- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02336412
Short Message Service (SMS) Reminders for Stroke Secondary Preventative Medications
The Use of Short Message Service (SMS) as a Reminder for Continuation of Treatment With Secondary Preventative Medications After Stroke or TIA
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Glasgow, United Kingdom, G11 6NT
- Western Infirmary, NHS Greater Glasgow and Clyde
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: SMS reminder
Daily SMS medication reminder
|
Daily SMS medication reminder
|
|
No Intervention: No SMS reminder
No daily SMS medication reminder
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Adherence rate to stroke secondary preventative medication
Time Frame: 3 months
|
Morisky Medication Adherence Scale (MMAS) - 8 items
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Effect of medication adherence on clinical outcomes
Time Frame: 3 months
|
Number of participants reaching target blood pressure level
|
3 months
|
|
Effect of medication adherence on clinical outcomes
Time Frame: 3 months
|
Number of participants reaching target cholesterol level
|
3 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Jesse Dawson, BSc MBChB MD, University of Glasgow
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- GN14NE625
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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