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

NCT ID: NCT02336412

Last Updated: 2016-02-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2015-10-31

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.

Conditions

Stroke; Ischemic Attack, Transient

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

SMS reminder

Daily SMS medication reminder

Group Type: EXPERIMENTAL

SMS reminder

Intervention Type: OTHER

Daily SMS medication reminder

No SMS reminder

No daily SMS medication reminder

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

SMS reminder

Daily SMS medication reminder

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Glasgow

OTHER

Sponsor Role: collaborator

NHS Greater Glasgow and Clyde

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jesse Dawson, BSc MBChB MD

Role: STUDY_DIRECTOR

University of Glasgow

Locations

Western Infirmary, NHS Greater Glasgow and Clyde

Glasgow, , United Kingdom

Countries

United Kingdom

Other Identifiers

GN14NE625

Identifier Type: -

Identifier Source: org_study_id