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

Ayeesha Kamran Kamal, Abdul Muqeet, Kashfa Farhat, Wardah Khalid, Anum Jamil, Ambreen Gowani, Aliya Amin Muhammad, Fabiha Zaidi, Danyal Khan, Touseef Elahi, Shahrukh Sharif, Sibtain Raz, Taha Zafar, Syedah Saira Bokhari, Nasir Rahman, Fateh Ali Tipoo Sultan, Saleem Sayani, Salim S Virani, Ayeesha Kamran Kamal, Abdul Muqeet, Kashfa Farhat, Wardah Khalid, Anum Jamil, Ambreen Gowani, Aliya Amin Muhammad, Fabiha Zaidi, Danyal Khan, Touseef Elahi, Shahrukh Sharif, Sibtain Raz, Taha Zafar, Syedah Saira Bokhari, Nasir Rahman, Fateh Ali Tipoo Sultan, Saleem Sayani, Salim S Virani

Abstract

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.

Figures

Fig. 1
Fig. 1
Study flow chart. Standardized Consolidated Standards of Reporting Trials (CONSORT) flow for the Talking Prescription (Talking Rx) program
Fig. 2
Fig. 2
Interactive Voice Recording Menu. Interactive Voice Recording Work Flow (IVR) –the participant is able to “listen to” his medications and how they work, their side effects and important interactions. All participants hear a mandatory recording that details essential information in addition to detailed descriptions. There is no cost to this recording and they may listen to it as many times as they wish for clarity
Fig. 3
Fig. 3
Participant timeline. Timeline for Talking Prescriptions (Talking Rx) − participants are followed for 3 months. The intervention arm receives Interactive Voice Recording (IVR) that improves prescription literacy and a short text message service (SMS) that cues medication adherence behavior. The Pill Count Sub-study is at 2-week follow-up

References

    1. Jafar TH, et al. Non-communicable diseases and injuries in Pakistan: strategic priorities. Lancet. 2013;381(9885):2281–90. doi: 10.1016/S0140-6736(13)60646-7.
    1. Yusuf S, et al. Effect of potentially modifiable risk factors associated with myocardial infarction in 52 countries (the INTERHEART study): case-control study. Lancet. 2004;364(9438):937–52. doi: 10.1016/S0140-6736(04)17018-9.
    1. Kamal AK, et al. The burden of stroke and transient ischemic attack in Pakistan: a community-based prevalence study. BMC Neurol. 2009;9:58. doi: 10.1186/1471-2377-9-58.
    1. Horton R. Pakistan: health is an opportunity to be seized. Lancet. 2013;381(9884):2137–8. doi: 10.1016/S0140-6736(13)60946-0.
    1. Bandura A. Self-efficacy: the exercise of control. New York: Freeman; 1997.
    1. Michie S, et al. A refined taxonomy of behaviour change techniques to help people change their physical activity and healthy eating behaviours: the CALO-RE taxonomy. Psychol Health. 2011;26(11):1479–98. doi: 10.1080/08870446.2010.540664.
    1. Morisky DE, et al. Predictive validity of a medication adherence measure in an outpatient setting. J Clin Hypertens. 2008;10(5):348–54. doi: 10.1111/j.1751-7176.2008.07572.x.
    1. Parker RM, et al. The test of functional health literacy in adults. J Gen Intern Med. 1995;10(10):537–41. doi: 10.1007/BF02640361.
    1. Baker DW, et al. Development of a brief test to measure functional health literacy. Patient Educ Couns. 1999;38(1):33–42. doi: 10.1016/S0738-3991(98)00116-5.
    1. Williams MV, et al. Relationship of functional health literacy to patients’ knowledge of their chronic disease: a study of patients with hypertension and diabetes. Arch Intern Med. 1998;158(2):166–72. doi: 10.1001/archinte.158.2.166.
    1. Bandura A. Social cognitive theory: an agentic perspective. Annu Rev Psychol. 2001;52(1):1–26. doi: 10.1146/annurev.psych.52.1.1.
    1. Rosenstock IM. The health belief model and preventive health behavior. Health Educ Behav. 1974;2(4):354–86. doi: 10.1177/109019817400200405.
    1. IVR Services from eOcean. . Last accessed on 2/29/2016.
    1. Wroe AL. Intentional and unintentional nonadherence: a study of decision making. J Behav Med. 2002;25(4):355–72. doi: 10.1023/A:1015866415552.
    1. Saleem F, et al. Translation and validation study of Morisky Medication Adherence Scale (MMAS): the Urdu version for facilitating person-centered healthcare in Pakistan. Int J Pers Cent Med. 2012;2(3):384–90.
    1. Morisky DE, Green LW, Levine DM. Concurrent and predictive validity of a self-reported measure of medication adherence. Med Care. 1986;24(1):67–74. doi: 10.1097/00005650-198601000-00007.
    1. Kamal AK, et al. Improving medication adherence in stroke patients through Short Text Messages (SMS4Stroke) – study protocol for a randomized, controlled trial. BMC Neurol. 2015;15(1):157. doi: 10.1186/s12883-015-0413-2.
    1. Kamal AK, et al. A randomized controlled behavioral intervention trial to improve medication adherence in adult stroke patients with prescription tailored Short Messaging Service (SMS)-SMS4Stroke study. BMC Neurol. 2015;15(1):212. doi: 10.1186/s12883-015-0471-5.
    1. Friedman RH, et al. A telecommunications system for monitoring and counseling patients with hypertension: impact on medication adherence and blood pressure control. Am J Hypertens. 1996;9(4):285–92. doi: 10.1016/0895-7061(95)00353-3.
    1. De Jongh T et al. Mobile phone messaging for facilitating self-management of long-term illnesses. The Cochrane Library. 2012. DOI:10.1002/14651858.CD007459.pub2.
    1. Strandbygaard U, Thomsen SF, Backer V. A daily SMS reminder increases adherence to asthma treatment: a three-month follow-up study. Respir Med. 2010;104(2):166–71. doi: 10.1016/j.rmed.2009.10.003.
    1. Lester RT, et al. Effects of a mobile phone short message service on antiretroviral treatment adherence in Kenya (WelTel Kenya1): a randomised trial. Lancet. 2010;376(9755):1838–45. doi: 10.1016/S0140-6736(10)61997-6.
    1. Mbuagbaw L, et al. The Cameroon mobile phone SMS (CAMPS) trial: a protocol for a randomized controlled trial of mobile phone text messaging versus usual care for improving adherence to highly active anti-retroviral therapy. Trials. 2011;12(1):5. doi: 10.1186/1745-6215-12-5.
    1. Prabhakaran L, et al. The use of text messaging to improve asthma control: a pilot study using the mobile phone short messaging service (SMS) J Telemed Telecare. 2010;16(5):286–90. doi: 10.1258/jtt.2010.090809.
    1. Ollivier L, et al. Use of short message service (SMS) to improve malaria chemoprophylaxis compliance after returning from a malaria endemic area. Malar J. 2009;8(236):1475–2875.
    1. Márquez CE, et al. Effectiveness of an intervention to provide information to patients with hypertension as short text messages and reminders sent to their mobile phone (HTA-Alert) Atencion primaria/Sociedad Española de Medicina de Familia y Comunitaria. 2004;34(8):399–405. doi: 10.1016/S0212-6567(04)78922-2.
    1. Pop-Eleches C, et al. Mobile phone technologies improve adherence to antiretroviral treatment in a resource-limited setting: a randomized controlled trial of text message reminders. AIDS (London, England) 2011;25(6):825. doi: 10.1097/QAD.0b013e32834380c1.
    1. Mukherjee D, Patil CG. Epidemiology and the global burden of stroke. World Neurosurg. 2011;76(6):S85–90. doi: 10.1016/j.wneu.2011.07.023.
    1. Strong K, Mathers C, Bonita R. Preventing stroke: saving lives around the world. Lancet Neurol. 2007;6(2):182–7. doi: 10.1016/S1474-4422(07)70031-5.
    1. Feigin VL, et al. Worldwide stroke incidence and early case fatality reported in 56 population-based studies: a systematic review. Lancet Neurol. 2009;8(4):355–69. doi: 10.1016/S1474-4422(09)70025-0.
    1. Khan M, et al. Functional, cognitive and psychological outcomes, and recurrent vascular events in Pakistani stroke survivors: a cross sectional study. BMC Res Notes. 2012;5(1):89. doi: 10.1186/1756-0500-5-89.
    1. Tomlinson M, et al. Scaling up mHealth: where is the evidence? PLoS Med. 2013;10(2):e1001382. doi: 10.1371/journal.pmed.1001382.
    1. Riley WT, et al. Health behavior models in the age of mobile interventions: are our theories up to the task? Transl Behav Med. 2011;1(1):53–71. doi: 10.1007/s13142-011-0021-7.
    1. Boutron I, et al. Extending the CONSORT statement to randomized trials of nonpharmacologic treatment: explanation and elaboration. Ann Intern Med. 2008;148(4):295–309. doi: 10.7326/0003-4819-148-4-200802190-00008.
    1. Chan A-W, et al. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ. 2013;346:e7586. doi: 10.1136/bmj.e7586.
    1. Editors PLoS Med A reality checkpoint for mobile health: three challenges to overcome. PLoS Med. 2013;10(2):e1001395. doi: 10.1371/journal.pmed.1001395.
    1. Atkinson NL. Developing a questionnaire to measure perceived attributes of eHealth innovations. Am J Health Behav. 2007;31(6):612–21. doi: 10.5993/AJHB.31.6.6.
    1. Haynes RB, et al. Interventions for enhancing medication adherence. Cochrane Database Syst Rev. 2008;2(2):CD000011.
    1. Urquhart J. The odds of the three nons when an aptly prescribed medicine isn’t working: non-compliance, non-absorption, non-response. Br J Clin Pharmacol. 2002;54(2):212–20. doi: 10.1046/j.1365-2125.2002.01629.x.
    1. Julius RJ, Novitsky MA, Jr, Dubin WR. Medication adherence: a review of the literature and implications for clinical practice. J Psychiatr Pract. 2009;15(1):34–44. doi: 10.1097/01.pra.0000344917.43780.77.
    1. Osterberg L, Blaschke T. Adherence to medication. N Engl J Med. 2005;353(5):487–97. doi: 10.1056/NEJMra050100.
    1. Vervloet M, et al. The effectiveness of interventions using electronic reminders to improve adherence to chronic medication: a systematic review of the literature. J Am Med Inform Assoc. 2012;19(5):696–704. doi: 10.1136/amiajnl-2011-000748.
    1. Pakistan Telecommunication Authority (PTA). Telecom indicators. 2014. 16 April 2014. Available from: . Last accessed on 2/29/2016.
    1. Glasgow RE, Vogt TM, Boles SM. Evaluating the public health impact of health promotion interventions: the RE-AIM framework. Am J Public Health. 1999;89(9):1322–7. doi: 10.2105/AJPH.89.9.1322.
    1. Abegunde DO, et al. The burden and costs of chronic diseases in low-income and middle-income countries. Lancet. 2007;370(9603):1929–38. doi: 10.1016/S0140-6736(07)61696-1.
    1. Glasgow RE. eHealth evaluation and dissemination research. Am J Prev Med. 2007;32(5):S119–26. doi: 10.1016/j.amepre.2007.01.023.

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