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BMJ Open May 2024Around one-third of the population of Saudi Arabia have been diagnosed with type 2 diabetes, a condition often requiring lifestyle changes. Personalised health coaching,... (Randomized Controlled Trial)
Randomized Controlled Trial
Feasibility and acceptability of a tailored health coaching intervention to improve type 2 diabetes self-management in Saudi Arabia: a mixed-methods randomised feasibility trial.
BACKGROUND
Around one-third of the population of Saudi Arabia have been diagnosed with type 2 diabetes, a condition often requiring lifestyle changes. Personalised health coaching, a strategy developed to assist individuals in overcoming challenges to adopt healthy behaviours, has not yet been widely applied in the country.
AIMS
We aim to explore the feasibility and acceptability of tailored health coaching in Saudi Arabia, in order to help those with type 2 diabetes to more effectively manage their condition.
METHODS
Using a mixed-methods approach, this research involved a randomised controlled trial with 30 Saudi adults who have type 2 diabetes. They were randomly allocated into either the intervention or control arm for 12 weeks. The Capability, Opportunity, Motivation and Behaviour framework was used to guide the intervention implementation along with the Behaviour Change Techniques Taxonomy V.1. The primary goal was to assess the suitability and duration of the intervention, recruitment, retention and completion rates. The secondary outcome focused on the preliminary efficacy of the health coaching measured by the glycaemic index, blood pressure, body mass index (BMI), waist circumference, weight, patient self-efficacy and diabetes self-management.
RESULTS
The results showed high rates of eligibility, recruitment and retention (a screening rate of 90%, a recruiting rate of 79% and a retention rate of 97%). Notable improvements were observed in the health coaching group across five outcomes: haemoglobin A1c, BMI, waist circumference, patient self-efficacy and diabetes self-care. Qualitative findings highlighted the participants' perceived benefits from the intervention, including enhanced motivation, better understanding of diabetes management and a supportive coaching relationship. Participants expressed high satisfaction with the intervention and advocated for its expansion.
CONCLUSION
The findings demonstrated positive outcomes, supporting the need for a larger randomised controlled trial to evaluate the efficacy of health coaching in improving diabetes self-management among individuals with type 2 diabetes in Saudi Arabia.
Topics: Humans; Diabetes Mellitus, Type 2; Saudi Arabia; Feasibility Studies; Male; Female; Self-Management; Middle Aged; Mentoring; Adult; Self Efficacy; Patient Acceptance of Health Care; Body Mass Index; Health Behavior; Motivation; Self Care
PubMed: 38760053
DOI: 10.1136/bmjopen-2023-078631 -
BMJ Open May 2024(STEPS) is a digital application (app) designed to help parents manage behaviour of their children who are referred to mental health services and are waiting for an...
INTRODUCTION
(STEPS) is a digital application (app) designed to help parents manage behaviour of their children who are referred to mental health services and are waiting for an assessment or treatment. STEPS is currently being evaluated in the Online Parent Training for the Initial Management of Attention-Deficit/Hyperactivity Disorder randomised controlled trial. Alongside the examination of STEPS' clinical and cost-effectiveness, we are conducting a process evaluation to better understand the contextual factors that may influence study outcomes. The purpose of this protocol is to describe the aims, objectives and methodology of the process evaluation prior to it taking place to add to the fidelity and rigour of the trial process and outcomes. Our goal is to adapt STEPS to optimise its benefits in future applications.
METHODS
In line with the Medical Research Council guidelines for evaluating complex interventions, the process evaluation will adopt a mixed method design using qualitative data collected from clinicians and parent interviews and app usage data from participants assigned to the intervention arm.
ANALYSIS
Qualitative data from semistructured interviews and free text box responses included in trial questionnaires will be analysed thematically using framework analysis to better understand how parents use STEPS, how it works and key factors that could aid or hinder its effective implementation in routine clinical practice.
ETHICS
The application for ethical approval for the study was submitted to the North West-Liverpool Central Research Ethics Committee and received a favourable opinion on further information on 26 November 2021, reference number 21/NW/0319.
DISSEMINATION
The process evaluation aims to explore how a digital app might support parents in managing their child's behaviour. Implications for policy and research will be explored and the clinical implications of offering the app to a wider audience to address the lack of support to parents as highlighted in this paper. We plan to publish findings in international, peer-reviewed journals as well as present at conferences.
TRIAL REGISTRATION NUMBER
The trial has been prospectively registered on 18 November 2021; ISRCTN816523503. https://www.isrctn.com/ISRCTN16523503.
Topics: Humans; Parenting; Parents; Child; Attention Deficit Disorder with Hyperactivity; Randomized Controlled Trials as Topic; Mobile Applications; Research Design
PubMed: 38760045
DOI: 10.1136/bmjopen-2023-081563 -
PloS One 2024Malaria treatment is faced with the challenge of access, affordability, availability, and quality of antimalarial medicines. Affordable medicines facility-malaria (AMFm)...
BACKGROUND
Malaria treatment is faced with the challenge of access, affordability, availability, and quality of antimalarial medicines. Affordable medicines facility-malaria (AMFm) program and subsequently Co-payment mechanism were developed to help increase access to quality assured Artemisinin-based combination therapies (ACTs) in seven countries in sub-Saharan Africa. We explored through a qualitative study, experience of healthcare personnel on Co-payment mechanism and the implication on its use in private drug outlets in Uganda.
METHOD
Private drug outlets that reported stocking antimalarial agents in moderate-to-high and low malaria transmission settings were purposively selected for inclusion in the study. In each drug outlet, data was collected from a pharmacist/dispenser through key informant interview. The interview was done using a key informant interview guide which covered the following areas, (i) sociodemographic characteristics, ii) awareness of healthcare personnel on the co-payment mechanism, (iii) awareness of healthcare personnel on quality assured artemisinin combination therapies (QAACT), (iv) antimalarial stocking in private drug outlets, (v) antimalarial dispensing prices, (vi) considerations made while stocking, and pricing antimalarial agents, vii) challenges in antimalarial dispensing, and (viii) access to antimalarial agents in private drug outlets. Data was managed using Atlas.ti and analyzed using framework methodology.
RESULTS
Data was collected from 25 key informants (12 pharmacists and 13 dispensers). Five themes emerged following data analysis, (i) antimalarial stocking influenced by price and client demand, (ii) access and purchasing behavior of drug outlet clients, (iii) basis of dispensing antimalarial agents in private drug outlets, (iv) awareness of QAACT, and (v) awareness of Co-payment mechanism. None of the study participants was aware of the existence of Co-payment mechanism and QAACT in the private sector. Duocotecin brand of ACTs was the most mentioned and dispensed ACT among the study participants in private drug outlets. Nearly all the pharmacists/dispensers said that many clients who request to purchase ACTs don't come with a prescription and prefer buying cheaper antimalarial agents. Study participants reported stocking and selling both ACTs and non-ACT antimalarial agents in the drug outlets. Pharmacists/dispensers in the drug outlets reported that most clients could not afford buying a full dose of an ACT. None of the study participants considered using Co-payment mechanism while stocking ACTs in the drug outlets.
CONCLUSION
There is lack of awareness and utilization of Co-payment mechanism in stocking, pricing, and dispensing of ACTs among pharmacists/dispensers in private drug outlets in Uganda. The antimalarial dispensing in drug outlets was mostly based on prescriptions, clients' preferences, and medicine affordability. The Ministry of Health needs to create demand for Co-payment mechanism through public awareness campaigns, training of healthcare personnel and behavior change communication in the private sector.
Topics: Uganda; Humans; Antimalarials; Malaria; Health Personnel; Artemisinins; Private Sector; Female; Health Services Accessibility; Male
PubMed: 38758832
DOI: 10.1371/journal.pone.0297416 -
JAMA Health Forum May 2024Controlled substances have regulatory requirements under the US Federal Controlled Substance Act that must be met before pharmacies can stock and dispense them. However,...
IMPORTANCE
Controlled substances have regulatory requirements under the US Federal Controlled Substance Act that must be met before pharmacies can stock and dispense them. However, emerging evidence suggests there are pharmacy-level barriers in access to buprenorphine for treatment for opioid use disorder even among pharmacies that dispense other opioids.
OBJECTIVE
To estimate the proportion of Medicaid-participating community retail pharmacies that dispense buprenorphine, out of Medicaid-participating community retail pharmacies that dispense other opioids and assess if the proportion dispensing buprenorphine varies by Medicaid patient volume or rural-urban location.
DESIGN, SETTING, AND PARTICIPANTS
This serial cross-sectional study included Medicaid pharmacy claims (2016-2019) data from 6 states (Kentucky, Maine, North Carolina, Pennsylvania, Virginia, West Virginia) participating in the Medicaid Outcomes Distributed Research Network (MODRN). Community retail pharmacies serving Medicaid-enrolled patients were included, mail-order pharmacies were excluded. Analyses were conducted from September 2022 to August 2023.
MAIN OUTCOMES AND MEASURES
The proportion of pharmacies dispensing buprenorphine approved for opioid use disorder among pharmacies dispensing an opioid analgesic or buprenorphine prescription to at least 1 Medicaid enrollee in each state. Pharmacies were categorized by median Medicaid patient volume (by state and year) and rurality (urban vs rural location according to zip code).
RESULTS
In 2016, 72.0% (95% CI, 70.9%-73.0%) of the 7038 pharmacies that dispensed opioids also dispensed buprenorphine to Medicaid enrollees, increasing to 80.4% (95% CI, 79.5%-81.3%) of 7437 pharmacies in 2019. States varied in the percent of pharmacies dispensing buprenorphine in Medicaid (range, 73.8%-96.4%), with significant differences between several states found in 2019 (χ2 P < .05), when states were most similar in the percent of pharmacies dispensing buprenorphine. A lower percent of pharmacies with Medicaid patient volume below the median dispensed buprenorphine (69.1% vs 91.7% in 2019), compared with pharmacies with above-median patient volume (χ2 P < .001).
CONCLUSIONS AND RELEVANCE
In this serial cross-sectional study of Medicaid-participating pharmacies, buprenorphine was not accessible in up to 20% of community retail pharmacies, presenting pharmacy-level barriers to patients with Medicaid seeking buprenorphine treatment. That some pharmacies dispensed opioid analgesics but not buprenorphine suggests that factors other than compliance with the Controlled Substance Act influence pharmacy dispensing decisions.
Topics: Humans; Medicaid; Buprenorphine; United States; Cross-Sectional Studies; Health Services Accessibility; Opioid-Related Disorders; Pharmacies; Community Pharmacy Services; Opiate Substitution Treatment; Narcotic Antagonists
PubMed: 38758569
DOI: 10.1001/jamahealthforum.2024.1077 -
Journal, Physical Therapy Education Jun 2024Effective academic-clinical partnerships require a greater understanding of how academic programs can best support clinical education (CE) faculty. This study aimed to...
INTRODUCTION
Effective academic-clinical partnerships require a greater understanding of how academic programs can best support clinical education (CE) faculty. This study aimed to determine resources and support that clinical partners need.
REVIEW OF LITERATURE
As the number of physical therapist (PT) programs, cohort sizes, and CE weeks have risen, so has demand for CE sites. Conversely, staffing reductions, increased administrative duties, and rising productivity expectations have decreased the time available for clinical instruction. To promote a successful CE experience, there must be a renewed understanding of CE faculty needs.
SUBJECTS
Clinical education faculty affiliated with any of the 8 contributing programs from the Ohio-Kentucky Consortium participated in survey research (n = 24) and subsequent interview (n = 4) and focus group (n = 6) research.
METHODS
Constructivist grounded theory design was used to explore the needs of CE faculty. Academic and clinical partners developed the initial survey and used survey results to establish interview questions. The investigators iteratively assessed data saturation and clarity of results of coded survey, interview, and focus group data to determine whether the study's aims of identifying CE faculty needs had been met.
RESULTS
The aggregated results yielded 5 main themes of Director of Clinical Education support for CE faculty needs: student readiness for CE experience; effective academic-clinical partner communication; collaborative management of exceptional students; judicious standardization of CE processes; and provision of CE faculty development resources.
DISCUSSION AND CONCLUSION
Clinical education faculty have noted challenges that affect their ability to mentor students. They want academic programs to be more collaborative and proactive with communication, resources, and support. Future research should address aids and barriers to proactive communication, resource provision, and academic-clinical partner collaboration.
Topics: Humans; Focus Groups; Surveys and Questionnaires; Faculty; Grounded Theory; Physical Therapists; Cooperative Behavior; Ohio
PubMed: 38758178
DOI: 10.1097/JTE.0000000000000326 -
MBio May 2024A recent demonstration of synergy between a temperate phage and the antibiotic ciprofloxacin suggested a scalable approach to exploiting temperate phages in therapy,...
A recent demonstration of synergy between a temperate phage and the antibiotic ciprofloxacin suggested a scalable approach to exploiting temperate phages in therapy, termed temperate phage-antibiotic synergy, which specifically interacted with the lysis-lysogeny decision. To determine whether this would hold true across antibiotics, we challenged with the phage HK97 and a set of 13 antibiotics spanning seven classes. As expected, given the conserved induction pathway, we observed synergy with classes of drugs known to induce an SOS response: a sulfa drug, other quinolones, and mitomycin C. While some β-lactams exhibited synergy, this appeared to be traditional phage-antibiotic synergy, with no effect on the lysis-lysogeny decision. Curiously, we observed a potent synergy with antibiotics not known to induce the SOS response: protein synthesis inhibitors gentamicin, kanamycin, tetracycline, and azithromycin. The synergy results in an eightfold reduction in the effective minimum inhibitory concentration of gentamicin, complete eradication of the bacteria, and, when administered at sub-optimal doses, drastically decreases the frequency of lysogens emerging from the combined challenge. However, lysogens exhibit no increased sensitivity to the antibiotic; synergy was maintained in the absence of RecA; and the antibiotic reduced the initial frequency of lysogeny rather than selecting against formed lysogens. Our results confirm that SOS-inducing antibiotics broadly result in temperate-phage-specific synergy, but that other antibiotics can interact with temperate phages specifically and result in synergy. This is the first report of a means of chemically blocking entry into lysogeny, providing a new means for manipulating the key lysis-lysogeny decision.IMPORTANCEThe lysis-lysogeny decision is made by most bacterial viruses (bacteriophages, phages), determining whether to kill their host or go dormant within it. With over half of the bacteria containing phages waiting to wake, this is one of the most important behaviors in all of biology. These phages are also considered unusable for therapy because of this behavior. In this paper, we show that many antibiotics bias this behavior to "wake" the dormant phages, forcing them to kill their host, but some also prevent dormancy in the first place. These will be important tools to study this critical decision point and may enable the therapeutic use of these phages.
PubMed: 38757974
DOI: 10.1128/mbio.00504-24 -
Digital Health 2024This study proposes a way of increasing dataset sizes for machine learning tasks in Internet-based Cognitive Behavioral Therapy through pooling interventions. To this...
OBJECTIVE
This study proposes a way of increasing dataset sizes for machine learning tasks in Internet-based Cognitive Behavioral Therapy through pooling interventions. To this end, it (1) examines similarities in user behavior and symptom data among online interventions for patients with depression, social anxiety, and panic disorder and (2) explores whether these similarities suffice to allow for pooling the data together, resulting in more training data when prediction intervention dropout.
METHODS
A total of 6418 routine care patients from the Internet Psychiatry in Stockholm are analyzed using (1) clustering and (2) dropout prediction models. For the latter, prediction models trained on each individual intervention's data are compared to those trained on all three interventions pooled into one dataset. To investigate if results vary with dataset size, the prediction is repeated using small and medium dataset sizes.
RESULTS
The clustering analysis identified three distinct groups that are almost equally spread across interventions and are instead characterized by different activity levels. In eight out of nine settings investigated, pooling the data improves prediction results compared to models trained on a single intervention dataset. It is further confirmed that models trained on small datasets are more likely to overestimate prediction results.
CONCLUSION
The study reveals similar patterns of patients with depression, social anxiety, and panic disorder regarding online activity and intervention dropout. As such, this work offers pooling different interventions' data as a possible approach to counter the problem of small dataset sizes in psychological research.
PubMed: 38757087
DOI: 10.1177/20552076241248920 -
Frontiers in Public Health 2024A significant rise in childhood obesity worldwide over the past three decades highlights the urgent need for early interventions, especially in preschools as key... (Randomized Controlled Trial)
Randomized Controlled Trial
BACKGROUND
A significant rise in childhood obesity worldwide over the past three decades highlights the urgent need for early interventions, especially in preschools as key settings for child development. This study aimed to assess the feasibility and fidelity of a randomised controlled trial of "I'm an Active Hero" (IAAH), a theory- and evidence-based multi-component behaviour change intervention targeting physical activity and sedentary behaviour amongst preschool-aged children.
METHODS
Two preschools in Taif city, Saudi Arabia were randomly assigned to either the intervention ( = 3 classrooms) or the usual curriculum control group ( = 3 classrooms). The intervention ran for 10 weeks from February to April 2023 and consisted of teacher-led physical activity and sedentary behaviour sessions in preschools, with an additional interactive home component. Primary outcome measures included intervention fidelity, recruitment rates, attrition rates, and compliance with trial procedures. Secondary outcomes included body mass index (BMI), objectively measured physical activity, and sedentary time via the ActiGraph GT3X accelerometer. Outcomes were measured at baseline and at 10 weeks in both study arms.
RESULTS
The preschool intervention component had high fidelity (93.3%), but the home component fidelity was lower (74%). A cluster-level recruitment rate of 12% (13/112 centres) was attained, whilst the individual-level recruitment rate stood at 36% (52/143 children, mean age of 4.16 years; 23 girls). Attrition was 10%. Compliance varied with 90% for BMI, 71% for accelerometery, and 45% for questionnaires. The intervention group showed small decreases in BMI, slight increases in physical activity, and decreases in sedentary time at follow-up compared to the control group. Parents, facilitators, and assistant teachers considered the intervention to be feasible and beneficial.
CONCLUSION
The IAAH intervention was feasible to implement in Saudi Arabian preschools. Facilitators showed high fidelity in delivering it. However, preliminary data did not demonstrate effectiveness. A more comprehensive evaluation across a broader population is warranted. The intervention could be revised to optimise recruitment, compliance, and fidelity of the home-based component. Successful elements from this pilot should be retained whilst adaptations to implementation are made to strengthen key areas.: ClinicalTrials.gov, NCT05754359.
Topics: Humans; Exercise; Female; Child, Preschool; Male; Saudi Arabia; Feasibility Studies; Sedentary Behavior; Health Promotion; Pediatric Obesity; Body Mass Index; Schools; Accelerometry
PubMed: 38756888
DOI: 10.3389/fpubh.2024.1379582 -
Women's Health (London, England) 2024Urinary incontinence is a growing issue among adult women globally. Limited data exist examining the impact of occupational, environmental, and behavioral factors on...
BACKGROUND
Urinary incontinence is a growing issue among adult women globally. Limited data exist examining the impact of occupational, environmental, and behavioral factors on urinary incontinence.
OBJECTIVE
This quantitative, cross-sectional pilot study examined the workplace behaviors of adult women experiencing urinary incontinence. It was hypothesized that specific jobs and work environments would be associated with increased urinary incontinence and urgency based on identified behaviors and work-related conditions.
DESIGN
This study is a quantitative, cross-sectional survey.
METHODS
Adult women (18 years and older) with a history of urinary incontinence were recruited from August 2022 to February 2023 to complete a one-time survey consisting of multiple-choice and short answer questions identifying specific workplace behaviors and symptoms of urinary incontinence. Descriptive statistics and data categorization were used to observe outcomes and examine relationships between urinary incontinence and particular professions.
RESULTS
Urinary incontinence and urgency-related symptoms affected healthcare and business professionals at a higher prevalence. The most commonly reported behaviors across all professions consisted of withholding urine and utilizing absorbance products.
CONCLUSION
The results of this study will help guide women's health practitioners in exploring current workplace behaviors that may contribute to urinary incontinence in adult women. With this knowledge, practitioners can provide meaningful education to employers and employees to prioritize toileting behaviors in the workplace.
Topics: Humans; Female; Pilot Projects; Workplace; Urinary Incontinence; Adult; Cross-Sectional Studies; Middle Aged; Surveys and Questionnaires; Aged; Prevalence
PubMed: 38756044
DOI: 10.1177/17455057241249865 -
Trials May 2024Prediabetes is a highly prevalent condition that heralds an increased risk of progression to type 2 diabetes, along with associated microvascular and macrovascular...
BACKGROUND
Prediabetes is a highly prevalent condition that heralds an increased risk of progression to type 2 diabetes, along with associated microvascular and macrovascular complications. The Diabetes Prevention Program (DPP) is an established effective intervention for diabetes prevention. However, participation in this 12-month lifestyle change program has historically been low. Digital DPPs have emerged as a scalable alternative, accessible asynchronously and recognized by the Centers for Disease Control and Prevention (CDC). Yet, most digital programs still incorporate human coaching, potentially limiting scalability. Furthermore, existing effectiveness results of digital DPPs are primarily derived from per protocol, longitudinal non-randomized studies, or comparisons to control groups that do not represent the standard of care DPP. The potential of an AI-powered DPP as an alternative to the DPP is yet to be investigated. We propose a randomized controlled trial (RCT) to directly compare these two approaches.
METHODS
This open-label, multicenter, non-inferiority RCT will compare the effectiveness of a fully automated AI-powered digital DPP (ai-DPP) with a standard of care human coach-based DPP (h-DPP). A total of 368 participants with elevated body mass index (BMI) and prediabetes will be randomized equally to the ai-DPP (smartphone app and Bluetooth-enabled body weight scale) or h-DPP (referral to a CDC recognized DPP). The primary endpoint, assessed at 12 months, is the achievement of the CDC's benchmark for type 2 diabetes risk reduction, defined as any of the following: at least 5% weight loss, at least 4% weight loss and at least 150 min per week on average of physical activity, or at least a 0.2-point reduction in hemoglobin A1C. Physical activity will be objectively measured using serial actigraphy at baseline and at 1-month intervals throughout the trial. Secondary endpoints, evaluated at 6 and 12 months, will include changes in A1C, weight, physical activity measures, program engagement, and cost-effectiveness. Participants include adults aged 18-75 years with laboratory confirmed prediabetes, a BMI of ≥ 25 kg/m (≥ 23 kg/m for Asians), English proficiency, and smartphone users. This U.S. study is conducted at Johns Hopkins Medicine in Baltimore, MD, and Reading Hospital (Tower Health) in Reading, PA.
DISCUSSION
Prediabetes is a significant public health issue, necessitating scalable interventions for the millions affected. Our pragmatic clinical trial is unique in directly comparing a fully automated AI-powered approach without direct human coach interaction. If proven effective, it could be a scalable, cost-effective strategy. This trial will offer vital insights into both AI and human coach-based behavioral change strategies in real-world clinical settings.
TRIAL REGISTRATION
ClinicalTrials.gov NCT05056376. Registered on September 24, 2021, https://clinicaltrials.gov/study/NCT05056376.
Topics: Humans; Diabetes Mellitus, Type 2; Prediabetic State; Artificial Intelligence; Mentoring; Randomized Controlled Trials as Topic; Multicenter Studies as Topic; Treatment Outcome; Risk Reduction Behavior; Time Factors; Adult; Male; Female; Middle Aged; Mobile Applications
PubMed: 38755706
DOI: 10.1186/s13063-024-08177-8