Non-randomised Feasibility Trial Research Articles

A Smart Water Bottle and Companion App (HidrateSpark 3) to Improve Bladder-Filling Compliance in Patients With Prostate Cancer Receiving Radiotherapy: Nonrandomized Trial of Feasibility and Acceptability.

Patients with prostate cancer undergoing radiation therapy (RT) need comfortably full bladders to reduce toxicities during treatment. Poor compliance is common with standard of care written or verbal instructions, leading to wasted patient value (PV) and clinic resources via poor throughput efficiency (TE). Herein, we assessed the feasibility and acceptability of a smartphone-based behavioral intervention (SBI) to improve bladder-filling compliance and methods for quantifying PV and TE. In total, 36 patients with prostate cancer were enrolled in a single-institution, closed-access, nonrandomized feasibility trial. The SBI consists of a fully automated smart water bottle and smartphone app. Both pieces alert the patient to empty his bladder and drink a personalized volume goal, based on simulation bladder volume, 1.25 hours before his scheduled RT. Patients were trained to adjust their volume goal and notification times to achieve comfortably full bladders. The primary end point was met if qualitative (QLC) and quantitative compliance (QNC) were >80%. For QLC, patients were asked if they prepared their bladders before daily RT. QNC was met if bladder volumes on daily cone-beam tomography were >75% of the simulation's volume. The Service User Technology Acceptability Questionnaire (SUTAQ) was given in person pre- and post-SBI. Additional acceptability and engagement end points were met if >3 out of 5 across 4 domains on the SUTAQ and >80% (15/18) of patients used the device >50% of the time, respectively. Finally, the impact of SBI on PV and TE was measured by time spent in a clinic and on the linear accelerator (linac), respectively, and contrasted with matched controls. QLC was 100% in 375 out of 398 (94.2%) total treatments, while QNC was 88.9% in 341 out of 398 (85.7%) total treatments. Of a total score of 5, patients scored 4.33 on privacy concerns, 4 on belief in benefits, 4.56 on satisfaction, and 4.24 on usability via SUTAQ. Further, 83% (15/18) of patients used the SBI on >50% of treatments. Patients in the intervention arm spent less time in a clinic (53.24, SEM 1.71 minutes) compared to the control (75.01, SEM 2.26 minutes) group (P<.001). Similarly, the intervention arm spent less time on the linac (10.67, SEM 0.40 minutes) compared to the control (14.19, SEM 0.32 minutes) group (P<.001). This digital intervention trial showed high rates of bladder-filling compliance and engagement. High patient value and TE were feasibly quantified by shortened clinic times and linac usage, respectively. Future studies are needed to evaluate clinical outcomes, patient experience, and cost-benefit. ClinicalTrials.gov NCT04946214; https://www.clinicaltrials.gov/study/NCT04946214.

Mentalisation-based online intervention for psychologically distressed parents: protocol of a non-randomised feasibility trial of the Lighthouse Parenting Programme-Online (LPP-Online)

IntroductionOnline-based interventions provide a low-threshold way to reach and support families. The mentalisation-based Lighthouse Parenting Programme is an established intervention aimed at preventing psychopathological development in children. The objective of...

Rehabilitation via HOMe-Based gaming exercise for the Upper limb post Stroke (RHOMBUS): a qualitative analysis of participants’ experience

ObjectiveTo report participants’ experiences of trial processes and use of the Neurofenix platform for home-based rehabilitation following stroke. The platform, consisting of the NeuroBall device and Neurofenix app, is a...

“It has changed my life”: unconditional cash transfers and personalized infant feeding support- a feasibility intervention trial among women living with HIV in western Kenya

BackgroundThe syndemic effects of poverty, food insecurity and living with HIV are recognized as global health priorities, including through the United Nations Sustainability Goals 1, 2 and 3. Today, women and girls account for 63% of all new HIV infections in eastern and southern Africa, including Kenya. Pregnant and postpartum women living with HIV in this setting face unique challenges including increased financial insecurity as women leave the work force to care for their newborn infants. This contributes to poverty, food scarcity and stress.MethodsTo address financial insecurity, improve infant feeding and reduce stress among mothers living with HIV in this setting, we developed a multilevel intervention, Supporting Healthy Mothers, consisting of 10 monthly unconditional cash transfers (10,000 KES, ~$75 USD/month) and personalized infant feeding support from pregnancy to 7 months postpartum. We conducted a non-randomized feasibility trial of this intervention among women engaged in HIV care in Kisumu, Kenya. From February 23, 2022 to March 23, 2022, we enrolled a total of 40 women who were 20–35 weeks pregnant—20 women to the intervention group at a public clinic, and 20 women to the control group at a similar clinic. Our aim was to assess feasibility, acceptability, and the potential impact of the intervention on food security, infant feeding and maternal mental health.ResultsAnalyzing data from all 40 participants, we found a significant reduction in food insecurity scores from baseline for the intervention group when compared to the control group at 6 weeks and 6 months postpartum (p = 0.0008 and p < 0.0001, respectively). Qualitative exit interviews with intervention group participants confirmed women felt more financially secure and had newly acquired practical knowledge and skills related to infant feeding. Women found the two intervention components highly acceptable and described an overall positive impact on wellbeing.ConclusionsThe Supporting Healthy Mothers intervention has potential to positively impact women across the perinatal period and beyond by increasing financial security and supporting women to overcome infant feeding challenges and should be assessed in larger trials.Trial registrationSupporting Healthy Mothers was registered with ClinicalTrials.gov Protocol Registration and Results System, initially published on February 1, 2022. ClinicalTrials.gov ID: NCT05219552 Protocol ID: K23MH116807.

Thriving families: The feasibility and preliminary efficacy of a multi-component physical literacy program for children with neurodevelopmental, emotional, or behavioural problems

Children with neurodevelopmental, emotional, or behavioural challenges participate in lower levels of physical activity (PA) and subsequently have poorer physical and mental health outcomes. We sought to determine the feasibility and preliminary efficacy of a multi-component physical literacy program for children with neurodevelopmental, emotional, or behavioural challenges. Thirty children and 28 parents were recruited to participate in the 10-week single-group non-randomised feasibility trial. Thriving Families was designed to promote children's physical literacy through (a) providing programmed opportunities for PA, (b) incorporating parents, (c) supporting motivation and engagement, and (d) utilising behaviour change techniques. Program feasibility was determined using qualitative and quantitative feedback. Preliminary efficacy was determined through pre-and post-intervention assessments of children's physical literacy. Results indicate that the program is acceptable and was well received. Effect size estimates for parent knowledge (d = 0.78) and confidence (d = 0.57) were moderate to large; however, little change was observed for parents' motivation to support PA and children's perceptions of PA support. Moderate or large effects were observed for pre-to-post-program change on children's domains of physical competence. The Thriving Families program appears to be feasible and acceptable for community-based implementation and may provide benefits for physical and psychological outcomes.

The feasibility of using a digital tool to enhance mobilisation following abdominal cancer surgery—a non-randomised controlled trial

BackgroundEarly mobilisation is strongly recommended following abdominal cancer surgery, but evidence on how to structure early mobilisation to improve outcomes and support patient adherence is lacking. Pedatim® (Phystec) is a novel digital tool designed to support mobilisation in hospital settings using prescribed activities and goals on a tablet. The aim of this study was to evaluate the feasibility of the Pedatim tablet to enhance mobilisation following abdominal cancer surgery.MethodsIn a non-randomised feasibility trial design, participants were recruited between January and May 2022 at Karolinska University Hospital, Sweden. Participants used a Pedatim tablet from postoperative day 1 (POD 1) until hospital discharge. The primary objective was to evaluate process feasibility, regarding recruitment, compliance, and acceptability. Recruitment was measured by percentage of available patients included, eligibility criteria sufficiency, and number of dropouts. Compliance was measured by number of patients using versus not using the board. Acceptability was measured using the System Usability Scale. The secondary objective was to evaluate scientific feasibility, defined as an indication of treatment effects where physical activity was assessed using an activPAL accelerometer. Unforeseen events relating to the tablet were also registered.ResultsBased on predetermined feasibility criteria, the overall study design was determined to be feasible regarding recruitment as 69% accepted participation (n = 20), compliance was 95%, and the acceptability mean score was high (77/100). Eligibility criteria were not feasible as 79% (n = 108) of available patients were excluded. The intervention was determined to be scientifically feasible, mean steps per day increased from 623 (SD 766) to 1823 (SD 1446), and mean sit-to-stand transitions per day increased from 11 (SD 8) to 29 (SD 12) POD 1–4. Technical issues emerged, highlighting the need for available technical support and “user champions” among healthcare professionals on the ward.ConclusionsUsing the Pedatim tablet to enhance mobilisation following abdominal cancer surgery was deemed feasible, but a randomised controlled trial is needed to determine the tool’s effectiveness. The study process was determined to be feasible with revisions of the eligibility criteria needed before a future trial. Involving healthcare professionals and providing available technical support are important for future implementation.

The Stride program: Feasibility and pre-to-post program change of an exercise service for university students experiencing mental distress

Rates of mental illness are disproportionately high for young adult and higher education (e.g., university student) populations. As such, universities and tertiary institutions often devote significant efforts to services and programs that support and treat mental illness and/or mental distress. However, within that portfolio of treatment approaches, structured exercise has been relatively underutilised and greater research attention is needed to develop this evidence base. The Stride program is a structured 12-week exercise service for students experiencing mental distress. We aimed to explore the feasibility of the program and assess pre- and post-program change, through assessments of student health, lifestyle, and wellbeing outcomes. Drawing from feasibility and effectiveness-implementation hybrid design literatures, we conducted a non-randomised feasibility trial of the Stride program. Participants were recruited from the Stride program (N = 114, Mage = 24.21 years). Feasibility results indicated the program was perceived as acceptable and that participants reported positive perceptions of program components, personnel, and sessions. Participants’ pre-to-post program change in depressive symptomatology, physical activity levels, mental health-related quality of life, and various behavioural outcomes were found to be desirable. Our results provide support for the feasibility of the Stride program, and more broadly for the delivery and potential effectiveness of structured exercise programs to support university students experiencing mental distress.

Psychological Flow Training: Feasibility and Preliminary Efficacy of an Educational Intervention on Flow

Despite there being an increasing number of applied flow studies across scientific disciplines, there exists no consistent or broadly applicable intervention to promote flow experiences. This study provides a detailed account of a new educational flow training program developed following recent advancements in the flow literature that have provided a more parsimonious understanding of flow experiences and antecedents. Guided by CONSORT guidelines for feasibility trials, we conducted a single-group, non-randomized feasibility trial of an educational flow training program (N = 26). We assessed participant retention, perceptions about and experiences of the program, perceptions about the flow education training, and preliminary assessments of flow as an outcome. Results broadly supported program feasibility, and participants reported positive experiences in, and perceptions of, program components. In terms of preliminary efficacy, we observed evidence of noteworthy change pre-to-post-program in flow (d = 0.84), performance (d = 0.81), competence (d = 0.96), well-being (d = 0.68), intrinsic motivation (d = 0.47), interest (d = 0.72), choice (d = 0.38), stress (d = -1.08), ability to handle stress (d = 0.74), and anxiety (d = − 0.86). These results provide preliminary evidence that it may be possible to ‘train’ flow in line with recent perspectives on a core three-dimensional flow experience (and antecedents). The study has developed a research foundation for flow intervention “curriculum” and quality standards, and for measuring results. It offers a foundation for the implementation of a larger-scale program.

Leveraging behavioral economics and implementation science to engage patients at risk for suicide in mental health treatment: a pilot study protocol

BackgroundPrimary care is an ideal setting to connect individuals at risk for suicide to follow-up care; however, only half of the patients referred from the primary care attend an initial mental health visit. We aim to develop acceptable, feasible, low-cost, and effective new strategies to increase treatment initiation among at-risk individuals identified in primary care.MethodsWe will conduct a multi-phase, mixed-methods study. First, we will conduct a chart review study by using administrative data, including medical records, to identify characteristics of primary care patients at risk for suicide who do or do not attend an initial mental health visit following a referral. Second, we will conduct a mixed methods study by using direct observations and qualitative interviews with key stakeholders (N = 65) to understand barriers and facilitators to mental health service initiation among at-risk individuals. Stakeholders will include patients with suicidal ideation referred from primary care who do and do not attend a first mental health visit, primary care and behavioral health providers, and individuals involved in the referral process. We also will collect preliminary self-report and behavioral data regarding potential mechanisms of behavior change (i.e., self-regulation and social support) from patients. Third, we will leverage these findings, relevant frameworks, and the extant literature to conduct a multi-arm, non-randomized feasibility trial. During this trial, we will rapidly prototype and test strategies to support attendance at initial mental health visits. Strategies will be developed with subject matter experts (N = 10) and iteratively pilot tested (~5 patients per strategy) and refined. Research will be completed in the Penn Integrated Care Program (PIC), which includes fourteen primary care clinics in Philadelphia that provide infrastructure for electronic referrals, patient communication, and data access.DiscussionWe will leverage frameworks and methods from behavioral economics and implementation science to develop strategies to increase mental health treatment initiation among individuals at risk for suicide identified in primary care. This project will lead to an evaluation of these strategies in a fully powered randomized trial and contribute to improvements in access to and engagement in mental health services for individuals at risk for suicide.Trial registrationClinicalTrials.gov Identifier: NCT05021224

Simulation-Based Education for Nurses in Caring for the Psychological Well-being of Survivors of Disaster.

Background Nurses require continuing education and training to maintain comprehensive and cooperative relationships with the survivors of disasters, understand their environment, and secure their safety. Method The aim of this study was to develop and test a psychological first aid nursing simulation that involved a standardized patient admitted to the emergency department after an earthquake. A nonrandomized feasibility trial was applied to test the effects of the program. The effects of the simulation were measured according to the participants' psychological first aid knowledge, performance competence, and self-efficacy. Data were analyzed using descriptive, difference, and correlation analyses. Results A total of 24 emergency nurses participated in this study. The results showed significant differences in psychological first aid knowledge, performance competence, and self-efficacy between the experimental group and the control group. Conclusion The psychological first aid training program used in this study was effective in improving nurses' psychological first aid knowledge, performance competence, and self-efficacy. [J Contin Educ Nurs. 2022;53(3):131-136.].

Web-Based Self-management Program (SPACE for COPD) for Individuals Hospitalized With an Acute Exacerbation of Chronic Obstructive Pulmonary Disease: Nonrandomized Feasibility Trial of Acceptability.

BackgroundHospital admissions due to the acute exacerbation of chronic obstructive pulmonary disease (AECOPD) are costly for individuals and health services. Pulmonary rehabilitation (PR) is known to reduce hospital readmissions when delivered after hospitalization, but the uptake and completion of PR following hospitalization remains poor (<10% of those eligible in the UK audit data). A web-based platform of the SPACE (Self-management Program of Activity Coping and Education) for COPD (chronic obstructive pulmonary disease) has previously shown promising results in patients with stable COPD but has not been tested following an AECOPD.ObjectiveThis study aims to assess the feasibility and acceptability of a web-based self-management program.MethodsA nonrandomized feasibility study for patients with confirmed AECOPD who were deemed web literate was conducted. All patients consented during their hospitalization and received access to the website following discharge in addition to usual care. The program aims to facilitate patients to better understand and manage their condition through education and home-based exercises. Participants were asked to complete the Bristol COPD Knowledge Questionnaire at baseline and after 6 months. A total of 14 participants were also interviewed (n=8 completers; n=6 noncompleters) regarding their experiences with the web-based program and trial. The interviews were analyzed using thematic analysis.ResultsIn total, 2080 patients were screened for eligibility, of which 100 patients (age: mean 71.2 years, SD 9.3 years; male: 55/100, 55%; forced expiratory volume in 1 second/forced vital capacity ratio: mean 0.46, SD 0.14; pack-years: mean 50.2, SD 31.0; current smokers: 35/100, 35%) were recruited (4.8% of those screened). The main reason for ineligibility was a lack of web literacy (1366/1980, 68.98%). In total, 18% (18/100) of patients had completed the web program by 6 months, with others still registered in the program (27/100, 27%), and more than half did not register (55/100, 55%). There was a mean change in Bristol COPD Knowledge Questionnaire scores at 6 months of 7.8 (SD 10.2) points. Qualitative interviews identified three main themes: preparing for, engagement with, and benefits of the study and program. A total of 57% (57/100) accepted a referral to PR on discharge and 19% (19/100) had completed the program after 6 months.ConclusionsOn the basis of the challenges of recruiting, retaining, and engaging participants in a web-based self-management program, it is not a feasible approach to roll out widely. This study acknowledges that this is a challenging time for patients with an AECOPD to engage in exercise and self-management education. However, for patients who were able to engage in such an intervention, the completion rate of PR was double the previous audit estimates from the United Kingdom, disease knowledge improved, and the intervention was of value to patients.Trial RegistrationISRCTN Registry 13081008; https://www.isrctn.com/ISRCTN13081008

A peer support intervention for first-time mothers: Feasibility and preliminary efficacy of the mummy buddy program

BackgroundThe transition to motherhood, although joyous, can be highly stressful, and the availability of professional postpartum support for mothers is often limited. Peer volunteer support programs may offer a viable and cost-effective method to provide community-based support for new mothers. AimTo determine the feasibility of a peer volunteer support program—The Mummy Buddy Program—in which experienced volunteer mothers are paired with, and trained to offer social support to, first-time mothers. MethodsUsing a single-group non-randomised feasibility trial, a total of 56 experienced mothers participated in the Mummy Buddy training program, which was focused on education and practical exercises relating to the provision of various forms of social support. Experienced mothers (‘Mummy Buddies’) were subsequently paired with expectant first-time mothers (n=47 pairs), and were encouraged to provide support until 24-weeks postpartum. FindingsIn terms of key feasibility considerations, 95.1% of Mummy Buddies felt that they were trained sufficiently to perform their role, and 85.8% of New Mothers were satisfied with the support provided by their Buddy. Analyses of preliminary efficacy (i.e., program outcomes) revealed that the first-time mothers maintained normal levels of stress and depressive symptomology, and possessed relatively strong maternal functioning, across the program duration. ConclusionThe Mummy Buddy Program appears to be a feasible and potentially valuable peer volunteer support program for first-time mothers. This study provides a foundation for program expansion and for work designed to examine program outcomes—for first-time mothers, Mummy Buddies, and entire family units—within a sufficiently-powered randomised controlled trial.

A peer-led intervention to promote sexual health in secondary schools: the STASH feasibility study

BackgroundYoung people report higher levels of unsafe sex and have higher rates of sexually transmitted infections than any other age group. Schools are well placed to facilitate early intervention, but more effective approaches are required. Peer-led approaches can augment school-based education, but often fail to capitalise on mechanisms of social influence. The potential of using social media in sexual health has not been tested in school settings.ObjectivesFinalise the design of the Sexually Transmitted infections And Sexual Health (STASH) intervention; assess the recruitment and retention of peer supporters, and acceptability to participants and stakeholders; assess the fidelity and reach, in addition to the barriers to and facilitators of, implementation; refine programme theory; understand the potential of social media; determine design parameters for a future randomised controlled trial, including economic evaluation; and establish whether or not progression criteria were met.DesignThis was a feasibility study comprising intervention development and refinement of the STASH pilot and non-randomised feasibility trial in six schools. Control data were provided by students in the year above the intervention group.SettingSecondary schools in Scotland.ParticipantsStudents aged 14–16 years, teachers and intervention delivery partners.InterventionsThe STASH intervention was adapted from A Stop Smoking In Schools Trial (ASSIST) (an effective peer-led smoking intervention). Based on diffusion of innovation theory, the STASH study involves peer nomination to identify the most influential students, with the aim of recruiting and training 15% of the year group as peer supporters. The peer supporters deliver sexual health messages to friends in their year group via conversations and use of Facebook (www.facebook.com; Facebook, Inc., Menlo Park, CA, USA) to share varied content from a curated set of web-based resources. Peer supporters are given support themselves via follow-up sessions and via trainer membership of Facebook groups.Main outcome measuresThe primary outcome was whether or not progression criteria were met in relation to intervention acceptability and feasibility. The study also piloted indicative primary outcomes for a full-scale evaluation.Data sourcesPeer supporter questionnaire; observations of activities; interviews with trainers, teachers, peer supporters and students; monitoring log of peer supporter activities (including on Facebook and meeting attendance); questionnaire to control year group (baseline characteristics, social networks, mediators and sexual health outcomes); baseline and follow-up questionnaire (approximately 6 months later) for intervention year group.ResultsA total of 104 students were trained as peer supporters (just over half of those nominated for the role by their peers). Role retention was very high (97%). Of 611 students completing the follow-up questionnaire, 58% reported exposure to STASH study activities. Intervention acceptability was high among students and stakeholders. Activities were delivered with good fidelity. The peer supporters were active, representative of their year group and well connected within their social network. Carefully managed social media use by peer supporters augmented conversations. A primary outcome of ‘always safer sex’ was identified, measured as no sex or always condom use for vaginal or anal sex in the last 6 months. The intervention cost £42 per student. Six progression criteria were met. A seventh criterion (regarding uptake of role by peer supporters) was not.LimitationsSmall feasibility study that cannot comment on effectiveness.ConclusionsThe STASH intervention is feasible and acceptable within the context of Scottish secondary schools. The results support continuation to a full-scale evaluation.Future workSmall-scale improvements to the intervention, refinement to programme theory and funding sought for full-scale evaluation.Trial registrationCurrent Controlled Trials ISRCTN97369178.FundingThis project was funded by the National Institute for Health Research (NIHR) Public Health Research programme and will be published in full inPublic Health Research; Vol. 8, No. 15. See the NIHR Journals Library website for further project information.

Scleroderma Patient-centered Intervention Network—Scleroderma Support group Leader EDucation (SPIN-SSLED) program: non-randomised feasibility trial

ObjectivesThe Scleroderma Patient-centered Intervention Network—Scleroderma Support group Leader EDucation (SPIN-SSLED) Programme was designed to improve confidence and self-efficacy and to reduce burden for support group leaders. Objectives were to (1)...

Supported Internet-Delivered Cognitive Behavioral Therapy Programs for Depression, Anxiety, and Stress in University Students: Open, Non-Randomised Trial of Acceptability, Effectiveness, and Satisfaction.

BackgroundMany university campuses have limited mental health services that cannot cope with the high demand. One alternative is to use internet-delivered cognitive behavioral therapy (iCBT) as a way of tackling barriers such as lack of availability and scheduling issues.ObjectiveThis study aimed to assess feasibility, acceptability, effectiveness, and satisfaction of a supported iCBT intervention offering 3 programs on depression, anxiety, and stress to university students. The design was an open or nonrandomized feasibility trial.MethodsParticipants were recruited from 3 counseling centers at a large midwestern University in the United States. Those agreeing to take part chose 1 of 3 iCBT programs—Space from Depression, Space from Anxiety, or Space from Stress —all comprised 8 modules of media-rich interactive content. Participants were supported throughout the trial by a trained professional. The Patient Health Questionnaire 9 (PHQ-9), Generalized Anxiety Disorder 7 (GAD-7) questionnaire, and stress subscale of the Depression Anxiety and Stress Scale (DASS-21) were completed at baseline, 8 weeks, and 3-month follow-up. A Satisfaction With Treatment (SAT) questionnaire was completed at 8 weeks, and qualitative interviews were completed by a subsample of participants at 3 months.ResultsA total of 102 participants were recruited, with 52 choosing Space from Anxiety, 31 choosing Space from Depression, and 19 choosing Space from Stress. Mixed-effects models showed a significant decrease in symptoms of depression (F4=6.36, P<.001), anxiety (F4=7.97, P<.001), and stress (F4=8.50, P<.001) over time across all 3 programs. The largest decreases in PHQ-9 scores at 8 weeks were among participants who chose the Space from Depression program (d=0.84); at 3 months, the largest decreases in PHQ-9 scores were among those who chose the Space from Stress program (d=0.74). The largest decreases in GAD-7 scores were among those who chose the Space from Anxiety program (d=0.74 at 8 weeks and d=0.94 at 3 months). The largest decrease in DASS-21 stress subscale scores was among those who chose the Space from Stress program (d=0.49 at 8 weeks and d=1.16 at 3 months). The mean time spent using the platform per session was 27.4 min (SD 33.8), and participants completed 53% (SD 37.6) of the total program content on average. Most (37/53, 69%) participants found the programs helpful or very helpful and liked the convenience and flexibility of the intervention. Qualitative interviews (n=14) indicated the intervention met students’ expectations, and they saw it as a valuable complement to face-to-face treatment.ConclusionsThe iCBT programs tested in our study appear to be feasible, acceptable, and effective in a university environment. Participants described the benefits of having a flexible, supported Web-based intervention available on campus. Larger trials should be conducted to further test the effectiveness of supported Web-based interventions that give students a choice of program depending on their symptom profile.

Designing and Implementing a Home-Based Couple Management Guide for Couples Where One Partner has Dementia (DemPower): Protocol for a Nonrandomized Feasibility Trial

BackgroundThe increasing rate of dementia and high health and social care costs call for effective measures to improve public health and enhance the wellbeing of people living with dementia and their relational networks. Most postdiagnostic services focus on the condition and the person with dementia with limited attention to the caring spouse or partner. The key focus of the study is to develop a guide for couples where one partner has a diagnosis of dementia. This couple management guide is delivered in the form of an app, DemPower.ObjectiveThis study aims to investigate the feasibility and acceptability of DemPower and to assess the criteria for a full-integrated clinical and economic randomized control trial. DemPower couple management app will be introduced to couples wherein one partner has dementia.MethodsThe study will recruit 25 couples in the United Kingdom and 25 couples in Sweden. Couples will be given 3 months to engage with the app, and the amount of time taken to complete the guide (can be <3 or >3 months) will be reviewed. A set of outcome measures will be obtained at baseline and postintervention stages.ResultsThe proposed study is at the recruitment phase. The DemPower app is being introduced to couples from consultation groups at a pretrial phase for identifying any bugs and exploring if any navigation challenges exist. The feasibility testing will begin in April 2018.ConclusionsThe study will determine how much support couples need to engage with DemPower and whether or not they make use of it in their everyday lives. If there is support for app use, a future study will assess whether it is superior to “usual care.”Trial RegistrationInternational Standard Randomized Controlled Trial Number (ISRCTN): 10122979; http://www.isrctn.com/ISRCTN10122979 (Archived by WebCite at http://www.webcitation.org/70rB1iWYI)Registered Report IdentifierRR1-10.2196/9087

Effects of a home-based exercise program on physical capacity and fatigue in patients with low to intermediate risk myelodysplastic syndrome—a pilot study

IntroductionFatigue is a frequent and disabling symptom in myelodysplastic syndromes (MDS). There is evidence for the benefit of exercise on fatigue in haematological malignancies, but clinical trials targeting patients with MDS do not exist. MethodsA prospective, non-randomized feasibility trial was conducted to assess the safety and efficacy of a home-based exercise intervention in patients with MDS. Exercise schedule contained endurance or strength training in daily turns over 12 weeks. Outcome measures included 6-min walking distance (6-MWD), an ergometer check, strength measurement of lower limb, abdomen and back, quality of life and fatigue. ResultsTwenty-one patients (13 male, 8 female) were included. Median age was 66 years (range 29–87). Fifteen patients (71%) continued the program till week 12 (T1), of whom eleven patients met criteria for program completion. There were no adverse events reported due to the intervention. 6-MWD significantly improved from 580m at T0 to 645m at T1 (p<0.05). Fatigue scores did not significantly change over time (MFI: 12.8 vs. 12.3 vs. 11.9; QLQ-C30 fatigue scale: 48.2 vs. 46.7 vs. 47.4). ConclusionThese data provide evidence that an unsupervised outpatient exercise program is feasible and can improve physical capacity. Randomized, controlled studies implementing these interventions are warranted.

Successful Endoscopic Ultrasound Guided Biopsies of Gastric Muscularis Propria in Gastroparesis Patients

Purpose: Loss of interstitial cell of Cajal (ICC) in the muscularis propria (MP) and inflammatory changes in the myenteric plexus are reported from full thickness biopsies (FTB) of the stomach wall in patients with gastroparesis (GP). These findings can aid in the diagnosis and treatment selection. However FTB use is limited by the need for surgery. We hypothesized that endoscopic ultrasound guided core biopsies (EUS-CB) can obtain sufficient MP tissue for histological examination in GP patients. We investigated the efficacy and safety of EUS-CB of the stomach antral wall in GP and compared the tissue to a surgically obtained FTB in the same patient. Methods: This is a prospective non-randomized feasibility trial. Patients with GP who were undergoing gastric neurostimulator placement were enrolled. Patients had a biopsy done by EUS FNA with a 19 G core needle, followed by FTB obtained surgically during neurostimualtor placement within 24 hours. Endoscopic and surgical specimens were compared for tissue morphology, count of ICC (c-kit stain), enteric neurons (S100 stain), and fibrosis (trichome) for each patient. Correlation coeffi cient of the ICC count per HPF was used to compare both specimens. Safety of the endoscopic procedure was assessed by examining the site of EUS biopsy during surgery as well as observing clinical outcomes. Results: Five female patients (mean age 41.6 years) were enrolled in the trial (four diabetic and one idiopathic GP). EUS-CBs were successful in obtaining sufficient tissue for histological assessment of ICC in all patients and for the myenteric plexus in 60% of patients (Table 1). There was a high correlation coefficient (0.8) when comparing both surgical and endoscopic groups for the loss of ICC. Figure 1 shows c-kit staining for ICC in the endoscopically obtained specimen. Mild serosal bruising and/or localized hematoma formations were noted at the sites of EUS biopsies in all five patients but no serosal tear or perforation was noted. No post-procedure complications were reported.Table: Table. Comparison of endoscopic and surgical biopsies obtained from the stomach's muscularis propriaFigure: C kit staining for ICC on EUS biopsy.Conclusion: EUS-CB of the gastric MP in GP patients is safe and provides enough tissue for complete histological assessment. This relatively non-invasive approach can replace surgical FTB and will revolutionize the diagnosis and management of patients with GP.