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Improving medication adherence with adjuvant aromatase inhibitor in women with breast cancer: study protocol of a randomised controlled trial to evaluate the effect of short message service (SMS) reminder.

ABSTRACT: BACKGROUND:Medication 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/DESIGN:In 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 ?2 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 (

SUBMITTER: He Y

PROVIDER: S-EPMC6038248 | biostudies-literature | 2018 Jul

REPOSITORIES: biostudies-literature

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Improving medication adherence with adjuvant aromatase inhibitor in women with breast cancer: study protocol of a randomised controlled trial to evaluate the effect of short message service (SMS) reminder.

He Yunxin Y Tan Eng Hooi EH Wong Andrea Li Ann ALA Tan Chuan Chien CC Wong Patrick P Lee Soo Chin SC Tai Bee Choo BC

BMC cancer 20180709 1

<h4>Background</h4>Medication 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 improvin ...[more]

PMID: 29986672

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Project description:ImportanceThe 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.ObjectiveTo measure the impact of Zindagi SMS, a two-way SMS reminder system, on treatment success of people with drug-sensitive tuberculosis.DesignWe 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.SettingPublic and private sector tuberculosis clinics in Karachi, Pakistan.ParticipantsNewly-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 outcomeThe primary outcome was clinically recorded treatment success based upon intention-to-treat.ResultsWe 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.ConclusionIn this large-scale randomized controlled effectiveness trial of SMS medication reminders for tuberculosis treatment, we found no significant impact.Trial registrationThe trial was registered with ClinicalTrials.gov, NCT01690754.

Project description:BackgroundThere has been extensive research across the globe to understand the barriers and facilitators of cervical cancer (CC) screening. However, few studies have focused on how such information has been used to develop text messages for mHealth screening programs, especially in resource-poor countries. This study elicited information on barriers and facilitators, the preferences of women regarding the modalities for delivery of health SMS messages on screening for cervical cancer, and demonstrates how this information was used to create a health screening program among women in the Greater Accra Region of Ghana.MethodsFour main activities were carried out, including (1) a total of five focus group discussions, (2) a baseline survey involving 62 female bankers and 68 women from the communities, (3) a stakeholder meeting involving experts in cervical cancer research and clinical care, and (4) pilot testing of the text messages. Focus group discussions and the baseline survey data were collected concurrently between February and May 2017 and the results were used to develop 5 specific communication objectives during the stakeholder engagements held in June 2017.ResultsIn all, 32 text messages were developed and pretested in July 2017(13 addressed knowledge on CC; 6 highlighted the importance of early detection; 5 allayed fear as a barrier to CC screening; 5 encouraged women to have time for their health, and 3 messages contained information on where to go for screening and the cost involved). Although awareness about the disease was high, knowledge of CC screening was low. For two-thirds of respondents (22/33), perceived lack of time, high cost, and fear (of cc, screening procedure, and potential for negative outcome) accounted for the reasons why respondents will not go for screening, while education on CC, especially from health workers and the mass media enabled uptake of CC screening.ConclusionSeveral factors prevent women from accessing screening services for CC, however, barriers such as low levels of education on CC, lack of time, and fear can be targeted in SMS messaging programs.

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:BackgroundDespite the extensive implementation of control measures and achievements in morbidity reductions, malaria continues to contribute to substantial morbidity and mortality in children under-five. Innovative approaches involving the use of mobile phones have been suggested to improve health outcomes. However, evidence of its effect on reducing the prevalence of malaria is limited. This study, therefore, aimed to assess the effect of a theory-driven mHealth intervention on the prevalence of malaria among children under-five living in rural districts of Ghana.MethodsWe conducted a quasi-experimental study of a 12-month intervention using a random sample of 332 caregivers with children under-five from two rural districts, assigned to either an intervention or a control group. Caregivers in the intervention group received voice short message service (SMS) on malaria prevention based on a behavior change theory to improve their health behaviors and practice, once a week for twelve months, while caregivers in the control group received none. Pre- and post-intervention assessment of the treatment effect (ATT) on malaria in children under-five was conducted using propensity score and difference-in-difference (DiD) analyses.ResultsAmong children whose caregivers received the intervention, the prevalence of malaria decreased from 58.4% at baseline to 37.8% at endline (difference: -20.6%; 95% CI: - 31.1, - 10.1) compared with children in the control group, where a reduction of 65.0 to 59.9% (difference - 5.1%; 95% CI: - 15.5, 5.4) was observed. The treatment effect at endline revealed a statistically significant reduction in malaria prevalence (ATT: -0.214; 95% CI: - 0.36, - 0.07) compared with the baseline (ATT: -0.035; 95% CI: - 0.16, 0.09). Overall, the intervention effect showed a significant reduction in the prevalence of malaria among children under-five was positive (DiD: - 0.154; p = 0.043).ConclusionThe results of the study indicate the effectiveness of mobile phone SMS as a control tool for reducing the burden of malaria in children under-five.

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:The effectiveness of mobile technology to improve medication adherence via customized Short Messaging Service (SMS) reminders for stroke has not been tested in resource poor areas. We designed a randomized controlled trial to test the effectiveness of SMS on improving medication adherence in stroke survivors in Pakistan.This was a parallel group, assessor-blinded, randomized, controlled, superiority trial. Participants were centrally randomized in fixed block sizes. Adult participants on multiple medications with access to a cell phone and stroke at least 4 weeks from onset (Onset as defined by last seen normal) were eligible. The intervention group, in addition to usual care, received reminder SMS for 2 months that contained a) Personalized, prescription tailored daily medication reminder(s) b) Twice weekly health information SMS. The Health Belief Model and Social Cognitive theory were used to design the language and content of messages. Frontline SMS software was used for SMS delivery. Medication adherence was self-reported and measured on the validated Urdu version of Morisky Medication Adherence Questionnaire. Multiple linear regression was used to model the outcome against intervention and other covariates. Analysis was conducted by intention-to-treat principle.Two hundred participants were enrolled. 38 participants were lost to follow-up. After 2 months, the mean medication score was 7.4 (95 % CI: 7.2-7.6) in the intervention group while 6.7 (95 % CI: 6.4-7.02) in the control group. The adjusted mean difference (?) was 0.54 (95 % CI: 0.22-0.85). The mean diastolic blood pressure in the intervention group was 2.6 mmHg (95 % CI; -5.5 to 0.15) lower compared to the usual care group.A short intervention of customized SMS can improve medication adherence and effect stroke risk factors like diastolic blood pressure in stroke survivors with complex medication regimens living in resource poor areas.Clinicaltrials.gov NCT01986023 last accessed at https://clinicaltrials.gov/ct2/show/NCT01986023.

Dataset Information

Improving medication adherence with adjuvant aromatase inhibitor in women with breast cancer: study protocol of a randomised controlled trial to evaluate the effect of short message service (SMS) reminder.

Publications

Improving medication adherence with adjuvant aromatase inhibitor in women with breast cancer: study protocol of a randomised controlled trial to evaluate the effect of short message service (SMS) reminder.

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