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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01986023
Enrollment
200
Registered
2013-11-18
Start date
2013-12-31
Completion date
2014-06-30
Last updated
2014-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Medication Adherence, Stroke

Keywords

Stroke, Medication Adherence, SMS, Randomised

Brief summary

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

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.

Interventions

BEHAVIORALSMS- Short Messaging Service

Sponsors

Aga Khan University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Medication Adherence Score2 monthsSubjects will undergo measurement of their medication Adherence Scores after 2 months of follow up on the Morisky Medication Adherence Questionnaire

Secondary

MeasureTime frameDescription
Patient Satisfaction with Intervention2 monthsThis is a self designed tool which will measure the level of patient satisfaction in the intervention arm with the SMS intervention
Acceptability of m-Health intervention2 monthsThis is a self designed tool which will measure the acceptability of m-Health intervention i.e. SMS among the participants in the intervention group

Other

MeasureTime frameDescription
SMS Reception, Quality Issues and Safety2 months1. Failure of SMS delivery at prespecified time e.g time of medication 2. Proportion of SMS received at night i.e after 10 pm.

Countries

Pakistan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 15, 2026