A Nursing Intervention Program to Improve Therapeutic Adherence in Elderly People With Acute Myocardial Infarction

Myocardial Infarction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04662762
• Other study ID #: PR034/16
• Status: Completed
• Phase: N/A
• Start date: April 1, 2016
• Est. completion date: May 28, 2020

Study information

• Verified date: December 2020
• Source: Hospital Universitari de Bellvitge
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: May 28, 2020
• Est. primary completion date: February 28, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 75 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Infarction
• Medication Adherence
• Myocardial Infarction

Intervention

Other:
• Nursing intervention programme
educational information

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitari de Bellvitge

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with therapeutic adherence	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.	12 months after admission
Secondary	Rate of readmission,	Need for hospital readmission	During the 12 months after the admission
Secondary	Rate of visits to the emergency room	Need for emergency visits at hospital	During the 12 months after the admission
Secondary	Rate of mortality	Deaths of cardiac origin were those caused by myocardial infarction, sudden death or heart failure.	During the 12 months after the admission