Feasibility Of Study Procedures Research Articles

484 A Preliminary Study on the Pharmacodynamics of Oral Cannabis Ingestion in Older Adults

OBJECTIVES/GOALS: Our study explores the dose-related effects of THC on cardiovascular measures, self-reported effects, balance, and cognitive function among older adults. We also evaluate the acceptability and feasibility of study procedures, to inform future study designs employing this population. METHODS/STUDY POPULATION: Using a within-subject, double-blind, placebo-controlled design and standard behavioral pharmacology methods, reasonably healthy male and female adults aged 55-70 years undergo an eligibility screening, followed by a mock session and 3 experimental sessions (>7 days apart). During experimental sessions, participants are administered cannabis-infused brownies with varying THC doses. Prior to and at multiple intervals post- consumption, subjects complete assessments including self reports and observer ratings, psychomotor and cognitive performance measures, and vital signs. Follow-up interviews regarding the experience will be conducted one day after each session. RESULTS/ANTICIPATED RESULTS: We anticipate our results to mirror those of previously reported studies conducted in adults under 45 years old in that a dose-response relationship exists for subjective drug effects and vital signs with the caveat that this relationship may be exacerbated in our population. We additionally anticipate findings that indicate THC impairs balance and coordination, potentially increasing the risk of falls and accidents among this population, and cognitive function, affecting attention, memory, and executive functions. Feedback provided during the follow-up interviews will help refine procedures for future studies, ensuring that the methodology is acceptable and feasible for this population. DISCUSSION/SIGNIFICANCE: Prior work demonstrates the safety and efficacy of THC in conditions common among older adults, however, no conclusive data regarding tolerability and safety in this population exists. The presented work is vital groundwork for future research on THC as a potential therapeutic for older adults.

Delivering a Postpartum Weight Loss Intervention via Facebook or In-Person Groups: Results From a Randomized Pilot Feasibility Trial.

Postpartum weight retention contributes to weight gain and obesity. Remotely delivered lifestyle interventions may be able to overcome barriers to attending in-person programs during this life phase. This study aimed to conduct a randomized feasibility pilot trial of a 6-month postpartum weight loss intervention delivered via Facebook or in-person groups. Feasibility outcomes were recruitment, sustained participation, contamination, retention, and feasibility of study procedures. Percent weight loss at 6 and 12 months were exploratory outcomes. Women with overweight or obesity who were 8 weeks to 12 months post partum were randomized to receive a 6-month behavioral weight loss intervention based on the Diabetes Prevention Program lifestyle intervention via Facebook or in-person groups. Participants completed assessments at baseline, 6 months, and 12 months. Sustained participation was defined by intervention meeting attendance or visible engagement in the Facebook group. We calculated percent weight change for participants who provided weight at each follow-up. Among individuals not interested in the study, 68.6% (72/105) were not interested in or could not attend in-person meetings and 2.9% (3/105) were not interested in the Facebook condition. Among individuals excluded at screening, 18.5% (36/195) were ineligible owing to reasons related to the in-person condition, 12.3% (24/195) related to the Facebook condition, and 2.6% (5/195) were unwilling to be randomized. Randomized participants (n=62) were a median of 6.1 (IQR 3.1-8.3) months post partum, with a median BMI of 31.7 (IQR 28.2-37.4) kg/m2. Retention was 92% (57/62) at 6 months and 94% (58/62) at 12 months. The majority (21/30, 70%) of Facebook and 31% (10/32) of in-person participants participated in the last intervention module. Half (13/26, 50%) of Facebook and 58% (15/26) of in-person participants would be likely or very likely to participate again if they had another baby, and 54% (14/26) and 70% (19/27), respectively, would be likely or very likely to recommend the program to a friend. In total, 96% (25/26) of Facebook participants reported that it was convenient or very convenient to log into the Facebook group daily compared with 7% (2/27) of in-person participants who said it was convenient or very convenient to attend group meetings each week. Average weight loss was 3.0% (SD 7.2%) in the Facebook condition and 5.4% (SD 6.8%) in the in-person condition at 6 months, and 2.8% (SD 7.4%) in the Facebook condition and 4.8% (SD 7.6%) in the in-person condition at 12 months. Barriers to attending in-person meetings hampered recruitment efforts and intervention participation. Although women found the Facebook group convenient and stayed engaged in the group, weight loss appeared lower. Research is needed to further develop care models for postpartum weight loss that balance accessibility with efficacy. ClinicalTrials.gov, NCT03700736; https://clinicaltrials.gov/ct2/show/NCT03700736.

A multi-site pilot study of a parent-centered tool to promote shared decision-making in hypospadias care

Using a user-centered design approach, we conducted a two-site pilot study to evaluate a decision aid (DA) website, the Hypospadias Hub, for parents of hypospadias patients. The objectives were to assess the Hub's acceptability, remote usability, and feasibility of study procedures, and to evaluate its preliminary efficacy. From June 2021-February 2022, we recruited English-speaking parents (≥18 years old) of hypospadias patients (≤5 years) and delivered the Hub electronically ≤2 months before their hypospadias consultation. We collected website analytic data using an ad tracker plug-in. We inquired about treatment preference, hypospadias knowledge, and decisional conflict (Decisional Conflict Scale) at baseline, after viewing the Hub (pre-consultation), and post-consultation. We administered the Decision Aid Acceptability Questionnaire (DAAQ) and the Preparation for Decision-Making Scale (PrepDM) which assessed how well the Hub prepared parents for decision-making with the urologist. Post-consultation, we assessed participants' perception of involvement in decision-making with the Shared Decision-making Questionnaire (SDM-Q-9) and the Decision Regret Scale (DRS). A bivariate analysis compared participants' baseline and pre/post-consultation hypospadias knowledge, decisional conflict, and treatment preference. Using a thematic analysis, we analyzed our semi-structured interviews to uncover how the Hub impacted the consultation and what influenced participants' decisions. Of 148 parents contacted, 134 were eligible and 65/134 (48.5%) enrolled: mean age 29.2, 96.9% female, 76.6% White (Extended Summary Figure). Pre/post-viewing the Hub, there was a statistically significant increase in hypospadias knowledge (54.3 vs. 75.6, p<0.001) and decrease in decisional conflict (36.0 vs. 21.9, p<0.001). Most participants (83.3%) thought Hub's length and amount of information (70.4%) was "about right", and 93.0% found most or everything was clear. Pre/post-consultation, there was a statistically significant decrease in decisional conflict (21.9 vs. 8.8, p<0.001). PrepDM's mean score was 82.6/100 (SD=14.1); SDM-Q-9's mean score was 82.5/100 (SD=16.7). DCS's mean score was 25.0/100 (SD=47.03). Each participant spent an average of 25.75min reviewing the Hub. Based on thematic analysis, the Hub helped participants feel prepared for the consultation. Participants engaged extensively with the Hub and demonstrated improved hypospadias knowledge and decision quality. They felt prepared for the consultation and perceived a high degree of involvement in decision-making. As the first pilot test of a pediatric urology DA, the Hub was acceptable and study procedures were feasible. We plan to conduct a randomized controlled trial of the Hub versus usual care to test its efficacy to improve the quality of shared decision-making and reduce long-term decisional regret.

Project ASPIRE: A feasibility randomized controlled trial of a brief intervention for reducing risk of depression and alcohol-related harms among South African adolescents

Objective: Brief interventions could reduce adolescents’ risk of depression and alcohol-related harms, but evidence of their feasibility and acceptability for low-and middle-income countries is lacking. To address this gap, we conducted a feasibility trial of the ASPIRE intervention, a four-session multi-component counselling intervention for South African adolescents. Method: We recruited 117 adolescents who met our inclusion criteria. Participants were randomly assigned to the ASPIRE intervention or a comparison condition. Outcomes were assessed at baseline, six-week, and three-month post-randomization time points. Primary outcomes were based on feasibility of study procedures and intervention delivery (assessed on seven predetermined progression criteria). Clinical outcomes (risk of depression and alcohol harms) were secondary. Results: Despite modifications to all study procedures arising from Covid-19 restrictions, five of the seven key progression criteria were fully met, including: feasibility of data collection and outcome measures, counsellor competencies, randomization and blinding, adverse advents, and acceptability of the intervention. The progression criterion for recruitment and intervention retention were not fully met. Conclusion: Findings suggest that the ASPIRE intervention was generally feasible to deliver and acceptable to adolescents. However, modifications to the trial design and intervention delivery are needed to optimize the validity of a definitive randomized controlled trial of the ASPIRE intervention.

Delivering a Post-Partum Weight Loss Intervention via Facebook or In-Person Groups: Results from a Randomized Pilot Feasibility Trial

Background Postpartum weight retention contributes to weight gain and obesity. Remote lifestyle interventions may overcome barriers to attending in-person programs during this phase. Objective We aimed to conduct a randomized feasibility pilot trial of a 6-month postpartum weight loss intervention delivered via Facebook or in-person groups. Feasibility outcomes were recruitment, sustained participation, contamination, retention, and feasibility of study procedures; percent weight loss at 6 and 12 months, exploratory outcomes. Methods Women with overweight or obesity who were 8 weeks to 12 months post partum were randomized to receive a 6-month behavioral weight loss intervention based on the Diabetes Prevention Program lifestyle intervention via Facebook or in-person groups. Participants completed assessments at baseline, 6 months, and 12 months. Sustained participation was defined with intervention meeting attendance or visible engagement in the Facebook group. Retention was defined as completing follow-up assessments (providing weight or completing the survey). We calculated the percent weight change for participants who provided weight at each follow-up. Results Among uninterested individuals, 69% (72/105) were not interested in or could not attend in-person meetings and 3% (3/105) were not interested in the Facebook condition. Among individuals excluded at screening, 18% (36/195) were ineligible due to reasons related to the in-person condition, 12% (24/195) related to Facebook and 3% (5/195) were unwilling to be randomized (all preferred Facebook). Randomized participants (n=62) were a median of 6.1 (IQR 3.1-8.3) months post partum with a median BMI of 31.7 (IQR 28.2-37.4) kg/m2. Retention was 92% (57/62) at 6 months and 94% (58/62) at 12 months. Overall, 70% (21/30) of Facebook participants and 31% (10/32) of in-person participants attended the last intervention module. Further, 50% (13/26) of Facebook participants and 58% (15/26) of in-person participants would be likely or very likely to participate again if they had another baby, and 54% (14/26) and 70% (19/27), respectively, would be likely or very likely to recommend the program to a friend. Moreover, 96% (25/26) of Facebook participants reported that it was convenient or very convenient to log into the Facebook group daily versus 7% (2/27) of in-person participants who said it was convenient or very convenient to attend group meetings each week. Contamination was low, and study procedures were feasible. Average weight loss was 3.0% (SD 7.2%) in the Facebook condition and 5.4% (SD 6.8%) in the in-person condition at 6 months and 2.8% (SD 7.4%) and 4.8% (SD 7.6%) at 12 months, respectively. Conclusions Barriers to attending in-person meetings hampered recruitment efforts and intervention participation. While women found web-based groups convenient and stayed engaged in the group, weight loss may be lower. Research is needed to further develop care models for postpartum weight loss that balance accessibility with efficacy. Conflicts of Interest None declared. Trial Registration ClinicalTrials.gov NCT03700736; https://clinicaltrials.gov/ct2/show/NCT03700736

Establishing Healthcare Worker Performance and Safety in Providing Critical Care for Patients in a Simulated Ebola Treatment Unit: Non-Randomized Pilot Study.

Improving the provision of supportive care for patients with Ebola is an important quality improvement initiative. We designed a simulated Ebola Treatment Unit (ETU) to assess performance and safety of healthcare workers (HCWs) performing tasks wearing personal protective equipment (PPE) in hot (35 °C, 60% relative humidity) or thermo-neutral (20 °C, 20% relative humidity) conditions. In this pilot phase to determine the feasibility of study procedures, HCWs in PPE were non-randomly allocated to hot or thermo-neutral conditions to perform peripheral intravenous (PIV) and midline catheter (MLC) insertion and endotracheal intubation (ETI) on mannequins. Eighteen HCWs (13 physicians, 4 nurses, 1 nurse practitioner; 2 with prior ETU experience; 10 in hot conditions) spent 69 (10) (mean (SD)) minutes in the simulated ETU. Mean (SD) task completion times were 16 (6) min for PIV insertion; 33 (5) min for MLC insertion; and 16 (8) min for ETI. Satisfactory task completion was numerically higher for physicians vs. nurses. Participants’ blood pressure was similar, but heart rate was higher (p = 0.0005) post-simulation vs. baseline. Participants had a median (range) of 2.0 (0.0–10.0) minor PPE breaches, 2.0 (0.0–6.0) near-miss incidents, and 2.0 (0.0–6.0) health symptoms and concerns. There were eight health-assessment triggers in five participants, of whom four were in hot conditions. We terminated the simulation of two participants in hot conditions due to thermal discomfort. In summary, study tasks were suitable for physician participants, but they require redesign to match nurses’ expertise for the subsequent randomized phase of the study. One-quarter of participants had a health-assessment trigger. This research model may be useful in future training and research regarding clinical care for patients with highly infectious pathogens in austere settings.

Assessing the feasibility, acceptability and impacts of an education program on hepatitis B testing uptake among ethnic Chinese in Australia: results of a randomised controlled pilot study

BackgroundIn Australia, Chinese migrants are among the populations most affected by hepatitis B virus (HBV) infection but often experience late diagnosis or access to clinical care. This study aims to explore approaches to increase HBV testing in Australia’s Chinese community and inform evaluation planning, specifically to i) assess the feasibility and acceptability of HBV educational programs, and ii) compare HBV testing uptake in people receiving a tailored education resource focussing on liver cancer prevention compared with a standard HBV education package.MethodsThis is a pre-post mixed-methods pilot and feasibility study. People of Chinese ethnicity and unsure of their HBV infection or immunity status were recruited from ten community sites in Melbourne, Australia in 2019–2020. Participants were randomised to receive an education package (comprised of a leaflet and in-person one-on-one educational session) with a focus on either 1) standard HBV-related information, or 2) liver cancer prevention. Participants completed a baseline questionnaire prior to receiving the intervention and were followed up at 6 months’ time for a questionnaire and an opt-in semi-structured interview. Primary study outcomes included feasibility of study procedures, measured by recruitment, participation, and retention rates; acceptability of the education program assessed by acceptability scores; and HBV testing uptake rate in each arm. Secondary outcomes include HBV-related knowledge change, assessed by pre-post comparison; and factors affecting participants’ testing behaviour analysed using qualitative data.ResultsFifty-four participants received an education package; baseline and follow-up data from 33 (61%) were available. The study procedures of recruitment and retention were feasible; the acceptability of the education program was moderate with improved HBV-related knowledge observed. Four participants self-reported being tested: one (1/15, 7%) in the standard HBV information group and three (3/18, 17%) in the liver cancer prevention information group. Factors identified as affecting testing included perceived relevance and seriousness of HBV, healthcare access and costs of testing, and perceptions of the role of primary care providers in HBV-related care.ConclusionA tailored education program targeting ethnic Chinese in Australia was feasible with moderate acceptability. A larger study is required to determine if a liver cancer prevention message would improve HBV testing uptake in Chinese community than standard HBV education message. Supports from healthcare providers, community-based testing programs, and public health education programs are likely needed to motivate diagnostic testing among Chinese people at risk of HBV infection.

Improving mobility and participation of older people with vertigo, dizziness and balance disorders in primary care using a care pathway: feasibility study and process evaluation

BackgroundCommunity-dwelling older people are frequently affected by vertigo, dizziness and balance disorders (VDB). We previously developed a care pathway (CPW) to improve their mobility and participation by offering standardized approaches for general practitioners (GPs) and physical therapists (PTs). We aimed to assess the feasibility of the intervention, its implementation strategy and the study procedures in preparation for the subsequent main trial.MethodsThis 12-week prospective cohort feasibility study was accompanied by a process evaluation designed according to the UK Medical Research Council’s Guidance for developing and evaluating complex interventions. Patients with VDB (≥65 years), GPs and PTs in primary care were included. The intervention consisted of a diagnostic screening checklist for GPs and a guide for PTs. The implementation strategy included specific educational trainings and a telephone helpline. Data for mixed-method process evaluation were collected via standardized questionnaires, field notes and qualitative interviews. Quantitative data were analysed using descriptive statistics, qualitative data using content analysis.ResultsA total of five GP practices (seven single GPs), 10 PT practices and 22 patients were included in the study. The recruitment of GPs and patients was challenging (response rates: GP practices: 28%, PT practices: 39%). Ninety-one percent of the patients and all health professionals completed the study. The health professionals responded well to the educational trainings; the utilization of the telephone helpline was low (one call each from GPs and PTs). Familiarisation with the routine of application of the intervention and positive attitudes were emphasized as facilitators of the implementation of the intervention, whereas a lack of time was mentioned as a barrier. Despite difficulties in the GPs’ adherence to the intervention protocol, the GPs, PTs and patients saw benefit in the intervention. The patients’ treatment adherence to physical therapy was good. There were minor issues in data collection, but no unintended consequences.ConclusionAlthough the process evaluation provided good support for the feasibility of study procedures, the intervention and its implementation strategy, we identified a need for improvement in recruitment of participants, the GP intervention part and the data collection procedures. The findings will inform the main trial to test the interventions effectiveness in a cluster RCT.Trial registrationProjektdatenbank Versorgungsforschung Deutschland (German registry Health Services Research) VfD_MobilE-PHY_17_003910, date of registration: 30.11.2017; Deutsches Register Klinischer Studien (German Clinical Trials Register) DRKS00022918, date of registration: 03.09.2020 (retrospectively registered).

Video directly observed therapy intervention using a mobile health application among opioid use disorder patients receiving office-based buprenorphine treatment: protocol for a pilot randomized controlled trial

BackgroundOffice-based buprenorphine treatment of opioid use disorder (OUD) does not typically include in-person directly observed therapy (DOT), potentially leading to non-adherence. Video DOT technologies may safeguard against this issue and thus enhance likelihood of treatment success. We describe the rationale and protocol for the Trial of Adherence Application for Buprenorphine treatment (TAAB) study, a pilot randomized controlled trial (RCT) to evaluate the effects of video DOT delivered via a smartphone app on office-based buprenorphine treatment outcomes, namely illicit opioid use and retention.MethodsParticipants will be recruited from office-based opioid addiction treatment programs in outpatient clinics at two urban medical centers and randomized to either video DOT (intervention) delivered via a HIPAA-compliant, asynchronous, mobile health (mHealth) technology platform, or treatment-as-usual (control). Eligibility criteria are: 18 years or older, prescribed sublingual buprenorphine for a cumulative total of 28 days or less from the office-based opioid treatment program, and able to read and understand English. Patients will be considered ineligible if they are unable or unwilling to use the intervention, provide consent, or complete weekly study visits. All participants will complete 13 in-person weekly visits and be followed via electronic health record data capture at 12- and 24-weeks post-randomization. Data gathered include the following: demographics; current and previous treatment for OUD; self-reported diversion of prescribed buprenorphine; status of their mental and physical health; and self-reported lifetime and past 30-day illicit substance use. Participants provide urine samples at each weekly visit to test for illicit drugs and buprenorphine. The primary outcome is percentage of weekly urines that are negative for opioids over the 12-weeks. The secondary outcome is engagement in treatment at week 12.DiscussionVideo DOT delivered through mHealth technology platform offers possibility of improving patients’ buprenorphine adherence by providing additional structure and accountability. The TAAB study will provide important preliminary estimates of the impact of this mHealth technology for patients initiating buprenorphine, as well as the feasibility of study procedures, thus paving the way for further research to assess feasibility and generate preliminary data for design of a future Phase III trial.Trial Registration ClinicalTrails.gov, NCT03779997, Registered on December 19, 2018.

Internet-based cognitive behavior therapy for problem gambling in routine care: protocol for a non-randomized pilot and feasibility trial

BackgroundProblem gambling and gambling disorder are major public health concerns worldwide, and awareness of associated negative consequences is rising. In parallel, treatment demand has increased, and Internet interventions offer a promising alternative for providing evidence-based treatment at scale to a low cost.MethodWe developed a novel Internet-delivered cognitive behavioral treatment for gambling, based on qualitative interviews with treatment-seeking gamblers, behavioral research on gambling behavior, and the pathway model for problem gambling. This research protocol describes a non-randomized pilot and feasibility trial conducted in routine addiction care with adult treatment-seeking patients (max N = 25) with problem gambling. The primary aim is to ensure acceptability and safety, measured by satisfaction, credibility, working alliance, and possible negative effects. Secondary aims are feasibility of study procedures in terms of recruitment and measurement procedures as well as potential effectiveness measured weekly by gambling symptoms as primary outcome and gambling behavior, quality of life, symptoms of depression and anxiety, alcohol, and drug use as secondary outcomes. Potential mediators measured weekly are loss of control, verbal rules, and well-being.DiscussionThis study is innovative in several respects, regarding both treatment development and implementation. The results of the study will guide a future randomized controlled trial, as well as the development of the intervention and intervention implementation within ordinary addiction care.Trial registrationClinical trials.gov, NCT ID: NCT03946098. Registered 10 May 2019

Exploration of the Nociception Level (NOL™) Index for Pain Assessment during Endotracheal Suctioning in Mechanically Ventilated Patients in the Intensive Care Unit: An Observational and Feasibility Study

BackgroundMany patients in the intensive care unit (ICU) suffer from pain and are non-communicative. Therefore, alternative pain measures are necessary. Although behavioral pain measures are available, physiological measures are lacking. The Nociception Level index (NOL™) provides a value from combination of multiple physiological parameters to measure pain and its use in the ICU is new. AimTo explore the use of a multiple physiological parameter measure for pain assessment, the NOL™ index, in mechanically ventilated patients able to self-report pain in the ICU. MethodsA prospective cohort study was performed. Data were collected before, during, and 15 minutes after a non-nociceptive procedure (noninvasive blood pressure using cuff inflation) and a nociceptive procedure (endotracheal suctioning). NOL index, 0 to 10 pain intensity, and Critical-Care Pain Observation Tool (CPOT) scores were also obtained. Data were analyzed using Friedman and Mann-Whitney tests. Feasibility of study procedures was described. ResultsOut of 28 patients who consented, 17 remained eligible and data were analyzed for 15. Technical issues prevented obtaining a NOL signal in 2 patients. NOL values were higher during endotracheal suctioning (median = 41.6) compared with before (median = 11.2) and after the procedure (median = 11.8) and compared with cuff inflation (median = 15.1; Friedman test, p < .001). NOL values were associated with pain intensity and CPOT scores (Mann-Whitney tests, p < .05). ConclusionsThe study procedures with the NOL were found feasible; NOL values could discriminate between nociceptive and non-nociceptive procedures, and values were associated with reference pain measures. Further NOL testing is required in other ICU patient groups and procedures.

A feasibility study of a home-based lifestyle-integrated physical exercise training and home modification for community-living older people (Part 2): the FIT-at-Home fall prevention program

Purpose This study was conducted in a home-based context where trained occupational therapists delivered progressive physical exercise training and home modification intervention for preventing falls, namely the FIT-at-Home intervention. We assessed the feasibility of the intervention’s content and mode of delivery from the occupational therapists’ perspective as well as the feasibility of study procedures. Methods We used a mixed-methods approach, which generated qualitative data from 14 OTs’ after delivering the intervention via interviews and quantitative data of the study procedures via questionnaires and documentation sheets. Results In total, 16 of the 17 older people completed the intervention. Of 9 recorded falls, no serious physical problems occurred. Qualitative data suggested that the intervention content and mode was feasible. Only minor adaptations to the program are needed based on the users’ feedback. The main benefit was seen in the fact that simple exercises can be integrated into everyday life for older people with restricted mobility. Conclusion The FIT-at-Home intervention comprising lifestyle-integrated balance and strength exercises and home safety is feasible for occupational therapists to deliver. The findings will help to further refine the intervention and study procedures. Implications for rehabilitation Falling is a frequent and serious health problem for many community-living older people, and the incidence of injurious falls increases with advancing age. Home visiting programs comprising physical exercise training and home modification appear to be beneficial for older people with poor health, functional limitations, and limited mobility. This study indicates that it is feasible to introduce lifestyle-integrated balance and strength exercises, performed as part of daily routine for older people at risk of falling. Behavioural self-management strategies have the potential to improve the implementation of exercises during the course of rehabilitation treatment and afterward.

Personalised Treatments for Acute Whiplash Injuries: a pilot study of nested N-of-1 trials in a multiple baseline single-case experimental design

BackgroundWhiplash associated disorder (WAD), a common and disabling condition, incurs huge burden and costs to Australia. Yet, current treatments for whiplash are not very effective; improved outcomes are urgently needed. Clinical guidelines recommend simple analgesia (paracetamol and non-steroidal anti-inflammatory drugs) but there have been no trials of guideline-recommended drugs. This study will investigate the effectiveness of evidence-based advice (EBA), paracetamol, naproxen, and both paracetamol and naproxen, in reducing daily neck pain and preventing chronic neck pain after whiplash injury. MethodsThis study is a pilot series of multi-cycle, double-blinded, randomised N-of-1 trials, nested in a multiple baseline design. The design will comprise three baselines of 5, 8 or 11 days duration. Post enrolment, participants will be randomly assigned to one of the baselines. Fifteen participants with acute (<2 weeks) Grade II WAD, experiencing at least moderate pain (NRS: ≥ 5/10), and at risk of poor recovery will be recruited from hospitals in Queensland, Australia, and through local physiotherapists. Patients will receive EBA plus a randomised sequence of three cycles of ten day treatment triplets (paracetamol designated as a C phase, naproxen, designated as a D phase, and both paracetamol and naproxen, designated as an E phase). DiscussionWe will test the effects of different treatments on the primary outcome of average neck pain intensity collected daily and at 4 and 7 months post-injury. Secondary outcomes, including disability, depression, post-traumatic stress symptoms, pain catastrophizing, and feasibility of study procedures, will also be evaluated. The results of this study will inform a larger trial aiming to strengthen the evidence on EBA and simple analgesics for WAD. Trial RegistrationClinical Trials Primary Registry: Australian and New Zealand Clinical Trials Registry. Clinical Trial Registration NumberACTRN12618001291279. Date of Registration31/07/2018. Primary Trial SponsorThe University of Queensland, Brisbane QLD 4072 Australia.Funding: The University of Queensland.

Improved participation of older people with joint contractures living in nursing homes: feasibility of study procedures in a cluster-randomised pilot trial

BackgroundAcquired joint contractures have a significant impact on functioning and quality of life in nursing home residents. There is very limited evidence on measures for prevention and treatment of disability due to joint contractures. We have developed the PECAN intervention (Participation Enabling CAre in Nursing) to improve social participation in nursing home residents. A cluster-randomised pilot trial was conducted to assess the feasibility of study procedures in preparation for a main trial according to the UK Medical Research Council (MRC) framework.MethodsNursing homes in two regions of Germany were randomly allocated either to the intervention or optimised standard care (control group). All residents with joint contractures aged > 65 years were eligible for the study. The residents’ data were collected through structured face-to-face interviews by blinded assessors at baseline, after 3 and 6 months. The primary outcome was social participation, measured by a subscale of the PaArticular Scales. Secondary outcomes included activities and instrumental activities of daily living, health-related quality of life, falls and fall-related consequences. Data on the trial feasibility were collected via documentation forms.ResultsSeven out of 12 nursing homes agreed to participate and remained in the trial. Of 265 residents who fulfilled the inclusion criteria, 129 were randomised either to the intervention (n = 64) or control group (n = 65) and analysed. A total of 109 (85%) completed the trial after 6 months. The mean age was 85.7 years (SD 7.0), 80% were women. The severity of the residents’ disability differed across the clusters. The completion rate was high (> 95%), apart from the Instrumental Activities of Daily Living Scale. Some items of the PaArticular Scales were not easily understood by residents. The frequency of falls did not differ between study groups.ConclusionOur data confirmed the feasibility of the overall study design. We also revealed the need to improve the procedures for the recruitment of residents and for data collection before implementation into a main trial. The next step will be an adequately powered main trial to assess the effectiveness and cost-effectiveness of the intervention.Trial registrationGerman clinical trials register, ID: DRKS00010037. Registered on 12 February 2016.

SaveMySkin: An Internet-based self-help intervention for skin picking. Study protocol for a randomized pilot study.

BackgroundSkin picking disorder is an under-recognized and understudied mental disorder associated with severe psychological and medical consequences. Affected individuals barely receive adequate treatment, given the scarcity of expertise in healthcare professionals and the lack of evidence-based interventions.The present study seeks to evaluate an Internet-based self-help intervention for skin picking (“SaveMySkin”) within a pilot study. The intervention is based on cognitive-behavioral therapy (CBT) and provides comprehensive information materials and exercises. A daily supportive monitoring and psychological as well as dermatological counseling via Internet-chat provide additional support. The research questions focus on user attitudes, expectations and reservations, acceptance, adherences and user satisfaction as well as the feasibility of study procedures. Intervention effects will be estimated in order to plan a subsequent efficacy trial.MethodsThe pilot study will be conducted within a 2-arm randomized controlled trial design. A sample of N = 100 participants will be recruited via Internet. Interested individuals will answer a short screening questionnaire and may register for the study, if they meet the inclusion criteria (age ≥ 17, at least mild severity of skin picking). Following a baseline assessment, the intervention group may use SaveMySkin. The control group will have access to the intervention after completion of a waiting time of three months.DiscussionThe present trial will provide information on the feasibility and acceptability of an Internet-based intervention for individuals with skin picking. Furthermore, the results will be used to design a randomized controlled trial investigating the efficacy of the intervention.Research registration numberGerman Register for Clinical Trials (DRKS): DRKS00015236;

A Pilot Randomized Controlled Trial of an Integrated In-person and Mobile Phone Delivered Counseling and Text Messaging Intervention to Reduce HIV Transmission Risk among Male Sex Workers in Chennai, India.

Men who have sex with men (MSM) are at increased risk for HIV infection in India, particularly those who engage in transactional sex with other men (i.e., male sex workers; MSW). Despite the need, HIV prevention efforts for Indian MSW are lacking. As in other settings, MSW in India increasingly rely on the use of mobile phones for sex work solicitation. Integrating mobile phone technology into an HIV prevention intervention for Indian MSW may mitigate some of the challenges associated with face-to face approaches, such as implementation, lack of anonymity, and time consumption, while at the same time proving to be both feasible and useful. This is a pilot randomized controlled trial to examine participant acceptability, feasibility of study procedures, and preliminary efficacy for reducing sexual risk for HIV. MSW (N=100) were equally randomized to: (1) a behavioral HIV prevention intervention integrating in-person and mobile phone delivered HIV risk reduction counseling, and daily, personalized text or voice messages as motivating "cognitive restructuring" cues for reducing condomless anal sex (CAS); or (2) a standard of care (SOC) comparison condition. Both groups received HIV counseling and testing at baseline and 6-months, and completed ACASI-based, behavioral and psychosocial assessments at baseline, 3, and 6months. Mixed-effects regression procedures specifying a Poisson distribution and log link with a random intercept and slope for month of follow-up was estimated to assess the intervention effect on the primary outcomes: (1) CAS acts with male clients who paid them for sex, and (2) CAS acts with male non-paying sexual partners-both outcomes assessed over the past month. The intervention was both feasible (98% retention at 6-months) and acceptable (>96% of all intervention sessions attended); all intervention participants rated the intervention as "acceptable" or "very acceptable." A reduction in the reported number of CAS acts with male clients who paid them for sex in the past month was seen in both study conditions. MSW in the intervention condition reported a faster rate of decline in the number of CAS acts with male clients in the past month from the baseline to both the 3-month (B=-1.20; 95% CI -1.68, -0.73; p<0.0001) and 6-month (B=-2.44; 95% CI -3.35, -1.53; p<0.00001) assessment visits compared to the SOC condition. Post-hoc contrasts indicated that, at 3months, participants in the intervention condition reported 1.43 (SD=0.29) CAS acts with male clients in the past month compared to 4.85 (SD=0.87) in the control condition (p=0.0003). Furthermore, at 6months, the intervention condition participants reported 0.24 (SD=0.09) CAS acts with male clients in the past month compared to 2.79 (SD=0.79) in the control condition (p<0.0001). Findings are encouraging and provide evidence of feasibility and acceptability, and demonstrate initial efficacy (for reducing sexual risk for HIV) of a behavioral HIV prevention intervention for Indian MSW that combines daily, personalized text or voice messages with mobile phone-delivered sexual risk reduction counseling and skills building. Future testing of the intervention in a fully powered randomized controlled efficacy trial is warranted.

Postpartum weight loss in overweight and obese women using the etonogestrel subdermal implant: a pilot study

ObjectiveTo compare weight loss during the first 6months postpartum in overweight and obese women using the etonogestrel implant, placed in the immediate postpartum period, with that of controls using nonhormonal contraception, utilizing a pilot design. Study designPilot, prospective cohort study. Analysis groups were divided by body mass index (overweight: 25–29.9kg/m2; Class I Obesity: 30–34.5kg/m2; Class II Obesity: 35–39.9kg/m2) and grouped by use of etonogestrel implant or nonhormonal contraception for all outcomes. Primary outcome was the proportion of women in each group returning to pregravid weight by 6months postpartum. Secondary outcomes included waist circumference, motivation to lose weight, eating habits, physical activity, feasibility of study procedures and assessment of recruitment potential in the first 6months postpartum. ResultsA total of 127 women enrolled between June 2014 and August 2015. Fifty-seven chose the etonogestrel implant for immediate postpartum contraception while 70 chose nonhormonal contraceptives. Six months after delivery, about half of women in each group returned to within 1.5 kg of pregravid weight (42% etonogestrel [ENG]-implant vs. 67% nonhormonal methods, p=.19). Retention rates were high with over 75% of total study population providing study data at 6months. Two nonhormonal contraceptive users conceived in the first 4months postpartum. ConclusionNo statistical difference in percentage return to pregravid weight was detected between groups, but data suggest that a somewhat lower proportion of implant users lost weight at 6months. Rapid recruitment, high retention and marked acceptance of immediate ENG implant use demonstrate feasibility for a larger, adequately powered trial. ImplicationsImmediate postpartum insertion of the ENG implant is safe and effective. Study findings suggest modest interference in overweight and obese women's ability to lose gestational weight. If future research demonstrates no statistical difference, increased uptake in immediate implant use should occur in most women, including those who are overweight or obese.