Short Message Service (SMS) Reminders for Stroke Secondary Preventative Medications
Primary Purpose
Stroke, Ischemic Attack, Transient
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
SMS reminder
Sponsored by
About this trial
This is an interventional supportive care trial for Stroke focused on measuring Medication adherence
Eligibility Criteria
Inclusion Criteria:
- diagnosed with stroke or TIA
- treated with any combination of anti-platelet, antihypertensive, and/or lipid-modifying drugs; at least one of which started over the past month
- living in the community
Exclusion Criteria:
- severe disability (modified Rankin Scale (mRS) ≥ 4)
- patients unable to consent
- patients with no facility to be reminded by SMS or voicemail message
Sites / Locations
- Western Infirmary, NHS Greater Glasgow and Clyde
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
SMS reminder
No SMS reminder
Arm Description
Daily SMS medication reminder
No daily SMS medication reminder
Outcomes
Primary Outcome Measures
Adherence rate to stroke secondary preventative medication
Morisky Medication Adherence Scale (MMAS) - 8 items
Secondary Outcome Measures
Effect of medication adherence on clinical outcomes
Number of participants reaching target blood pressure level
Effect of medication adherence on clinical outcomes
Number of participants reaching target cholesterol level
Full Information
NCT ID
NCT02336412
First Posted
January 8, 2015
Last Updated
January 29, 2016
Sponsor
NHS Greater Glasgow and Clyde
Collaborators
University of Glasgow
1. Study Identification
Unique Protocol Identification Number
NCT02336412
Brief Title
Short Message Service (SMS) Reminders for Stroke Secondary Preventative Medications
Official Title
The Use of Short Message Service (SMS) as a Reminder for Continuation of Treatment With Secondary Preventative Medications After Stroke or TIA
Study Type
Interventional
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
October 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NHS Greater Glasgow and Clyde
Collaborators
University of Glasgow
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Secondary preventative medications are prescribed to reduce the risk of recurrent stroke following ischaemic stroke. However, continuation rates can be as low as 50% and are likely to be multifactorial. One factor will be patients forgetting to take the medication or a reduced appreciation of the importance of the medication as the time from the stroke passes. Numerous approaches to improve persistence to secondary preventative medications have been tried. One simple approach is use of mobile phone text messages as a reminder for patients to take their medications. In this study, we will introduce an educational and motivational strategy to inform patients about their medications and explore whether a reminder intervention, using Short Message Service (SMS), improves adherence to antiplatelet drugs, antihypertensive medications and lipid lowering drugs. We will also explore whether this improves blood pressure and cholesterol levels in the first 3 months after stroke.
Detailed Description
We aim to recruit adult patients diagnosed with stroke or transient ischaemic attack (TIA) who were prescribed secondary preventative medication and are living in the community. They will be provided with a patient information sheet (PIS) with details on the study and will be contacted later to ask if they wish to take part. If so, an arrangement will be made for them to attend a clinic review where they will sign the consent form. Immediately then participants who consent will be randomized into control (will receive education and motivation interviews but not text messages to remind them) or intervention (will receive education and motivation interviews and will be sent a daily text message to remind them of taking their medication). Baseline assessment will include medical history and medications prescribed. They will be given detailed information on their specific prescribed medication and will be handed booklets with relevant information. They will be asked to answer a medication adherence questionnaire and will be given a medication diary to fill in at home. All participants will receive ambulatory blood pressure monitoring.
Cholesterol measurement will be made using a finger prick monitor. Participants in the intervention group will be informed that they will receive a daily text message in the morning to remind them about their medications.
Follow-up visits will take place after 1 and 3 months in which the same checks will be carried out as at the baseline visit. At 1 month, the cholesterol level and ambulatory blood pressure level will be repeated. Participants will be encouraged to ask if they have any concerns regarding their medications. At the end of the second visit, participants will be asked if they are satisfied with the care they received during the visits as a quality assessment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Ischemic Attack, Transient
Keywords
Medication adherence
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SMS reminder
Arm Type
Experimental
Arm Description
Daily SMS medication reminder
Arm Title
No SMS reminder
Arm Type
No Intervention
Arm Description
No daily SMS medication reminder
Intervention Type
Other
Intervention Name(s)
SMS reminder
Intervention Description
Daily SMS medication reminder
Primary Outcome Measure Information:
Title
Adherence rate to stroke secondary preventative medication
Description
Morisky Medication Adherence Scale (MMAS) - 8 items
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Effect of medication adherence on clinical outcomes
Description
Number of participants reaching target blood pressure level
Time Frame
3 months
Title
Effect of medication adherence on clinical outcomes
Description
Number of participants reaching target cholesterol level
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
diagnosed with stroke or TIA
treated with any combination of anti-platelet, antihypertensive, and/or lipid-modifying drugs; at least one of which started over the past month
living in the community
Exclusion Criteria:
severe disability (modified Rankin Scale (mRS) ≥ 4)
patients unable to consent
patients with no facility to be reminded by SMS or voicemail message
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jesse Dawson, BSc MBChB MD
Organizational Affiliation
University of Glasgow
Official's Role
Study Director
Facility Information:
Facility Name
Western Infirmary, NHS Greater Glasgow and Clyde
City
Glasgow
ZIP/Postal Code
G11 6NT
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Short Message Service (SMS) Reminders for Stroke Secondary Preventative Medications
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