Effect of 5-Minute Movies Shown via a Mobile Phone App on Risk Factors and Mortality After Stroke in a Low- to Middle-Income Country: Randomized Controlled Trial for the Stroke Caregiver Dyad Education Intervention (Movies4Stroke).

BACKGROUND: Pakistan is the sixth most populous nation in the world and has an estimated 4 million stroke survivors. Most survivors are taken care of by community-based caregivers, and there are no inpatient rehabilitation facilities. OBJECTIVE: The objective of this study was to evaluate the effectiveness and safety of locally designed 5-min movies rolled out in order of relevance that are thematically delivered in a 3-month program to deliver poststroke education to stroke survivor and caregiver dyads returning to the community. METHODS: This study was a randomized controlled, outcome assessor-blinded, parallel group, single-center superiority trial in which participants (stroke survivor-caregiver dyads) with first-ever stroke (both ischemic and hemorrhagic) incidence were randomized within 48 hours of their stroke into either the video-based education intervention group or the control group. The video-based education intervention group had health education delivered through short videos that were shown to the participants and their caregivers at the time of admission, before discharge, and the first and third months of follow-up after discharge. The control group had standardized care including predischarge education and counseling according to defined protocols. All participants enrolled in the video education intervention and control groups were followed for 12 months after discharge for outcome assessment in the outpatient stroke clinics. The primary outcome measures were the proportion of participants achieving control of blood pressure, blood sugar, and blood cholesterol in the video intervention versus the control group. Several predefined secondary outcomes were included in this study, of which we report the mortality and functional disability in this paper. Analysis was by performed using the intention-to-treat principle. RESULTS: A total of 310 stroke survivors and their caregiver dyads (participant dyads) were recruited over a duration of 6 months. In total, 155 participant dyads were randomized into the intervention and control groups, each. The primary outcome of control of three major risk factors revealed that at 12 months, there was a greater percentage of participants with a systolic BP<125 mm Hg (18/54, 33% vs 11/52, 21%; P=.16), diastolic BP<85 mm Hg (44/54, 81% vs 37/52, 71%; P=.21), HbA1c level<7% (36/55, 65% vs 30/40, 75%; P=.32), and low-density lipoprotein level<100 mg/dL (36/51, 70% vs 30/45, 67%; P=.68) in the intervention group than in the control group. The secondary outcome reported is the mortality among the stroke survivors because the number of stroke-related complications was higher in the control group than in the intervention group (13/155, 8.4% vs 2/155, 1.3%), and this difference was statistically significant (P<.001). CONCLUSIONS: The Movies4Stroke trial failed to achieve its primary specified outcome. However, secondary outcomes that directly related to survival skills of stroke survivors demonstrated the effectiveness of the video-based intervention on improving stroke-related mortality and survival without disability. TRIAL REGISTRATION: ClinicalTrials.gov NCT02202330; https://www.clinicaltrials.gov/ct2/show/NCT02202330.

Addressing cost and time barriers in chronic disease management through telemedicine: an exploratory research in select low- and middle-income countries.

BACKGROUND: Despite evidence supporting telehealth provision in developed countries, there is limited evidence regarding its economic benefits for patients living in areas where access and cost present major barriers to health care, particularly in low- and middle-income countries (LMICs). This study explores the economic benefits of telemedicine for patients, in terms of cost and times savings, and its potential role in improving chronic disease outcomes. METHODS: This retrospective cross-sectional study compared telemedicine services with hypothetical in-person consultations, with a focus on patient travel time and travel cost savings. A database containing teleconsultation visits (N = 25,182) conducted at health facilities in remote regions of Afghanistan, Pakistan, Tajikistan, and the Kyrgyz Republic, was analyzed. A two-sample homoscedastic t test was used to determine differences between the two groups. A one-way sensitivity analysis was also conducted, presuming in-person teleconsultations at 90%, 75%, and 50%. RESULTS: The study extracted data from 25,182 teleconsultation visits (12,814 males; 12,368 females). The cumulative patient savings through the program amounted to USD 9,175,132, and 1,876,146 h, or 213.1 years. A significant difference was seen between the two groups in terms of mean time savings (p-value <0.05), and a nearly significant difference was observed in terms of mean cost savings (p-value = 0.05). CONCLUSIONS: This study suggests that considerable economic benefits imparted to patients in low-resource settings of LMICs via accessing telemedicine. Telemedicine has great potential to improve chronic disease outcomes in low-resource areas by reducing socioeconomic barriers related to cost and access, and increasing uptake of services, thereby enabling early intervention and long-term management.

Personalized Text Messages and Automated Calls for Improving Vaccine Coverage Among Children in Pakistan: Protocol for a Community-Based Cluster Randomized Clinical Trial.

BACKGROUND: A major reason for poor childhood vaccine coverage in developing countries is the lack of awareness among parents and caregivers regarding the need for immunization and the importance of completing the entire series of vaccines. Short message service (SMS)-based interventions have been quite effective in different programs such as smoking cessation, treatment adherence, health care scheduled appointment attendance, antenatal care attendance, and compliance to immunization. However, there are limited data from low- and middle-income countries on the role of SMS and automated call-based messages and interventions to improve routine immunization (RI) coverage. OBJECTIVE: The primary objective of this study is to evaluate whether automated mobile phone-based personalized messages (SMS or automated call) can improve RI uptake at 6, 10, and 14 weeks of age per the expanded program immunization schedule, compared with a usual care control group. Secondary objectives include assessing the effects of different types of automated SMS text or calls on RI coverage at 20 weeks of age. METHODS: This is a mixed methods study using a clustered randomized controlled trial with 4 intervention arms and 1 control arm, augmented by qualitative interviews for personalizing the message. The study is being conducted in Pakistan (an urban site in Karachi and a rural site Matiari). In Karachi, 250 administrative structures are taken as 1 cluster, whereas in Matiari, a catchment area of 4 Lady Health Workers is considered as 1 cluster. The intervention targets families to receive weekly 1-way or 2-way (interactive) personalized automated SMS or automated phone call messages regarding vaccination. Possible barriers to vaccination are assessed in each family at the time of inclusion to determine the type of personalized messages that should be sent to the family to increase the chance of a positive response. Finally, in-depth interviews using purposive sampling are conducted before and after the trial to determine the family's vaccination experience and related factors. RESULTS: All study participants for the cluster randomized trial were enrolled by January 14, 2019. Study exit interviews at 20-weeks follow-up visits will be completed by June 2019. CONCLUSIONS: The results of this study will be useful to understand the respective effects of SMS text messages versus automated phone-based communication to improve RI coverage and timelines. Moreover, information regarding families' perceptions of vaccination and the daily life challenges for timely visits to the vaccine clinic will be used for developing more complex interventions that use mobile phone messages and possibly other approaches to overcome barriers in the uptake of correct and timely immunization practices. TRIAL REGISTRATION: ClinicalTrials.gov NCT03341195; https://clinicaltrials.gov/ct2/show/NCT03341195 (Archived by WebCite at http://www.webcitation.org/78EWA56Uo). INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/12851.

Making prescriptions "talk" to stroke and heart attack survivors to improve adherence: Results of a randomized clinical trial (The Talking Rx Study).

BACKGROUND: We developed and tested the effectiveness of a tailored health information technology driven intervention: "Talking Prescriptions" (Talking Rx) to improve medication adherence in a resource challenged environment. METHODS: We conducted a parallel, randomized, controlled, assessor-blinded trial at the Aga Khan University (AKU), Karachi, Pakistan. Adults with diagnosis of cerebrovascular accident (CVA) or coronary artery disease (CAD) diagnosed least one month before enrollment, on anti-platelets and statins, with access to a mobile phone were enrolled. The intervention group received a) Daily Interactive Voice Response (IVR) call services regarding specific statin and antiplatelet b) Daily tailored medication reminders for statin and antiplatelet and c) Weekly lifestyle modification messages for a period of 3 months. We assessed Medication adherence to statin and antiplatelets by a validated version of the 8-item Morisky Medication Adherence scale 8 (MMAS-8) at 3 months by a blinded assessment officer. Analysis was conducted by intention-to-treat principle (ITT). RESULTS: Between April 2015 and December 2015, 197 participants (99 in intervention and 98 in the usual care group) enrolled in the Talking Rx Study. The dropout rate was 9.6%. Baseline group characteristics were similar. At baseline, the mean MMAS-8 was 6.68 (SD = 1.28) in the intervention group and 6.77 (SD = 1.36) in usual care group. At end of follow-up, the mean MMAS-8 increased to 7.41(0.78) in the intervention group compared with 7.38 (0.99) in usual care group with mean difference of 0.03 (S.D 0.13) (95% C.I [-0.23, 0.29]), which was not statistically significant. (P-Value = 0.40) CVA patients showed a relatively greater magnitude of adherence via the MMAS-8 at the end of follow up where the mean MMAS-8 increased to 7.29 (S.D 0.82) in the intervention group as compared to 7.07(S.D 1.24) in usual care group with mean difference of 0.22 (SD = 0.22) 95% C.I (-0.20, 0.65) with (P-value = 0.15). Around 84% of those on intervention arm used the service, calling at least 3 times and listening to their prescriptions for an average of 8 minutes. No user was excluded due to technologic reasons. CONCLUSION: The use of a phone based medication adherence program was feasible in LMIC settings with high volume clinics and low patient literacy. In this early study, with limited follow up, the program did not achieve any statistically significant differences in adherence behavior as self-reported by the MMAS-8 Scale. TRIAL REGISTRATION: Clinical Trials.gov NCT02354040.

Facilitators and barriers to NCD prevention in Pakistanis-invincibility or inevitability: a qualitative research study.

BACKGROUND: Non-communicable diseases (NCD) are the leading causes of death globally. In Pakistan, they are among the top ten causes of mortality, especially in the productive age group (30-69 years). Evidence suggests that health perceptions and beliefs strongly influence the health behavior of an individual. We performed focus group interviews to delineate the same so as to design the user interface of a non-invasive stroke risk monitoring device. METHODS: It was a qualitative study, designed to explore how health perceptions and beliefs influence behavior for NCD prevention. Four focus group discussions (FGD) were conducted with 30 stable participants who had diabetes mellitus, ischemic heart disease, blood pressure, and stroke. The data was collected using a semi-structured interview guide designed to explore participants' perceptions of their illnesses, self-management behaviors and factors affecting them. The interviews were transcribed and content analysis was done using steps of content analysis by Morse and Niehaus [10]. RESULTS: Medication adherence, self-monitoring of blood sugars and blood pressures, and medical help seeking were the commonly performed self-management behaviors by the participants. Personal experience of illness, familial inheritance of disease, education and fear of premature death when life responsibilities were unfulfilled, emerged as strong facilitators of self-management behaviors. A sense of personal invincibility, Fatalism or inevitability, lack of personal threat realization, limited knowledge, inadequate health education, health care and financial constraints appeared as key barriers to the self-management of chronic disease in participants. CONCLUSIONS: Behavioural interventional messaging will have to engender a sense of personal vulnerability and yet empower self-efficacy solutions at the individual level to deal with both invincibility and inevitability barriers to adoption of healthy behavior.

Using a tailored health information technology- driven intervention to improve health literacy and medication adherence in a Pakistani population with vascular disease (Talking Rx) - study protocol for a randomized controlled trial.

BACKGROUND: Vascular disease, manifesting as myocardial infarction and stroke, is a major cause of morbidity and mortality, especially in low- and middle-income countries. Current estimates are that only one in six patients have good adherence to medications and very few have sufficient health literacy. Our aim is to explore the effectiveness and acceptability of Prescription Interactive Voice Response (IVR) Talking Prescriptions (Talking Rx) and SMS reminders in increasing medication adherence and health literacy in Pakistani patients with vascular disease. METHODS: This is a randomized, controlled, single center trial. Adult participants, with access to a cell phone and a history of vascular disease, taking multiple risk-modifying medications (inclusive of anti-platelets and statins) will be selected from cerebrovascular and cardiovascular clinics. They will be randomized in a 1:1 ratio via a block design to the intervention or the control arm with both groups having access to a helpline number to address their queries in addition to standard of care as per institutional guidelines. Participants in the intervention group will also have access to Interactive Voice Response (IVR) technology tailored to their respective prescriptions in the native language (Urdu) and will have the ability to hear information about their medication dosage, correct use, side effects, mechanism of action and how and why they should use their medication, as many times as they like. Participants in the intervention arm will also receive scheduled SMS messages reminding them to take their medications. The primary outcome measure will be the comparison of the difference in adherence to anti-platelet and statin medication between baseline and at 3-month follow-up in each group measured by the Morisky Medication Adherence Scale. To ascertain the impact of our intervention on health literacy, we will also compare a local content-validated and modified version of Test of Health Literacy in Adults (TOFHLA) between the intervention and the control arm. We estimate that a sample size of 86 participants in each arm will be able to detect a difference of 1 point on the MMAS with a power of 90 % and significance level of 5 %. Accounting for an attrition rate of 15 %, we plan to enroll 100 participants in each arm (total study population = 200). We hypothesize that a linguistically tailored health IT intervention based on IVR and SMS will be associated with an improvement in adherence (to anti-platelet and lipid-lowering medications) and an improvement in health literacy in Pakistani patients with vascular disease. DISCUSSION: This innovative study will provide early data for the feasibility of the use of IT based prescriptions in an lower middle incorme country setting with limited numeracy and literacy skills. TRIAL REGISTRATION: Clinical Trials.gov: NCT02354040 - 2 February 2015.

Translating knowledge for action against stroke--using 5-minute videos for stroke survivors and caregivers to improve post-stroke outcomes: study protocol for a randomized controlled trial (Movies4Stroke).

BACKGROUND: Two thirds of the global mortality of stroke is borne by low and middle income countries (LMICs). Pakistan is the world's sixth most populous country with a stroke-vulnerable population and is without a single dedicated chronic care center. In order to provide evidence for a viable solution responsive to this health care gap, and leveraging the existing >70% mobile phone density, we thought it rational to test the effectiveness of a mobile phone-based video intervention of short 5-minute movies to educate and support stroke survivors and their primary caregivers. METHODS: Movies4Stroke will be a randomized control, outcome assessor blinded, parallel group, single center superiority trial. Participants with an acute stroke, medically stable, with mild to moderate disability and having a stable primary caregiver will be included. After obtaining informed consent the stroke survivor-caregiver dyad will be randomized. Intervention participants will have the movie program software installed in their phone, desktop, or Android device which will allow them to receive, view and repeat 5-minute videos on stroke-related topics at admission, discharge and first and third months after enrollment. The control arm will receive standard of care at an internationally accredited center with defined protocols. The primary outcome measure is medication adherence as ascertained by a locally validated Morisky Medication Adherence Scale and control of major risk factors such as blood pressure, blood sugar and blood cholesterol at 12 months post discharge. Secondary outcome measures are post-stroke complications and mortality, caregiver knowledge and change in functional outcomes after acute stroke at 1, 3, 6, 9 and 12 months. Movies4Stroke is designed to enroll 300 participant dyads after inflating 10% to incorporate attrition and non-compliance and has been powered at 95% to detect a 15% difference between intervention and usual care arm. Analysis will be done by the intention-to-treat principle. DISCUSSION: Movies4Stroke is a randomized trial testing an application aimed at supporting caregivers and stroke survivors in a LMIC with no rehabilitation or chronic support systems. TRIAL REGISTRATION: NCT02202330 (28 January 2015).

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

BACKGROUND: 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. METHODS: 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. RESULTS: 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 (Δ) 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. CONCLUSION: 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. TRIAL REGISTRATION: Clinicaltrials.gov NCT01986023 last accessed at https://clinicaltrials.gov/ct2/show/NCT01986023.

Improving medication adherence in stroke patients through Short Text Messages (SMS4Stroke)-study protocol for a randomized, controlled trial.

BACKGROUND: Stroke is a major cause of morbidity and mortality, especially in low and middle income countries. Medical management is the mainstay of therapy to prevent recurrence of stroke. Current estimates are that only 1 in 6 patients have perfect adherence to medication schedules. Using SMS (Short Messaging Service) as reminders to take medicines have been used previously for diseases such as diabetes and HIV with moderate success. We aim to explore the effectiveness and acceptability of SMS in increasing adherence to medications in patients with stroke. METHODS: This will be a randomized, controlled, assessor blinded single center superiority trial. Adult participants with access to a cell phone and a history of stroke longer than 1 month on multiple risk modifying medications will be selected from Neurology and Stroke Clinic. They will be randomized into two parallel groups in a 1:1 ratio via block technique with one group receiving the standard of care as per institutional guidelines while the parallel group receiving SMS reminders for each dose of medicine in addition to the standard of care. In addition intervention group will receive messages for lifestyle changes, medication information, risk factors and motivation for medication adherence. These will bemodeled on Social Cognitive Theory and Health Belief Model and will be categorized by Michies Taxonomy of Behavioral Change Communication. Patient compliance to medicines will be measured at baseline and then after 2 months in each group by using the Morisky Medication Adherence Scale. The change in compliance to medication regimen after the intervention and the difference between the two groups will be used to determine the effectiveness of SMS reminders as a tool to increase medication compliance. The acceptability of the SMS will be determined by a tool designed for this study whose attributes are based Rogers Diffusion of innovation theory. A sample size of 86 participants in each arm will be sufficient to detect a difference of 1 point on the MMAS with a power of 90 % and significance level of 5 % between the two groups; using an attrition rate of 15 %, 200 participants in all will be randomized. DISCUSSION: The SMS for Stroke Study will provide evidence for feasibility and effectiveness of SMS in improving post stroke medication adherence in an LMIC setting. TRIAL REGISTRATION: https://clinicaltrials.gov/ct2/show/NCT01986023 11 /11/2013.