Intervention Usual Care Research Articles

Individualised, targeted step count intervention following gastrointestinal cancer surgery: The Fit-4-Home randomised clinical trial.

To determine the effectiveness of an individualised, daily targeted step count intervention and usual care compared with usual care alone on improving surgical and patient reported outcomes. The Fit-4-Home trial was a pragmatic, randomised controlled trial conducted from April 2019 to February 2021. Patients undergoing elective surgery for liver, stomach or pancreatic cancer in two Australian hospitals were recruited. Participants were randomly allocated to receive an individualised, targeted step count intervention and usual care (intervention) or usual care alone (control). A wearable activity tracker was provided to the intervention group to monitor their daily step count target. Primary outcome was the length of stay in the gastrointestinal ward. Secondary outcomes included postoperative complication rates, discharge destination, quality of life, physical activity, pain, fatigue, distress and hospital re-admission within 30 days. Outcome measures were compared between groups using non-parametric statistics. Of the 96 patients recruited, 47 were randomised to the intervention group and 49 were randomised to the control group. The median (interquartile) length of stay in the ward was 7 days (5.0-13.0) in the intervention group and 7 days (5.0- 12.0) in the control group (p= 0.330). Fatigue scores were worse in the intervention group when compared to control (p= 0.018). No other differences between groups were observed. An individualised, daily targeted step count intervention and usual care did not confer additional benefits in reducing the length of stay in the ward compared to usual care alone for patients undergoing gastrointestinal cancer surgery. Registered with the Australia and New Zealand Clinical Trials Registry (ACTRN12619000194167).

Design of a multifaceted strategy based on automated text messaging in patients with recent heart failure admission.

AimsTo evaluate a telemonitoring strategy based on automated text messaging and telephone support after heart failure (HF) hospitalization.Methods and resultsThe MESSAGE‐HF study is a prospective multicentre, randomized, nationwide trial enrolling patients from 30 clinics in all regions of Brazil. HF patients with reduced left ventricular ejection fraction (<40%) and access to mobile phones are eligible after an acute decompensated HF hospitalization. Patients meeting eligibility criteria undergo an initial feasibility text messaging assessment and are randomized to usual care or telemonitoring intervention. All patients receive a HF booklet with basic information and recommendations about self‐care. Patients in the intervention group receive four daily short text messages (educational and feedback) during the first 30 days of the protocol to optimize self‐care; the feedback text messages from patients could trigger diuretic adjustments or a telephone call from the healthcare team. After 30 days, the frequency of text messages can be adjusted. Patients are followed up after 30, 90, and 180 days, with final status ascertained at 365 days by telephone. Our primary endpoint is the change in N‐terminal pro‐brain natriuretic peptide (NT‐proBNP) levels after 180 days. Secondary endpoints include changes in NT‐proBNP after 30 days; health‐related quality of life, HF self‐care, and knowledge scales after 30 and 180 days; and a composite outcome of HF hospitalization and cardiovascular death, adjudicated by a blinded and independent committee.ConclusionsThe MESSAGE‐HF trial is evaluating an educational and self‐care promotion strategy involving a simple, intensive, and tailored telemonitoring system. If proven effective, it could be applied to a broader population worldwide.

Inhaled budesonide for COVID-19 in people at high risk of complications in the community in the UK (PRINCIPLE): a randomised, controlled, open-label, adaptive platform trial

SummaryBackgroundA previous efficacy trial found benefit from inhaled budesonide for COVID-19 in patients not admitted to hospital, but effectiveness in high-risk individuals is unknown. We aimed to establish whether inhaled budesonide reduces time to recovery and COVID-19-related hospital admissions or deaths among people at high risk of complications in the community.MethodsPRINCIPLE is a multicentre, open-label, multi-arm, randomised, controlled, adaptive platform trial done remotely from a central trial site and at primary care centres in the UK. Eligible participants were aged 65 years or older or 50 years or older with comorbidities, and unwell for up to 14 days with suspected COVID-19 but not admitted to hospital. Participants were randomly assigned to usual care, usual care plus inhaled budesonide (800 μg twice daily for 14 days), or usual care plus other interventions, and followed up for 28 days. Participants were aware of group assignment. The coprimary endpoints are time to first self-reported recovery and hospital admission or death related to COVID-19, within 28 days, analysed using Bayesian models. The primary analysis population included all eligible SARS-CoV-2-positive participants randomly assigned to budesonide, usual care, and other interventions, from the start of the platform trial until the budesonide group was closed. This trial is registered at the ISRCTN registry (ISRCTN86534580) and is ongoing.FindingsThe trial began enrolment on April 2, 2020, with randomisation to budesonide from Nov 27, 2020, until March 31, 2021, when the prespecified time to recovery superiority criterion was met. 4700 participants were randomly assigned to budesonide (n=1073), usual care alone (n=1988), or other treatments (n=1639). The primary analysis model includes 2530 SARS-CoV-2-positive participants, with 787 in the budesonide group, 1069 in the usual care group, and 974 receiving other treatments. There was a benefit in time to first self-reported recovery of an estimated 2·94 days (95% Bayesian credible interval [BCI] 1·19 to 5·12) in the budesonide group versus the usual care group (11·8 days [95% BCI 10·0 to 14·1] vs 14·7 days [12·3 to 18·0]; hazard ratio 1·21 [95% BCI 1·08 to 1·36]), with a probability of superiority greater than 0·999, meeting the prespecified superiority threshold of 0·99. For the hospital admission or death outcome, the estimated rate was 6·8% (95% BCI 4·1 to 10·2) in the budesonide group versus 8·8% (5·5 to 12·7) in the usual care group (estimated absolute difference 2·0% [95% BCI –0·2 to 4·5]; odds ratio 0·75 [95% BCI 0·55 to 1·03]), with a probability of superiority 0·963, below the prespecified superiority threshold of 0·975. Two participants in the budesonide group and four in the usual care group had serious adverse events (hospital admissions unrelated to COVID-19).InterpretationInhaled budesonide improves time to recovery, with a chance of also reducing hospital admissions or deaths (although our results did not meet the superiority threshold), in people with COVID-19 in the community who are at higher risk of complications.FundingNational Institute of Health Research and United Kingdom Research Innovation.

Development and Results of an Implementation Plan for High-Intensity Gait Training.

High-intensity gait training is recommended in stroke rehabilitation to improve gait speed, walking distance, and balance. However, identifying effective and efficient implementation methods is a challenge for rehabilitation providers. This article describes the development of an implementation plan, presents findings of each implementation phase, and identifies the project's impact on clinicians and the health system. Two inpatient rehabilitation facilities, including 9 physical therapists, collaborated with a knowledge translation center to implement this program. We developed an implementation plan using the Knowledge-to-Action Framework and utilized the Consolidated Framework for Implementation Research to identify barriers and select implementation strategies. Using mix-methods research, including surveys and informal discussions, we evaluated current practice, barriers, outcomes, and the sustainability of high-intensity gait training in practice. A multicomponent implementation plan that targeted barriers was developed. Before implementation, clinicians reported providing several balance, strength training, and gait interventions to improve walking. Barriers to using high-intensity gait training included knowledge, beliefs, adaptability of high-intensity gait training, resources, culture, and others. Twenty-six implementation strategies were selected to target the barriers. Surveys and informal discussions identified significant changes in perceived practice, adoption of high-intensity gait training, and positive impacts on the health system. The 2-year follow-up survey indicated that the new practice was sustained. Using a multicomponent implementation plan that targeted barriers, we successfully implemented high-intensity gait training in clinical practice. Contributors to successful implementation may include the implementation methods, usual care interventions, and clinicians' readiness for this change.Video Abstract available for more insights from the authors (see the Video, Supplemental Digital Content 1, available at: http://links.lww.com/JNPT/A352.).

Unsupervised Exercise Training Was Not Found to Improve the Metabolic Health or Phenotype over a 6-Month Dietary Intervention: A Randomised Controlled Trial with an Embedded Economic Analysis.

Ectopic fat leads to metabolic health problems. This research aimed to assess the effectiveness of a hypocaloric diet intervention together with an unsupervised exercise training program in comparison with a hypocaloric diet alone to reduce ectopic fat deposition. Sixty-one premenopausal women with overweight or obesity participated in this controlled trial and were each randomised into either a usual care group (hypocaloric diet) or intervention group (hypocaloric diet + unsupervised exercise training). Ectopic fat deposition, metabolic parameters, incremental costs from a societal perspective and incremental quality-adjusted life years (QALYs) were assessed before, during and after the six-month intervention period. In the total sample, there was a significant decrease in visceral adipose tissue (VAT: −18.88 cm2, 95% CI −11.82 to −25.95), subcutaneous abdominal adipose tissue (SAT: −46.74 cm2, 95% CI −29.76 to −63.18), epicardial fat (ECF: −14.50 cm3, 95% CI −10.9 to −18.98) and intrahepatic lipid content (IHL: −3.53%, 95% CI −1.72 to −5.32). Consequently, an “adapted” economic analysis revealed a non-significant decrease in costs and an increase in QALYs after the intervention. No significant differences were found between groups. A multidisciplinary lifestyle approach seems successful in reducing ectopic fat deposition and improving the metabolic risk profile in women with overweight and obesity. The addition of unsupervised exercise training did not further improve the metabolic health or phenotype over the six months.

Doxycycline for community treatment of suspected COVID-19 in people at high risk of adverse outcomes in the UK (PRINCIPLE): a randomised, controlled, open-label, adaptive platform trial

BackgroundDoxycycline is often used for treating COVID-19 respiratory symptoms in the community despite an absence of evidence from clinical trials to support its use. We aimed to assess the efficacy of doxycycline to treat suspected COVID-19 in the community among people at high risk of adverse outcomes.MethodsWe did a national, open-label, multi-arm, adaptive platform randomised trial of interventions against COVID-19 in older people (PRINCIPLE) across primary care centres in the UK. We included people aged 65 years or older, or 50 years or older with comorbidities (weakened immune system, heart disease, hypertension, asthma or lung disease, diabetes, mild hepatic impairment, stroke or neurological problem, and self-reported obesity or body-mass index of 35 kg/m2 or greater), who had been unwell (for ≤14 days) with suspected COVID-19 or a positive PCR test for SARS-CoV-2 infection in the community. Participants were randomly assigned using response adaptive randomisation to usual care only, usual care plus oral doxycycline (200 mg on day 1, then 100 mg once daily for the following 6 days), or usual care plus other interventions. The interventions reported in this manuscript are usual care plus doxycycline and usual care only; evaluations of other interventions in this platform trial are ongoing. The coprimary endpoints were time to first self-reported recovery, and hospitalisation or death related to COVID-19, both measured over 28 days from randomisation and analysed by intention to treat. This trial is ongoing and is registered with ISRCTN, 86534580.FindingsThe trial opened on April 2, 2020. Randomisation to doxycycline began on July 24, 2020, and was stopped on Dec 14, 2020, because the prespecified futility criterion was met; 2689 participants were enrolled and randomised between these dates. Of these, 2508 (93·3%) participants contributed follow-up data and were included in the primary analysis: 780 (31·1%) in the usual care plus doxycycline group, 948 in the usual care only group (37·8%), and 780 (31·1%) in the usual care plus other interventions group. Among the 1792 participants randomly assigned to the usual care plus doxycycline and usual care only groups, the mean age was 61·1 years (SD 7·9); 999 (55·7%) participants were female and 790 (44·1%) were male. In the primary analysis model, there was little evidence of difference in median time to first self-reported recovery between the usual care plus doxycycline group and the usual care only group (9·6 [95% Bayesian Credible Interval [BCI] 8·3 to 11·0] days vs 10·1 [8·7 to 11·7] days, hazard ratio 1·04 [95% BCI 0·93 to 1·17]). The estimated benefit in median time to first self-reported recovery was 0·5 days [95% BCI −0·99 to 2·04] and the probability of a clinically meaningful benefit (defined as ≥1·5 days) was 0·10. Hospitalisation or death related to COVID-19 occurred in 41 (crude percentage 5·3%) participants in the usual care plus doxycycline group and 43 (4·5%) in the usual care only group (estimated absolute percentage difference −0·5% [95% BCI −2·6 to 1·4]); there were five deaths (0·6%) in the usual care plus doxycycline group and two (0·2%) in the usual care only group.InterpretationIn patients with suspected COVID-19 in the community in the UK, who were at high risk of adverse outcomes, treatment with doxycycline was not associated with clinically meaningful reductions in time to recovery or hospital admissions or deaths related to COVID-19, and should not be used as a routine treatment for COVID-19.FundingUK Research and Innovation, Department of Health and Social Care, National Institute for Health Research.

Characteristics and effects of integrated nutrition and stimulation interventions to improve the nutritional status and development of children under 5 years of age: a systematic review and meta-analysis

IntroductionAround 250 million children in low-income and middle-income countries are at risk of not fulfilling their developmental potential. There is a need to update syntheses investigating the effects of combined...

How effective are digital interventions in increasing flu vaccination among pregnant women? A systematic review and meta-analysis.

Flu can have serious consequences for pregnant woman and unborn babies. Vaccination provides safe and effective protection, yet uptake among pregnant women is below national targets. Digital interventions are effective at increasing adherence to health interventions. This review aimed to establish whether digital interventions are effective at increasing rates of flu vaccination among pregnant women, and to determine the overall effect size. Systematic searches identified digital intervention trials, aiming to increase rate of flu vaccination among pregnant women. Random-effects meta-analysis provided a combined effect size and examined which mode of digital interventions had the largest effects on flu vaccination. Ten studies were included in the review. The majority of digital interventions were more effective at increasing rates of flu vaccination (7-81.3% uptake) than usual care or non-digital interventions (7.3-47.1% uptake). When meta-analysed, digital interventions had a small, non-significant effect (odds ratio [OR]=1.29, 95% confidence interval [CI]: 0.71, 2.31), P=0.40. Text messages (OR=1.25, 95% CI: 0.58, 2.67), P=0.57 appeared less effective than other digital interventions (OR=1.58, 95% CI: 1.02, 2.46), P=0.04. Overall, there is a lack of high-quality studies reporting the effectiveness of digital interventions at increasing flu vaccination during pregnancy. Future interventions may benefit from using video or social media to communicate messages for maximum success in targeting an increase in rates of flu vaccination in pregnancy.

Herbal medicine for irritable bowel syndrome: An overview of systematic reviews protocol.

Background:Irritable bowel syndrome (IBS) is a common disorder characterized by the recurrence of abdominal pain and changes in bowel habits. Owing to the limitations of conventional treatments, patients with IBS are often dissatisfied with the effect of treatment and have a poor quality of life. Herbal medicines (HMs) are frequently used for the treatment of IBS. This protocol was designed through an overview of systematic reviews (SRs), to investigate the safety and efficacy of HMs for treating IBS.Methods:SRs published up to May 2021 will be searched from the following 6 electronic databases: Medline (via PubMed), EMBASE, Cochrane Database of Systematic Reviews, Allied and Complementary Medicine Database, Oriental Medicine Advanced Searching Integrated System, and China National Knowledge Infrastructure database. SRs and/or meta-analyses on the use of HMs for IBS will be included in this overview. The effects of a placebo, no treatment, usual care, or conventional treatment will be compared with those of HMs. Two investigators will independently extract the data and assess the methodological and evidence quality for each main finding. The total clinical effectiveness rate will be measured as the primary outcome.Results:This overview is expected to provide data on the use of HMs for the treatment of IBS based on qualitative and quantitative syntheses of the included SR data.Conclusion:This overview will evaluate and propose the efficacy and safety of HMs for the treatment of IBS.Registration number:DOI 10.17605/OSF.IO/NT6WZ (https://osf.io/nt6wz).

Efficacy of Mobile Health in Patients With Low Back Pain: Systematic Review and Meta-analysis of Randomized Controlled Trials

BackgroundLow back pain is one of the most common health problems and a main cause of disability, which imposes a great burden on patients. Mobile health (mHealth) affects many aspects of people’s lives, and it has progressed rapidly, showing promise as an effective intervention for patients with low back pain. However, the efficacy of mHealth interventions for patients with low back pain remains unclear; thus, further exploration is necessary.ObjectiveThe purpose of this study was to evaluate the efficacy of mHealth interventions in patients with low back pain compared to usual care.MethodsThis was a systematic review and meta-analysis of randomized controlled trials designed according to the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-analysis) statement standard. We searched for studies published in English before October 2020 in the PubMed, EMBASE, Web of Science, and Cochrane Library databases. Two researchers independently scanned the literature, extracted data, and assessed the methodological quality of the included studies. Bias risks were assessed using the Cochrane Collaboration tool. We used RevMan 5.4 software to perform the meta-analysis.ResultsA total of 9 studies with 792 participants met the inclusion criteria. The simultaneous use of mHealth and usual care showed a better reduction in pain intensity than usual care alone, as measured by the numeric rating scale (mean difference [MD] –0.85, 95% CI –1.29 to –0.40; P<.001), and larger efficacy in reducing disability, as measured by the Rolland-Morris Disability Questionnaire (MD –1.54, 95% CI –2.35 to –0.73; P<.001). Subgroup analyses showed that compared with usual care, mHealth using telephone calls significantly reduced pain intensity (MD –1.12, 95% CI –1.71 to –0.53; P<.001) and disability score (MD –1.68, 95% CI –2.74 to –0.63; P<.001). However, without the use of telephone calls, mHealth had no obvious advantage over usual care in improving pain intensity (MD –0.48, 95% CI –1.16 to 0.20; P=.16) and the disability score (MD –0.41, 95% CI –1.88 to 1.05; P=.58). The group that received a more sensitive feedback intervention showed a significantly reduced disability score (MD –4.30, 95% CI –6.95 to –1.69; P=.001).ConclusionsThe use of simultaneous mHealth and usual care interventions has better efficacy than usual care alone in reducing pain intensity and disability in patients with low back pain. Moreover, the results of subgroup analysis revealed that mHealth using telephone calls might play a positive role in improving pain intensity and disability in patients with low back pain.

Geriatric co-management and interdisciplinary transitional care reduced hospital readmissions in frail older patients in Argentina: results from a randomized controlled trial.

Hospitalization is a moment of extreme vulnerability for frail older adults. There is scarce evidence on the effectiveness of geriatric co-management or transitional care interventions in Latin America. To assess whether geriatric co-management combined with an interdisciplinary transitional care intervention could reduce 30-day hospital readmission rate compared to usual care in hospitalized frail older patients in a tertiary hospital in Argentina. Single-blinded randomized controlled trial. Usual care treatment arm: all procedures performed during hospitalization were overseen by a senior internal medicine specialist and complied with pre-defined protocols. Patients had access to specialist care if needed, as well as hospital-at-home or home-based primary care services after discharge. Intervention treatment arm: in addition to usual care, a geriatric co-management team performed a comprehensive geriatric assessment during hospitalization, provided tailored recommendations to minimize geriatric syndromes and planned transition of care. A health and social care counselor oversaw continuity of care in patients' homes after discharge. We included 120 participants in each of the intervention and usual care (control) arms. Thirty-day hospital readmissions were 47.7% lower in the intervention arm (18.3% vs 35.0%; P = 0.040); and emergency room visits within the first 6months after discharge were 27.8% lower (43.3% vs 60.0%; P = 0.010). There was a non-statistically significant decrease in 6-month mortality in the intervention arm (25.0% vs 35.0%; P = 0.124). Geriatric co-management of frail older patients during hospitalization combined with an interdisciplinary transitional care intervention reduced 30-day hospital readmissions and emergency visits 6months after discharge. Trial registration number: RENIS IS003081.

The effect of multimodal comprehensive care methodology training on oral health care professionals\u2019 empathy for patients with dementia

BackgroundThe prevalence of oral diseases in people with dementia has increased, and patients with dementia have worse oral health than people without dementia. However, in the provision of oral care, these patients often exhibit care-resistant behaviours. Empathy is important for health care professionals who provide dental care for people with dementia. A study was conducted to assess whether a multimodal comprehensive care methodology training programme, Humanitude™, was associated with an improvement in empathy for people with dementia among oral health care professionals.MethodsThis research was a pre-post prospective study. A total of 45 dentists and dental hygienists participated in a 7-h multimodal comprehensive care methodology training programme. Participants’ empathy for their patients was evaluated with the Jefferson Scale of Physician Empathy-Health Professionals Version (JSPE-HP) before the training and 1 month after the training (primary outcome). Each participant listed 3 patients with poor oral health due to the refusal of usual oral care or dental treatment from his or her clinical practice. The oral health of the 3 care-resistant patients listed by each participant was evaluated by the Oral Health Assessment Tool (OHAT) before the training and 1 month after the training (secondary outcome).ResultsThe post-training response rate was 87% (21 dentists and 18 dental hygienists). From pre-training to post-training, the multimodal comprehensive care methodology training significantly increased the mean empathy score (from 113.97 to 122.95, P < 0.05, effect size = 0.9). Regardless of gender, profession and years of clinical experience, all post-training subgroup scores were higher than the pre-training subgroup scores. The tongue, natural teeth, and oral hygiene scores of patients with dementia who resisted usual oral care or dental treatment, as assessed by the OHAT, were significantly improved compared with those before the training.ConclusionsThe multimodal comprehensive care methodology training was associated with an improvement in oral health professionals’ empathy for patients with dementia. These findings suggest that randomized controlled trials with large sample sizes will be needed.Trial registrationUMIN Clinical Trials Registry (UMIN-CTR), UMIN000041687. Registered 4 September 2020 – Retrospectively registered, https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047586

Educational intervention to adopt selective laser trabeculoplasty as first-line glaucoma treatment: Randomized controlled trial: Educational intervention on selective laser trabeculoplasty.

To determine the efficacy of an educational intervention on patient adoption and attitudes toward selective laser trabeculoplasty (SLT) as first-line treatment for glaucoma. This study is a randomized controlled trial. Subjects include 33 patients within 1-year diagnosis of either primary open-angle glaucoma, ocular hypertension, or pseudoexfoliation syndrome. After informed consent, subjects were randomly assigned to a Usual Care or Educational Intervention group. All subjects completed a pre-intervention questionnaire. The Educational Intervention group was shown a slideshow presentation and a 3-min video and given a post-intervention questionnaire. Follow-up examinations were reviewed for 6 months to determine subject completion of SLT, the primary outcome. Secondary outcomes include assessment of attitude toward SLT before and after intervention. Age, gender, and baseline characteristics between the groups did not differ. The Usual Care group had a higher proportion of African Americans (77% vs 31%, p = 0.04). At 6 months following the intervention, 63% of subjects underwent SLT compared to 35% of Usual Care subjects (p = 0.12). Older age was associated with decreased SLT uptake (OR 0.90, 95% CI 0.82-0.99, p = 0.03). Prior to the intervention, there were no differences in attitudes of both groups regarding SLT therapy. Nineteen percent of Educational Intervention subjects changed positively toward SLT (p = 0.08) and 50% scheduled an SLT appointment after intervention (p = 0.005). A slideshow and video-based educational intervention may positively enhance patient adoption of SLT.Clinical trial registration name, number, URL: Educational Intervention to Adopt SLT as First-Line Glaucoma Treatment, NCT03365778, https://clinicaltrials.gov/ct2/show/NCT03365778.

Text Messaging and Home Blood Pressure Monitoring for Patients with Uncontrolled Hypertension: Proposal for a Feasibility Pilot Randomized Controlled Trial.

BackgroundA decrease in blood pressure, even modestly (ie, 2 mmHg), lowers cardiovascular morbidity and mortality. Low patient adherence to antihypertensive medication is the most significant modifiable patient-related barrier to achieving controlled blood pressure. Preliminary studies have shown that SMS text messaging and home blood pressure monitoring (HBPM) can be effective in promoting medication adherence and blood pressure control. The best strategy to engage with older patients of low socioeconomic status who are low adopters of technology and disproportionally affected by uncontrolled hypertension is still unknown.ObjectiveThe objective of this study is to improve blood pressure control in the older, low socioeconomic status population. The study will test two aims: First, we aim to evaluate the feasibility of conducting a randomized controlled trial by using an SMS-based approach among nonadherent, older patients of low socioeconomic status who have uncontrolled hypertension. Feasibility will be assessed in terms of recruitment rates per month (primary outcome); patient acceptability will be evaluated by monitoring retention rates and SMS response rates and using the validated Systems Usability Scale (secondary outcomes). Second, we aim to estimate the effects of the SMS approach on lowering blood pressure and adherence to antihypertensive medications.MethodsWe will recruit 24 patients of low socioeconomic status with uncontrolled hypertension (systolic BP>140 mmHg or diastolic BP>90 mmHg) showing low medication adherence and taking at least two antihypertensives, who have presented to two outpatient clinics of Wake Forest Baptist Health (Winston Salem, North Carolina, USA). Participants will be randomly assigned to either SMS and HBPM (n=12) or usual care and HBPM (n=12) intervention. Clinicians adjusting the patients’ medications will be blinded to the study assignment. Text messages will be sent from a secure platform to assess medication adherence and HBPM on a weekly basis. The content and delivery frequency of the proposed SMS intervention are based on input from three focus groups conducted in Spring 2019. Participants in both study arms will receive education on HBPM and using an HBPM device. We hypothesize that we will successfully recruit 24 participants and the intervention will be acceptable to the participants. It will also improve medication adherence (assessed by question Medication Adherence Questionnaire scores) and blood pressure control.ResultsOur study was funded in July 2020. As of May 2021, we have enrolled 6 participants.ConclusionsOur findings will help design a larger efficacy trial to advance the field of eHealth delivery systems particularly for older adults of low socioeconomic status. This study addresses a highly significant topic and targets a population of high morbidity and mortality that has been traditionally underrepresented in clinical trials.Trial RegistrationClinicalTrials.gov NCT03596242; https://clinicaltrials.gov/ct2/show/NCT03596242International Registered Report Identifier (IRRID)PRR1-10.2196/18984

Effects of neurodynamic interventions on pain sensitivity and function in patients with multiple sclerosis: a randomized clinical trial

ObjectiveTo assess the effects of adding a neurodynamic intervention into a multimodal management approach in individuals with multiple sclerosis (MS) with upper extremity pain symptoms. DesignRandomized clinical trial. SettingTertiary hospital center. ParticipantsThirty-two individuals with MS were randomly assigned to multimodal usual care alone (n=16) or multimodal usual care plus neurodynamic intervention (n=16). InterventionsBoth groups received 5 sessions of multimodal usual care of 30minutes duration, twice per week. Subjects allocated to the neurodynamic group also received bilateral neurodynamic slider interventions targeting the upper extremity nerve trunks. Outcome measuresPressure pain thresholds (PPTs) at the radial, median and ulnar nerve trunks, second metacarpal and tibialis anterior, pain intensity in the upper extremity (NPRS, 0–10), light touch detection threshold (von Frey hairs) and manual dexterity (nine-hole peg test) were assessed before and after the intervention. ResultsSubjects receiving the neurodynamic interventions experienced larger improvements in PPTs at all locations (moderate effect size, between-groups differences from 89.5 to 186.5kPa), a higher decrease in pain intensity at rest (large effect, difference 1.7, 95%CI 0.4 to 3.0) and improvements in sensitivity to light touch (moderate effect, difference −0.7, 95%CI −1.3 to −0.1) and in manual dexterity (large effect, difference 7.7, 95%CI 4.0 to 11.4seconds) than those that did not receive the neurodynamic intervention. ConclusionsThe inclusion of neural mobilization into a multimodal management approach resulted in reduction of pressure sensitivity, greater reduction in pain and improvement in sensitivity to light touch and manual dexterity in MS. Further studies are necessary to confirm these findings at longer term follow-ups. (ClinicalTrials.gov: NCT03595631)

Digital delivery of a contingency management intervention for substance use disorder: A feasibility study with DynamiCare Health

Digital health tools can provide convenient delivery of evidence-based treatments. The DynamiCare Health smartphone app delivers a contingency management intervention for substance use disorder consisting of remote self-testing for alcohol (breath) and drugs (saliva) with remote test validation and delivery of financial incentives for negative test results. This study examined feasibility, engagement (duration and consistency of app utilization), and impact on usual care treatment participation when a community substance use treatment program implemented this digital therapy among its patients. The study randomly assigned patients with alcohol use disorder (N = 61) to receive either DynamiCare along with treatment-as-usual (TAU; N = 29) or TAU only (N = 32) during a 90-day evaluation period. Mean duration between first and last app use was 64 (±35) days, with mean earnings of $248 (±$209, out of $600 maximum). Among those with any app use (n = 25), compliance was 68% and 74%, respectively for requested breath and saliva samples. Overall, two thirds of patients (66%) assigned to the app used it for at least 57 days and with high rates of self-testing compliance. Those completing the assessment (n = 13; 45% of sample) endorsed high satisfaction ratings. DynamiCare versus TAU participants were more likely to be retained in usual care treatment at 90 days (24% vs 3%; (χ2 (1, 61) = 5.9, p < 0.05), but sustained app utilization was associated with a wide range of usual care treatment participation. These data suggest that DynamiCare Health is feasible and potentially beneficial as a complement to community substance use treatment programs.

Digital interventions for the management of chronic obstructive pulmonary disease.

Digital interventions for the management of chronic obstructive pulmonary disease.

The effects of exergames on muscle strength: A systematic review and meta-analysis.

This systematic review and meta-analysis examined studies on the chronic effects of exergames on muscle strength in humans. PubMed, Scopus, CENTRAL, Web of Science, SciELO, Biblioteca Virtual em Saúde, and Google Scholar were searched, and manual searches of the reference lists of included studies and hand-searches on Physiotherapy Evidence Database and ResearchGate were conducted from inception to August 10, 2020. Randomized and non-randomized exergame intervention studies with or without a non-exercise group and/or a "usual care intervention group" (any other intervention that did not incorporate exergames), which evaluated muscle strength through direct measurements, were included. Forty-seven and 25 studies were included in the qualitative review and meta-analysis, respectively. The between-groups meta-analyses showed no significant differences between exergames and non-exercise control groups for handgrip strength in heathy/unhealthy middle-aged/older adults or knee extension maximum voluntary isometric contraction (MVIC) in healthy older adults. However, exergames provided a greater increase in handgrip strength, knee flexion MVIC, and elbow extension MVIC, but not knee extension MVIC or elbow flexion MVIC, in individuals with different health statuses when compared to usual care interventions. Also, there was a greater increase in handgrip strength in children with hemiplegic cerebral palsy favouring usual care plus exergames compared to usual care interventions. These results suggest that exergames may improve upper and lower limb muscle strength in individuals with different heath statuses compared to usual care interventions, but not muscle strength in middle age/older adults after accounting for random error. Also, exergames appear to be a useful tool for improving handgrip strength in children with hemiplegic cerebral palsy when added to usual care. However, as the exergame interventions were applied in different populations and there currently are many different approaches to perform exergames, future randomized controlled trials with high methodological quality and large sample sizes are needed to provide more compelling evidence in favour of a specific exergame protocol, or to elucidate exergame protocol design principles that appear to strongly influence outcomes.

Comparative analysis of effectiveness of asthma control test-guided treatment versus usual care in patients with asthma from China

ObjectiveThe present study compared the effectiveness of asthma control test (ACT)-guided treatment vs. usual care (UC) in patients with asthma from China. MethodsThis prospective, phase IV, multicenter, cluster-randomized, open-label 24-week study was conducted in China; patients were randomized to either ACT-guided treatment or UC group. The patients recorded peak expiratory flow, symptoms, and medication in a diary card every day and completed ACT at every clinic visit. For the UC group, patients completed ACT after the physician's treatment decision. ResultsIn total, 83.6% patients (n = 443/530; ACT: n = 209, UC: n = 234) completed the study. A significantly higher proportion of patients (adjusted OR [95% CI]: 7.87 (1.29, 48.11; p = 0.027) responded to the treatment and had ACT total score ≥20 or demonstrated an improvement of >3 points in ACT total score in ≥1 post-baseline assessment in the ACT-guided treatment vs. UC group. A higher proportion of patients had an ACT total score ≥20 and an improvement of >3 points in ACT total score at Week 24 in the ACT-guided treatment vs. the UC group (adjusted OR (95% CI):2.28 (1.07, 4.85; p = 0.036). A significant difference (p = 0.005) in change from baseline in ACT total score was observed in ACT-guided treatment vs. UC group at Week 24. The mean annual exacerbation rate was similar in both the groups. ConclusionsACT-guided treatment was more effective in achieving ACT total score ≥20 or showing an improvement of >3 points in the ACT total score and well tolerated compared with UC treatment in the 24-week treatment period. Trial registrationClinical trials.gov Identifier: NCT02868281, https://clinicaltrials.gov/; GlaxoSmithKline study ID: 201097, https://www.gsk-studyregister.com/.

Evaluation of the Addition of Pharmacist Management to a Medication Assistance Program in Patients with Hypertension and Diabetes Resistant to Usual Care

Objective: To evaluate the effect of a medication assistance program and the addition of pharmacist management on clinical outcomes in patients with hypertension and diabetes through an Advanced Pharmaceutical Care program. Methods: This was a prospective quality improvement study on patients with hypertension and/or diabetes resistant to usual care. The primary outcomes were change in A1C, blood glucose, and blood pressure between 3 phases: usual care, free medications, and free medications plus pharmacist management. Secondary outcomes included achievement of A1C, blood glucose, and blood pressure goals as well as pharmacist interventions. Results: Seven patients were included in the study. The mean A1C decreased from 11.3% to 8.3% with free medications (p = 0.28) and from 8.3% to 6.4% with pharmacist management (p = 0.119). Mean blood pressure during usual care, free medications, and pharmacist intervention was 150/87 mm Hg, 148/85 mm Hg, and 125/78 mm Hg, respectively. After pharmacist management, 75% of patients with type 2 diabetes were able to achieve A1C and blood glucose goals, and 71% of patients with hypertension achieved blood pressure <130/80 mm Hg. Conclusions: The Advanced Pharmaceutical Care program allowed pharmacists to identify and overcome patient-specific barriers to care, provide individualized disease state education, and optimize medication management. Medication assistance led to improvements in A1C and blood pressure, but did not affect achievement of disease state goals. Pharmacist involvement in hypertension and diabetes care led to clinically significant reductions in blood pressure and A1C and enabled patients to reach guideline-recommended blood pressure and glycemic goals.