Tailored Intervention to Improve Patient Adherence to Secondary Stroke Prevention Medication

This study has been completed.
Sponsor:
Collaborator:
University of Southern Denmark
Information provided by (Responsible Party):
Ulla Hedegaard, Odense University Hospital
ClinicalTrials.gov Identifier:
NCT01684176
First received: September 10, 2012
Last updated: June 20, 2014
Last verified: June 2014

September 10, 2012
June 20, 2014
August 2012
February 2013   (final data collection date for primary outcome measure)
  • Medication Adherence to antiplatelets, anticoagulants and statins measured by proportion of days covered (PDC). [ Time Frame: One year from inclusion ] [ Designated as safety issue: No ]
  • For antiplatelets, anticoagulants and statins: Percent of patients that are at least 80% adherent (PDC>0.8) [ Time Frame: 1 year from inclusion ] [ Designated as safety issue: No ]
Medication adherence to antiplatelets, anticoagulants and lipid-lowering therapies [ Time Frame: One year from inclusion ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01684176 on ClinicalTrials.gov Archive Site
  • Medication Adherence to antihypertensives measured by proportion of days covered (PDC) [ Time Frame: One year from inclusion ] [ Designated as safety issue: No ]
  • Percent of patients that are at least 80% adherent (PDC>0.8) to antihypertensives [ Time Frame: One year from inclusion ] [ Designated as safety issue: No ]
  • Non-persistence with thromboprophylactic agents ( antiplatelets, anticoagulants, statins and antihypertensives) measured by percent of patients that are not supplied with medication for more than 3 continuous months [ Time Frame: One year from inclusion ] [ Designated as safety issue: No ]
  • Accept rate for thromboprophylactic agents measured by percent of patients starting treatment within 0-90 days after discharge. [ Time Frame: 3 months from discharge ] [ Designated as safety issue: No ]
  • Composite endpoint: stroke, myocardial infarction or cardiovascular death [ Time Frame: One year from inclusion ] [ Designated as safety issue: No ]
  • Medication adherence to antihypertensive therapies [ Time Frame: One year from inclusion ] [ Designated as safety issue: No ]
  • Stroke leading to hospital admission [ Time Frame: One year from inclusion ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Tailored Intervention to Improve Patient Adherence to Secondary Stroke Prevention Medication
Pharmacist Intervention Programme to Improve Medication Adherence in Stroke Patients

Patient suffering a Transient Ischemic Attack (TIA) or stroke are subsequently at high risk of a new stroke, however, poor adherence to secondary prevention medications occurs frequently within this patient group. The purpose of this study is to evaluate whether a complex tailored pharmacist intervention will lead to increased adherence to secondary stroke prevention medications and less new stroke events when compared to a usual care group. Interventions focus on motivational interviewing, medication review and telephone follow up.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
  • Stroke
  • Transient Ischemic Attack
  • Behavioral: Complex tailored intervention
  • Behavioral: Usual care
  • Experimental: Complex tailored intervention

    The intervention consists of 3 elements:

    1. Medication review with recommendations focused on antithrombotics and adherence to guidelines and patient´s adherence to medications.
    2. Discharge consultation with an pharmacist using motivational interviewing techniques.
    3. Follow-up telephone calls one week, two months and six months after discharge.
    Interventions:
    • Behavioral: Complex tailored intervention
    • Behavioral: Usual care
  • Placebo Comparator: Usual care
    Usual care
    Intervention: Behavioral: Usual care
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
211
June 2014
February 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age: 18 years or older
  • Patient admitted or receiving ambulatory treatment for an acute transient ischemic attack or ischemic stroke which has occurred within the previous 30 days.
  • The patient or a carer usually dispenses the patient's medications
  • Written consent

Exclusion Criteria:

  • Cognitive or physical impairment that would preclude comprehension of a conversation
  • Terminal illness
  • Lives in a care home or an institution
  • Receives dose dispensed medicine from a pharmacy
  • Medicine is dispensed by a nurse in the patient's home
  • Correctional mental health patients
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT01684176
AKF-381
No
Ulla Hedegaard, Odense University Hospital
Odense University Hospital
University of Southern Denmark
Not Provided
Odense University Hospital
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP