Improving Medication Adherence Through SMS (Short Messaging Service) in Adult Stroke Patients: a Randomised Controlled Behaviour Intervention Trial
A Randomized Controlled SMS Intervention For Improving Medication Adherence in Adult Stroke Patients
1 other identifier
interventional
200
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2013
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 5, 2013
CompletedFirst Posted
Study publicly available on registry
November 18, 2013
CompletedStudy Start
First participant enrolled
December 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2014
CompletedAugust 19, 2014
August 1, 2014
6 months
November 5, 2013
August 18, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (2)
Patient Satisfaction with Intervention
2 months
Acceptability of m-Health intervention
2 months
Other Outcomes (1)
SMS Reception, Quality Issues and Safety
2 months
Study Arms (2)
SMS Short Message Service Arm plus Prescription
EXPERIMENTALIntervention 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.
Standard Prescriptions and Counselling
NO INTERVENTIONThe 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
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Chronic Renal Failure (because such patients keep getting admitted often and also have several contraindications for therapy)
- Any known malignancy
- Enrolled in another study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Aga Khan University
Karachi, 74800, Pakistan
Related Publications (2)
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.
PMID: 26486857DERIVEDKamal 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.
PMID: 26311325DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ayeesha K Kamal, MBBS
Aga Khan University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
November 5, 2013
First Posted
November 18, 2013
Study Start
December 1, 2013
Primary Completion
June 1, 2014
Study Completion
June 1, 2014
Last Updated
August 19, 2014
Record last verified: 2014-08