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SMS reminders to improve adherence and cure of tuberculosis patients in Cameroon (TB-SMS Cameroon): a randomised controlled trial.

ABSTRACT: In Cameroon, the National Tuberculosis Control Program that applies selective directly observed treatments faces difficulties in its implementation for a lack of resources, leading to only 65% of patients with sputum smear-positive pulmonary tuberculosis being cured after 6 months of treatment. This study aimed to evaluate the effectiveness of daily Short Message Service reminders to increase adherence and the proportion of adult tuberculosis patients cured after 6 months of treatment.A simple blinded, randomised controlled, multicentre study carried out in 12 Treatment and Diagnostic Centres of Yaoundé. The patients included were randomly assigned to two groups: patients in the intervention group received daily SMS reminders in addition to the usual treatment; those in the control group received the usual treatment only. The primary outcomes were the number and proportion of treatment success at 5 months, and the number and proportion of patients cured at 6 months. Data analysis was by intention to treat.Two hundred and seventy-nine participants were randomized into intervention group (n?=?137) and control group (n?=?142). At five months, there were 111 treatment success (81%) in the intervention group and 106 (74.6%) in the control group (OR?=?1.45 [0.81, 2.56]; p?=?0.203). At 6 months, there were 87 patients cured (63.5%) in the intervention group and 88 (62%) in the control group (OR?=?1.06 [0.65, 1.73]; p?=?0.791). The number of drop-outs at 6 months was 47 (34.3%) in intervention group, and 46 (32.4%) in the control group. 48.9% (23/47) and 39.1% (18/46) of these drop-outs were sputum-negative at 5 months. At three different appointments, there were no significant differences between the two groups in any secondary outcomes. Very high and similar satisfaction was found for general management of patients in both groups: 99.5 and 99.2% (p?=?0.41).Our study suggests that SMS reminders do not increase treatment success and cure proportions. However, the low proportion of patients cured at 6 month may be an underestimation due to a high dropout rate between the fifth and the sixth months of treatment. Future trials should focus on reducing the dropout rate.The trial was registered on the Pan-African Clinical Trials Registry ( PACTR201307000583416 of 22 July 2013) and the protocol was published.

SUBMITTER: Bediang G

PROVIDER: S-EPMC5932834 | biostudies-other | 2018 May

REPOSITORIES: biostudies-other

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SMS reminders to improve adherence and cure of tuberculosis patients in Cameroon (TB-SMS Cameroon): a randomised controlled trial.

Bediang Georges G Stoll Beat B Elia Nadia N Abena Jean-Louis JL Geissbuhler Antoine A

BMC public health 20180502 1

<h4>Background</h4>In Cameroon, the National Tuberculosis Control Program that applies selective directly observed treatments faces difficulties in its implementation for a lack of resources, leading to only 65% of patients with sputum smear-positive pulmonary tuberculosis being cured after 6 months of treatment. This study aimed to evaluate the effectiveness of daily Short Message Service reminders to increase adherence and the proportion of adult tuberculosis patients cured after 6 months of t ...[more]

PMID: 29720146

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Project description:Mobile text messaging and medication monitors (medication monitor boxes) have the potential to improve adherence to tuberculosis (TB) treatment and reduce the need for directly observed treatment (DOT), but to our knowledge they have not been properly evaluated in TB patients. We assessed the effectiveness of text messaging and medication monitors to improve medication adherence in TB patients.In a pragmatic cluster-randomised trial, 36 districts/counties (each with at least 300 active pulmonary TB patients registered in 2009) within the provinces of Heilongjiang, Jiangsu, Hunan, and Chongqing, China, were randomised using stratification and restriction to one of four case-management approaches in which patients received reminders via text messages, a medication monitor, combined, or neither (control). Patients in the intervention arms received reminders to take their drugs and reminders for monthly follow-up visits, and the managing doctor was recommended to switch patients with adherence problems to more intensive management or DOT. In all arms, patients took medications out of a medication monitor box, which recorded when the box was opened, but the box gave reminders only in the medication monitor and combined arms. Patients were followed up for 6 mo. The primary endpoint was the percentage of patient-months on TB treatment where at least 20% of doses were missed as measured by pill count and failure to open the medication monitor box. Secondary endpoints included additional adherence and standard treatment outcome measures. Interventions were not masked to study staff and patients. From 1 June 2011 to 7 March 2012, 4,292 new pulmonary TB patients were enrolled across the 36 clusters. A total of 119 patients (by arm: 33 control, 33 text messaging, 23 medication monitor, 30 combined) withdrew from the study in the first month because they were reassessed as not having TB by their managing doctor (61 patients) or were switched to a different treatment model because of hospitalisation or travel (58 patients), leaving 4,173 TB patients (by arm: 1,104 control, 1,008 text messaging, 997 medication monitor, 1,064 combined). The cluster geometric mean of the percentage of patient-months on TB treatment where at least 20% of doses were missed was 29.9% in the control arm; in comparison, this percentage was 27.3% in the text messaging arm (adjusted mean ratio [aMR] 0.94, 95% CI 0.71, 1.24), 17.0% in the medication monitor arm (aMR 0.58, 95% CI 0.42, 0.79), and 13.9% in the combined arm (aMR 0.49, 95% CI 0.27, 0.88). Patient loss to follow-up was lower in the text messaging arm than the control arm (aMR 0.42, 95% CI 0.18-0.98). Equipment malfunction or operation error was reported in all study arms. Analyses separating patients with and without medication monitor problems did not change the results. Initiation of intensive management was underutilised.This study is the first to our knowledge to utilise a randomised trial design to demonstrate the effectiveness of a medication monitor to improve medication adherence in TB patients. Reminders from medication monitors improved medication adherence in TB patients, but text messaging reminders did not. In a setting such as China where universal use of DOT is not feasible, innovative approaches to support patients in adhering to TB treatment, such as this, are needed.Current Controlled Trials, ISRCTN46846388.

Project description:BACKGROUND:Literature on persuasion suggests compliance increases when requests are accompanied with a reason (i.e. the "because-heuristic"). The reliability of outcomes in physical activity research is dependent on sufficient accelerometer wear-time. This study tested whether SMS reminders-especially those that provided a rationale-are associated with increased accelerometer wear-time. METHODS:We conducted a within-trial partially randomised controlled trial during baseline data collection in a school-based physical activity intervention trial. Of 375 participants (mean age?=?18.1), 280 (75%) opted to receive daily SMS reminders to wear their accelerometers. These 280 participants were then randomised to receive either succinct reminders or reminders including a rationale. Data was analyzed across groups using both frequentist and Bayesian methods. RESULTS:No differences in total accelerometer wear minutes were detected between the succinct reminder group (Mdn?=?4909, IQR?=?3429-5857) and the rationale group (Mdn?=?4808, IQR?=?3571-5743); W?=?8860, p?=?0.65, CI95?=?-?280.90-447.20. Similarly, we found no differences in wear time between participants receiving SMS reminders (Mdn?=?4859, IQR?=?3527-5808) and those not receiving them (Mdn?=?5067, IQR?=?3201-5885); W?=?10,642.5, p?=?0.77, CI95?=?-?424.20-305.30. Bayesian ANOVA favored a model of equal weartime means, over one of unequal means, by a Bayes Factor of 12.05. Accumulated days of valid accelerometer wear data did not differ either. Equivalence testing indicated rejection of effects more extreme than a Cohen's d (standardised mean difference) of ±~0.3. CONCLUSIONS:This study casts doubt on the effectiveness of using the because-heuristic via SMS messaging, to promote accelerometer wear time among youth. The because-heuristic might be limited to face-to-face communication and situations where no intention for or commitment to the behavior has yet been made. Other explanations for null effects include non-reading of messages, and reminder messages undermining the self-reminding strategies which would occur naturally in the absence of reminders. TRIAL REGISTRATION:DRKS DRKS00007721 . Registered 14.04.2015. Retrospectively registered.

Project description:Summary Background Drug-sensitive tuberculosis treatment requires 6 months of therapy, so adherence problems are common. Digital adherence technologies might improve tuberculosis treatment outcomes. We aimed to evaluate the effect of a daily reminder medication monitor, monthly review of adherence data by the health-care provider, and differentiated care for patients with adherence issues, on tuberculosis treatment adherence and outcomes. Methods We did a cluster-randomised superiority trial across four prefectures in China. 24 counties or districts (clusters) were randomly assigned (1:1) to intervention or control groups. We enrolled patients aged 18 years or older with GeneXpert-positive, rifampicin-sensitive pulmonary tuberculosis, who were receiving daily fixed-dose combination treatment. Patients in the intervention group received a medication monitor for daily drug-dosing reminders, monthly review of adherence data by health-care provider, and management of poor adherence; and patients in the control group received routine care (silent-mode monitor-measured adherence). Only the independent endpoints review committee who assessed endpoint data for some participants were masked to study group assignment. Patients were followed up (with sputum solid culture) at 12 and 18 months. The primary outcome was a composite of death, loss to follow-up, treatment failure, switch to multidrug-resistant tuberculosis treatment, or tuberculosis recurrence by 18 months from treatment start, analysed in the intention-to-treat population. Analysis accounted for study design with multiple imputation for the primary outcome. This trial is now complete and is registered with ISRCTN, 35812455. Findings Between Jan 26, 2017, and April 3, 2019, 15 257 patients were assessed for eligibility and 3074 were enrolled, 2686 (87%) of whom were included in the intention-to-treat population. 1909 (71%) of 2686 patients were male, 777 (29%) were female, and the median age was 44 years (IQR 29–58). By 18 months from treatment start, using multiple imputation for missing outcomes, 239 (16% [geometric mean of cluster-level proportion]) of 1388 patients in the control group and 224 (16%) of 1298 in the intervention group had a primary composite outcome event (289 [62%] of 463 events were loss to follow-up during treatment and 42 [9%] were tuberculosis recurrence). The intervention had no effect on risk of the primary composite outcome (adjusted risk ratio 1·01, 95% CI 0·73–1·40). Interpretation Our digital medication monitor intervention had no effect on unfavourable outcomes, which included loss to follow-up during treatment, tuberculosis recurrence, death, and treatment failure. There was a failure to change patient management following identification of treatment non-adherence at monthly reviews. A better understanding of adherence patterns and how they relate to poor outcomes, coupled with a more timely review of adherence data and improved implementation of differentiated care, may be required. Funding Bill & Melinda Gates Foundation.

Project description:Interventions to support people with hypertension in attending clinics and taking their medication have potential to improve outcomes, but delivery on a wide scale and at low cost is challenging. Some trials evaluating clinical interventions using short message service (SMS) text-messaging systems have shown important outcomes, although evidence is limited. We have developed a novel SMS system integrated with clinical care for use by people with hypertension in a low-resource setting. We aim to test the efficacy of the system in improving blood pressure control and treatment adherence compared to usual care.The SMS Text-message Adherence suppoRt trial (StAR) is a pragmatic individually randomised three-arm parallel group trial in adults treated for hypertension at a single primary care centre in Cape Town, South Africa. The intervention is a structured programme of clinic appointment, medication pick-up reminders, medication adherence support and hypertension-related education delivered remotely using an automated system with either informational or interactive SMS text-messages. Usual care is supplemented by infrequent non-hypertension related SMS text-messages. Participants are 1:1:1 individually randomised, to usual care or to one of the two active interventions using minimisation to dynamically adjust for gender, age, baseline systolic blood pressure, years with hypertension, and previous clinic attendance. The primary outcome is the change in mean systolic blood pressure at 12-month follow-up from baseline measured with research staff blinded to trial allocation. Secondary outcomes include the proportion of patients with 80% or more of days medication available, proportion of participants achieving a systolic blood pressure less than 140 mmHg and a diastolic blood pressure less than 90 mmHg, hospital admissions, health status, retention in clinical care, satisfaction with treatment and care, and patient related quality of life. Anonymised demographic data are collected on non-participants.The StAR trial uses a novel, low cost system based on widely available mobile phone technology to deliver the SMS-based intervention, manage communication with patients, and measure clinically relevant outcomes. The results will inform implementation and wider use of mobile phone based interventions for health care delivery in a low-resource setting.NCT02019823.

Dataset Information

SMS reminders to improve adherence and cure of tuberculosis patients in Cameroon (TB-SMS Cameroon): a randomised controlled trial.

Publications

SMS reminders to improve adherence and cure of tuberculosis patients in Cameroon (TB-SMS Cameroon): a randomised controlled trial.

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