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

Primary Purpose

Medication Adherence, Stroke

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
SMS- Short Messaging Service
Sponsored by
Aga Khan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Medication Adherence focused on measuring Stroke, Medication Adherence, SMS, Randomised

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Aga Khan University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

SMS Short Message Service Arm plus Prescription

Standard Prescriptions and Counselling

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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

Full Information

First Posted
November 5, 2013
Last Updated
August 18, 2014
Sponsor
Aga Khan University
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1. Study Identification

Unique Protocol Identification Number
NCT01986023
Brief Title
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

2. Study Status

Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
December 2013 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aga Khan University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Medication Adherence, Stroke
Keywords
Stroke, Medication Adherence, SMS, Randomised

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SMS Short Message Service Arm plus Prescription
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard Prescriptions and Counselling
Arm Type
No Intervention
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
SMS- Short Messaging Service
Primary Outcome Measure Information:
Title
Medication Adherence Score
Description
Subjects will undergo measurement of their medication Adherence Scores after 2 months of follow up on the Morisky Medication Adherence Questionnaire
Time Frame
2 months
Secondary Outcome Measure Information:
Title
Patient Satisfaction with Intervention
Description
This is a self designed tool which will measure the level of patient satisfaction in the intervention arm with the SMS intervention
Time Frame
2 months
Title
Acceptability of m-Health intervention
Description
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
Time Frame
2 months
Other Pre-specified Outcome Measures:
Title
SMS Reception, Quality Issues and Safety
Description
Failure of SMS delivery at prespecified time e.g time of medication Proportion of SMS received at night i.e after 10 pm.
Time Frame
2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ayeesha K Kamal, MBBS
Organizational Affiliation
Aga Khan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aga Khan University
City
Karachi
ZIP/Postal Code
74800
Country
Pakistan

12. IPD Sharing Statement

Citations:
PubMed Identifier
26486857
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.
Results Reference
derived
PubMed Identifier
26311325
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.
Results Reference
derived

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

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