ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01986023
Recruitment Status : Completed
First Posted : November 18, 2013
Last Update Posted : August 19, 2014
Sponsor:
Information provided by (Responsible Party):
Dr. Ayeesha Kamran Kamal, Aga Khan University

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.


Condition or disease Intervention/treatment Phase
Medication Adherence Stroke Behavioral: SMS- Short Messaging Service Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Randomized Controlled SMS Intervention For Improving Medication Adherence in Adult Stroke Patients
Study Start Date : December 2013
Actual Primary Completion Date : June 2014
Actual Study Completion Date : June 2014

Arm Intervention/treatment
Experimental: SMS Short Message Service Arm plus Prescription
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
No Intervention: Standard Prescriptions and Counselling
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



Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  1. SMS Reception, Quality Issues and Safety [ Time Frame: 2 months ]
    1. Failure of SMS delivery at prespecified time e.g time of medication
    2. Proportion of SMS received at night i.e after 10 pm.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01986023


Locations
Pakistan
Aga Khan University
Karachi, Pakistan, 74800
Sponsors and Collaborators
Aga Khan University
Investigators
Principal Investigator: Ayeesha K Kamal, MBBS Aga Khan University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. Ayeesha Kamran Kamal, Associate Professor, Aga Khan University
ClinicalTrials.gov Identifier: NCT01986023     History of Changes
Other Study ID Numbers: D43TW008660 ( U.S. NIH Grant/Contract )
First Posted: November 18, 2013    Key Record Dates
Last Update Posted: August 19, 2014
Last Verified: August 2014

Keywords provided by Dr. Ayeesha Kamran Kamal, Aga Khan University:
Stroke
Medication Adherence
SMS
Randomised

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases