Improving Medication Adherence Through SMS (Short Messaging Service) in Adult Stroke Patients: a Randomised Controlled Behaviour Intervention Trial

Study Overview
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Brief Summary
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The impact of medications used for secondary stroke prevention relies heavily upon patient adherence. Adherence is defined as the extent to which a person's behavior - taking medication, following a diet, and/or executing lifestyle changes, corresponds with agreed recommendations from a health care provider. It is said that optimal adherence to medications may reduce the risk of a poor outcome by 26%. The purpose of this study which is a non-pharmacologic behavioral study is to encourage adherence to medications in stroke survivors by tailored and specific SMS reminders. (Short Text Messages). These SMS reminders will support and assist stroke patients to take medications as prescribed and on time. We hypothesise that SMS will improve the adherence of patients to stroke medications by 2 points on the Morisky Medication Adherence Scale.

Detailed Description
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Stroke remains a major cause of death and disability globally, accounting for 46.6 million disability adjusted life-years (DALYs) worldwide. More than 85% of all stroke-related deaths occur in low- and middle-income (LMI) countries. In a study from our center in Pakistan, the all-cause mortality due to stroke was 12.9% in the first year. Vascular causes in general and recurrent stroke in particular accounted for the bulk of the mortality cases. Recurrence of a stroke in Pakistan is documented to be as high as 53% in the first year, as opposed to international rates of approximately 30% in the first month. Evidence based guidelines recommend risk factor control with antiplatelet agents, anti-hypertensive medications, lipid lowering drugs and appropriate anti-diabetic therapy to reduce the risk of stroke recurrence. When taken together, the combination of an antihypertensive, statin and antiplatelet agent can reduce total stroke risk by 80%. However, the impact of drugs used for secondary stroke prevention relies heavily upon patient adherence. Adherence is defined as the extent to which a person's behavior - taking medication, following a diet, and/or executing lifestyle changes, corresponds with agreed recommendations from a health care provider. It is said that optimal adherence to medications may reduce the risk of a poor outcome by 26%. The purpose of this study which is a non-pharmacologic behavioral study is to encourage adherence to medications in stroke survivors by tailored and specific SMS (Short Text Messages) reminders. These SMS reminders will support and assist stroke patients to take medications as prescribed and on time. We hypothesise that SMS will improve the adherence of patients to stroke medications by 2 points on the Morisky Medication Adherence Scale.

Official Title
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A Randomized Controlled SMS Intervention For Improving Medication Adherence in Adult Stroke Patients

Conditions
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Medication Adherence, Stroke

Intervention / Treatment
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* Behavioral: SMS- Short Messaging Service


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults > 18 years Diagnosed with stroke at least one month ago on neuroimaging (CT or MRI) Taking more than one drug for risk factor control Possessing a personal mobile phone Modified Rankin scores <3 (to exclude severely disabled persons) Able to operate sms Do not intend to travel outside the country in the next 2 months (because the followup period is 2 months and during this period mobile communication through sms is required) Give informed consent Exclusion Criteria: Chronic Renal Failure (because such patients keep getting admitted often and also have several contraindications for therapy) Any known malignancy Enrolled in another study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SMS Short Message Service Arm plus Prescription<br>Intervention is as follows: Drug reminder SMS will be sent to the participants in the intervention arm customised to their stroke prescription. These SMS will be interactive in a way that the participants will have to answer back if they have taken their medicine or not in a Yes/No format. Moreover behaviour change SMS will also be sent to the intervention arm twice weekly. In addition , Participants will be encouraged to take medication using a taxonomy of behavioral change intervention techniques. | Behavioral: SMS- Short Messaging Service<br> <br> |
| No Intervention: Standard Prescriptions and Counselling<br>The usual care arm will undergo standard treatment and counselling regarding their treatment and the education regarding their medication as per standard of care. They will receive a standard written prescription and no SMS | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Medication Adherence Score | Subjects will undergo measurement of their medication Adherence Scores after 2 months of follow up on the Morisky Medication Adherence Questionnaire | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Satisfaction with Intervention | This is a self designed tool which will measure the level of patient satisfaction in the intervention arm with the SMS intervention | 2 months | 
| Acceptability of m-Health intervention | This is a self designed tool which will measure the acceptability of m-Health intervention i.e. SMS among the participants in the intervention group | 2 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stroke, Medication Adherence, SMS, Randomised