scholarly journals Protocol for a pragmatic randomised controlled trial to evaluate the effectiveness of improving tuberculosis patients’ treatment adherence via electronic monitors and an app versus usual care in Tibet

2019 ◽  
Author(s):  
Xiaolin Wei ◽  
Joseph P Hicks ◽  
Pasang Pande ◽  
Zhitong Zhang ◽  
Victoria Haldane ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
Treatment Adherence ◽  
Controlled Trial ◽  
Smartphone App ◽  
Health Staff ◽  
Pulmonary Tb ◽  
Tb Control ◽  
Electronic Monitors ◽  
Randomised Controlled

Abstract Background: Treatment non-adherence is a serious challenge to effective tuberculosis (TB) control in Tibet. In this study, we will pilot and evaluate the effectiveness of using new technologies, including electronic monitors (e-monitors) and a smartphone app, to improve treatment adherence among new pulmonary TB patients in Tibet, China. Methods: This is a prospective, pragmatic, multicentre, individual-randomized trial with blinded evaluation of outcomes and data analysis, and unblinded treatment. New pulmonary TB patients of Shigatse, Tibet will be randomized to either the intervention or control arm in a 1:1 ration at the time of their diagnoses. All patients will be treated according to the WHO standard TB treatment regimens and China National TB program guidelines. In the control arm, patients will receive their medicines in e-monitors that are deactivated for its reminder function but are able to collect medication adherence history. In the intervention arm, patients will take medications in e-monitors that will record their medication adherence and share with health staff via a smartphone app. Patients will be opted to receive video observed treatment when adherence is problematic. The primary outcome is the rate of poor adherence measured per month during their treatment. It will be calculated from monthly-level data for each patient indicating the number of doses missed per month, with poor monthly adherence defined as the patient having missed ≥20% of doses per month. We will conduct a qualitative process evaluation to explore operational questions regarding acceptability, cultural appropriateness and burden of technology use, a cost-effectiveness analysis and long-term effects on TB control. Discussion: Our study is one of the first trials to evaluate the use of e-monitors and smartphone app to improve communications between TB patients and health staff in low-and-middle income countries (LMICs). All intervention activities are designed to be embedded into routine practice of TB care with strong local ownership. Through the trial, we intend to understand the effectiveness of our intervention, as well as its feasibility, cost-effectiveness and long-term impact to inform future scale-up in remote areas of China and LMICs. Trial Registration: Current Controlled Trials ISRCTN52132803, registered on 9 November 2018. Keywords: Tuberculosis, treatment adherence, mhealth, randomised controlled trial, Tibet

scholarly journals Protocol for a randomised controlled trial to evaluate the effectiveness of improving tuberculosis patients’ treatment adherence via electronic monitors and an app versus usual care in Tibet

2019 ◽  
Author(s):  
Xiaolin Wei ◽  
Joseph P Hicks ◽  
Pasang Pande ◽  
Zhitong Zhang ◽  
Victoria Haldane ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
Medication Adherence ◽  
Treatment Adherence ◽  
Outcome Evaluation ◽  
Poor Adherence ◽  
World Health ◽  
Pulmonary Tb ◽  
Tb Control ◽  
Electronic Monitors

Abstract Background: Treatment non-adherence is a serious challenge to effective tuberculosis (TB) control in Tibet. In this study we will pilot and evaluate the effectiveness of using new electronic monitors (e-monitors) and a smartphone app to improve treatment adherence among new pulmonary TB patients in Tibet. Methods: We will use a multicentre, parallel-group, individually-randomized controlled superiority trial with blinded outcome evaluation and unblinded treatment. We will randomise new pulmonary TB outpatients (aged ≥15 years old and free from communication impairment) from Shigatse, Tibet to either the intervention or control arm in a 1:1 ratio at the time of their diagnosis. All patients will be treated according to the World Health Organisation standard 6-month TB treatment regimen and the China National TB programme guidelines. Intervention arm patients will be given their medication via e-monitors that have automatic voice reminders, and record medication adherence data and share it with health staff via cloud connection. Intervention patients will also be encouraged of receiving smartphone-based video observed treatment if their adherence is problematic. Control arm patients will receive their medication in e-monitors that will collect medication adherence history, but will have their reminder function deactivated and are not linked to the app. The primary outcome is the rate of poor adherence, measured monthly during treatment as a binary indicator where poor adherence means missing ≥20% doses in a month. We will conduct a qualitative process evaluation to explore operational questions regarding acceptability, cultural appropriateness and burden of technology use, as well as a cost-effectiveness analysis and an analysis of the long-term effects of the intervention on TB control. Discussion: Our study is one of the first trials to evaluate the use of e-monitors and smartphone apps for customised treatment support in low- and middle-income countries (LMICs). All intervention activities are designed to be embedded into routine TB care with strong local ownership. Through the trial we intend to understand the feasibility of our intervention, its effectiveness, its cost-effectiveness and its long-term impacts to inform future scale-up in remote areas of China and other LMICs. Trial registration: Current Controlled Trials ISRCTN52132803, registered on 9 November 2018.

TeleClinical Care: A randomised controlled trial of a smartphone-based model of care to support cardiac patients transitioning from hospital to the community (Preprint)

2021 ◽  
Author(s):  
Praveen Indraratna ◽  
Uzzal Biswas ◽  
James McVeigh ◽  
Andrew Mamo ◽  
Joseph Magdy ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
Medication Adherence ◽  
Randomised Controlled Trial ◽  
Cardiac Rehabilitation ◽  
Usual Care ◽  
Controlled Trial ◽  
Smartphone App ◽  
Model Of Care ◽  
Intervention Cost ◽  
Randomised Controlled

BACKGROUND This is the first randomised controlled trial (RCT) of a mobile health intervention that combines telemonitoring and educational components for both acute coronary syndrome (ACS) and heart failure (HF) inpatients to prevent readmission. OBJECTIVE Objective: To evaluate the feasibility, efficacy and cost-effectiveness of a smartphone app-based model of care (TeleClinical Care – TCC) plus usual care in patients being discharged from hospital after an ACS or HF admission, in comparison to usual care alone. METHODS Methods: In this pilot, 2-centre RCT, a smartphone app-based model of care (TeleClinical Care – TCC) was applied at discharge. The primary endpoint was the incidence of unplanned 30-day readmissions. Secondary endpoints included all-cause readmissions, cardiac readmissions, cardiac rehabilitation completion, medication adherence, cost-effectiveness and user satisfaction. Intervention arm participants received the app and Bluetooth-enabled devices for measuring weight, blood pressure and physical activity daily, plus usual care. The devices automatically transmitted recordings to the patient’s smartphone and then subsequently to a central server. Abnormal readings were flagged by email to a monitoring team. Control participants received usual care. RESULTS Results: 164 hospital inpatients were randomised at the time of discharge (TCC n=81, control n = 83, mean age 61.5 years, 79% male, 78% admitted with ACS). There were 11 unplanned 30-day readmissions in both groups (P = .97). Over a mean follow-up of 193 days, the intervention was associated with a significant reduction in unplanned hospital readmissions (21 vs. 41 readmissions, P = 0.015), including cardiac readmissions (11 vs. 25, P = .025), and higher rates of cardiac rehabilitation completion (39% vs. 18%, P = .025) and medication adherence (75% vs. 50%, P = .002). The average usability rating of the app was 4.5/5. The intervention cost AUD $6,028 per cardiac readmission saved. When modelled in a mainstream clinical setting, however, enrolment of 237 patients was projected to have the same healthcare expenditure compared to usual care, and enrolment of 500 patients was projected to save approximately AUD $100,000. CONCLUSIONS Conclusion: TCC was feasible and safe for ACS and HF inpatients. The incidence of 30-day readmissions was similar, however long-term benefits were demonstrated including fewer total readmissions over 6 months, improved medication adherence and improved cardiac rehabilitation completion. CLINICALTRIAL The study was registered with the Australia New Zealand Clinical Trials Registry (ACTRN12618001547235).

scholarly journals Cost-effectiveness of an app-based treatment for urinary incontinence in comparison to care as usual in general practice: A pragmatic randomised controlled trial over 12 months

2021 ◽  
Author(s):  
Anne Loohuis ◽  
Henk van der Worp ◽  
Nienke Wessels ◽  
Janny Dekker ◽  
Marijke Slieker-ten Hove ◽  
...  
Keyword(s):  
Primary Care ◽  
Urinary Incontinence ◽  
Cost Effectiveness ◽  
Mobile Apps ◽  
Controlled Trial ◽  
Intention To Treat ◽  
Life Years ◽  
Randomised Controlled

Objective: Long-term cost-effectiveness of app-based treatment for female stress, urgency, or mixed urinary incontinence (UI) compared to care-as-usual in primary care. Design: A pragmatic, randomised controlled, superiority trial. Setting: Primary care in the Netherlands from 2015 to 2018, follow-up at 12 months. Population: Women with ≥2 UI-episodes per week, access to mobile apps, wanting treatment. 262 women randomised equally to app or care-as-usual; 89 (68%) and 83 (63%) attended follow-up. Methods: The standalone app included conservative management for UI with motivation aids (e.g., reminders). Care-as-usual delivered according to the Dutch GP guideline for UI. Main outcome measures: Effectiveness assessed by the change in symptom severity score (ICIQ-UI-SF) and the change in quality of life (ICIQ-LUTS-QoL, EQ-5D-5L) on superiority with linear regression on an intention-to-treat basis. Cost-effectiveness and -utility from a societal perspective, based on Incontinence Impact Adjusted Life Years (IIALYs) and Quality Adjusted Life years (QALYs). Results: Clinically relevant improvement of UI severity for both app (-2.17 ± 2.81) and care-as-usual (-3.43 ± 3.6), with a non-significant mean difference of 0.903 (-0.66 to 1.871). Costs were lower for app-based treatment with \euro-161 (95%CI: -180 to -151) per year. Cost-effectiveness showed small mean differences in effect for IIALY (0.04) and QALY (-0.03) and thus larger ICER (-3,696) and ICUR (\euro6,379). Conclusion: App-based treatment is a viable alternative to care-as-usual for UI in primary care in terms of long-term cost-effectiveness. Funding: Dutch Organisation for Health Research and Development (ZonMw: 837001508), sub-funding P.W. Boer Foundation Dutch Trial Register identifier: Trial NL4948 (www.trialregister.nl/trial/4948).

scholarly journals A feasibility randomised controlled trial of a motivational interviewing-based intervention for weight loss maintenance in adults

2015 ◽  
Vol 19 (50) ◽  
pp. 1-378 ◽  
Author(s):  
Sharon A Simpson ◽  
Rachel McNamara ◽  
Christine Shaw ◽  
Mark Kelson ◽  
Yvonne Moriarty ◽  
...  
Keyword(s):  
Weight Loss ◽  
Cost Effectiveness ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Health Technology ◽  
Face To Face ◽  
Intensive Intervention ◽  
Secondary Outcomes ◽  
Randomised Controlled

BackgroundObesity has significant health and NHS cost implications. Relatively small reductions in weight have clinically important benefits, but long-term weight loss maintenance (WLM) is challenging. Behaviour change interventions have been identified as key for WLM. Motivation is crucial to supporting behaviour change, and motivational interviewing (MI) has been identified as a successful approach to changing health behaviours. The study was designed as an adequately powered, pragmatic randomised controlled trial (RCT); however, owing to recruitment issues, the study became a feasibility trial.ObjectivesTo assess recruitment, retention, feasibility, acceptability, compliance and delivery of a 12-month intervention to support WLM. Secondary objectives were to assess the impact of the intervention on body mass index (BMI) and other secondary outcomes.DesignThree-arm individually randomised controlled trial comprising an intensive arm, a less intensive arm and a control arm.SettingCommunity setting in South Wales and the East Midlands.ParticipantsIndividuals aged 18–70 years with a current or previous BMI of ≥ 30 kg/m2who could provide evidence of at least 5% weight loss during the previous 12 months.InterventionParticipants received individually tailored MI, which included planning and self-monitoring. The intensive arm received six face-to-face sessions followed by nine telephone sessions. The less intensive arm received two face-to-face sessions followed by two telephone sessions. The control arm received a leaflet advising them on healthy lifestyle.Main outcome measuresFeasibility outcomes included numbers recruited, retention and adherence. The primary effectiveness outcome was BMI at 12 months post randomisation. Secondary outcomes included waist circumference, waist-to-hip ratio, physical activity, proportion maintaining weight loss, diet, quality of life, health service resource usage, binge eating and well-being. A process evaluation assessed intervention delivery, adherence, and participants’ and practitioners’ views. Economic analysis aimed to assess cost-effectiveness in terms of quality-adjusted life-years (QALYs).ResultsA total of 170 participants were randomised. Retention was good (84%) and adherence was excellent (intensive, 83%; less intensive, 91%). The between-group difference in mean BMI indicated the intensive arm had BMIs 1.0 kg/m2lower than the controls [95% confidence interval (CI) –2.2 kg/m2to 0.2 kg/m2]. Similarly, a potential difference was found in weight (average difference of 2.8 kg, 95% CI –6.1 kg to 0.5 kg). The intensive arm had odds of maintaining on average 43% [odds ratio(OR) 1.4, 95% CI 0.6 to 3.5] higher than controls. None of these findings were statistically significant. Further analyses controlling for level of adherence indicated that average BMI was 1.2 kg/m2lower in the intensive arm than the control arm (95% CI –2.5 kg/m2to 0.0 kg/m2). The intensive intervention led to a statistically significant difference in weight (mean –3.7 kg, 95% CI –7.1 kg to –0.3 kg). The other secondary outcomes showed limited evidence of differences between groups. The intervention was delivered as planned, and both practitioners and participants were positive about the intervention and its impact. Although not powered to assess cost-effectiveness, results of this feasibility study suggest that neither intervention as currently delivered is likely to be cost-effective in routine practice.ConclusionThis is the first trial of an intervention for WLM in the UK, the intervention is feasible and acceptable, and retention and adherence were high. The main effectiveness outcome showed a promising mean difference in the intensive arm. Owing to the small sample size, we are limited in the conclusions we can draw. However, findings suggest that the intensive intervention may facilitate long-term weight maintenance and, therefore, further testing in an effectiveness trial may be indicated. Research examining WLM is in its infancy, further research is needed to develop our understanding of WLM and to expand theory to inform the development of interventions to be tested in rigorously designed RCTs with cost-effectiveness assessed.Trial registrationCurrent Controlled Trials ISRCTN35774128.FundingThis project was funded by the National Institute for Health Research Health Technology Assessment programme and will be published in full inHealth Technology Assessment; Vol. 19, No. 50. See the NIHR Journals Library website for further project information.

scholarly journals Evaluating the effects of an exercise program (Staying UpRight) for older adults in long-term care on rates of falls: study protocol for a randomised controlled trial

Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Lynne Taylor ◽  
John Parsons ◽  
Denise Taylor ◽  
Elizabeth Binns ◽  
Sue Lord ◽  
...  
Keyword(s):  
Older Adults ◽  
Cost Effectiveness ◽  
Randomised Controlled Trial ◽  
Long Term Care ◽  
Controlled Trial ◽  
Exercise Program ◽  
Control Group ◽  
Term Care ◽  
Randomised Controlled

Abstract Background Falls are two to four times more frequent amongst older adults living in long-term care (LTC) than community-dwelling older adults and have deleterious consequences. It is hypothesised that a progressive exercise program targeting balance and strength will reduce fall rates when compared to a seated exercise program and do so cost effectively. Methods/design This is a single blind, parallel-group, randomised controlled trial with blinded assessment of outcome and intention-to-treat analysis. LTC residents (age ≥ 65 years) will be recruited from LTC facilities in New Zealand. Participants (n = 528 total, with a 1:1 allocation ratio) will be randomly assigned to either a novel exercise program (Staying UpRight), comprising strength and balance exercises designed specifically for LTC and acceptable to people with dementia (intervention group), or a seated exercise program (control group). The intervention and control group classes will be delivered for 1 h twice weekly over 1 year. The primary outcome is rate of falls (per 1000 person years) within the intervention period. Secondary outcomes will be risk of falling (the proportion of fallers per group), fall rate relative to activity exposure, hospitalisation for fall-related injury, change in gait variability, volume and patterns of ambulatory activity and change in physical performance assessed at baseline and after 6 and 12 months. Cost-effectiveness will be examined using intervention and health service costs. The trial commenced recruitment on 30 November 2018. Discussion This study evaluates the efficacy and cost-effectiveness of a progressive strength and balance exercise program for aged care residents to reduce falls. The outcomes will aid development of evidenced-based exercise programmes for this vulnerable population. Trial registration Australian New Zealand Clinical Trials Registry ACTRN12618001827224. Registered on 9 November 2018. Universal trial number U1111-1217-7148.

Sign in / Sign up

Export Citation Format

Share Document