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Completed

NCT Number: NCT01986023

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aga Khan University

Karachi, 74800, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SMS- Short Messaging Service

Behavioral

Primary outcomes

  1. Medication Adherence Score

    Time frame: 2 months

    Subjects will undergo measurement of their medication Adherence Scores after 2 months of follow up on the Morisky Medication Adherence Questionnaire

Secondary outcomes

  1. Patient Satisfaction with Intervention

    Time frame: 2 months

    This is a self designed tool which will measure the level of patient satisfaction in the intervention arm with the SMS intervention

  2. Acceptability of m-Health intervention

    Time frame: 2 months

    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

Other outcomes

  1. SMS Reception, Quality Issues and Safety

    Time frame: 2 months

    • Failure of SMS delivery at prespecified time e.g time of medication
    • Proportion of SMS received at night i.e after 10 pm.

Sponsors and collaborators

Lead sponsor

Aga Khan University

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Nov 18, 2013
Registry last updated
Aug 19, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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