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Clinical Trials/NCT04662762
NCT04662762
Completed
N/A

A Nursing Intervention Program Significantly Improves Therapeutic Adherence in Elderly People With Acute Myocardial Infarction: a Randomized Controlled Study

Hospital Universitari de Bellvitge0 sites160 target enrollmentApril 1, 2016

Overview

Phase
N/A
Intervention
Not specified
Conditions
Medication Adherence
Sponsor
Hospital Universitari de Bellvitge
Enrollment
160
Primary Endpoint
Number of patients with therapeutic adherence
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

The objective of this study was to assess the impact of a nursing intervention on therapeutic adherence in elderly patients after acute myocardial infarction compared to a control group

Detailed Description

A comprehensive geriatric assessment was performed during the first admission in all patients. Patients were randomly allocated to a nursing intervention group or a usual care group. In patients from the intervention group, a nursing intervention programme was performed 3 months after admission, based on education, support and patient monitoring to improve therapeutic adherence and a 6 month phone call. The main outcome measured was therapeutic adherence at 12 months, as defined by a combination of adherence measurement tools (Morisky-Green and Hayness-Sacket scales, attendance at visits and withdrawal of medication from the pharmacy). Therapeutic adherence was assessed by nurses blinded to the assignment group.

Registry
clinicaltrials.gov
Start Date
April 1, 2016
End Date
May 28, 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Hospital Universitari de Bellvitge
Responsible Party
Principal Investigator
Principal Investigator

Elena Calvo

Principal investigator

Hospital Universitari de Bellvitge

Eligibility Criteria

Inclusion Criteria

  • Patients with STEMI aged 75 years or older underwent primary percutaneous coronary intervention (PCI)

Exclusion Criteria

  • Patients who refused to participate in the study
  • Patients unable to perform geriatric assessment.
  • Patients admitted to nursing homes or social health centres.

Outcomes

Primary Outcomes

Number of patients with therapeutic adherence

Time Frame: 12 months after admission

The main outcome measured was therapeutic adherence 12 months after admission. The definition of adherence was a single measure taking into account 4 different methods (see below). Patients were considered adherent when the 4 criteria were present (called "global adherence").Measurement unit was: Number of patients with therapeutic adherence * Morisky-Green Scale (MGLS): consists of a series of four questions with dichotomous answers (yes/no) that affect the patient's behaviour regarding compliance. * Self-reported compliance communication: Haynes-Sackett method: involves asking the patient one question. If the answer is affirmative, is considered adherent. * Records of dispensations in the pharmacy: Patients who withdrew all medications during the year were considered adherent. * Attendance at scheduled appointments: It is recorded if the patient has missed any of the control visits by both the doctor and the nurse during the first year.

Secondary Outcomes

  • Rate of readmission,(During the 12 months after the admission)
  • Rate of visits to the emergency room(During the 12 months after the admission)
  • Rate of mortality(During the 12 months after the admission)

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