Dataset Information

Impact of a Daily SMS Medication Reminder System on Tuberculosis Treatment Outcomes: A Randomized Controlled Trial.

ABSTRACT:

Importance

The rapid uptake of mobile phones in low and middle-income countries over the past decade has provided public health programs unprecedented access to patients. While programs have used text messages to improve medication adherence, there have been no high-powered trials evaluating their impact on tuberculosis treatment outcomes.

Objective

To measure the impact of Zindagi SMS, a two-way SMS reminder system, on treatment success of people with drug-sensitive tuberculosis.

Design

We conducted a two-arm, parallel design, effectiveness randomized controlled trial in Karachi, Pakistan. Individual participants were randomized to either Zindagi SMS or the control group. Zindagi SMS sent daily SMS reminders to participants and asked them to respond through SMS or missed (unbilled) calls after taking their medication. Non-respondents were sent up to three reminders a day.

Setting

Public and private sector tuberculosis clinics in Karachi, Pakistan.

Participants

Newly-diagnosed patients with smear or bacteriologically positive pulmonary tuberculosis who were on treatment for less than two weeks; 15 years of age or older; reported having access to a mobile phone; and intended to live in Karachi throughout treatment were eligible to participate. We enrolled 2,207 participants, with 1,110 randomized to Zindagi SMS and 1,097 to the control group.

Main outcome

The primary outcome was clinically recorded treatment success based upon intention-to-treat.

Results

We found no significant difference between the Zindagi SMS or control groups for treatment success (719 or 83% vs. 903 or 83%, respectively, p = 0·782). There was no significant program effect on self-reported medication adherence reported during unannounced visits during treatment.

Conclusion

In this large-scale randomized controlled effectiveness trial of SMS medication reminders for tuberculosis treatment, we found no significant impact.

Trial registration

The trial was registered with ClinicalTrials.gov, NCT01690754.

SUBMITTER: Mohammed S

PROVIDER: S-EPMC5089745 | biostudies-literature | 2016

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Impact of a Daily SMS Medication Reminder System on Tuberculosis Treatment Outcomes: A Randomized Controlled Trial.

Mohammed Shama S Glennerster Rachel R Khan Aamir J AJ

PloS one 20161101 11

<h4>Importance</h4>The rapid uptake of mobile phones in low and middle-income countries over the past decade has provided public health programs unprecedented access to patients. While programs have used text messages to improve medication adherence, there have been no high-powered trials evaluating their impact on tuberculosis treatment outcomes.<h4>Objective</h4>To measure the impact of Zindagi SMS, a two-way SMS reminder system, on treatment success of people with drug-sensitive tuberculosis. ...[more]

PMID: 27802283

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Project description:We conducted a pilot randomized controlled trial among patients initiating treatment for drug-sensitive tuberculosis (TB). Participants received real-time electronic adherence monitors and were randomized (1:1:1) to: (i) daily SMS (reminders to TB patients and notifications to social supporters sent daily for 3 months, then triggered by late or missed dosing for 3 months); (ii) weekly SMS (reminders to TB patients and notifications to social supporters sent weekly for 3 months, then triggered by late or missed dosing for 3 months); or (iii) control (no SMS). Feasibility was mainly verified by the technical function of the intervention at Month 6. The primary outcome was percent adherence as ascertained by the real time monitor. Quantitative feasibility/acceptability data were summarized descriptively. Percentage adherence and adherence patterns were assessed and compared by linear regression models. Qualitative acceptability data was collected through interviews and analyzed using content analysis. Among 63 participants, the median age was 35 years, 75% had no regular income, and 84% were living with HIV. Feasibility was demonstrated as most of the daily [1913/2395 (80%)] and weekly [631/872 (72%)] SMS reminders to TB patients were sent successfully. Also, most of the daily [1577/2395 (66%)] and weekly [740/872 (85%)] SMS notifications to social supporters and adherence data (96%) were sent successfully. Challenges included TB status disclosure, and financial constraints. All patients perceived the intervention to be useful in reminding and motivating them to take medication. Median adherence (IQR) in the daily SMS, weekly SMS, and control arms was 96.1% (84.8, 98.0), 92.5% (80.6, 96.3), and 92.2% (56.3, 97.8), respectively; however, differences between the intervention and control arms were not statistically significant. Real-time monitoring linked to SMS was feasible and acceptable and may have improved TB medication adherence. Larger studies are needed to further assess impact on adherence and clinical outcomes. Trial registration. ClinicalTrials.gov registration number: NCT03800888. https://ichgcp.net/clinical-trials-registry/NCT03800888.

Project description:BACKGROUND:According to WHO stroke is a growing societal challenge and the third leading cause of global disease-burden estimated using disability-adjusted life years. Rehabilitation after stroke is an area of mutual interest for health care in many countries. Within the health care sector there is a growing emphasis on ICT services to provide clients with easier access to information, self-evaluation, and self-management. ICT-supported care programs possible to use in clients' home environments are also recommended when there are long distances to the health care specialists. The aim of this study was to evaluate the technical usability of a SMS-based reminder system as well as user opinions when using such a system to assist clients to remember to perform daily rehabilitation activities, to rate their performance and to allow Occupational therapists (OT's) to track and follow-up clients' results over time. METHODS:Fifteen persons with stroke were invited to participate in the study and volunteered to receive daily SMS-based reminders regarding three activities to perform on a daily basis as well as answer daily SMS-based questions about their success rate during eight weeks. Clients, a number of family members, as well as OTs were interviewed to evaluate their opinions of using the reminder system. RESULTS:All clients were positive to the reminder system and felt that it helped them to regain their abilities. Their OTs agreed that the reminder and follow-up system was of benefit in the rehabilitation process. However, some technical and other issues were limiting the use of the system for some clients. The issues were mostly linked to the fact that the SMS system was based on a Swedish phone number, so that all messages needed to be sent internationally. CONCLUSION:In conclusion, it seems that this type of SMS-based reminder systems could be of good use in the rehabilitation process after stroke, even in low income counties where few clients have access to Internet or smart phones, and where access to healthcare services is limited. However, since the results are based on clients', OTs' and family members' expressed beliefs, we suggest that future research objectively investigate the intervention's beneficial effects on the clients' physical and cognitive health.

Project description:BackgroundClinic attendance, metabolic control, engagement in self-management, and psychological health are suboptimal in young-onset (age of onset <40 years) type 2 diabetes.ObjectiveWe examined the effectiveness of an enhanced SMS text message-based support and reminder program in improving clinic attendance, metabolic control, engagement in self-management, and psychological health in young-onset type 2 diabetes.MethodsA 12-month, parallel-arm, randomized controlled trial comparing an enhanced, semipersonalized SMS text message-based intervention (incorporating 1-8 supportive and/or informative text messages per month) against standard care was conducted in a specialized clinic for young adult type 2 diabetes. The primary outcome was maintenance of 100% attendance at scheduled quarterly clinical appointments. Secondary outcomes included (1) metabolic indices, (2) pathology and self-monitored blood glucose (SMBG) data availability, and (3) psychosocial well-being.ResultsA total of 40 participants were randomized, and 32 completed their 12-month study visit. The average participant age was 32.7 (SD 5.1) years, 50% (20/40) were male, and baseline glycated hemoglobin A1c (HbA1c) was 7.3% (SD 1.9%) (56 mmol/mol, SD 20). A higher proportion of the intervention group achieved 100% attendance (12/21, 57%, vs 5/19, 26%, for the control group); Kaplan-Meier analysis demonstrated significantly greater cumulative attendance in the intervention group (P=.04). There were no between-group differences in HbA1c, BMI, lipids, or availability of pathology and SMBG data. Odds of recording an improvement in the Diabetes Empowerment Scale-Short Form score were higher in the intervention group at 6 months (odds ratio [OR] 4.3, 95% CI 1.1-17), with attenuation of this effect at study end (OR 3.1, 95% CI 0.9-11). Program acceptability was high; >90% of participants would recommend the program to new patients.ConclusionsAn enhanced SMS text message-based support and reminder program doubled scheduled clinic attendance rates for patients with young-onset type 2 diabetes. The program was highly acceptable and provided early support for patient empowerment but had no significant effect on measures of metabolic control or self-management.Trial registrationAustralian and New Zealand Clinical Trials Registry (ACTRN12618000479202); https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=373579.

Project description:BackgroundDespite a variety of efficient and cost-effective antihypertensive medication, hypertension remains a serious health and economic burden. High consumption of cardiovascular drugs in the Slovak Republic does result neither in better hypertension control nor in significant decrease in cardiovascular mortality. At the same time, Slovakia has alarmingly low patients' adherence to medication intake. Studies have shown the efficiency of short messaging service (SMS) reminders to improve patients' adherence and health outcomes at low costs. Since SMS is popular among Slovaks, this approach may be feasible also in Slovakia. The primary objective is to assess if daily SMS reminders of antihypertensive medication intake provided by pharmacists in addition to the standard pharmaceutical care increase the proportion of adherent older hypertensive ambulatory patients.MethodsThe SPPA trial is a pragmatic randomized parallel group (1:1) trial in 300 older hypertensive patients carried out in community pharmacies in Slovakia. Trial pharmacies will be selected from all main regions of Slovakia. Trial intervention comprises daily personalized SMS reminders of medication intake embedded into usual pharmaceutical practice. The primary outcome is a combined adherence endpoint consisting of subjective self-reported medication adherence via the eight-item Morisky Medication Adherence Scale (MMAS-8) and objective pill count rate. Secondary outcomes include: change in the MMAS-8; comparison of adherence rates using pill count; change in systolic blood pressure; and patient satisfaction. Also, direct treatment costs will be evaluated and a cost-effectiveness analysis will be carried out.DiscussionThe SPPA trial engages community pharmacists and mobile health (mHealth) technologies via evidence-based pharmaceutical care to efficiently and cost-effectively addresses current main healthcare challenges: high prevalence of hypertension; overconsumption of cardiovascular medicines; low adherence to medication treatment; and resulting uncontrolled blood pressure. The results may identify new possibilities and capacities in healthcare with low additional costs and high value to patients.Trial registrationClinicalTrials.gov, NCT03105687 . Registered on 07 March 2017.

Project description:BackgroundMedication nonadherence is a global public health challenge that results in suboptimal health outcomes and increases health care costs. Forgetting to take medicines is one of the most common reasons for unintentional medication nonadherence. Research findings indicate that voice-activated virtual home assistants, such as Amazon Echo and Google Home devices, may be useful in promoting medication adherence.ObjectiveThis study aims to create a medication adherence app (skill), MedBuddy, for Amazon Echo devices and measure the use, usability, and usefulness of this medication-taking reminder skill.MethodsA single-group, mixed methods, cohort feasibility study was conducted with women who took oral contraceptives (N=25). Participants were undergraduate students (age: mean 21.8 years, SD 6.2) at an urban university in the Southeast United States. Participants were given an Amazon Echo Dot with MedBuddy-a new medication reminder skill for Echo devices created by our team-attached to their study account, which they used for 60 days. Participants self-reported their baseline and poststudy medication adherence. MedBuddy use was objectively evaluated by tracking participants' interactions with MedBuddy through Amazon Alexa. The usability and usefulness of MedBuddy were evaluated through a poststudy interview in which participants responded to both quantitative and qualitative questions.ResultsParticipants' interactions with MedBuddy, as tracked through Amazon Alexa, only occurred on half of the study days (mean 50.97, SD 29.5). At study end, participants reported missing their medication less in the past 1 and 6 months compared with baseline (χ21=0.9 and χ21=0.4, respectively; McNemar test: P<.001 for both). However, there was no significant difference in participants' reported adherence to consistently taking medication within the same 2-hour time frame every day in the past 1 or 6 months at the end of the study compared with baseline (χ21=3.5 and χ21=0.4, respectively; McNemar test: P=.63 and P=.07, respectively). Overall feedback about usability was positive, and participants provided constructive feedback about the skill's features that could be improved. Participants' evaluation of MedBuddy's usefulness was overwhelmingly positive-most (15/23, 65%) said that they would continue using MedBuddy as a medication reminder if provided with the opportunity and that they would recommend it to others. MedBuddy features that participants enjoyed were an external prompt separate from their phone, the ability to hear the reminder prompt from a separate room, multiple reminders, and verbal responses to prompts.ConclusionsThe findings of this feasibility study indicate that the MedBuddy medication reminder skill may be useful in promoting medication adherence. However, the skill could benefit from further usability enhancements.

Project description:ImportanceForgetfulness is a major contributor to nonadherence to chronic disease medications and could be addressed with medication reminder devices.ObjectiveTo compare the effect of 3 low-cost reminder devices on medication adherence.Design, setting, and participantsThis 4-arm, block-randomized clinical trial involved 53 480 enrollees of CVS Caremark, a pharmacy benefit manager, across the United States. Eligible participants were aged 18 to 64 years and taking 1 to 3 oral medications for long-term use. Participants had to be suboptimally adherent to all of their prescribed therapies (with a medication possession ratio of 30% to 80%) in the 12 months before randomization. Participants were stratified on the basis of the medications they were using at randomization: medications for cardiovascular or other nondepression chronic conditions (the chronic disease stratum) and antidepressants (the antidepressant stratum). In each stratum, randomization occurred within blocks defined by whether all of the patient's targeted medications were dosed once daily. Patients were randomized to receive in the mail a pill bottle strip with toggles, digital timer cap, or standard pillbox. The control group received neither notification nor a device. Data were collected from February 12, 2013, through March 21, 2015, and data analyses were on the intention-to-treat population.Main outcomes and measuresThe primary outcome was optimal adherence (medication possession ratio ≥80%) to all eligible medications among patients in the chronic disease stratum during 12 months of follow-up, ascertained using pharmacy claims data. Secondary outcomes included optimal adherence to cardiovascular medications among patients in the chronic disease stratum as well as optimal adherence to antidepressants.ResultsOf the 53 480 participants, mean (SD) age was 45 (12) years and 56% were female. In the primary analysis, 15.5% of patients in the chronic disease stratum assigned to the standard pillbox, 15.1% assigned to the digital timer cap, 16.3% assigned to the pill bottle strip with toggles, and 15.1% assigned to the control arm were optimally adherent to their prescribed treatments during follow-up. There was no statistically significant difference in the odds of optimal adherence between the control and any of the devices (standard pillbox: odds ratio [OR], 1.03 [95% CI, 0.95-1.13]; digital timer cap: OR, 1.00 [95% CI, 0.92-1.09]; and pill bottle strip with toggles: OR, 0.94 [95% CI, 0.85-1.04]). In direct comparisons, the odds of optimal adherence were higher with a standard pillbox than with the pill bottle strip (OR, 1.10 [95% CI, 1.00-1.21]). Secondary analyses yielded similar results.Conclusions and relevanceLow-cost reminder devices did not improve adherence among nonadherent patients who were taking up to 3 medications to treat common chronic conditions. The devices may have been more effective if coupled with interventions to ensure consistent use or if targeted to individuals with an even higher risk of nonadherence.Trial registrationclinicaltrials.gov Identifier: NCT02015806.

Project description:BackgroundMedication adherence refers to whether a patient takes medication according to the frequency prescribed, or continues to take a prescribed medication. Inadequate adherence to medication may cause alterations in risk-benefit ratios, resulting in reduced benefits, increased risks or both, and is significantly associated with adverse clinical outcomes and higher healthcare costs. We aim to examine the effect of a computer generated short message service (SMS) reminder in improving medication adherence, and inhibiting the aromatisation process amongst breast cancer women receiving oral aromatase inhibitor therapy.Methods/designIn this randomised controlled trial, eligible patients will be equally allocated to receive either SMS reminder or standard care. The former receives weekly SMS reminder to take medication while the latter does not receive any. The primary endpoint of medication adherence at 1-year is assessed using the Simplified Medication Adherence Questionnaire, and compared using the χ2 test. Adjustment for baseline covariate and potential confounders will be made using the logistic regression. Secondary outcomes involving estrone and androstenedione levels will be compared using the analysis of covariance, whereas the estradiol levels (< 18.4 pmol/L versus ≥18.4 pmol/L) will be compared using the χ2 test, and the logistic regression. Further, the assessment of knowledge, attitude, behaviour, and barriers and facilitating factors of medication adherence will be made via logistic regression.DiscussionThis will be the first study to evaluate short-term clinical outcomes from SMS reminder for breast cancer patients on aromatase inhibitor therapy. Random allocation to SMS reminder or control arm ensures that patients in both arms will be comparable with respect to demographic and clinical characteristics, and any difference in outcomes can be attributed to the intervention. Participants are not blinded to the assignment of intervention, thus there may be potential for bias in outcome assessments.Trial registrationNCT02524548 . Retrospectively registered on 17 August 2015.

Project description: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.

Dataset Information

Impact of a Daily SMS Medication Reminder System on Tuberculosis Treatment Outcomes: A Randomized Controlled Trial.

Importance

Objective

Design

Setting

Participants

Main outcome

Results

Conclusion

Trial registration

Publications

Impact of a Daily SMS Medication Reminder System on Tuberculosis Treatment Outcomes: A Randomized Controlled Trial.

Similar Datasets

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