Clinical trial NCT01986023: Improving Medication Adherence Through SMS (Short Messaging Service) in Adult Stroke Patients: a Randomised Controlled Behaviour Intervention Trial
Official title: A Randomized Controlled SMS Intervention For Improving Medication Adherence in Adult Stroke Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Medication Adherence
Stroke
Keywords: Stroke
Medication Adherence
SMS
Randomised
Lead sponsor: Aga Khan University
Sponsor class: OTHER
First posted: 2013-11-18
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Medication Adherence Score
timeFrame: 2 months
Secondary outcomes:
measure: Patient Satisfaction with Intervention
timeFrame: 2 months
measure: Acceptability of m-Health intervention
timeFrame: 2 months
Other outcomes:
measure: SMS Reception, Quality Issues and Safety
timeFrame: 2 months
Locations:
city: Karachi
country: Pakistan
facility: Aga Khan University
Study officials:
affiliation: Aga Khan University
name: Ayeesha K Kamal, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kamal AK, Shaikh Q, Pasha O, Azam I, Islam M, Memon AA, Rehman H, Akram MA, Affan M, Nazir S, Aziz S, Jan M, Andani A, Muqeet A, Ahmed B, Khoja S. 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 Oct 21;15:212. doi: 10.1186/s12883-015-0471-5.
citation: Kamal AK, Shaikh QN, Pasha O, Azam I, Islam M, Memon AA, Rehman H, Affan M, Nazir S, Aziz S, Jan M, Andani A, Muqeet A, Ahmed B, Khoja S. Improving medication adherence in stroke patients through Short Text Messages (SMS4Stroke)-study protocol for a randomized, controlled trial. BMC Neurol. 2015 Aug 28;15:157. doi: 10.1186/s12883-015-0413-2.