StrokeNCT02336412
Short Message Service (SMS) Reminders for Stroke Secondary Preventative Medications
A study testing SMS reminder in people with Stroke and Ischemic Attack, Transient, run by NHS Greater Glasgow and Clyde at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Ischemic Attack, Transient
- What is being tested?
- SMS reminder
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2015to Oct 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- severe disability (modified Rankin Scale (mRS) ≥ 4)
- patients unable to consent
- patients with no facility to be reminded by SMS or voicemail message
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Western Infirmary, NHS Greater Glasgow and Clyde
Glasgow, G11 6NT
About this study
Official title: The Use of Short Message Service (SMS) as a Reminder for Continuation of Treatment With Secondary Preventative Medications After Stroke or TIA
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.
Read the 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
- Being tested
- SMS reminder
- Keywords
- Medication adherence
- Medical subject headings
- Stroke, Ischemic Attack, Transient, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SMS reminderOther
Daily SMS medication reminder
| Study group | Role | What they receive |
|---|---|---|
| SMS reminder | Experimental | Daily SMS medication reminder Receives: Other: SMS reminder |
| No SMS reminder | No intervention | No daily SMS medication reminder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence rate to stroke secondary preventative medication
Morisky Medication Adherence Scale (MMAS) - 8 items
Measured: 3 months
Secondary outcomes (2)
Effect of medication adherence on clinical outcomes
Number of participants reaching target blood pressure level
Measured: 3 months
Effect of medication adherence on clinical outcomes
Number of participants reaching target cholesterol level
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2015 (estimated)
- Study startJan 2015
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- NHS Greater Glasgow and Clyde
- Sponsor type
- University, hospital or other
- Collaborators
- University of Glasgow
- Responsible party
- Sponsor
- Investigators
- Jesse Dawson, BSc MBChB MD, Study director, University of Glasgow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02336412
- Sponsor's protocol ID
- GN14NE625
- Status last verified
- Jan 2016
- First submitted
- 8 Jan 2015
- Last updated
- 1 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Short Message Service (SMS) as a Reminder for Continuation of Treatment With Secondary Preventative Medications After Stroke or TIA
- ClinicalTrials.gov ID
- NCT02336412
- Acronym / sponsor ID
- GN14NE625
- Conditions
- Stroke, Ischemic Attack, Transient
- Keywords
- Medication adherence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- NHS Greater Glasgow and ClydeUniversity, hospital or other
- Collaborators
- University of Glasgow
- Study start
- Jan 2015
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 13 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SMS reminder | Experimental | Other: SMS reminderDaily SMS medication reminder |
| No SMS reminder | No intervention | –No daily SMS medication reminder |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- severe disability (modified Rankin Scale (mRS) ≥ 4)
- patients unable to consent
- patients with no facility to be reminded by SMS or voicemail message
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SMS reminderDaily SMS medication reminder | Other | SMS reminder |
Primary outcome
Adherence rate to stroke secondary preventative medication
Time frame: 3 months
Morisky Medication Adherence Scale (MMAS) - 8 items
2 secondary outcomes
Effect of medication adherence on clinical outcomes
Time frame: 3 months
Effect of medication adherence on clinical outcomes
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jesse Dawson, BSc MBChB MD study director
University of Glasgow
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SMS reminder in people with Stroke and Ischemic Attack, Transient, run by NHS Greater Glasgow and Clyde at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence rate to stroke secondary preventative medication (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2016.