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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01986023
• Other study ID #: D43TW008660
• Status: Completed
• Phase: N/A
• First received: November 5, 2013
• Last updated: August 18, 2014
• Start date: December 2013
• Est. completion date: June 2014

Study information

• Verified date: August 2014
• Source: Aga Khan University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Pakistan: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Medication Adherence
• Stroke

Intervention

Behavioral:
• SMS- Short Messaging Service

Locations

Country	Name	City	State
Pakistan	Aga Khan University	Karachi

Sponsors (1)

Lead Sponsor	Collaborator
Aga Khan University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	SMS Reception, Quality Issues and Safety	Failure of SMS delivery at prespecified time e.g time of medication; Proportion of SMS received at night i.e after 10 pm.	2 months	Yes
Primary	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	No
Secondary	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	No
Secondary	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	Yes