). Over 4 weeks, each participant will undergo 20 treatment sessions. The primary outcome will be the LARS score. The secondary outcomes will be anorectal manometry and pelvic floor muscle electromyography findings and the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Colorectal 29 (EORTC QLQ-CR29) scores. Data will be collected at baseline, post-intervention (1 month), and follow-up (6 months).DiscussionWe anticipate that this study will contribute further evidence regarding the efficacy of B-PEPNS in alleviating LARS symptoms and enhancing the quality of life for patients following rectal cancer surgery.Trial registrationChinese Clincal Trials Register ChiCTR2300078101. Registered 28 November 2023.

Biomarker Driven Antifungal Stewardship (BioDriveAFS) in acute leukaemia—a multi-centre randomised controlled trial to assess clinical and cost effectiveness: a study protocol for a randomised controlled trial

BackgroundAcute leukaemias (AL) are life-threatening blood cancers that can be potentially cured with treatment involving myelosuppressive, multiagent, intensive chemotherapy (IC). However, such treatment is associated with a risk of serious infection, in particular invasive fungal infection (IFI) associated with prolonged neutropenia. Current practice guidelines recommend primary antifungal (AF) prophylaxis to be administered to high-risk patients to reduce IFI incidence. AFs are also used empirically to manage prolonged neutropenic fever. Current strategies lead to substantial overuse of AFs. Galactomannan (GM) and β-D-glucan (BG) biomarkers are also used to diagnose IFI. Combining both biomarkers may enhance the predictability of IFI compared to administering each test alone. Currently, no large-scale randomised controlled trial (RCT) has directly compared a biomarker-based diagnostic screening strategy without AF prophylaxis to AF prophylaxis (without systematic biomarker testing).MethodsBioDriveAFS is a multicentre, parallel, two-arm RCT of 404 participants from UK NHS Haematology departments. Participants will be allocated on a 1:1 basis to receive either a biomarker-based antifungal stewardship (AFS) strategy, or a prophylactic AF strategy, which includes existing standard of care (SoC).The co-primary outcomes will be AF exposure in the 12-month post randomisation and the patient-reported EQ-5D-5L measured at 12-month post randomisation. Secondary outcomes will include total AF exposure, probable/proven IFI, survival (all-cause mortality and IFI mortality), IFI treatment outcome, AF-associated adverse effects/events/complications, resource use, episodes of neutropenic fever requiring hospital admission or outpatient management, AF resistance in fungi (non-invasive and invasive) and a Desirability of Outcome Ranking.The trial will have an internal pilot phase during the first 9 months. A mixed methods process evaluation will be integrated in parallel to the internal pilot phase and full trial, aiming to robustly assess how the intervention is delivered. Cost-effectiveness analysis will also be performed.DiscussionThe BioDriveAFS trial aims to further the knowledge of strategies that will safely optimise AF use through comparison of the clinical and cost-effectiveness of a biomarker-led diagnostic strategy versus prophylactic AF to prevent and manage IFI within acute leukaemia. The evidence generated from the study will help inform global clinical practice and approaches within antifungal stewardship.Trial registrationISRCTN11633399. Registered 24/06/2022.

Strengths, challenges, and strategies for implementing pragmatic multicenter randomized controlled trials (RCTs): example of the Personalized Citizen Assistance for Social Participation (APIC) trial

BackgroundRandomized controlled trials (RCTs) are rigorous scientific research designs for evaluating intervention effectiveness. However, implementing RCTs in a real-world context is challenging. To develop strategies to improve its application, it is essential to understand the strengths and challenges of this design. This study thus aimed to explore the strengths, challenges, and strategies for improving the implementation of a pragmatic multicenter, prospective, two-arm RCT evaluating the effects of the Personalized Citizen Assistance for Social Participation (Accompagnement-citoyen Personnalisé d’Intégration Communautaire: APIC; weekly 3-h personalized stimulation sessions given by a trained volunteer over a 12-month period) on older adults’ health, social participation, and life satisfaction.MethodsA multiple case study was conducted with 14 participants, comprising one research assistant, seven coordinators, and six managers of six community organizations serving older adults, who implemented the APIC in the context of a RCT. Between 2017 and 2023, qualitative data were extracted from 24 group meetings, seven semi-directed interviews, emails exchanged with the research team, and one follow-up document.ResultsAged between 30 and 60 (median ± SIQR: 44.0 ± 6.3), most participants were women from organizations already offering social participation interventions for older adults and working with the public sector. Reported strengths of this RCT were its relevance in assessing an innovative intervention to support healthy aging, and the sharing of common goals, expertise, and strategies with community organizations. Challenges included difficulties recruiting older adults, resistance to potential control group assignments, design complexity, and efforts to mobilize and engage volunteers. The COVID-19 pandemic lockdown and health measures exacerbated challenges related to recruiting older adults and mobilizing volunteers and complicated delivery of the intervention. The strategies that mostly overcame difficulties in recruiting older adults were reducing sample size, simplifying recruitment procedures, emphasizing the health follow-up, extending partnerships, and recognizing and supporting volunteers better. Because of the lockdown and physical distancing measures, the intervention was also adapted for remote delivery, including via telephone or videoconferencing.ConclusionKnowledge of the strengths and challenges of pragmatic RCTs can contribute to the development of strategies to facilitate implementation studies and better evaluate health and social participation interventions delivered under real-life conditions.Trial registrationNCT03161860; Pre-results. Registered on May 22, 2017.

Exploring the feasibility of conducting a randomised controlled trial of group-based pregnancy care and education: a pilot randomised controlled trial in Melbourne, Australia

BackgroundIn group-based pregnancy models, antenatal care and childbirth/parenting education are provided in groups of eight to 10 women, usually with two midwives, and six to eight sessions. Current evidence is inconclusive regarding potential benefit or harm. We aimed to explore the feasibility of implementing an adequately powered randomised controlled trial (RCT).MethodsA two-arm pilot RCT was conducted in a tertiary maternity hospital in Melbourne, Australia. Women were randomly allocated to either the intervention to receive group-based antenatal care and education (group care) or to usual care, which included hospital-based midwife, caseload midwifery, team midwifery, or GP shared care. Participants were English-speaking, primiparous, low risk, and < 24 weeks gestation at booking. Data collection: feasibility measures throughout pilot, baseline questionnaire at recruitment, clinical outcome data from the medical record, and a telephone-administered questionnaire 6 weeks postpartum. A focus group explored midwives’ views.ResultsSeventy-four women were recruited from May to June 2017 (group care = 40, usual care = 34). Study uptake was 35%. Women allocated to group care rated their overall pregnancy care more highly (88% good/very good vs 77% in usual care). There was no evidence of harm related to group care. Overarching themes from the midwives were that group care helped ‘build connections’ and ‘empower women’. All midwives would work in the model again and believed it should be expanded.ConclusionGroup care was acceptable to both women and midwives with no evidence of harm. The pilot demonstrated the feasibility of undertaking a large adequately powered RCT, important given the inconclusive evidence on clinical outcomes regarding the model, and its current relatively widespread implementation.Trial registrationAustralian New Zealand Clinical Trials Registry (ANZCTR): ACTRN12623000858695.

Smoking, nicotine and pregnancy 2 (SNAP2) trial: protocol for a randomised controlled trial of an intervention to improve adherence to nicotine replacement therapy during pregnancy

IntroductionSmoking during pregnancy is harmful to unborn babies, infants and women. Nicotine replacement therapy (NRT) is offered as the usual stop-smoking support in the UK. However, this is often used...

Testing a new model of telehealth-delivered treatment for primary care patients with alcohol use disorder: A randomized controlled trial protocol

BackgroundThe majority of adults suffering from alcohol use disorders (AUD) do not receive treatment. To address this gap in care, we must develop new models to increase identification, engagement and delivery of accessible and effective treatment. This paper describes the protocol for a randomized controlled trial (RCT) testing a novel telehealth treatment model for primary care patients with untreated AUD. MethodsWe aim to recruit 300 adults across 2 healthcare systems for this two-arm RCT. Participants, initially identified for recruitment based on AUD-related indicators in their electronic health record (EHR), are RCT-eligible if they meet AUD criteria (mild, moderate, severe), report ≥ 3 drinking days/week in past 30 days, and have not received AUD psychotherapy in the past 90 days. Participants are randomized to an intervention or enhanced usual care control (EUC) condition, both individually-delivered. The intervention includes a telephone-delivered motivational interviewing (MI) engagement session and 8 sessions of MI-Cognitive Behavioral Therapy (MI-CBT). EUC involves AUD psychoeducation, advice to reduce drinking and seek treatment, and provision of community resources. Outcomes will be measured at 3-, 6-, and 12-months; primary outcomes include: AUD psychotherapy initiation and engagement (within the study and external community) and alcohol consumption (percent drinking days and heavy drinking days). ConclusionsThis study addresses whether proactive patient identification and engagement and delivery of patient-centered telehealth psychotherapy to patients with untreated AUD is effective in increasing treatment use and improving alcohol outcomes. If effective, this could be a highly scalable model for reducing the public health impact of AUD. Trial RegistrationClinicalTrials.gov # NCT05410561. University of Michigan HUM00204315. Ann Arbor VA IRB #1655886.

Improving walking via real-time visual feedback after stroke in treadmill training (RE-VISIT): a protocol for randomized controlled trial

BACKGROUND: After a stroke, most patients often suffer reduced walking ability and balance. Restoring walking ability and improving balance are major goals of stroke rehabilitation. Treadmills are often used in clinical setups to achieve these goals. Adding dimensions to the visual feedback in addition to the mirror for real-time frontal view is proven to enhance the gait. It is, therefore, important to design additional real-time visual feedback in treadmill training, in particular for the sagittal view involved side. OBJECTIVE: The objective of this study is to test if the real-time sagittal visual feedback during treadmill training is superior to the conventional mirror feedback treadmill training program of equivalent intensity in improving walking speed and balance after stroke. METHODS/DESIGN: The RE-VISIT trial (Real-time Visual feedback after Stroke in Treadmill training) is registered in the Clinical Trial Registry of India (CTRI/2023/10/058299). In this two-arm randomized control trial, which will be a single-blinded study, 42 eligible stroke survivors undergoing rehabilitation will be randomly allocated (1:1 ratio) to either real-time visual sagittal feedback along with front mirror (experimental) group or only front mirror treadmill training (control) group, all the participants will receive 15 sessions of treadmill training for up to 15 min at a safe self-selected speed over 5-6 weeks. The RE-VISIT (experimental) group will receive real-time, visual sagittal view feedback of the involved lower limb trajectory along with the routine front mirror view during treadmill training and will be asked to modify their gait pattern. The control group will receive treadmill walking training only with the routine front mirror view feedback. Clinical and gait assessments will be conducted at the baseline, immediately following the final session of training, and at the 9th week during follow-up. The outcome measures of interest are walking speed (primary) and balance (secondary), which will be measured prior to baseline, post 15 sessions of training, and at the 9th week following training. DISCUSSION: This REVISIT trial will provide insight and contribute to the existing innovation and modifications of incorporating real-time visual feedback during treadmill training in post-stroke gait rehabilitation. The findings will help the better designing of a gait rehabilitation program with a treadmill for post-stroke subjects to improve walking speed, and balance for those who have greater difficulties in community ambulation. We anticipate that those in the REVISIT training will demonstrate improved walking ability.

Peers plus mobile app for treatment in HIV (PATH): protocol for a randomized controlled trial to test a community-based integrated peer support and mHealth intervention to improve viral suppression among Hispanic and Black people living with HIV

BackgroundSignificant disparities continue to exist in the HIV care continuum, whereby Hispanic and Black people living with HIV (PLWH) are less likely to achieve viral suppression compared to their White counterparts. Studies have shown that intervention approaches that involve peer navigation may play an important role in supporting patients to stay engaged in HIV care. However, implementation may be challenging in real-world settings where there are limited resources to support peer navigators. Combining a peer navigation approach with scalable mobile health (mHealth) technology may improve impact and implementation outcomes.MethodsWe combined a peer navigation intervention with a mHealth application and are conducting a randomized controlled trial (RCT) to test the efficacy of this integrated “Peers plus mobile App for Treatment in HIV” (PATH) intervention to improve HIV care engagement, and ultimately sustained viral suppression, among Hispanic and Black PLWH. We will enroll up to 375 PLWH into a two-arm prospective RCT, conducting follow-up assessments every 3 months up to 12 months post-baseline. Participants randomized to the control arm will continue to receive usual care Ryan White Program case management services. Individuals randomized to receive the PATH intervention will receive usual care plus access to two main intervention components: (1) a peer navigation program and (2) a mHealth web application. The primary outcome is sustained HIV viral suppression (undetectable viral load observed at 6- and 12-month follow-up). Secondary outcomes are retention in HIV care, gaps in HIV medical visits, and self-reported ART adherence. Recruitment for the RCT began in November 2021 and will continue until June 2024. Follow-up assessments and medical chart abstractions will be conducted to collect measurements of outcome variables.DiscussionThe efficacy trial of PATH will help to fill gaps in our scientific understanding of how a combined peer navigation and mHealth approach may produce effects on HIV care outcomes while addressing potential implementation challenges of peer navigation in Ryan White-funded clinics.Trial registrationThe PATH trial is registered at the United States National Institutes of Health National Library of Medicine (ClinicalTrials.gov) under ID # NCT05427318. Registered on 22 June 2022.

An overview of the Be Well Home Health Navigator Program to reduce contaminants in well water: Design and methods

BackgroundThe Be Well Home Health Navigator Program is a prospective, randomized controlled trial (RCT) implemented to compare a community health navigator program to usual care program to reduce contaminants in drinking water. Design and settingThis 4-year two-armed RCT will involve well owners in Oregon that have private drinking water wells that contain arsenic, nitrate, or lead above maximum contaminant levels. InterventionThe intervention leverages the trusted relationship between Cooperative Extension Service (CES) Community Educators and rural well owners to educate, assist and motivate to make decisions and set actionable steps to mitigate water contamination. In this study, CES will serve as home health navigators to deliver: 1) individualized feedback, 2) positive reinforcement, 3) teach-back moments, 4) decision-making skills, 5) navigation to resources, 6) self-management, and 7) repeated contact for shaping and maintenance of behaviors. Usual care includes information only with no access to individual meetings with CES. Measurable outcomesPre-specified primary outcomes include 1) adoption of treatment to reduce exposure to arsenic, nitrate, or lead in water which may include switching to bottled water and 2) engagement with well stewardship behaviors assessed at baseline, and post-6 and 12 months follow-up. Water quality will be measured at baseline and 12-month through household water tests. Secondary outcomes include increased health literacy scores and risk perception assessed at baseline and 6-month surveys. ImplicationsThe results will demonstrate the efficacy of a domestic well water safety program to disseminate to other CES organizations.Trial registration number: NCT05395663

REST: a preoperative tailored sleep intervention for patients undergoing total knee replacement – feasibility study for a randomised controlled trial

ObjectivesTo test the feasibility of a randomised controlled trial (RCT) of a novel preoperative tailored sleep intervention for patients undergoing total knee replacement.DesignFeasibility two-arm two-centre RCT using 1:1 randomisation with...

Cognitive Functional Therapy compared with usual physiotherapy care in people with persistent low back pain: a mixed methods feasibility randomised controlled trial in the United Kingdom National Health Service

ObjectivesTo determine the feasibility of completing a definitive randomised controlled trial (RCT), evaluating the clinical and cost-effectiveness of Cognitive Functional Therapy (CFT) in comparison to usual physiotherapy care (UPC), for people with persistent low back pain (LBP). Design and settingA two-arm parallel feasibility RCT completed in a United Kingdom (UK) Secondary Care National Health Service (NHS) physiotherapy service. ParticipantsSixty adult participants who reported LBP lasting for more than three months, that was not attributable to a serious (e.g. cancer) or specific (e.g. radiculopathy) underlying cause, were invited to participate. Participants were allocated at random to receive CFT or UPC. InterventionsCognitive Functional Therapy and Usual Physiotherapy Care for persistent LBP. Main outcome measuresThe primary outcome was the feasibility of completing a definitive RCT, defined by recruitment of at least 5 participants per month, delivery of CFT per protocol and securing relevant and acceptable outcome measures. Data concerning study processes, resources, management and participant reported outcome measures were collected at baseline, 3, 6 and 12-month follow-up. ResultsSixty participants (n = 30 CFT and n = 30 UPC) were recruited with 80% (n = 48), 72% (n = 43) and 53% (n = 32) retained at 3, 6 and 12-month follow-up respectively. NHS physiotherapists were trained to competence and delivered CFT with fidelity. CFT was tolerated by participants with no adverse events. Relevant and clinically important outcome data were collected at all time points (0.4%, 3%, 1% and 0.8% of data was missing from the returned outcome measure booklets at baseline and 3, 6 and 12-month follow-up respectively). The Roland-Morris disability questionnaire was considered the most suitable primary outcome measure with a proposed sample size of 540 participants for a definitive cluster RCT. ConclusionIt is feasible to conduct a randomised study of CFT in comparison to UPC for NHS patients. A future study should incorporate an internal pilot to address aspects of feasibility further, including participant retention strategies. Clinical trial registration numberISRCTN12965286 Contribution of the paper•Cognitive Functional Therapy (CFT) has shown encouraging results for reducing pain and disability in people with persistent LBP in previous clinical trials. The clinical and cost-effectiveness of CFT has not previously been evaluated in a definitive trial in the United Kingdom National Health Service. This is the first study to evaluate the feasibility of completing such a trial.•The findings of this study confirmed that;•NHS patients can be recruited on time and to target, with no safety concerns regarding a randomised controlled trial.•NHS physiotherapists can be trained to competence to deliver CFT with fidelity.•Clinically relevant and important data can be collected using standardised outcome measures.•New knowledge about the feasibility of completing a definitive trial of CFT in the UK NHS has been gained.

SPiRIT study protocol (Shoulder Pain: Randomised trial of Injectable Treatments): a randomised feasibility and pilot study of autologous protein solution (APS) vs corticosteroids for treating subacromial shoulder pain

BackgroundThe management of subacromial shoulder pain represents a significant challenge and is typically managed through either physiotherapy, joint injection or surgical intervention. Recent surgical trials have questioned the efficacy and there is a need to improve the evidence base for the non-surgical management of this condition.The study aims to provide evidence of the feasibility of conducting a randomised controlled trial to compare the efficacy of autologous protein solution (APS) against the current standard of care, corticosteroid injection (CSI) for subacromial shoulder pain. Autologous protein solution (APS) is a blood-derived biological injection which has been shown to have anti-inflammatory effects.MethodsA parallel-group two-arm randomised control trial will be conducted, comparing APS and CSI for shoulder pain. Fifty patients will be recruited. Feasibility will be assessed by examination of the conversion rate of eligible participants to the total number of participants recruited, whether it is possible to collect the appropriate outcome measures and the levels of retention/data compliance at follow-up dates.DiscussionCSI is the mainstay of conservative management of subacromial shoulder pain. Trials and systematic reviews have reported differing conclusions, but the consensus view is that any benefits seen from CSI use are most likely to be short-term and there remains a significant number of patients who go on to have surgical intervention despite CSI.Biological injections, such as APS are being increasingly used, in the anticipation they may offer improved longer lasting outcomes for shoulder pain. However, the evidence to demonstrate the comparative efficacy of CSI versus APS does not currently exist. If feasible, a fully powered study will offer clarity to the treatment pathway of thousands of patients each year with subacromial pain.Trial registrationThe study is funded by the National Institute for Health Research–Research for Patient Benefit, NIHR 201473, Trial Registration Number (ISRCTN12536844: SPiRIT. Shoulder pain: randomised trial of injectable treatments–date of Registration 15/9/2021). Protocol Version V1.0_30Jul2021. IRAS Project ID: 294,982.

Abstract A016: Reducing the growing disparity of colorectal cancer screening among underserved populations in rural health clinics: The PRIME-CRC trial

Abstract Introduction: Colorectal cancer (CRC), the third leading cause of cancer death in the United States, can be significantly reduced if it is detected early. Although overall CRC screening rates have increased significantly, disparities persist among low-income individuals, adults with low literacy and those living in rural areas. These groups all have screening completion rates below 50%. Purpose of Study: To assess the effectiveness of a patient-centered, shared decision making, health literacy strategy to promote longer-term adherence to colorectal cancer (CRC) screening in resource-limited, rural health clinics via colonoscopy or annual fecal immunochemical test (FIT). Methods Used: A two-arm randomized control trial implemented in 6 rural community clinics. Clinics reported CRC baseline screening rates of 17% to 38%. Eligible patients, age 45-75, who were not up to date on CRC screening were recruited. Clinic based RAs screened and consented patients. They collected baseline data and then recommended screening and gave brief literacy and culturally appropriate education using a pamphlet developed by the authors (4th grade level). The RA used shared decision-making techniques to aid patients in selecting the test they prefer and that met their needs – colonoscopy or FIT. All patients who selected the FIT kit were given simplified instructions (3rd grade level) and a demonstration of how to use it and those who chose colonoscopy were given simplified colonoscopy prep instructions and had a referral made to GI clinic. Patients were randomized into intervention (INT) arm or enhanced usual care (EUC) arm. Those in INT who selected the FIT (and had not returned it) at 4, 8 and 12 weeks received an automated follow-up call or text from a provider at their clinic using plain language and motivational messages encouraging patients to complete the FIT (colonoscopy INT patients received reminder calls prior to appointment to remind them about prepping for procedure and their appointment). Summary of Results: 734 patients have been enrolled to date: 361 in INT arm and 373 in EUC arm; 64.1% are African American, 60.3% women; 38% have limited literacy; 71.8% highest level of education completed was high school or less; only 5.6% have annual incomes &amp;gt; $50,000. 72.4% of patients had heard of tests to screen for CRC and 75.4% had a doctor or nurse recommend screening for CRC in the past. With regard to screening tests, 5.6% of patients have chosen a colonoscopy and 94.4% have selected a FIT. Screening to date in Year 1: 56.0% completed screening by FIT in INT arm versus 54.2% in EUC arm; only 20% have completed screening by colonoscopy to date. Conclusions: Simplified instructions accompanied by a face-to-face demonstration of FIT, use of “teach back” to confirm understanding with a follow-up automated text message or call if needed, facilitated completion rates of all patients, particularly those with limited literacy. This has not been effective to date with colonoscopy. Citation Format: Connie L. Arnold, Joseph Dean, James Morris, Elise Reed, Laura Curtis, Terry Davis. Reducing the growing disparity of colorectal cancer screening among underserved populations in rural health clinics: The PRIME-CRC trial [abstract]. In: Proceedings of the 16th AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2023 Sep 29-Oct 2;Orlando, FL. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2023;32(12 Suppl):Abstract nr A016.

Long-Term Outcomes and Cost-Effectiveness of an Internet-Based Self-Help Intervention for Social Anxiety Disorder in University Students: Results of a Randomized Controlled Trial

Social anxiety disorder (SAD) is widespread among university students and is associated with high costs for the society. While unguided internet- and mobile-based interventions (IMIs) may have short-term effects in reducing SAD symptoms, evidence for their long-term efficacy and cost-effectiveness is still limited. The aim of this study is to examine the 6-month outcomes of an IMI for university students with SAD. Participants were recruited via mass mails sent to enrolled students and included if they were at least 18 years old, met the diagnostic criteria of SAD in a structured clinical interview for DSM-IV axis I disorders (SCID-I), and provided written informed consent. In a prospective study designed as a two-armed randomized-controlled trial, 200 students (mean age 26.7 years) diagnosed with SAD were randomly assigned to an IMI or a waitlist control (WLC) condition. The IMI consisted of nine weekly sessions based on the cognitive-behavioral treatment model for social phobia by Clark and Wells. The primary outcome was SAD symptom severity assessed via the Social Phobia Scale (SPS) and the Social Interaction Anxiety Scale (SIAS). A health economic evaluation from a societal and healthcare perspective examined the costs related to the symptom-free status and quality-adjusted life years (QALYs) gained. Statistically significant differences in SAD symptom severity previously found at posttreatment favoring the IMI were maintained at a 6-month follow-up [SIAS (Cohen’s d = 0.59 ; 95% CI, 0.30, 0.87) and SPS (Cohen’s d = 0.83 ; 95% CI, 0.54, 1.1)]. From a societal perspective, at a willingness to pay (WTP) of €0, the intervention was found to have a 92% and 93% probability of cost-effectiveness compared with the WLC per symptom-free status and QALY gained, respectively. From a healthcare perspective, the likelihood of cost-effectiveness of the intervention was 97% per symptom-free status at a WTP of €1000 (US$1326) and 96% per QALY gained at a WTP of €6000 (US$7956). This IMI is effective in treating university students with SAD and has an acceptable likelihood of cost-effectiveness compared with WLC from a societal perspective. This intervention can be integrated into university healthcare to reach students with SAD as it is scalable, shows a high probability of cost-effectiveness, and overcomes known treatment barriers. This trial is registered with DRKS00011424.

Do the integrated theories of self-determination and planned behavior explain the change in active life engagement following a motivational counseling intervention among older people?

BackgroundAn integrated model based on self-determination and planned behavior theories has been used to explain physical activity and other health-related behaviors mainly among younger populations, not older adults. The present study aimed to conduct a secondary analysis to explore whether changes in theory-based constructs explain a change in activity level (including 17 activities in essential life areas) among 75- and 80-year-old individuals. MethodsData came from the Promoting well-being through active aging (AGNES) study, a two-arm single-blinded randomized control trial, where participants in the intervention group (n = 101) received year-long individualized counseling between 2017–19 in Jyväskylä, Finland. Activity frequency was assessed using the University of Jyväskylä Active Aging Scale (UJACAS) activity sub-score, perceived autonomy support with the Health Climate Questionnaire, autonomous motivation with a sub-scale from the Self-Regulation Questionnaire, and attitude with three items. Subjective norm, perceived behavioral control, and intention were each assessed with one item. Change in variables between baseline and the 12-month follow-up was specified via latent factors. Various structural equation models were tested to assess whether the basic or modified model, including additional paths from baseline variables to change factors, provided a better data fit. ResultsIn the modified integrated model, baseline attitude and change in attitude directly explained the change in activity frequency. Moreover, statistically significant indirect paths were observed from baseline autonomous motivation through baseline attitude, and from activity frequency through change in attitude to change in activity frequency. ConclusionsThe theoretical integrated model did not account for the change in active life engagement. The modified integrated model revealed significant change paths, highlighting autonomous motivation and attitudes as influential change constructs. For future intervention design, the modified integrated model appears useful in identifying behavior change pathways for older adults.