Dataset Information

A randomized controlled behavioral intervention trial to improve medication adherence in adult stroke patients with prescription tailored Short Messaging Service (SMS)-SMS4Stroke study.

ABSTRACT: 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.

SUBMITTER: Kamal AK

PROVIDER: S-EPMC4618367 | biostudies-literature | 2015 Oct

REPOSITORIES: biostudies-literature

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A randomized controlled behavioral intervention trial to improve medication adherence in adult stroke patients with prescription tailored Short Messaging Service (SMS)-SMS4Stroke study.

Kamal Ayeesha Kamran AK Shaikh Quratulain Q Pasha Omrana O Azam Iqbal I Islam Muhammad M Memon Adeel Ali AA Rehman Hasan H Akram Masood Ahmed MA Affan Muhammad M Nazir Sumaira S Aziz Salman S Jan Muhammad M Andani Anita A Muqeet Abdul A Ahmed Bilal B Khoja Shariq S

BMC neurology 20151021

<h4>Background</h4>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.<h4>Methods</h4>This was a parallel group, assessor-blinded, randomized, controlled, superiority trial. Participants were centrally randomized in fixed block s ...[more]

PMID: 26486857

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Project description:There is growing evidence that mobile health (mHealth) approaches including short messaging service (SMS) can improve antiretroviral therapy (ART) adherence, but consensus is lacking regarding communication of HIV-related information. Most interventions to date have delivered SMS that do not overtly refer to HIV or ART in order to avoid risk of status disclosure. In formative work for an ongoing randomized controlled trial (RCT) evaluating one-way and two-way educational SMS for prevention of mother-to-child-transmission (PMTCT) adherence in Kenya, we conducted 10 focus group discussions (FGDs) with 87 HIV-infected peripartum women to determine desirability and preferred terminology of HIV-related content. SMS for the RCT were developed based on FGD findings. Roughly half of FGD participants supported receiving SMS containing overtly HIV-related terms, such as "HIV" and "medication", citing desire for detailed educational messages about ART and PMTCT. Those opposed to overt content expressed concerns about confidentiality. Many participants argued that acceptability of HIV-related content depended on the recipient's disclosure status and others' access to her phone. Based on these findings, both covert and overt SMS were developed for the RCT and participants who owned their phone or had disclosed their HIV status to anyone with access to their phone were able to choose one of three options: (1) covert SMS only, (2) overt SMS only in response to HIV-related questions from the participant, (3) overt SMS routinely, initiated by the study. Of the 825 participants in the RCT, 94% were eligible to receive overt SMS. Of these, 66% opted to receive routine overt SMS and 10% to receive participant-initiated overt SMS. These findings show there may be interest in overt HIV-related information by SMS when risk of status disclosure is low, and support use of messaging strategies that allows participant choice in HIV-related content while protecting against undesired disclosure.

Project description:BackgroundHypertension (HTN) is a major public health concern in the United States, with almost 78 million Americans age 20 years and over suffering from the condition. Moreover, HTN is a key risk factor for health disease and stroke. African Americans disproportionately shoulder the burdens of HTN, with greater prevalence, disease severity, earlier onset, and more HTN-related complications than age-matched whites. Medication adherence for the treatment of HTN is poor, with estimates indicating that only about half of hypertensive patients are adherent to prescribed medication regimens. Although no single intervention for improving medication adherence has emerged as superior to others, text message medication reminders have the potential to help improve medication adherence in African Americans with uncontrolled HTN as mobile phone adoption is very high in this population.ObjectiveThe purpose of this two-phased study was to develop (Phase I) and test in a randomized controlled trial (RCT) (Phase II) a text message system, BPMED, to improve the quality of medication management through increasing medication adherence in African Americans with uncontrolled HTN.MethodsIn Phase I, we recruited 16 target end-users from a primary care clinic, to assist in the development of BPMED through participating in one of three focus groups. Focus groups sought to gain patient perspectives on HTN, medication adherence, mobile phone use, and the use of text messaging to support medication adherence. Potential intervention designs were presented to participants, and feedback on the designs was solicited. In Phase II, we conducted two pilot RCTs to determine the feasibility, acceptability, and preliminary efficacy of BPMED in primary care and emergency department settings. Both pilot studies recruited approximately 60 participants, who were randomized equally between usual care and the BPMED intervention.ResultsAlthough data collection is now complete, data analysis from the two pilot RCTs is still ongoing and results are expected in 2015.ConclusionsThis study was designed to determine preliminary feasibility and acceptability of our approach among African Americans with uncontrolled HTN in primary care and emergency department settings. Results from these studies are of great interest as little work has been done to document the use of text message medication reminders to improve HTN-related outcomes, particularly within underserved urban minorities.Trial registrationClinicaltrials.gov NCT01465217; https://clinicaltrials.gov/ct2/show/NCT01465217 (Archived by WebCite at http://www.webcitation.org/6V0tto0lZ).

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.

Dataset Information

A randomized controlled behavioral intervention trial to improve medication adherence in adult stroke patients with prescription tailored Short Messaging Service (SMS)-SMS4Stroke study.

Publications

A randomized controlled behavioral intervention trial to improve medication adherence in adult stroke patients with prescription tailored Short Messaging Service (SMS)-SMS4Stroke study.

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