NCT02336412

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable stroke

Timeline
Completed

Started Jan 2015

Shorter than P25 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

January 8, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 13, 2015

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

February 1, 2016

Status Verified

January 1, 2016

Enrollment Period

9 months

First QC Date

January 8, 2015

Last Update Submit

January 29, 2016

Conditions

Keywords

Medication adherence

Outcome Measures

Primary Outcomes (1)

  • Adherence rate to stroke secondary preventative medication

    Morisky Medication Adherence Scale (MMAS) - 8 items

    3 months

Secondary Outcomes (2)

  • Effect of medication adherence on clinical outcomes

    3 months

  • Effect of medication adherence on clinical outcomes

    3 months

Study Arms (2)

SMS reminder

EXPERIMENTAL

Daily SMS medication reminder

Other: SMS reminder

No SMS reminder

NO INTERVENTION

No daily SMS medication reminder

Interventions

Daily SMS medication reminder

SMS reminder

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • severe disability (modified Rankin Scale (mRS) ≥ 4)
  • patients unable to consent
  • patients with no facility to be reminded by SMS or voicemail message

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Western Infirmary, NHS Greater Glasgow and Clyde

Glasgow, G11 6NT, United Kingdom

Location

MeSH Terms

Conditions

StrokeIschemic Attack, TransientMedication Adherence

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesBrain IschemiaPatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Jesse Dawson, BSc MBChB MD

    University of Glasgow

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 8, 2015

First Posted

January 13, 2015

Study Start

January 1, 2015

Primary Completion

October 1, 2015

Study Completion

October 1, 2015

Last Updated

February 1, 2016

Record last verified: 2016-01

Locations