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

August 18, 2014 updated by: Dr. Ayeesha Kamran Kamal, Aga Khan University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
      • Karachi, Pakistan, 74800
        • Aga Khan University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
2 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 months
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
2 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aga Khan University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2013

Primary Completion (ACTUAL)

June 1, 2014

Study Completion (ACTUAL)

June 1, 2014

Study Registration Dates

First Submitted

November 5, 2013

First Submitted That Met QC Criteria

November 11, 2013

First Posted (ESTIMATE)

November 18, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

August 19, 2014

Last Update Submitted That Met QC Criteria

August 18, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D43TW008660 (NIH)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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