Short Message Service (SMS) Reminders for Stroke Secondary Preventative Medications

Stroke Clinical Trial

Official title:

The Use of Short Message Service (SMS) as a Reminder for Continuation of Treatment With Secondary Preventative Medications After Stroke or TIA

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02336412
• Other study ID #: GN14NE625
• Status: Completed
• Phase: N/A
• First received: January 8, 2015
• Last updated: January 29, 2016
• Start date: January 2015
• Est. completion date: October 2015

Study information

• Verified date: January 2016
• Source: NHS Greater Glasgow and Clyde
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: National Health Service
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Ischemic Attack, Transient
• Stroke

Intervention

Other:
• SMS reminder
Daily SMS medication reminder

Locations

Country	Name	City	State
United Kingdom	Western Infirmary, NHS Greater Glasgow and Clyde	Glasgow

Sponsors (2)

Lead Sponsor	Collaborator
NHS Greater Glasgow and Clyde	University of Glasgow

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adherence rate to stroke secondary preventative medication	Morisky Medication Adherence Scale (MMAS) - 8 items	3 months	No
Secondary	Effect of medication adherence on clinical outcomes	Number of participants reaching target blood pressure level	3 months	No
Secondary	Effect of medication adherence on clinical outcomes	Number of participants reaching target cholesterol level	3 months	No