Strategy to Improve Antiplatelet Therapy Adherence After Coronary Stent Implantation

NCT01689493 | Completed

• 1 other identifier: APHM 2010-A00933-36
• Study Type: interventional
• Target: 800
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the effectiveness of an adherence protocol intervention among stented patients to improve adherence to antiplatelet therapy (primary endpoint). Secondary endpoints will assess whether the intervention reduces cardiovascular events (ACS, stent thrombosis, re- hospitalization and coronary angiography, revascularization, all-cause mortality) and its cost-effectiveness.

Conditions

Coronary Artery Stent Thrombosis; Multiple Drug Use; Patient Compliance

Outcome Measures

Primary Outcomes (1)

• Adherence to antiplatelet therapy

  Investigators propose to assess the effectiveness of a multi-faceted patient-centered adherence intervention among patients following stent implantation to improve adherence to antiplatelet therapy (evaluated on biological effect of antiplatelet agent).

  one month

Secondary Outcomes (1)

• Clinical effect of the adherence intervention protocol

  one and six month

Study Arms (2)

usual care

NO INTERVENTION

usual care arm, without SMS reminder

patient education and daily SMS

ACTIVE COMPARATOR

Multifaceted patient centered intervention including : collaborative care, patient education , and daily SMS.

Behavioral: patient education and daily SMS

Interventions

patient education and daily SMS BEHAVIORAL

The proposed intervention will be based on several conceptual frameworks (Chronic Care Model and Medication Adherence Model) and adapt elements of prior successfully adherence interventions, including: collaborative care, patient education, tailoring of medication regimens, and daily mobile phone short message service (SMS).

patient education and daily SMS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- All patients admitted with acute coronary syndrome (ACS) or more stable condition undergoing angiocoronarography and implantation of one or more stent (BMS or DES).

You may not qualify if:

• age\< 18, inability to understand consent form
• irreversible, non-cardiac medical condition (e.g. metastatic cancer) likely to affect 6-month survival or ability to execute study protocol;
• lack of telephone/cell phone;
• no social insurance;
• inability to perform the one and six month hospital consultation.

Sponsors & Collaborators

• Hôpital de la Timone: lead

Study Sites (1)

CHU Timone hospital . Sc CARDIOLOGIE. Rue saint Pierre.

Marseille, 13005, France

Location

MeSH Terms

Conditions

Patient Compliance

Interventions

Patient Education as Topic

Condition Hierarchy (Ancestors)

Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Health Education; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• jacques quilici, MD

  AP-HM

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Staff Member

Study Record Dates

• First Submitted: August 16, 2012
• First Posted: September 21, 2012
• Study Start: May 1, 2011
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: September 21, 2012

Record last verified: 2012-09

Locations

FR (1)